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Trial record 83 of 1404 for:    Peru

A Study of ARRY-438162 in Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00650767
Recruitment Status : Completed
First Posted : April 2, 2008
Results First Posted : November 7, 2016
Last Update Posted : November 7, 2016
Sponsor:
Information provided by (Responsible Party):
Array BioPharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: ARRY-438162, MEK inhibitor; oral
Drug: Placebo; oral
Enrollment 201
Recruitment Details

The ARRAY-162-201 study began recruitment on 04-April-2008 (First Patient First Visit) and concluded on 07-July-2009 (Last Patient Last Visit).

This study was conducted at 36 sites in the United States, Europe and South America.

Pre-assignment Details Participant Flow and Baseline Demographics represent the Intent-to-Treat (ITT) population, which is all patients who were randomized to a treatment group.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo. Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo. Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Period Title: Overall Study
Started 51 50 50 50
Completed 46 41 36 39
Not Completed 5 9 14 11
Reason Not Completed
Adverse Event             0             3             10             8
Death             1             0             0             0
Withdrawal by Subject             2             4             3             3
Lost to Follow-up             1             1             1             0
Other             1             1             0             0
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid Total
Hide Arm/Group Description

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo. Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo. Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo. Total of all reporting groups
Overall Number of Baseline Participants 51 50 50 50 201
Hide Baseline Analysis Population Description
Baseline Demographics represent the Intent-to-Treat (ITT) population, which is all patients who were randomized to a treatment group.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 50 participants 50 participants 50 participants 201 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
43
  84.3%
45
  90.0%
41
  82.0%
45
  90.0%
174
  86.6%
>=65 years
8
  15.7%
5
  10.0%
9
  18.0%
5
  10.0%
27
  13.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 50 participants 50 participants 50 participants 201 participants
52.0  (12.67) 51.6  (11.98) 54.8  (11.88) 51.4  (11.74) 52.6  (11.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 50 participants 50 participants 50 participants 201 participants
Female
43
  84.3%
42
  84.0%
43
  86.0%
44
  88.0%
172
  85.6%
Male
8
  15.7%
8
  16.0%
7
  14.0%
6
  12.0%
29
  14.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 51 participants 50 participants 50 participants 50 participants 201 participants
Hispanic Or Latino 24 21 23 24 92
Not Hispanic Or Latino 27 29 27 26 109
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 51 participants 50 participants 50 participants 50 participants 201 participants
74.1  (18.26) 68.2  (14.17) 72.1  (17.95) 67.2  (13.86) 69.2  (15.49)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 51 participants 50 participants 50 participants 50 participants 201 participants
160.2  (8.63) 159.5  (8.11) 158.6  (9.22) 158.0  (7.44) 158.7  (8.25)
Smoking Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 51 participants 50 participants 50 participants 50 participants 201 participants
Current Smoker 6 10 9 12 37
Never Smoked 38 39 36 36 149
Past Smoker 7 1 5 2 15
1.Primary Outcome
Title American College of Rheumatology 20% (ACR20) Response Rate at Week 12
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Intent-to-Treat (ITT) population, which is all patients who were randomized to a treatment group.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 51 50 50 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
45.1
(31.1 to 59.7)
58.0
(43.2 to 71.8)
60.0
(45.2 to 73.6)
54.0
(39.3 to 68.2)
2.Secondary Outcome
Title American College of Rheumatology 20% (ACR20) Response Rate at Week 1
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.

Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.2
(4.6 to 24.8)
20.8
(10.5 to 35.0)
32.7
(19.9 to 47.5)
46.0
(31.8 to 60.7)
3.Secondary Outcome
Title American College of Rheumatology 20% (ACR20) Response Rate at Week 2
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.

Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
18.4
(8.8 to 32.0)
31.3
(18.7 to 46.3)
32.7
(19.9 to 47.5)
50.0
(35.5 to 64.5)
4.Secondary Outcome
Title American College of Rheumatology 20% (ACR20) Response Rate at Week 4
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.

Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
44.9
(30.7 to 59.8)
54.2
(39.2 to 68.6)
44.9
(30.7 to 59.8)
58.0
(43.2 to 71.8)
5.Secondary Outcome
Title American College of Rheumatology 20% (ACR20) Response Rate at Week 8
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.

Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
49.0
(34.4 to 63.7)
56.3
(41.2 to 70.5)
53.1
(38.3 to 67.5)
48.0
(33.7 to 62.6)
6.Secondary Outcome
Title American College of Rheumatology 20% (ACR20) Response Rate at Week 16 (Follow-up)
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.

Time Frame Week 16 (Follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
40.8
(27.0 to 55.8)
52.1
(37.2 to 66.7)
49.0
(34.4 to 63.7)
46.0
(31.8 to 60.7)
7.Secondary Outcome
Title American College of Rheumatology 50% (ACR50) Response Rate at Week 1
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.

Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2.0
(0.1 to 10.9)
6.3
(1.3 to 17.2)
2.0
(0.1 to 10.9)
4.0
(0.5 to 13.7)
8.Secondary Outcome
Title American College of Rheumatology 50% (ACR50) Response Rate at Week 2
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.

Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6.1
(1.3 to 16.9)
8.3
(2.3 to 20.0)
10.2
(3.4 to 22.2)
16.0
(7.2 to 29.1)
9.Secondary Outcome
Title American College of Rheumatology 50% (ACR50) Response Rate at Week 4
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.

Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
10.2
(3.4 to 22.2)
8.3
(2.3 to 20.0)
12.2
(4.6 to 24.8)
16.0
(7.2 to 29.1)
10.Secondary Outcome
Title American College of Rheumatology 50% (ACR50) Response Rate at Week 8
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.

Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
16.3
(7.3 to 29.7)
27.1
(15.3 to 41.8)
16.3
(7.3 to 29.7)
22.0
(11.5 to 36.0)
11.Secondary Outcome
Title American College of Rheumatology 50% (ACR50) Response Rate at Week 12
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24.5
(13.3 to 38.9)
25.0
(13.6 to 39.6)
22.4
(11.8 to 36.6)
22.0
(11.5 to 36.0)
12.Secondary Outcome
Title American College of Rheumatology 50% (ACR50) Response Rate at Week 16 (Follow-up)
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.

Time Frame Week 16 (Follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
16.3
(7.3 to 29.7)
27.1
(15.3 to 41.8)
30.6
(18.3 to 45.4)
14.0
(5.8 to 26.7)
13.Secondary Outcome
Title American College of Rheumatology 70% (ACR70) Response Rate at Week 1
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.

Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 7.3)
2.1
(0.1 to 11.1)
0.0
(0.0 to 7.3)
2.0
(0.1 to 10.6)
14.Secondary Outcome
Title American College of Rheumatology 70% (ACR70) Response Rate at Week 2
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.

Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2.0
(0.1 to 10.9)
4.2
(0.5 to 14.3)
0.0
(0.0 to 7.3)
2.0
(0.1 to 10.6)
15.Secondary Outcome
Title American College of Rheumatology 70% (ACR70) Response Rate at Week 4
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.

Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 7.3)
4.2
(0.5 to 14.3)
2.0
(0.1 to 10.9)
2.0
(0.1 to 10.6)
16.Secondary Outcome
Title American College of Rheumatology 70% (ACR70) Response Rate at Week 8
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.

Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
4.1
(0.5 to 14.0)
4.2
(0.5 to 14.3)
4.1
(0.5 to 14.0)
4.0
(0.5 to 13.7)
17.Secondary Outcome
Title American College of Rheumatology 70% (ACR70) Response Rate at Week 12
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.2
(2.3 to 19.6)
12.5
(4.7 to 25.2)
8.2
(2.3 to 19.6)
6.0
(1.3 to 16.5)
18.Secondary Outcome
Title American College of Rheumatology 70% (ACR70) Response Rate at Week 16 (Follow-up)
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.

Time Frame Week 16 (Follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6.1
(1.3 to 16.9)
6.3
(1.3 to 17.2)
6.1
(1.3 to 16.9)
10.0
(3.3 to 21.8)
19.Secondary Outcome
Title American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
16.8  (6.44) 14.8  (5.49) 15.0  (5.98) 17.0  (5.95)
20.Secondary Outcome
Title American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.

Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
14.9  (6.81) 11.6  (6.24) 11.6  (6.46) 11.1  (5.84)
21.Secondary Outcome
Title American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.

Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.3  (6.50) 10.2  (6.49) 11.4  (6.31) 10.0  (6.00)
22.Secondary Outcome
Title American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.

Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.6  (7.46) 9.0  (6.31) 9.6  (6.84) 8.9  (6.02)
23.Secondary Outcome
Title American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.

Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.9  (7.21) 8.1  (7.04) 8.3  (6.27) 7.5  (5.50)
24.Secondary Outcome
Title American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.4  (7.09) 7.1  (7.05) 7.8  (7.50) 7.8  (6.57)
25.Secondary Outcome
Title American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.

Time Frame Week 16 (Follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.1  (7.13) 7.4  (7.15) 9.2  (7.37) 8.9  (6.97)
26.Secondary Outcome
Title American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.7  (4.45) 11.4  (4.10) 12.3  (4.96) 13.0  (5.31)
27.Secondary Outcome
Title American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.

Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.3  (5.72) 8.0  (4.65) 9.6  (4.80) 9.1  (4.96)
28.Secondary Outcome
Title American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.

Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.4  (5.45) 6.9  (4.98) 8.7  (4.58) 7.3  (5.76)
29.Secondary Outcome
Title American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.

Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.9  (5.14) 5.8  (4.00) 7.0  (4.70) 7.1  (6.03)
30.Secondary Outcome
Title American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.

Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.7  (5.25) 5.5  (4.64) 6.9  (5.51) 6.5  (5.96)
31.Secondary Outcome
Title American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.3  (5.67) 5.3  (4.86) 6.3  (5.54) 6.3  (5.92)
32.Secondary Outcome
Title American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
Hide Description

The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.

The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.

Time Frame Week 16 (Follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.5  (5.69) 4.8  (4.63) 6.9  (5.72) 6.5  (5.96)
33.Secondary Outcome
Title Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
Hide Description The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
68.7  (18.94) 61.9  (20.32) 62.4  (21.42) 63.0  (18.95)
34.Secondary Outcome
Title Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
Hide Description The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
61.5  (25.16) 47.9  (22.94) 48.4  (22.53) 42.6  (20.62)
35.Secondary Outcome
Title Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
Hide Description The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
56.5  (23.89) 46.4  (22.61) 47.7  (25.20) 39.6  (22.60)
36.Secondary Outcome
Title Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
Hide Description The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
50.3  (23.78) 44.5  (25.23) 44.8  (24.48) 39.0  (19.75)
37.Secondary Outcome
Title Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
Hide Description The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
49.7  (26.53) 46.1  (24.97) 46.4  (25.42) 41.5  (23.39)
38.Secondary Outcome
Title Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
Hide Description The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
45.9  (28.15) 43.9  (27.39) 43.8  (26.93) 42.3  (21.46)
39.Secondary Outcome
Title Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
Hide Description The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Time Frame Week 16 (Follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
50.7  (27.93) 47.1  (26.32) 48.7  (27.09) 48.5  (23.93)
40.Secondary Outcome
Title Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
Hide Description

The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).

Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
65.2  (20.59) 60.1  (20.80) 63.4  (19.25) 55.4  (20.34)
41.Secondary Outcome
Title Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
Hide Description

The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).

Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).

Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
57.2  (24.52) 45.8  (22.65) 48.3  (22.82) 42.3  (20.66)
42.Secondary Outcome
Title Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
Hide Description

The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).

Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).

Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
57.6  (21.74) 46.3  (23.62) 49.4  (22.61) 40.3  (22.33)
43.Secondary Outcome
Title Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
Hide Description

The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).

Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).

Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
50.5  (23.96) 43.5  (24.57) 46.7  (23.70) 40.0  (20.55)
44.Secondary Outcome
Title Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
Hide Description

The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).

Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).

Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
48.7  (26.34) 42.9  (24.69) 45.5  (22.95) 41.8  (21.60)
45.Secondary Outcome
Title Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
Hide Description

The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).

Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
45.5  (26.71) 40.6  (23.24) 43.4  (24.82) 41.1  (19.75)
46.Secondary Outcome
Title Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
Hide Description

The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).

Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).

Time Frame Week 16 (Follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
46.9  (26.69) 42.6  (22.99) 47.5  (27.18) 44.8  (21.95)
47.Secondary Outcome
Title Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
Hide Description

The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).

The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
61.2  (16.71) 66.0  (13.80) 61.0  (15.23) 59.7  (13.26)
48.Secondary Outcome
Title Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
Hide Description

The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).

The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).

Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
53.7  (17.80) 47.7  (19.55) 46.8  (18.21) 41.1  (17.14)
49.Secondary Outcome
Title Physician’s Global Assessment of Arthritis - Visual Analog Score (VAS)
Hide Description

The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).

The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).

Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
47.9  (18.61) 41.8  (18.67) 43.9  (19.45) 35.3  (18.27)
50.Secondary Outcome
Title Physician’s Global Assessment of Arthritis - Visual Analog Score (VAS)
Hide Description

The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).

The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).

Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
42.0  (19.83) 39.9  (21.55) 38.8  (18.40) 34.7  (19.20)
51.Secondary Outcome
Title Physician’s Global Assessment of Arthritis - Visual Analog Score (VAS)
Hide Description

The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).

The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).

Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
39.5  (20.96) 37.0  (21.21) 36.8  (18.88) 32.7  (22.50)
52.Secondary Outcome
Title Physician’s Global Assessment of Arthritis - Visual Analog Score (VAS)
Hide Description

The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).

The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
35.8  (21.96) 34.9  (22.19) 35.7  (21.06) 31.2  (21.64)
53.Secondary Outcome
Title Physician’s Global Assessment of Arthritis - Visual Analog Score (VAS)
Hide Description

The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).

The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).

Time Frame Week 16 (Follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
36.7  (20.86) 33.2  (19.22) 40.7  (21.92) 34.6  (20.37)
54.Secondary Outcome
Title Health Assessment Questionnaire – Disability Index (HAQ-DI)
Hide Description

The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.

The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.6  (0.59) 1.5  (0.52) 1.5  (0.53) 1.5  (0.65)
55.Secondary Outcome
Title Health Assessment Questionnaire – Disability Index (HAQ-DI)
Hide Description

The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.

The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.

Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.6  (0.66) 1.3  (0.58) 1.3  (0.63) 1.2  (0.68)
56.Secondary Outcome
Title Health Assessment Questionnaire – Disability Index (HAQ-DI)
Hide Description

The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.

The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.

Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.5  (0.59) 1.3  (0.59) 1.3  (0.62) 1.0  (0.62)
57.Secondary Outcome
Title Health Assessment Questionnaire – Disability Index (HAQ-DI)
Hide Description

The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.

The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.

Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.4  (0.63) 1.3  (0.68) 1.2  (0.63) 1.1  (0.60)
58.Secondary Outcome
Title Health Assessment Questionnaire – Disability Index (HAQ-DI)
Hide Description

The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.

The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.

Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.4  (0.70) 1.2  (0.72) 1.2  (0.62) 1.1  (0.66)
59.Secondary Outcome
Title Health Assessment Questionnaire – Disability Index (HAQ-DI)
Hide Description

The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.

The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.3  (0.72) 1.1  (0.66) 1.1  (0.68) 1.1  (0.64)
60.Secondary Outcome
Title Health Assessment Questionnaire – Disability Index (HAQ-DI)
Hide Description

The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.

The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.

Time Frame Week 16 (Follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.3  (0.76) 1.2  (0.70) 1.2  (0.64) 1.1  (0.62)
61.Secondary Outcome
Title C-Reactive Protein (CRP) at Baseline
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: mg/dL
1.9  (1.42) 1.8  (1.18) 2.4  (1.86) 2.4  (1.95)
62.Secondary Outcome
Title C-Reactive Protein (CRP) at Week 1
Hide Description [Not Specified]
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: mg/dL
2.2  (2.20) 1.9  (2.85) 2.0  (2.17) 1.4  (1.58)
63.Secondary Outcome
Title C-Reactive Protein (CRP) at Week 2
Hide Description [Not Specified]
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: mg/dL
1.9  (1.70) 1.9  (1.70) 2.5  (2.36) 2.1  (2.07)
64.Secondary Outcome
Title C-Reactive Protein (CRP) at Week 4
Hide Description [Not Specified]
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: mg/dL
1.9  (1.55) 2.2  (3.18) 2.6  (3.02) 2.2  (2.25)
65.Secondary Outcome
Title C-Reactive Protein (CRP) at Week 8
Hide Description [Not Specified]
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: mg/dL
2.1  (2.24) 2.0  (1.88) 2.6  (2.39) 3.0  (3.34)
66.Secondary Outcome
Title C-Reactive Protein (CRP) at Week 12
Hide Description [Not Specified]
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: mg/dL
2.1  (2.14) 1.8  (1.87) 2.5  (2.51) 2.9  (2.91)
67.Secondary Outcome
Title C-Reactive Protein (CRP) at Week 16 (Follow-up)
Hide Description [Not Specified]
Time Frame Week 16 (Follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: mg/dL
1.9  (1.79) 2.3  (3.33) 2.0  (1.68) 2.3  (2.50)
68.Secondary Outcome
Title Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
Hide Description The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.1  (0.77) 5.9  (0.61) 6.0  (0.79) 6.1  (0.77)
69.Secondary Outcome
Title Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
Hide Description The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.8  (1.01) 5.0  (1.03) 5.2  (1.08) 5.0  (0.97)
70.Secondary Outcome
Title Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
Hide Description The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.4  (0.94) 4.9  (1.17) 5.3  (1.06) 4.8  (1.14)
71.Secondary Outcome
Title Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
Hide Description The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.2  (1.13) 4.7  (1.28) 5.0  (1.19) 4.7  (1.24)
72.Secondary Outcome
Title Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
Hide Description The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.9  (1.23) 4.6  (1.34) 4.8  (1.15) 4.6  (1.40)
73.Secondary Outcome
Title Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
Hide Description The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.8  (1.26) 4.3  (1.39) 4.6  (1.42) 4.6  (1.43)
74.Secondary Outcome
Title Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
Hide Description The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Time Frame Week 16 (Follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.8  (1.20) 4.4  (1.27) 4.8  (1.42) 4.7  (1.42)
75.Secondary Outcome
Title SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
Hide Description

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.

The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
29.8  (8.45) 31.4  (7.78) 31.6  (8.29) 33.8  (9.58)
76.Secondary Outcome
Title SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
Hide Description

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.

The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
33.8  (9.05) 36.0  (9.10) 34.3  (9.73) 38.7  (8.74)
77.Secondary Outcome
Title SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
Hide Description

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.

The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
34.2  (9.86) 37.2  (9.25) 34.9  (10.32) 38.2  (10.36)
78.Secondary Outcome
Title SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
Hide Description

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.

The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
34.5  (11.08) 37.2  (9.83) 36.4  (10.91) 38.8  (9.63)
79.Secondary Outcome
Title SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
Hide Description

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.

The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time Frame Week 16 (Follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
35.4  (11.10) 36.0  (9.75) 35.5  (8.99) 37.8  (9.84)
80.Secondary Outcome
Title SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
Hide Description

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.

The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
30.3  (8.47) 32.7  (8.07) 32.3  (7.68) 32.9  (8.49)
81.Secondary Outcome
Title SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
Hide Description

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.

The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.
Arm/Group Title Placebo ARRY-438162: 10 mg Bid ARRY-438162: 40 mg qd ARRY-438162: 20 mg Bid
Hide Arm/Group Description:

Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.

Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
Overall Number of Participants Analyzed 49 48 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
34.8  (8.20) 37.1  (9.69) 37.1  (7.89) 38.6  (7.88)
82.Secondary Outcome
Title SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
Hide Description

The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.

The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.

Time Frame Week 8