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Trial record 52 of 62 for:    Baricitinib

A Study in Participants With Moderate to Severe Rheumatoid Arthritis (RA-BEGIN)

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: NCT01711359
Recruitment Status : Completed
First Posted : October 22, 2012
Results First Posted : August 15, 2017
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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: Baricitinib
Drug: Methotrexate
Drug: Baricitinib Placebo
Drug: MTX Placebo
Drug: Folic Acid
Enrollment 588
Recruitment Details  
Pre-assignment Details

Participants who did not respond (nonresponders) to study drug were eligible for rescue treatment beginning at Week 24.

Nonresponders were defined as lack of improvement of at least 20% in both tender joint count and swollen joint count.

Arm/Group Title Methotrexate Baricitinib Baricitinib + MTX
Hide Arm/Group Description Methotrexate (MTX) administered orally once weekly with dose ranging from 10 to 20 milligram (mg) per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly. Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly. Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Period Title: Treatment Period
Started 213 160 215
Received at Least One Dose of Study Drug 210 159 215
Rescued 26 7 6
Completed 161 136 173
Not Completed 52 24 42
Reason Not Completed
Withdrawal by Subject             18             7             13
Lack of Efficacy             13             2             2
Adverse Event             8             10             24
Physician Decision             4             3             2
Death             3             0             0
Entry Criteria Not Met             1             0             0
Sponsor Decision             1             0             0
Lost to Follow-up             1             1             1
Randomized, Not Treated             3             1             0
Period Title: Follow Up
Started 25 [1] 15 [1] 28 [2]
Completed 0 0 0
Not Completed 25 15 28
[1]
Participants from treatment who entered the post-treatment follow-up period.
[2]
Participants from treatment and rescue who entered the post-treatment follow-up period.
Arm/Group Title Methotrexate Baricitinib Baricitinib + MTX Total
Hide Arm/Group Description Methotrexate (MTX) administered orally once weekly with dose ranging from 10 to 20 milligram (mg) per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly. Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly. Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly. Total of all reporting groups
Overall Number of Baseline Participants 210 159 215 584
Hide Baseline Analysis Population Description
Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 210 participants 159 participants 215 participants 584 participants
50.5  (13.4) 50.9  (13.0) 48.5  (13.5) 49.9  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants 159 participants 215 participants 584 participants
Female
148
  70.5%
121
  76.1%
156
  72.6%
425
  72.8%
Male
62
  29.5%
38
  23.9%
59
  27.4%
159
  27.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants 159 participants 215 participants 584 participants
American Indian or Alaska Native
11
   5.2%
10
   6.3%
20
   9.3%
41
   7.0%
Asian
60
  28.6%
44
  27.7%
61
  28.4%
165
  28.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
   4.8%
5
   3.1%
10
   4.7%
25
   4.3%
White
128
  61.0%
98
  61.6%
123
  57.2%
349
  59.8%
More than one race
1
   0.5%
2
   1.3%
1
   0.5%
4
   0.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants 159 participants 215 participants 584 participants
Argentina
41
  19.5%
29
  18.2%
33
  15.3%
103
  17.6%
Austria
1
   0.5%
1
   0.6%
1
   0.5%
3
   0.5%
Belgium
6
   2.9%
10
   6.3%
11
   5.1%
27
   4.6%
Brazil
8
   3.8%
3
   1.9%
9
   4.2%
20
   3.4%
Canada
5
   2.4%
5
   3.1%
7
   3.3%
17
   2.9%
Germany
5
   2.4%
5
   3.1%
4
   1.9%
14
   2.4%
Greece
0
   0.0%
0
   0.0%
1
   0.5%
1
   0.2%
India
18
   8.6%
12
   7.5%
17
   7.9%
47
   8.0%
Italy
8
   3.8%
2
   1.3%
4
   1.9%
14
   2.4%
Japan
36
  17.1%
29
  18.2%
39
  18.1%
104
  17.8%
Mexico
12
   5.7%
14
   8.8%
20
   9.3%
46
   7.9%
Portugal
1
   0.5%
0
   0.0%
2
   0.9%
3
   0.5%
Russian Federation
11
   5.2%
13
   8.2%
12
   5.6%
36
   6.2%
South Africa
7
   3.3%
4
   2.5%
9
   4.2%
20
   3.4%
Korea, Republic of
4
   1.9%
1
   0.6%
2
   0.9%
7
   1.2%
Sweden
3
   1.4%
0
   0.0%
1
   0.5%
4
   0.7%
United Kingdom
7
   3.3%
3
   1.9%
4
   1.9%
14
   2.4%
United States
37
  17.6%
28
  17.6%
39
  18.1%
104
  17.8%
Duration of Rheumatoid Arthritis  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 210 participants 159 participants 215 participants 584 participants
0.2
(0.1 to 0.6)
0.2
(0.1 to 1.1)
0.2
(0.1 to 1.0)
0.2
(0.1 to 0.8)
Tender Joint Count of 68 evaluable joints  
Mean (Standard Deviation)
Unit of measure:  Number of joints
Number Analyzed 210 participants 159 participants 215 participants 584 participants
26.5  (14.8) 26.4  (14.1) 27.7  (14.5) 26.9  (14.5)
Swollen Joint Count of 66 evaluable joints  
Mean (Standard Deviation)
Unit of measure:  Number of joints
Number Analyzed 210 participants 159 participants 215 participants 584 participants
16.4  (10.6) 16.1  (9.2) 16.3  (9.5) 16.3  (9.8)
High sensitivity C-reactive protein  
Mean (Standard Deviation)
Unit of measure:  Milligrams per liter (mg/L)
Number Analyzed 210 participants 159 participants 215 participants 584 participants
22.34  (21.78) 23.75  (26.24) 24.27  (29.42) 23.44  (25.98)
1.Primary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)
Hide Description ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "ACR20 Responder" is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using nonresponder imputation (NRI).
Arm/Group Title Methotrexate Baricitinib Baricitinib + MTX
Hide Arm/Group Description:
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Overall Number of Participants Analyzed 210 159 215
Measure Type: Number
Unit of Measure: Percent of participants
61.9 76.7 78.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methotrexate, Baricitinib
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments Noninferiority is concluded if the lower bound of the 95% CI for the difference in response rate is >-12%
Method of Estimation Estimation Parameter Newcombe-Wilson method
Estimated Value 14.8
Confidence Interval (2-Sided) 95%
5.5 to 24.1
Estimation Comments Estimation Parameter: Newcombe-Wilson method without continuity correction for difference in the response rate (Baricitinib minus Methotrexate).
2.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)
Hide Description ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "ACR20 Responder" is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using nonresponder imputation (NRI).
Arm/Group Title Methotrexate Baricitinib Baricitinib + MTX
Hide Arm/Group Description:
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Overall Number of Participants Analyzed 210 159 215
Measure Type: Number
Unit of Measure: Percent of participants
55.7 73.0 72.6
3.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Hide Description HAQ-DI assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area are averaged to calculate the HAQ-DI score, which ranges from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicates an improvement in the participant's condition.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified baseline observation carried forward (mBOCF).
Arm/Group Title Methotrexate Baricitinib Baricitinib + MTX
Hide Arm/Group Description:
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Overall Number of Participants Analyzed 210 159 215
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.73  (0.71) -1.01  (0.74) -0.92  (0.74)
4.Secondary Outcome
Title Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)
Hide Description Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using the following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.
Arm/Group Title Methotrexate Baricitinib Baricitinib + MTX
Hide Arm/Group Description:
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Overall Number of Participants Analyzed 210 159 215
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.01  (1.51) -2.74  (1.39) -2.82  (1.58)
5.Secondary Outcome
Title Change From Baseline in the Modified Total Sharp Score (mTSS)
Hide Description

X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS (van der Heijde 2000). This methodology quantified the extent of bone erosions and joint space narrowing for 44 and 42 joints, with higher scores representing greater damage.

The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448.

Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessments. Missing values due to discontinuation of study, rescue, or missing data were imputed using linear extrapolation (LE).
Arm/Group Title Methotrexate Baricitinib Baricitinib + MTX
Hide Arm/Group Description:
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Overall Number of Participants Analyzed 191 152 198
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.64  (1.81) 0.43  (1.18) 0.32  (1.14)
6.Secondary Outcome
Title Percentage of Participants Who Achieved a Simplified Disease Activity Index (SDAI) Score ≤3.3
Hide Description SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Arm/Group Title Methotrexate Baricitinib Baricitinib + MTX
Hide Arm/Group Description:
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Overall Number of Participants Analyzed 210 159 215
Measure Type: Number
Unit of Measure: percentage of participants
10.5 22.0 22.8
7.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Hide Description ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. "ACR50 Responder" is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders.
Time Frame Week 12, Week 24, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Arm/Group Title Methotrexate Baricitinib Baricitinib + MTX
Hide Arm/Group Description:
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Overall Number of Participants Analyzed 210 159 215
Measure Type: Number
Unit of Measure: Percent of participants
Week 12 32.9 54.7 60.0
Week 24 43.3 59.7 63.3
Week 52 37.6 57.2 61.9
8.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Hide Description ACR70 Responder Index is composite of clinical, laboratory, and functional measures in RA. "ACR70 Responder" is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinued study or drug or were rescued before analysis timepoint were deemed non-responders.
Time Frame Week 12, Week 24, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Arm/Group Title Methotrexate Baricitinib Baricitinib + MTX
Hide Arm/Group Description:
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Overall Number of Participants Analyzed 210 159 215
Measure Type: Number
Unit of Measure: Percent of participants
Week 12 15.7 30.8 33.5
Week 24 21.4 42.1 39.5
Week 52 25.2 42.1 46.0
9.Secondary Outcome
Title Change From Baseline in Clinical Disease Activity Index (CDAI) Score
Hide Description The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Time Frame Baseline, Week 24; Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of study drug with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified last observation carried forward (mLOCF).
Arm/Group Title Methotrexate Baricitinib Baricitinib + MTX
Hide Arm/Group Description:
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Overall Number of Participants Analyzed 200 157 208
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 24 -22.12  (16.12) -28.20  (13.96) -29.86  (14.05)
Week 52 -21.95  (18.07) -28.94  (14.58) -30.72  (14.87)
10.Secondary Outcome
Title Change From Baseline in Disease Activity Score 28–Erythrocyte Sedimentation Rate (DAS28-ESR)
Hide Description DAS28 consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), erythrocyte sedimentation rate (ESR) (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using the following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.
Time Frame Baseline, Week 24; Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Arm/Group Title Methotrexate Baricitinib Baricitinib + MTX
Hide Arm/Group Description:
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Overall Number of Participants Analyzed 203 159 209
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 24 -2.20  (1.53) -2.76  (1.45) -3.06  (1.46)
Week 52 -2.32  (1.77) -2.84  (1.57) -3.22  (1.48)
11.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission
Hide Description The ACR/EULAR definitions of RA remission include a "Boolean-based definition". The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.
Time Frame Week 12, Week 24, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Arm/Group Title Methotrexate Baricitinib Baricitinib + MTX
Hide Arm/Group Description:
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Overall Number of Participants Analyzed 210 159 215
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 5.7 13.8 14.4
Week 24 8.6 18.9 16.3
Week 52 11.4 17.0 20.9
12.Secondary Outcome
Title Change From Baseline in Joint Space Narrowing and Bone Erosion Scores
Hide Description X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing. The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints, with 0 indicating no erosion and the highest score (5 for the hand and 10 for the foot) indicating extensive loss of bone from more than one half of the articulating bone. Erosion scores ranged from 0 (no erosion) to 280 (high erosion).
Time Frame Baseline, Week 24; Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment. Missing values due to discontinuation of study, rescue, or missing data were imputed using LE.
Arm/Group Title Methotrexate Baricitinib Baricitinib + MTX
Hide Arm/Group Description:
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Overall Number of Participants Analyzed 210 159 215
Mean (Standard Deviation)
Unit of Measure: units on a scale
JSN Week 24 Number Analyzed 191 participants 152 participants 198 participants
0.15  (0.94) 0.08  (0.44) 0.05  (0.44)
JSN Week 52 Number Analyzed 192 participants 154 participants 199 participants
0.23  (1.00) 0.26  (1.14) 0.08  (0.88)
Bone Erosion Week 24 Number Analyzed 191 participants 152 participants 198 participants
0.49  (1.14) 0.35  (0.92) 0.27  (0.95)
Bone Erosion Week 52 Number Analyzed 192 participants 154 participants 199 participants
0.80  (1.80) 0.55  (1.48) 0.33  (1.21)
13.Secondary Outcome
Title Change From Baseline in Duration of Morning Joint Stiffness
Hide Description Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Arm/Group Title Methotrexate Baricitinib Baricitinib + MTX
Hide Arm/Group Description:
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Overall Number of Participants Analyzed 204 159 209
Median (95% Confidence Interval)
Unit of Measure: Minutes
-40.0
(-55.0 to -30.0)
-55.0
(-60.0 to -40.0)
-60.0
(-80.0 to -50.0)
14.Secondary Outcome
Title Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)
Hide Description Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents "no tiredness" and 10 represents "as bad as you can imagine".
Time Frame Baseline, Week 24; Baseline Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Arm/Group Title Methotrexate Baricitinib Baricitinib + MTX
Hide Arm/Group Description:
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Overall Number of Participants Analyzed 204 159 209
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 24 -2.2  (2.7) -3.0  (3.1) -3.0  (2.8)
Week 52 -2.3  (2.8) -2.9  (3.1) -3.0  (2.9)
15.Secondary Outcome
Title Change From Baseline in Worst Joint Pain Numeric Rating Scale (NRS)
Hide Description Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents "no pain" and 10 represents "pain as bad as you can imagine".
Time Frame Baseline, Week 24; Baseline Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Arm/Group Title Methotrexate Baricitinib Baricitinib + MTX
Hide Arm/Group Description:
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Overall Number of Participants Analyzed 204 159 209
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 24 -2.8  (2.5) -3.9  (2.7) -3.9  (2.6)
Week 52 -3.0  (2.8) -3.9  (2.9) -4.1  (2.7)
16.Secondary Outcome
Title Change From Baseline in Mental Component Score (MCS) and Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)
Hide Description The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.
Time Frame Baseline, Week 24; Baseline Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Arm/Group Title Methotrexate Baricitinib Baricitinib + MTX
Hide Arm/Group Description:
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Overall Number of Participants Analyzed 202 159 207
Mean (Standard Deviation)
Unit of Measure: units on a scale
MCS Week 24 3.4  (10.8) 5.9  (11.7) 4.6  (11.6)
MCS Week 52 2.4  (10.9) 5.8  (11.9) 5.0  (11.5)
PCS Week 24 9.4  (9.2) 12.5  (9.1) 13.2  (9.6)
PCS Week 52 9.4  (10.1) 11.6  (9.6) 13.3  (9.8)
17.Secondary Outcome
Title Change From Baseline in European Quality of Life–5 Dimensions–5 Level (EQ-5D-5L) Scores
Hide Description European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
Time Frame Baseline, Week 24; Baseline Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Arm/Group Title Methotrexate Baricitinib Baricitinib + MTX
Hide Arm/Group Description:
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Overall Number of Participants Analyzed 202 159 207
Mean (Standard Deviation)
Unit of Measure: units on a scale
Index Score (US Algorithm) Week 24 0.142  (0.189) 0.197  (0.164) 0.194  (0.180)
Index Score (US Algorithm) Week 52 0.138  (0.203) 0.186  (0.177) 0.185  (0.186)
Index Score (UK Algorithm) Week 24 0.205  (0.274) 0.285  (0.241) 0.282  (0.255)
Index Score (UK Algorithm) Week 52 0.197  (0.294) 0.271  (0.258) 0.268  (0.266)
18.Secondary Outcome
Title Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
Hide Description A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.
Time Frame Baseline, Week 24; Baseline Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Arm/Group Title Methotrexate Baricitinib Baricitinib + MTX
Hide Arm/Group Description:
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Overall Number of Participants Analyzed 202 159 207
Mean (Standard Deviation)
Unit of Measure: millimeter
Self-Perceived Health Week 24 14.5  (28.3) 24.1  (26.0) 21.4  (31.4)
Self-Perceived Health Week 52 13.6  (30.1) 24.5  (28.7) 24.5  (30.6)
19.Secondary Outcome
Title Change From Baseline in Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) Scores
Hide Description The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 ("Not at all") to 4 ("Very much") for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.
Time Frame Baseline, Week 24; Baseline Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Arm/Group Title Methotrexate Baricitinib Baricitinib + MTX
Hide Arm/Group Description:
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Overall Number of Participants Analyzed 204 159 209
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 24 9.3  (11.2) 13.0  (10.8) 12.3  (11.5)
Week 52 9.1  (10.9) 11.3  (10.8) 12.6  (11.8)
20.Secondary Outcome
Title Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
Hide Description The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.
Time Frame Baseline, Week 24; Baseline Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and an observed value at the time point being summarized.
Arm/Group Title Methotrexate Baricitinib Baricitinib + MTX
Hide Arm/Group Description:
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Overall Number of Participants Analyzed 210 159 215
Mean (Standard Deviation)
Unit of Measure: Percentage of Impairment
Absenteeism Week 24 (n=76, 56, 90) -3.6  (35.5) -8.7  (30.4) -7.6  (26.5)
Absenteeism Week 52 (n=52, 51, 71) -3.0  (29.2) -8.4  (29.7) -7.3  (21.8)
Presenteeism Week 24(n=70, 51, 86) -19  (25) -26  (27) -32  (26)
Presenteeism Week 52 (n=51, 47, 75) -26  (26) -27  (24) -33  (25)
Work Productivity Loss Week 24 (n=70, 71, 86) -17.8  (30.2) -25.6  (29.1) -30.9  (29.6)
Work Productivity Loss Week 52 (n=51, 47, 75) -24.1  (30.5) -27.6  (27.3) -33.8  (27.5)
Activity Impairment Week 24 (n=184, 145, 192) -25  (26) -36  (28) -31  (28)
Activity Impairment Week 52 (n=141, 131, 172) -28  (27) -34  (27) -37  (27)
21.Secondary Outcome
Title Population Pharmacokinetics (PK): Peak Concentration at Steady State (Cmax,ss) of Baricitinib
Hide Description [Not Specified]
Time Frame Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 24; Week 32; Pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.
Arm/Group Title Baricitinib
Hide Arm/Group Description:
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Overall Number of Participants Analyzed 355
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanomole/Liter (nmol/L)
135
(23.1%)
22.Secondary Outcome
Title Population PK: Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib
Hide Description [Not Specified]
Time Frame Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 24; Week 32; Pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.
Arm/Group Title Baricitinib
Hide Arm/Group Description:
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Overall Number of Participants Analyzed 355
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanomole/Liter (nmol/L)
1280
(47.2%)
Time Frame [Not Specified]
Adverse Event Reporting Description All enrolled participants including those receiving rescue therapy, with events occurring after rescue accounted separately. Rescue therapy occurred at Week 24 or later, if determined to be nonresponders (lack of improvement of at least 20% in both tender joint count and swollen joint count).
 
Arm/Group Title Methotrexate Baricitinib Baricitinib + MTX Rescue Period Methotrexate - Follow-up Baricitinib - Follow-up Baricitinib + MTX - Follow-up
Hide Arm/Group Description Methotrexate (MTX) administered orally once weekly with dose ranging from 10 to 20 milligram (mg) per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly. Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly. Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly. Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug. No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug. No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug. Includes participants who were rescued to Baricitinib + MTX.
All-Cause Mortality
Methotrexate Baricitinib Baricitinib + MTX Rescue Period Methotrexate - Follow-up Baricitinib - Follow-up Baricitinib + MTX - Follow-up
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Methotrexate Baricitinib Baricitinib + MTX Rescue Period Methotrexate - Follow-up Baricitinib - Follow-up Baricitinib + MTX - Follow-up
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/210 (9.52%)      12/159 (7.55%)      17/215 (7.91%)      1/39 (2.56%)      0/25 (0.00%)      0/15 (0.00%)      0/28 (0.00%)    
Cardiac disorders               
Atrial fibrillation  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Coronary artery disease  1  0/210 (0.00%)  0 1/159 (0.63%)  1 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Myocardial infarction  1  0/210 (0.00%)  0 1/159 (0.63%)  1 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Myocardial ischaemia  1  0/210 (0.00%)  0 0/159 (0.00%)  0 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Eye disorders               
Cataract  1  1/210 (0.48%)  1 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Gastrointestinal disorders               
Chronic gastritis  1  0/210 (0.00%)  0 0/159 (0.00%)  0 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Duodenal ulcer  1  0/210 (0.00%)  0 1/159 (0.63%)  1 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Enterocolitis  1  0/210 (0.00%)  0 0/159 (0.00%)  0 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Gastric ulcer haemorrhage  1  1/210 (0.48%)  1 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Umbilical hernia  1  1/210 (0.48%)  1 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
General disorders               
Drowning  1  1/210 (0.48%)  1 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Fatigue  1  0/210 (0.00%)  0 1/159 (0.63%)  1 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Non-cardiac chest pain  1  0/210 (0.00%)  0 0/159 (0.00%)  0 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Oedema peripheral  1  0/210 (0.00%)  0 1/159 (0.63%)  1 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Pyrexia  1  0/210 (0.00%)  0 0/159 (0.00%)  0 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Hepatobiliary disorders               
Cholecystitis  1  0/210 (0.00%)  0 1/159 (0.63%)  1 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Infections and infestations               
Acute hepatitis B  1  0/210 (0.00%)  0 0/159 (0.00%)  0 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Bronchitis haemophilus  1  0/210 (0.00%)  0 1/159 (0.63%)  1 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Campylobacter gastroenteritis  1  0/210 (0.00%)  0 0/159 (0.00%)  0 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Cellulitis  1  1/210 (0.48%)  1 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Diverticulitis  1  0/210 (0.00%)  0 1/159 (0.63%)  1 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Escherichia sepsis  1  1/210 (0.48%)  1 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Herpes zoster  1  2/210 (0.95%)  2 1/159 (0.63%)  1 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Infectious colitis  1  0/210 (0.00%)  0 1/159 (0.63%)  1 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Lung infection  1  1/210 (0.48%)  1 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Meningitis bacterial  1  1/210 (0.48%)  1 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Pneumocystis jirovecii pneumonia  1  0/210 (0.00%)  0 0/159 (0.00%)  0 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Pneumonia  1  1/210 (0.48%)  1 1/159 (0.63%)  1 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Pyelonephritis acute  1  0/210 (0.00%)  0/159 (0.00%)  0 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Sepsis  1  1/210 (0.48%)  1 1/159 (0.63%)  1 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Urinary tract infection  1  1/210 (0.48%)  1 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Injury, poisoning and procedural complications               
Fall  1  2/210 (0.95%)  2 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Femur fracture  1  1/210 (0.48%)  1 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Overdose  1  0/210 (0.00%)  0 0/159 (0.00%)  0 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Spinal compression fracture  1  2/210 (0.95%)  2 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Tibia fracture  1  1/210 (0.48%)  1 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Toxicity to various agents  1  0/210 (0.00%)  0 0/159 (0.00%)  0 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Wrist fracture  1  1/210 (0.48%)  1 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Investigations               
Lymphocyte count decreased  1  0/210 (0.00%)  0 0/159 (0.00%)  0 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Musculoskeletal and connective tissue disorders               
Rheumatoid arthritis  1  1/210 (0.48%)  1 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Cervix carcinoma  1  0/210 (0.00%)  0 1/159 (0.63%)  1 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Gallbladder adenosquamous carcinoma  1  0/210 (0.00%)  0 0/159 (0.00%)  0 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Malignant melanoma  1  0/210 (0.00%)  0 0/159 (0.00%)  0 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Nervous system disorders               
Cerebral haemorrhage  1  1/210 (0.48%)  1 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Headache  1  0/210 (0.00%)  0 0/159 (0.00%)  0 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Migraine  1  0/210 (0.00%)  0 1/159 (0.63%)  1 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Syncope  1  0/210 (0.00%)  0 0/159 (0.00%)  0 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Renal and urinary disorders               
Acute kidney injury  1  0/210 (0.00%)  0 0/159 (0.00%)  0 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Reproductive system and breast disorders               
Genital prolapse  1  0/210 (0.00%)  0 0/159 (0.00%)  0 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Asthma  1  0/210 (0.00%)  0 0/159 (0.00%)  0 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Chronic obstructive pulmonary disease  1  1/210 (0.48%)  1 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Pneumothorax spontaneous  1  0/210 (0.00%)  0 0/159 (0.00%)  0 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Pulmonary embolism  1  1/210 (0.48%)  1 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Pulmonary fibrosis  1  1/210 (0.48%)  1 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Methotrexate Baricitinib Baricitinib + MTX Rescue Period Methotrexate - Follow-up Baricitinib - Follow-up Baricitinib + MTX - Follow-up
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   115/210 (54.76%)      81/159 (50.94%)      129/215 (60.00%)      21/39 (53.85%)      2/25 (8.00%)      2/15 (13.33%)      0/28 (0.00%)    
Blood and lymphatic system disorders               
Anaemia  1  2/210 (0.95%)  2 2/159 (1.26%)  2 6/215 (2.79%)  6 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Thrombocytosis  1  0/210 (0.00%)  0 4/159 (2.52%)  4 3/215 (1.40%)  3 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Cardiac disorders               
Cardiomegaly  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Left ventricular hypertrophy  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Ear and labyrinth disorders               
Ear pruritus  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Endocrine disorders               
Hypothyroidism  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Eye disorders               
Scleritis  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Scleromalacia  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Gastrointestinal disorders               
Constipation  1  3/210 (1.43%)  3 2/159 (1.26%)  3 7/215 (3.26%)  8 0/39 (0.00%)  0 0/25 (0.00%)  0 1/15 (6.67%)  1 0/28 (0.00%)  0
Abdominal discomfort  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Large intestine polyp  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Stomatitis  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Abdominal pain upper  1  6/210 (2.86%)  6 3/159 (1.89%)  4 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Diarrhoea  1  12/210 (5.71%)  15 3/159 (1.89%)  3 5/215 (2.33%)  6 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Dyspepsia  1  1/210 (0.48%)  1 3/159 (1.89%)  3 8/215 (3.72%)  9 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Gastrooesophageal reflux disease  1  1/210 (0.48%)  1 0/159 (0.00%)  0 5/215 (2.33%)  5 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Nausea  1  13/210 (6.19%)  16 7/159 (4.40%)  7 20/215 (9.30%)  26 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Vomiting  1  6/210 (2.86%)  6 5/159 (3.14%)  5 5/215 (2.33%)  8 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
General disorders               
Oedema peripheral  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 1/25 (4.00%)  1 0/15 (0.00%)  0 0/28 (0.00%)  0
Fatigue  1  5/210 (2.38%)  5 3/159 (1.89%)  3 8/215 (3.72%)  8 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Pyrexia  1  4/210 (1.90%)  5 1/159 (0.63%)  1 5/215 (2.33%)  6 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Hepatobiliary disorders               
Hepatic function abnormal  1  5/210 (2.38%)  5 1/159 (0.63%)  1 8/215 (3.72%)  9 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Infections and infestations               
Hepatitis E  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Herpes zoster  1  0/210 (0.00%)  0 3/159 (1.89%)  3 5/215 (2.33%)  5 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Nasopharyngitis  1  17/210 (8.10%)  20 16/159 (10.06%)  21 21/215 (9.77%)  32 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Pharyngitis  1  4/210 (1.90%)  6 2/159 (1.26%)  2 7/215 (3.26%)  9 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Upper respiratory tract infection  1  15/210 (7.14%)  15 12/159 (7.55%)  14 16/215 (7.44%)  19 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Vaginal infection  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/28 (3.57%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Bronchitis  1  4/210 (1.90%)  4 5/159 (3.14%)  5 9/215 (4.19%)  10 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Gastroenteritis  1  4/210 (1.90%)  4 10/159 (6.29%)  10 6/215 (2.79%)  6 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Influenza  1  4/210 (1.90%)  4 7/159 (4.40%)  7 11/215 (5.12%)  11 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Rhinitis  1  7/210 (3.33%)  7 1/159 (0.63%)  1 2/215 (0.93%)  3 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Sinusitis  1  5/210 (2.38%)  5 1/159 (0.63%)  1 7/215 (3.26%)  8 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Urinary tract infection  1  7/210 (3.33%)  7 6/159 (3.77%)  7 14/215 (6.51%)  16 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Vulvovaginal candidiasis  1  1/148 (0.68%)  1 0/159 (0.00%)  0 6/156 (3.85%)  8 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Injury, poisoning and procedural complications               
Ankle fracture  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Arthropod bite  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Joint injury  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Thermal burn  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 2/39 (5.13%)  2 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Wrist fracture  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Investigations               
Alanine aminotransferase increased  1  5/210 (2.38%)  5 1/159 (0.63%)  1 13/215 (6.05%)  15 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Aspartate aminotransferase increased  1  3/210 (1.43%)  3 0/159 (0.00%)  0 7/215 (3.26%)  8 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Blood creatine phosphokinase increased  1  2/210 (0.95%)  2 4/159 (2.52%)  5 10/215 (4.65%)  11 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Blood creatinine increased  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Liver function test abnormal  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Lymphocyte count increased  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Weight increased  1  3/210 (1.43%)  3 4/159 (2.52%)  4 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Metabolism and nutrition disorders               
Hypercholesterolaemia  1  3/210 (1.43%)  3 4/159 (2.52%)  4 4/215 (1.86%)  4 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Hyperlipidaemia  1  1/210 (0.48%)  1 3/159 (1.89%)  3 6/215 (2.79%)  6 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Dyslipidaemia  1  2/210 (0.95%)  2 2/159 (1.26%)  2 8/215 (3.72%)  8 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Musculoskeletal and connective tissue disorders               
Arthralgia  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 1/25 (4.00%)  1 0/15 (0.00%)  0 0/28 (0.00%)  0
Back pain  1  5/210 (2.38%)  5 3/159 (1.89%)  3 9/215 (4.19%)  10 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Muscle spasms  1  1/210 (0.48%)  2 2/159 (1.26%)  2 7/215 (3.26%)  7 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Rheumatoid arthritis  1  7/210 (3.33%)  7 3/159 (1.89%)  3 1/215 (0.47%)  1 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Nervous system disorders               
Dizziness  1  5/210 (2.38%)  6 1/159 (0.63%)  1 3/215 (1.40%)  4 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Headache  1  3/210 (1.43%)  3 5/159 (3.14%)  6 6/215 (2.79%)  7 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Sciatica  1  0/210 (0.00%)  0 4/159 (2.52%)  4 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Pregnancy, puerperium and perinatal conditions               
Pregnancy  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/28 (3.57%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Psychiatric disorders               
Depression  1  4/210 (1.90%)  4 6/159 (3.77%)  6 2/215 (0.93%)  2 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Renal and urinary disorders               
Polyuria  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Catarrh  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Cough  1  13/210 (6.19%)  14 5/159 (3.14%)  7 6/215 (2.79%)  6 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Sinus congestion  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Skin and subcutaneous tissue disorders               
Eczema asteatotic  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 1/15 (6.67%)  1 0/28 (0.00%)  0
Miliaria  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 1/15 (6.67%)  1 0/28 (0.00%)  0
Seborrhoeic dermatitis  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 0/39 (0.00%)  0 0/25 (0.00%)  0 1/15 (6.67%)  1 0/28 (0.00%)  0
Dermatitis  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Petechiae  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Pruritus  1  0/210 (0.00%)  0 0/159 (0.00%)  0 0/215 (0.00%)  0 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Alopecia  1  5/210 (2.38%)  5 1/159 (0.63%)  1 6/215 (2.79%)  6 0/39 (0.00%)  0 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Vascular disorders               
Hypertension  1  7/210 (3.33%)  7 2/159 (1.26%)  2 13/215 (6.05%)  13 1/39 (2.56%)  1 0/25 (0.00%)  0 0/15 (0.00%)  0 0/28 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01711359     History of Changes
Other Study ID Numbers: 14062
I4V-MC-JADZ ( Other Identifier: Eli Lilly and Company )
First Submitted: October 18, 2012
First Posted: October 22, 2012
Results First Submitted: March 10, 2017
Results First Posted: August 15, 2017
Last Update Posted: September 19, 2019