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Trial record 54 of 62 for:    Baricitinib

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

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: NCT01721057
Recruitment Status : Completed
First Posted : November 2, 2012
Results First Posted : June 12, 2017
Last Update Posted : September 18, 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: Placebo
Drug: Baricitinib
Drug: cDMARD
Enrollment 684
Recruitment Details  
Pre-assignment Details

Participants who did not respond (nonresponders) to study drug were eligible for rescue treatment beginning at Week 16.

Nonresponders were defined as lack of improvement of at least 20% in both tender joint count and swollen joint count at both Weeks 14 and 16 compared to baseline.

Arm/Group Title Placebo Baricitinib 2 mg Baricitinib 4 mg Rescue Placebo-Follow Up Baricitinib 2 mg- Follow Up Baricitinib 4 mg- Follow Up
Hide Arm/Group Description

Placebo administered orally (PO) once daily (QD)through Week 24.

Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg PO QD through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg PO QD through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study. 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 4 mg.

Period Title: Treatment Period
Started 228 229 227 0 0 0 0
Received at Least 1 Dose of Study Drug 228 229 227 0 0 0 0
Rescued 55 21 15 0 0 0 0
Completed 200 [1] 210 [1] 204 [1] 0 0 0 0
Not Completed 28 19 23 0 0 0 0
Reason Not Completed
Withdrawal by Subject             11             5             8             0             0             0             0
Adverse Event             7             10             12             0             0             0             0
Lack of Efficacy             7             3             0             0             0             0             0
Lost to Follow-up             1             0             0             0             0             0             0
Physician Decision             0             1             3             0             0             0             0
Death             2             0             0             0             0             0             0
[1]
"Completers" include rescued participants.
Period Title: Rescue Period
Started 0 [1] 0 [1] 0 [1] 91 [2] 0 0 0
Completed 0 0 0 88 0 0 0
Not Completed 0 0 0 3 0 0 0
Reason Not Completed
Adverse Event             0             0             0             1             0             0             0
Lack of Efficacy             0             0             0             2             0             0             0
[1]
Participants who were nonresponders based on tender/swollen joint count entered into rescue group.
[2]
Participants who were determined to be nonresponders based on tender/swollen joint count.
Period Title: Follow Up
Started 0 0 0 0 [1] 17 [2] 19 [2] 22 [3]
Completed 0 0 0 0 17 19 22
Not Completed 0 0 0 0 0 0 0
[1]
Rescued participants who entered post-treatment follow-up are included in Baricitinib 4 mg FollowUp
[2]
Participants from treatment who entered the post-treatment follow-up period.
[3]
Participants from treatment and rescue who entered the post-treatment follow-up period.
Arm/Group Title Placebo Baricitinib 2 mg Baricitinib 4 mg Total
Hide Arm/Group Description

Placebo administered orally (PO) once daily (QD) through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Baricitinib 2 mg PO QD through week 24.

Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg PO QD through week 24.

Participants continued to take background cDMARD therapy throughout study.

Total of all reporting groups
Overall Number of Baseline Participants 228 229 227 684
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 228 participants 229 participants 227 participants 684 participants
51.4  (12.5) 52.2  (12.3) 51.8  (12.1) 51.8  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 228 participants 229 participants 227 participants 684 participants
Female
189
  82.9%
184
  80.3%
187
  82.4%
560
  81.9%
Male
39
  17.1%
45
  19.7%
40
  17.6%
124
  18.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 228 participants 229 participants 227 participants 684 participants
Hispanic or Latino
12
   5.3%
15
   6.6%
17
   7.5%
44
   6.4%
Not Hispanic or Latino
45
  19.7%
43
  18.8%
43
  18.9%
131
  19.2%
Unknown or Not Reported
171
  75.0%
171
  74.7%
167
  73.6%
509
  74.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 228 participants 229 participants 227 participants 684 participants
American Indian or Alaska Native
3
   1.3%
2
   0.9%
9
   4.0%
14
   2.0%
Asian
60
  26.3%
61
  26.6%
59
  26.0%
180
  26.3%
Native Hawaiian or Other Pacific Islander
1
   0.4%
0
   0.0%
0
   0.0%
1
   0.1%
Black or African American
10
   4.4%
9
   3.9%
9
   4.0%
28
   4.1%
White
153
  67.1%
156
  68.1%
148
  65.2%
457
  66.8%
More than one race
1
   0.4%
1
   0.4%
1
   0.4%
3
   0.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   0.4%
1
   0.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Argentina Number Analyzed 228 participants 229 participants 227 participants 684 participants
25 21 18 64
Australia Number Analyzed 228 participants 229 participants 227 participants 684 participants
8 1 6 15
Belgium Number Analyzed 228 participants 229 participants 227 participants 684 participants
1 4 6 11
Canada Number Analyzed 228 participants 229 participants 227 participants 684 participants
10 10 8 28
Croatia Number Analyzed 228 participants 229 participants 227 participants 684 participants
0 2 2 4
Czech Republic Number Analyzed 228 participants 229 participants 227 participants 684 participants
7 5 3 15
Germany Number Analyzed 228 participants 229 participants 227 participants 684 participants
4 2 3 9
Hungary Number Analyzed 228 participants 229 participants 227 participants 684 participants
7 8 5 20
India Number Analyzed 228 participants 229 participants 227 participants 684 participants
19 19 20 58
Italy Number Analyzed 228 participants 229 participants 227 participants 684 participants
3 3 4 10
Japan Number Analyzed 228 participants 229 participants 227 participants 684 participants
8 6 7 21
Korea, Republic of Number Analyzed 228 participants 229 participants 227 participants 684 participants
6 7 4 17
Mexico Number Analyzed 228 participants 229 participants 227 participants 684 participants
3 8 11 22
Poland Number Analyzed 228 participants 229 participants 227 participants 684 participants
18 13 20 51
Portugal Number Analyzed 228 participants 229 participants 227 participants 684 participants
2 2 1 5
Romania Number Analyzed 228 participants 229 participants 227 participants 684 participants
1 3 2 6
Russian Federation Number Analyzed 228 participants 229 participants 227 participants 684 participants
4 10 6 20
Slovakia Number Analyzed 228 participants 229 participants 227 participants 684 participants
3 5 3 11
Spain Number Analyzed 228 participants 229 participants 227 participants 684 participants
14 10 10 34
Taiwan Number Analyzed 228 participants 229 participants 227 participants 684 participants
26 28 28 82
United Kingdom Number Analyzed 228 participants 229 participants 227 participants 684 participants
1 4 0 5
United States Number Analyzed 228 participants 229 participants 227 participants 684 participants
58 58 60 176
Duration of Rheumatoid Arthritis   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 228 participants 225 participants 225 participants 678 participants
7.2  (7.5) 7.6  (7.6) 7.7  (7.9) 7.5  (7.6)
[1]
Measure Analysis Population Description: Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug and had evaluable baseline data.
Tender Joint Count of 68 Evaluable Joints  
Mean (Standard Deviation)
Unit of measure:  Number of Joints
Number Analyzed 228 participants 229 participants 227 participants 684 participants
24.3  (15.0) 23.5  (14.1) 24.3  (14.0) 24.0  (14.3)
Swollen Joint Count of 66 Evaluable Joints  
Mean (Standard Deviation)
Unit of measure:  Number of Joints
Number Analyzed 228 participants 229 participants 227 participants 684 participants
13.1  (7.2) 13.6  (8.7) 13.5  (6.9) 13.4  (7.6)
High Sensitivity C-Reactive Protein (hsCRP)  
Mean (Standard Deviation)
Unit of measure:  Milligram per Liter (mg/L)
Number Analyzed 228 participants 229 participants 227 participants 684 participants
17.7  (20.4) 18.2  (21.5) 14.2  (14.5) 16.7  (19.1)
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 discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using non-responder imputation (NRI).
Arm/Group Title Placebo Baricitinib 2 mg Baricitinib 4 mg
Hide Arm/Group Description:

Placebo administered orally (PO) once daily (QD)through Week 24.

Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg PO QD through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg PO QD through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Overall Number of Participants Analyzed 228 229 227
Measure Type: Number
Unit of Measure: percentage of participants
39.5 65.9 61.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Baricitinib 4 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Hide Description The HAQ-DI questionnaire 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 were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of the 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 Placebo Baricitinib 2 mg Baricitinib 4 mg
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24.

Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Overall Number of Participants Analyzed 228 229 227
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.30  (0.45) -0.52  (0.59) -0.52  (0.60)
3.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 composite score of 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 using visual analog scale (VAS) (participant global VAS). DAS28 was calculated using 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 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.
Arm/Group Title Placebo Baricitinib 2 mg Baricitinib 4 mg
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24.

Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Overall Number of Participants Analyzed 228 229 227
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.05  (1.23) -1.83  (1.22) -1.91  (1.21)
4.Secondary Outcome
Title Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) ≤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), Participant'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 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Arm/Group Title Placebo Baricitinib 2 mg Baricitinib 4 mg
Hide Arm/Group Description:

Placebo administered orally (PO) once daily (QD) through Week 24.

Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg PO QD through week 24.

Participants will continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg PO QD through week 24.

Participants continued to take background cDMARD therapy throughout study.

Overall Number of Participants Analyzed 228 229 227
Measure Type: Number
Unit of Measure: percentage of participants
0.9 9.2 8.8
5.Secondary Outcome
Title Mean Duration of Morning Joint Stiffness(MJS) in the Prior 7 Days as Collected in Electronic Daily Diaries
Hide Description Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes into daily electronic diaries. If MJS duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit is calculated. A decrease in duration of MJS indicated an improvement in the participant's condition.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.
Arm/Group Title Placebo Baricitinib 2 mg Baricitinib 4 mg
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24.

Participants continued disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Overall Number of Participants Analyzed 221 223 222
Median (95% Confidence Interval)
Unit of Measure: minutes
60.0
(50.7 to 76.7)
44.4
(30.0 to 60.0)
34.6
(23.7 to 51.4)
6.Secondary Outcome
Title Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries
Hide Description Participants rated the severity of their MJS by selecting a number from 0 to 10 that best described their overall level of MJS from the time they woke up, where 0 represents "no joint stiffness" and 10 represents "joint stiffness as bad as you can imagine". Participants reported their severity daily in electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in severity rating indicated an improvement in the participant's condition.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.
Arm/Group Title Placebo Baricitinib 2 mg Baricitinib 4 mg
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24.

Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Overall Number of Participants Analyzed 221 223 222
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.2  (2.3) 3.5  (2.5) 3.4  (2.2)
7.Secondary Outcome
Title Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries
Hide Description Participants rated their tiredness by selecting a number from 0 to 10 that best described their level of worst tiredness during the past 24 hours, where 0 represents "no tiredness" and 10 represents "as bad as you can imagine". Participants reported their worst tiredness in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in tiredness severity rating indicated an improvement in the participant's condition.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.
Arm/Group Title Placebo Baricitinib 2 mg Baricitinib 4 mg
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24.

Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Overall Number of Participants Analyzed 221 223 222
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.5  (2.2) 4.0  (2.5) 4.0  (2.3)
8.Secondary Outcome
Title Mean Worst Joint Pain Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries
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". Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in joint pain severity rating indicated an improvement in the participant's condition.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.
Arm/Group Title Placebo Baricitinib 2 mg Baricitinib 4 mg
Hide Arm/Group Description:

Placebo administered orally (PO) once daily (QD) through Week 24.

Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg PO QD through week 24.

Participants will continue to take background cDMARD therapy throughout study.

Baricitinib 4 mg PO QD through week 24.

Participants will continue to take background cDMARD therapy throughout study.

Overall Number of Participants Analyzed 221 223 222
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.7  (2.2) 3.9  (2.5) 3.8  (2.2)
9.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 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 discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.

Time Frame Week 12, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Arm/Group Title Placebo Baricitinib 2 mg Baricitinib 4 mg
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24.

Participants will continue to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Overall Number of Participants Analyzed 228 229 227
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 12.7 33.6 33.5
Week 24 21.5 41.5 44.1
10.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 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 discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.
Time Frame Week 12, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Arm/Group Title Placebo Baricitinib 2 mg Baricitinib 4 mg
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24.

Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Overall Number of Participants Analyzed 228 229 227
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 3.1 17.9 18.1
Week 24 7.9 25.3 24.2
11.Secondary Outcome
Title Change From Baseline in Measures of 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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of the 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 Placebo Baricitinib 2 mg Baricitinib 4 mg
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24.

. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Overall Number of Participants Analyzed 218 224 219
Mean (Standard Deviation)
Unit of Measure: units on a scale
-14.29  (16.04) -20.99  (14.48) -23.18  (13.47)
12.Secondary Outcome
Title Change From Baseline in Measures of Simplified Disease Activity Index (SDAI) Score
Hide Description The 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 visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). A negative change from baseline indicates an improvement.
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 the 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 Placebo Baricitinib 2 mg Baricitinib 4 mg
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24.

Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 24.

Participants will continue to take background cDMARD therapy throughout study.

Overall Number of Participants Analyzed 218 224 219
Mean (Standard Deviation)
Unit of Measure: units on a scale
-14.55  (16.37) -21.87  (14.99) -23.78  (13.94)
13.Secondary Outcome
Title Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (DAS28-ESR)
Hide Description DAS28 consisted of composite score of 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 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 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Arm/Group Title Placebo Baricitinib 2 mg Baricitinib 4 mg
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24.

Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Overall Number of Participants Analyzed 220 226 221
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.16  (1.27) -1.89  (1.23) -1.97  (1.16)
14.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission – Boolean Remission
Hide Description The ACR/EULAR definitions of RA remission includes 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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Arm/Group Title Placebo Baricitinib 2 mg Baricitinib 4 mg
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24.

Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Overall Number of Participants Analyzed 228 229 227
Measure Type: Number
Unit of Measure: percentage of participants
0.4 7.0 6.6
15.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 a brief 13-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 12; Baseline Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of the 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 Placebo Baricitinib 2 mg Baricitinib 4 mg
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24.

Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Overall Number of Participants Analyzed 216 227 216
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 12 7.6  (10.3) 8.7  (11.1) 8.8  (10.6)
Week 24 7.8  (11.0) 9.2  (10.7) 9.7  (10.8)
16.Secondary Outcome
Title Change From Baseline in Mental Component Score (MCS), 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 (mental [MCS] and physical [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 12; Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of the 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 Placebo Baricitinib 2 mg Baricitinib 4 mg
Hide Arm/Group Description:

Placebo administered orally (PO) once daily (QD) through Week 24.

Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg PO QD through week 24.

Participants will continue to take background cDMARD therapy throughout study.

Baricitinib 4 mg PO QD through week 24.

Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally daily through Week 24.

Participants will continue to take background cDMARD therapy throughout study.

Overall Number of Participants Analyzed 218 229 219
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 12, MCS 3.3  (10.6) 3.6  (10.5) 3.3  (11.0)
Week 24, MCS 2.7  (11.5) 3.0  (10.4) 3.3  (11.3)
Week 12, PCS 4.1  (7.3) 7.7  (8.5) 7.0  (8.3)
Week 24, PCS 4.9  (8.0) 8.5  (9.0) 8.6  (9.0)
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 12; Baseline Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of the 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 Placebo Baricitinib 2 mg Baricitinib 4 mg
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24.

Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Overall Number of Participants Analyzed 216 227 216
Mean (Standard Deviation)
Unit of Measure: units on a scale
Index Score (US Algorithm) Week 12 0.054  (0.155) 0.117  (0.151) 0.109  (0.165)
Index Score (US Algorithm) Week 24 0.051  (0.149) 0.113  (0.172) 0.129  (0.173)
Index Score (UK Algorithm) Week 12 0.074  (0.230) 0.167  (0.221) 0.159  (0.237)
Index Score (UK Algorithm) Week 24 0.075  (0.218) 0.162  (0.254) 0.185  (0.250)
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 12; Baseline Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of the 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 Placebo Baricitinib 2 mg Baricitinib 4 mg
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24.

Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 24.

Participants will continue to take background cDMARD therapy throughout study.

Overall Number of Participants Analyzed 216 227 216
Mean (Standard Deviation)
Unit of Measure: mm
Self-Perceived Health, Week 12 5.7  (23.8) 13.4  (21.8) 11.5  (25.2)
Self-Perceived Health, Week 24 8.4  (25.1) 13.1  (25.8) 10.4  (28.8)
19.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 12; Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population: all randomized participants who received at least 1 dose of the study drug. Change from baseline includes participants with a baseline value and an observed value at the time point being summarized.
Arm/Group Title Placebo Baricitinib 2 mg Baricitinib 4 mg
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24.

Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Overall Number of Participants Analyzed 228 229 227
Mean (Standard Deviation)
Unit of Measure: percentage of impairment
Absenteeism Week 12 Number Analyzed 73 participants 72 participants 69 participants
2.6  (23.5) -6.3  (26.5) 2.5  (24.7)
Absenteeism Week 24 Number Analyzed 44 participants 62 participants 56 participants
-2.1  (13.9) -3.8  (28.2) 4.0  (27.2)
Presenteeism Week 12 Number Analyzed 71 participants 69 participants 66 participants
-8  (26) -17  (25) -15  (27)
Presenteeism Week 24 Number Analyzed 44 participants 61 participants 53 participants
-17  (26) -20  (23) -17  (21)
Work Productivity Loss Week 12 Number Analyzed 71 participants 69 participants 66 participants
-4.2  (27.7) -17.6  (30.4) -9.9  (23.7)
Work Producivity Loss Week 24 Number Analyzed 44 participants 61 participants 53 participants
-15.9  (26.1) -19.6  (25.0) -14.3  (23.0)
Activity Impairment Week 12 Number Analyzed 206 participants 222 participants 213 participants
-13  (25) -19  (27) -19  (25)
Activity Impairment Week 24 Number Analyzed 141 participants 187 participants 187 participants
-18  (27) -23  (28) -21  (27)
20.Secondary Outcome
Title Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104
Hide Description [Not Specified]
Time Frame Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24:predose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug with evaluable PK data.
Arm/Group Title Baricitinib 2 mg Baricitinib 4 mg
Hide Arm/Group Description:

Baricitinib 2 mg PO QD through week 24.

Participants will continue to take background cDMARD therapy throughout study.

Baricitinib 4 mg PO QD through week 24.

Participants will continue to take background cDMARD therapy throughout study.

Overall Number of Participants Analyzed 246 245
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter (ng/mL)
70.2
(26.2%)
138
(25.7%)
21.Secondary Outcome
Title Population PK: Maximum Concentration at Steady State of Dosing (AUC,ss) of LY3009104
Hide Description [Not Specified]
Time Frame Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24; predose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug with evaluable PK data.
Arm/Group Title Baricitinib 2 mg Baricitinib 4 mg
Hide Arm/Group Description:

Baricitinib 2 mg PO QD through week 24.

Participants will continue to take background cDMARD therapy throughout study.

Baricitinib 4 mg PO QD through week 24.

Participants will continue to take background cDMARD therapy throughout study.

Overall Number of Participants Analyzed 246 245
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms per mL per hour (ng/mL*h)
637
(44.5%)
1210
(47%)
Time Frame [Not Specified]
Adverse Event Reporting Description All randomized participants who received at least 1 dose of study drug.
 
Arm/Group Title Placebo-Treatment Period Baricitinib 2 Mg-Treatment Period Baricitinib 4 Mg-Treatment Period Rescue Placebo-Follow Up Baricitinib 2 mg- Follow Up Baricitinib 4 mg- Follow Up
Hide Arm/Group Description

Placebo administered orally once daily through Week 24.

Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 24.

Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study. 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 4 mg.

All-Cause Mortality
Placebo-Treatment Period Baricitinib 2 Mg-Treatment Period Baricitinib 4 Mg-Treatment Period Rescue Placebo-Follow Up Baricitinib 2 mg- Follow Up Baricitinib 4 mg- 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
Placebo-Treatment Period Baricitinib 2 Mg-Treatment Period Baricitinib 4 Mg-Treatment Period Rescue Placebo-Follow Up Baricitinib 2 mg- Follow Up Baricitinib 4 mg- 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   13/228 (5.70%)      6/229 (2.62%)      12/227 (5.29%)      1/91 (1.10%)      1/17 (5.88%)      0/19 (0.00%)      1/22 (4.55%)    
Blood and lymphatic system disorders               
Anaemia  1  1/228 (0.44%)  1 0/229 (0.00%)  0 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Cardiac disorders               
Angina pectoris  1  0/228 (0.00%)  0 0/229 (0.00%)  0 1/227 (0.44%)  1 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Atrial fibrillation  1  0/228 (0.00%)  0 1/229 (0.44%)  1 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Myocardial infarction  1  1/228 (0.44%)  1 0/229 (0.00%)  0 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Ventricular tachycardia  1  1/228 (0.44%)  1 0/229 (0.00%)  0 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Gastrointestinal disorders               
Diverticulum intestinal  1  1/228 (0.44%)  1 0/229 (0.00%)  0 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Dyspepsia  1  0/228 (0.00%)  0 0/229 (0.00%)  0 1/227 (0.44%)  1 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Gastrointestinal haemorrhage  1  1/228 (0.44%)  1 0/229 (0.00%)  0 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Hepatobiliary disorders               
Cholecystitis acute  1  0/228 (0.00%)  0 0/229 (0.00%)  0 1/227 (0.44%)  1 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Infections and infestations               
Appendicitis  1  0/228 (0.00%)  0/229 (0.00%)  0/227 (0.00%)  0/91 (0.00%)  1/17 (5.88%)  1 0/19 (0.00%)  0 0/22 (0.00%)  0
Bacterial infection  1  0/228 (0.00%)  0 0/229 (0.00%)  0 1/227 (0.44%)  1 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Bronchitis  1  1/228 (0.44%)  1 0/229 (0.00%)  0 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Cellulitis  1  0/228 (0.00%)  0/229 (0.00%)  0/227 (0.00%)  1/91 (1.10%)  1 0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Disseminated tuberculosis  1  0/228 (0.00%)  0 0/229 (0.00%)  0 1/227 (0.44%)  1 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Gastroenteritis  1  0/228 (0.00%)  0 1/229 (0.44%)  1 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Lower respiratory tract infection  1  0/228 (0.00%)  0 0/229 (0.00%)  0 1/227 (0.44%)  1 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Pelvic abscess  1  0/228 (0.00%)  0/229 (0.00%)  0/227 (0.00%)  0/91 (0.00%)  1/17 (5.88%)  1 0/19 (0.00%)  0 0/22 (0.00%)  0
Pneumonia  1  2/228 (0.88%)  2 1/229 (0.44%)  1 1/227 (0.44%)  1 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Sepsis  1  0/228 (0.00%)  0 0/229 (0.00%)  0 1/227 (0.44%)  1 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Urinary tract infection  1  1/228 (0.44%)  1 0/229 (0.00%)  0 0/227 (0.00%)  0 1/91 (1.10%)  1 0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Viral infection  1  0/228 (0.00%)  0 0/229 (0.00%)  0 1/227 (0.44%)  1 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Wound infection staphylococcal  1  1/228 (0.44%)  1 0/229 (0.00%)  0 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Injury, poisoning and procedural complications               
Animal bite  1  0/228 (0.00%)  0 0/229 (0.00%)  0 1/227 (0.44%)  1 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Fall  1  2/228 (0.88%)  2 0/229 (0.00%)  0 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Patella fracture  1  1/228 (0.44%)  1 0/229 (0.00%)  0 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Tibia fracture  1  0/228 (0.00%)  0 0/229 (0.00%)  0 1/227 (0.44%)  1 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Upper limb fracture  1  1/228 (0.44%)  1 0/229 (0.00%)  0 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Musculoskeletal and connective tissue disorders               
Back pain  1  1/228 (0.44%)  1 0/229 (0.00%)  0 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Muscular weakness  1  0/228 (0.00%)  0 0/229 (0.00%)  0 1/227 (0.44%)  1 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Myalgia  1  0/228 (0.00%)  0 0/229 (0.00%)  0 1/227 (0.44%)  1 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Myositis  1  0/228 (0.00%)  0 0/229 (0.00%)  0 1/227 (0.44%)  1 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Polymyositis  1  0/228 (0.00%)  0/229 (0.00%)  0/227 (0.00%)  0/91 (0.00%)  1/17 (5.88%)  1 0/19 (0.00%)  0 0/22 (0.00%)  0
Rheumatoid arthritis  1  1/228 (0.44%)  1 0/229 (0.00%)  0 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Spinal pain  1  0/228 (0.00%)  0 0/229 (0.00%)  0 1/227 (0.44%)  1 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Synovial cyst  1  1/228 (0.44%)  1 0/229 (0.00%)  0 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Nervous system disorders               
Migraine  1  0/228 (0.00%)  0 1/229 (0.44%)  1 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Subarachnoid haemorrhage  1  1/228 (0.44%)  1 0/229 (0.00%)  0 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Psychiatric disorders               
Depression  1  1/228 (0.44%)  1 0/229 (0.00%)  0 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Post-traumatic stress disorder  1  0/228 (0.00%)  0 1/229 (0.44%)  1 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Suicidal ideation  1  1/228 (0.44%)  1 0/229 (0.00%)  0 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Renal and urinary disorders               
Renal failure  1  1/228 (0.44%)  1 0/229 (0.00%)  0 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Acute respiratory distress syndrome  1  0/228 (0.00%)  0 1/229 (0.44%)  1 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Acute respiratory failure  1  0/228 (0.00%)  0 1/229 (0.44%)  1 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Allergic bronchitis  1  0/228 (0.00%)  0 0/229 (0.00%)  0 1/227 (0.44%)  1 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Interstitial lung disease  1  0/228 (0.00%)  0 0/229 (0.00%)  0 1/227 (0.44%)  1 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Pleural effusion  1  0/228 (0.00%)  0 0/229 (0.00%)  0 1/227 (0.44%)  1 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Pulmonary embolism  1  0/228 (0.00%)  0 0/229 (0.00%)  0 1/227 (0.44%)  1 0/91 (0.00%)  0/17 (0.00%)  0 0/19 (0.00%)  0 1/22 (4.55%)  1
Skin and subcutaneous tissue disorders               
Psoriasis  1  0/228 (0.00%)  0 1/229 (0.44%)  1 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Rash pruritic  1  0/228 (0.00%)  0 0/229 (0.00%)  0 1/227 (0.44%)  1 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Subcutaneous emphysema  1  1/228 (0.44%)  1 0/229 (0.00%)  0 0/227 (0.00%)  0 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo-Treatment Period Baricitinib 2 Mg-Treatment Period Baricitinib 4 Mg-Treatment Period Rescue Placebo-Follow Up Baricitinib 2 mg- Follow Up Baricitinib 4 mg- 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   105/228 (46.05%)      108/229 (47.16%)      127/227 (55.95%)      21/91 (23.08%)      2/17 (11.76%)      0/19 (0.00%)      4/22 (18.18%)    
Blood and lymphatic system disorders               
Anaemia  1  6/228 (2.63%)  6 6/229 (2.62%)  6 4/227 (1.76%)  4 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Cardiac disorders               
Sinus bradycardia  1  0/228 (0.00%)  0/229 (0.00%)  0/227 (0.00%)  0/91 (0.00%)  0/17 (0.00%)  0 0/19 (0.00%)  0 1/22 (4.55%)  1
Gastrointestinal disorders               
Abdominal pain  1  0/228 (0.00%)  0 5/229 (2.18%)  5 3/227 (1.32%)  3 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Abdominal pain upper  1  1/228 (0.44%)  1 5/229 (2.18%)  5 4/227 (1.76%)  4 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Constipation  1  3/228 (1.32%)  4 7/229 (3.06%)  7 5/227 (2.20%)  5 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Diarrhoea  1  10/228 (4.39%)  11 10/229 (4.37%)  11 4/227 (1.76%)  5 2/91 (2.20%)  2 1/17 (5.88%)  1 0/19 (0.00%)  0 0/22 (0.00%)  0
Dyspepsia  1  2/228 (0.88%)  2 1/229 (0.44%)  1 5/227 (2.20%)  5 2/91 (2.20%)  2 0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Gastritis  1  0/228 (0.00%)  0/229 (0.00%)  0/227 (0.00%)  0/91 (0.00%)  0/17 (0.00%)  0 0/19 (0.00%)  0 1/22 (4.55%)  1
Gastrooesophageal reflux disease  1  5/228 (2.19%)  5 2/229 (0.87%)  2 1/227 (0.44%)  1 2/91 (2.20%)  2 0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Lip disorder  1  0/228 (0.00%)  0/229 (0.00%)  0/227 (0.00%)  0/91 (0.00%)  0/17 (0.00%)  0 0/19 (0.00%)  0 1/22 (4.55%)  1
Mouth ulceration  1  0/228 (0.00%)  0 5/229 (2.18%)  6 3/227 (1.32%)  3 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Nausea  1  8/228 (3.51%)  9 7/229 (3.06%)  7 5/227 (2.20%)  5 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Vomiting  1  4/228 (1.75%)  5 7/229 (3.06%)  7 4/227 (1.76%)  4 2/91 (2.20%)  2 0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
General disorders               
Fatigue  1  5/228 (2.19%)  5 2/229 (0.87%)  3 5/227 (2.20%)  5 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Oedema peripheral  1  6/228 (2.63%)  6 3/229 (1.31%)  3 3/227 (1.32%)  3 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Pyrexia  1  2/228 (0.88%)  2 1/229 (0.44%)  1 5/227 (2.20%)  7 0/91 (0.00%)  1/17 (5.88%)  1 0/19 (0.00%)  0 0/22 (0.00%)  0
Infections and infestations               
Bronchitis  1  11/228 (4.82%)  12 6/229 (2.62%)  7 7/227 (3.08%)  8 2/91 (2.20%)  2 0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Gastroenteritis  1  1/228 (0.44%)  1 4/229 (1.75%)  4 9/227 (3.96%)  9 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Nasopharyngitis  1  18/228 (7.89%)  19 10/229 (4.37%)  10 18/227 (7.93%)  22 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Pharyngitis  1  3/228 (1.32%)  3 6/229 (2.62%)  6 8/227 (3.52%)  8 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Rash pustular  1  0/228 (0.00%)  0/229 (0.00%)  0/227 (0.00%)  0/91 (0.00%)  1/17 (5.88%)  1 0/19 (0.00%)  0 0/22 (0.00%)  0
Sinusitis  1  6/228 (2.63%)  6 3/229 (1.31%)  3 4/227 (1.76%)  4 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Upper respiratory tract infection  1  18/228 (7.89%)  19 14/229 (6.11%)  16 24/227 (10.57%)  26 2/91 (2.20%)  2 0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Urinary tract infection  1  4/228 (1.75%)  5 12/229 (5.24%)  13 9/227 (3.96%)  9 3/91 (3.30%)  3 0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Investigations               
Alanine aminotransferase increased  1  2/228 (0.88%)  3 5/229 (2.18%)  6 5/227 (2.20%)  6 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Aspartate aminotransferase increased  1  1/228 (0.44%)  2 3/229 (1.31%)  3 6/227 (2.64%)  7 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Blood creatine phosphokinase increased  1  0/228 (0.00%)  0 8/229 (3.49%)  8 15/227 (6.61%)  17 0/91 (0.00%)  1/17 (5.88%)  1 0/19 (0.00%)  0 0/22 (0.00%)  0
Metabolism and nutrition disorders               
Hypercholesterolaemia  1  2/228 (0.88%)  2 5/229 (2.18%)  5 9/227 (3.96%)  9 4/91 (4.40%)  4 0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Hyperlipidaemia  1  2/228 (0.88%)  2 2/229 (0.87%)  2 6/227 (2.64%)  6 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthralgia  1  3/228 (1.32%)  3 6/229 (2.62%)  8 6/227 (2.64%)  6 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Back pain  1  10/228 (4.39%)  10 9/229 (3.93%)  9 5/227 (2.20%)  5 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Nervous system disorders               
Dizziness  1  4/228 (1.75%)  4 3/229 (1.31%)  3 7/227 (3.08%)  9 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Headache  1  8/228 (3.51%)  10 15/229 (6.55%)  17 9/227 (3.96%)  10 3/91 (3.30%)  3 0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Psychiatric disorders               
Depression  1  7/228 (3.07%)  7 0/229 (0.00%)  0 1/227 (0.44%)  1 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Reproductive system and breast disorders               
Erectile dysfunction  1  0/39 (0.00%)  0 0/45 (0.00%)  0 1/40 (2.50%)  1 0/13 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0
Vulvovaginal pruritus  1  0/189 (0.00%)  0 0/184 (0.00%)  0 0/187 (0.00%)  0 0/78 (0.00%)  0 1/11 (9.09%)  1 0/15 (0.00%)  0 0/19 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Cough  1  3/228 (1.32%)  4 9/229 (3.93%)  11 9/227 (3.96%)  10 0/91 (0.00%)  0/17 (0.00%)  0 0/19 (0.00%)  0 1/22 (4.55%)  1
Dyspnoea  1  0/228 (0.00%)  0/229 (0.00%)  0/227 (0.00%)  0/91 (0.00%)  0/17 (0.00%)  0 0/19 (0.00%)  0 1/22 (4.55%)  1
Oropharyngeal pain  1  2/228 (0.88%)  2 4/229 (1.75%)  4 9/227 (3.96%)  9 3/91 (3.30%)  3 0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Skin and subcutaneous tissue disorders               
Acne  1  0/228 (0.00%)  0/229 (0.00%)  0/227 (0.00%)  2/91 (2.20%)  2 0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Alopecia  1  4/228 (1.75%)  4 1/229 (0.44%)  1 6/227 (2.64%)  6 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Dermatitis bullous  1  0/228 (0.00%)  0/229 (0.00%)  0/227 (0.00%)  0/91 (0.00%)  1/17 (5.88%)  1 0/19 (0.00%)  0 0/22 (0.00%)  0
Vascular disorders               
Hypertension  1  2/228 (0.88%)  2 10/229 (4.37%)  10 6/227 (2.64%)  6 0/91 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/22 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
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: NCT01721057     History of Changes
Other Study ID Numbers: 14059
I4V-MC-JADX ( Other Identifier: Eli Lilly and Company )
First Submitted: November 1, 2012
First Posted: November 2, 2012
Results First Submitted: May 1, 2017
Results First Posted: June 12, 2017
Last Update Posted: September 18, 2019