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

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: NCT01710358
Recruitment Status : Completed
First Posted : October 19, 2012
Results First Posted : August 15, 2017
Last Update Posted : August 15, 2017
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: Adalimumab
Drug: Baricitinib
Drug: Methotrexate
Drug: Adalimumab Placebo
Drug: Baricitinib Placebo
Enrollment 1307
Recruitment Details  
Pre-assignment Details

Participants who did not respond (nonresponders) to study drug were eligible for rescue treatment beginning at Week16. Participants not rescued at Week 16 may be rescued at the discretion of the investigator anytime thereafter.

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

Arm/Group Title Placebo Baricitinib Adalimumab
Hide Arm/Group Description

Placebo administered orally (PO) once daily (QD) through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50.

At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Participants continued to take background methotrexate (MTX) therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.

Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Period Title: Treatment Period Part A (Weeks 0 to 24)
Started 489 488 330
Received at Least 1 Dose of Study Drug 488 487 330
Rescued 128 35 40
Completed 438 [1] 459 [1] 307 [1]
Not Completed 51 29 23
Reason Not Completed
Adverse Event             15             18             7
Death             0             2             0
Entry Criteria Not Met             0             1             1
Lack of Efficacy             15             1             3
Lost to Follow-up             0             1             0
Physician Decision             1             0             0
Sponsor Decision             4             0             0
Withdrawal by Subject             15             5             12
Randomized But Not Treated             1             1             0
[1]
Includes all participants rescued during Part A.
Period Title: Treatment Period Part B (Weeks 24 to 52)
Started 310 [1] 424 [1] 267 [1]
Received at Least 1 Dose of Study Drug 306 [2] 424 267
Rescued 5 8 11
Completed 294 [3] 402 [3] 252 [3]
Not Completed 16 22 15
Reason Not Completed
Adverse Event             10             16             5
Death             1             0             1
Lack of Efficacy             0             0             1
Lost to Follow-up             0             0             1
Physician Decision             0             1             0
Sponsor Decision             1             2             0
Withdrawal by Subject             4             3             7
[1]
Excludes participants rescued during Part A.
[2]
Participants originally randomized to placebo received baricitinib during Part B.
[3]
Includes all participants rescued during Part B.
Period Title: Rescue Period
Started 0 [1] 227 [2] 0 [1]
Completed 0 196 0
Not Completed 0 31 0
Reason Not Completed
Adverse Event             0             15             0
Death             0             1             0
Lack of Efficacy             0             7             0
Withdrawal by Subject             0             8             0
[1]
Participants who were nonresponders based on tender/swollen joint count entered into rescue group.
[2]
Baricitinib 4 mg administered PO QD through Week 52. Participants continued background MTX therapy.
Period Title: Follow-up Period
Started 33 [1] 76 [2] 20 [1]
Completed 33 76 20
Not Completed 0 0 0
[1]
Participants from treatment who entered the post-treatment follow-up period.
[2]
Rescued participants who entered post-treatment follow-up are included in Baricitinib 4mg follow up.
Arm/Group Title Placebo Baricitinib Adalimumab Total
Hide Arm/Group Description

Placebo administered orally once daily through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50.

At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.

Participants continued to take background methotrexate (MTX) therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.

Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Participants continued to take background MTX) therapy throughout study.

Total of all reporting groups
Overall Number of Baseline Participants 488 487 330 1305
Hide Baseline Analysis Population Description
Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 488 participants 487 participants 330 participants 1305 participants
53.4  (11.8) 53.5  (12.2) 52.9  (12.3) 53.3  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 488 participants 487 participants 330 participants 1305 participants
Female 382 375 251 1008
Male 106 112 79 297
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 488 participants 487 participants 330 participants 1305 participants
American Indian or Alaska Native 26 19 18 63
Asian 148 143 101 392
Native Hawaiian or Other Pacific Islander 0 0 0 0
Black or African American 4 2 4 10
White 302 312 204 818
More than one race 7 11 3 21
Unknown or Not Reported 1 0 0 1
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 488 participants 487 participants 330 participants 1305 participants
Argentina 91 107 57 255
Belgium 2 3 3 8
Canada 5 4 2 11
China 21 22 11 54
Croatia 1 0 0 1
Czechia 16 10 10 36
France 8 8 7 23
Germany 0 0 2 2
Greece 1 0 2 3
Hungary 18 11 8 37
Japan 93 93 63 249
South Korea 21 21 15 57
Latvia 2 2 5 9
Lithuania 4 12 10 26
Mexico 50 36 39 125
Poland 26 35 19 80
Portugal 1 1 1 3
Romania 8 6 2 16
Russia 27 28 23 78
Slovakia 8 8 4 20
Slovenia 4 1 0 5
South Africa 24 21 11 56
Spain 15 11 5 31
Taiwan 6 5 7 18
United Kingdom 2 6 0 8
United States 34 36 24 94
Duration of Rheumatoid Arthritis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 488 participants 487 participants 330 participants 1305 participants
10.4  (8.7) 10.3  (8.8) 9.6  (8.5) 10.1  (8.7)
Tender Joint Count of 68 Evaluable Joints  
Mean (Standard Deviation)
Unit of measure:  Number of Joints
Number Analyzed 488 participants 487 participants 330 participants 1305 participants
23.3  (13.5) 23.4  (13.0) 23.4  (13.7) 23.4  (13.3)
Swollen Joint Count of 66 Evaluable Joints  
Mean (Standard Deviation)
Unit of measure:  Number of Joints
Number Analyzed 488 participants 487 participants 330 participants 1305 participants
15.5  (9.4) 15.0  (8.2) 15.4  (9.1) 15.3  (8.9)
High Sensitivity C-Reactive Protein (hsCRP)  
Mean (Standard Deviation)
Unit of measure:  Milligrams per liter (mg/L)
Number Analyzed 488 participants 487 participants 330 participants 1305 participants
19.66  (20.97) 22.20  (22.85) 21.78  (20.83) 21.14  (21.67)
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 timepoint were 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 study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using nonresponder imputation (NRI).
Arm/Group Title Placebo Baricitinib Adalimumab
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.

At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.

Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Overall Number of Participants Analyzed 488 487 330
Measure Type: Number
Unit of Measure: percentage of participants
40.2 69.6 61.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Baricitinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
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 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. 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 Placebo Baricitinib Adalimumab
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.

At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.

Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.

Starting at Week 16, participants who are were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Participants will continued to take background MTX therapy throughout study.

Overall Number of Participants Analyzed 452 470 312
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.84  (2.32) 0.35  (1.59) 0.29  (1.47)
3.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 includes 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 Adalimumab
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.

At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.

Starting at Week 16, nonresponder participants originally randomized to baricitinib will continue to receive baricitinib 4 mg administered orally once daily through Week 52.

Participants will continue to take background MTX therapy throughout study.

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.

Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 52.

Participants will continue to take background MTX therapy throughout study.

Overall Number of Participants Analyzed 488 487 330
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.33  (0.51) -0.65  (0.59) -0.56  (0.54)
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 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 includes 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 Adalimumab
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.

At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.

Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

.

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Overall Number of Participants Analyzed 488 487 330
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.01  (1.12) -2.27  (1.22) -1.98  (1.28)
5.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response
Hide Description

ACR50 and ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR50 and ACR70 Responder is a participant who has at least 50% or 70% improvement, respectively, 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 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 Adalimumab
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.

At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.

Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Overall Number of Participants Analyzed 488 487 330
Measure Type: Number
Unit of Measure: percentage of participants
ACR50 Week 12 16.8 45.0 34.8
ACR50 Week 24 19.3 50.5 45.5
ACR50 Week 52 NA [1]  55.9 47.0
ACR70 Week 12 4.7 18.9 12.7
ACR70 Week 24 8.0 29.8 21.8
ACR70 Week 52 NA [1]  37.2 30.6
[1]
No data available. There is no Placebo Arm at week 52.
6.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 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 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 Adalimumab
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.

At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.

Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Overall Number of Participants Analyzed 481 478 324
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 12 -13.53  (13.88) -23.00  (12.66) -20.42  (13.47)
Week 24 -14.21  (15.13) -25.04  (13.61) -22.92  (14.63)
Week 52 NA [1]   (NA) -26.44  (14.42) -23.48  (15.28)
[1]
NA= No data available. There is no Placebo Arm at week 52.
7.Secondary Outcome
Title Percentage of Participants Achieving 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 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 Placebo Baricitinib Adalimumab
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.

At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.

Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Overall Number of Participants Analyzed 488 487 330
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 1.8 8.4 7.3
Week 24 3.1 16.0 13.6
Week 52 NA [1]  22.6 17.9
[1]
NA= No data available. There is no Placebo Arm at week 52.
8.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, 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 Placebo Baricitinib Adalimumab
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.

At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.

Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Baricitinib: Administered orally

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Overall Number of Participants Analyzed 488 487 330
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 1.0 7.2 5.2
Week 24 2.7 12.1 10.0
Week 52 NA [1]  15.6 13.0
[1]
NA= No data available. There is no Placebo Arm at week 52.
9.Secondary Outcome
Title Median of Individual Participant Mean Duration of Morning Joint Stiffness in the Prior 7 Days as Collected in Electronic Diaries
Hide Description Participants recorded the duration of their morning joint stiffness (MJS) in hours and minutes into electronic diaries daily. If morning joint stiffness 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 was calculated. A decrease in duration of morning joint stiffness 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 Adalimumab
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.

At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.

Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Overall Number of Participants Analyzed 479 479 323
Median (95% Confidence Interval)
Unit of Measure: Minutes
60.0
(60.0 to 75.0)
27.1
(20.0 to 30.0)
36.6
(30.0 to 45.7)
10.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 morning joint stiffness by selecting a number from 0 to 10 that best described their overall level of morning joint stiffness 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 was calculated.
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 Adalimumab
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.

At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.

Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Overall Number of Participants Analyzed 479 479 323
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.1  (2.3) 3.0  (2.2) 3.4  (2.3)
11.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 worst tiredness during the last 24 hours, where 0 represents "no tiredness" and 10 represents "as bad as you can imagine". Participants reported their worst tiredness in electronic diaries. The average value across the 7 days preceding each visit is calculated.
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 Adalimumab
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.

At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.

Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Overall Number of Participants Analyzed 479 479 323
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.4  (2.3) 3.6  (2.2) 3.9  (2.3)
12.Secondary Outcome
Title Mean Worst Joint Pain 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 was calculated.
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 Adalimumab
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.

At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.

Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Overall Number of Participants Analyzed 479 479 323
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.6  (2.2) 3.4  (2.2) 4.0  (2.3)
13.Secondary Outcome
Title Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale 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, 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, 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 Adalimumab
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.

At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.

Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Overall Number of Participants Analyzed 475 479 320
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 12 6.8  (9.9) 9.6  (10.4) 9.5  (10.1)
Week 24 6.6  (10.4) 10.4  (10.8) 9.9  (11.2)
Week 52 NA [1]   (NA) 10.8  (10.9) 9.8  (10.8)
[1]
NA= No data available. There is no Placebo Arm at week 52.
14.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, 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, 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 Adalimumab
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.

At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.

Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Overall Number of Participants Analyzed 475 479 320
Mean (Standard Deviation)
Unit of Measure: units on a scale
MCS Week 12 3.2  (10.3) 3.3  (10.5) 3.8  (10.8)
MCS Week 24 2.2  (11.4) 3.8  (10.9) 3.9  (11.6)
MCS Week 52 NA [1]   (NA) 4.0  (10.8) 3.7  (11.2)
PCS Week 12 4.3  (7.1) 8.9  (8.1) 7.6  (8.2)
PCS Week 24 4.6  (7.8) 9.9  (8.2) 8.3  (9.1)
PCS Week 52 NA [1]   (NA) 10.4  (9.0) 9.0  (9.2)
[1]
No data available. There is no Placebo Arm at week 52.
15.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, 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, 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 Adalimumab
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.

At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.

Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Overall Number of Participants Analyzed 475 479 320
Mean (Standard Deviation)
Unit of Measure: units on a scale
Index Score (US Algorithm) Week 12 0.073  (0.151) 0.132  (0.156) 0.130  (0.159)
Index Score (US Algorithm) Week 24 0.065  (0.168) 0.143  (0.168) 0.137  (0.167)
Index Score (US Algorithm) Week 52 NA [1]   (NA) 0.152  (0.163) 0.141  (0.189)
Index Score (UK Algorithm) Week 12 0.107  (0.221) 0.188  (0.228) 0.186  (0.232)
Index Score (UK Algorithm) Week 24 0.094  (0.247) 0.203  (0.244) 0.195  (0.245)
Index Score (UK Algorithm) Week 52 NA [1]   (NA) 0.215  (0.235) 0.198  (0.273)
[1]
NA= No data available. There is no Placebo Arm at week 52.
16.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, 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, 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 Adalimumab
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.

At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.

Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Overall Number of Participants Analyzed 475 479 320
Mean (Standard Deviation)
Unit of Measure: millimeter
Self-Perceived Health Week 12 7.9  (26.2) 14.9  (25.8) 10.7  (26.9)
Self-Perceived Health Week 24 5.6  (27.1) 17.5  (28.3) 12.6  (28.9)
Self-Perceived Health Week 52 NA [1]   (NA) 19.9  (28.0) 13.3  (29.7)
[1]
NA= No data available. There is no Placebo Arm at week 52.
17.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, Week 24, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all randomized participants who received at least 1 dose of the study drug, with a baseline value and an observed value at the time point being summarized.
Arm/Group Title Placebo Baricitinib Adalimumab
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.

At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.

Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Baricitinib: Administered orally

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Overall Number of Participants Analyzed 458 474 315
Mean (Standard Deviation)
Unit of Measure: percentage of impairment
Absenteeism Week 12 (n=160,168,118) 0.5  (27.7) -4.9  (20.6) -0.5  (25.7)
Absenteeism Week 24 (n=118,139,102) -1.6  (24.5) -1.8  (25.2) -3.2  (23.8)
Absenteeism Week 52 (n=0,124,92) NA [1]   (NA) -3.8  (25.1) -3.7  (24.3)
Presenteeism Week 12 (n=147,160,113) -11  (23) -21  (26) -16  (24)
Presenteeism Week 24 (n=110,134,99) -11  (22) -23  (27) -22  (26)
Presenteeism Week 52 (n=0,119,88) NA [1]   (NA) -25  (27) -25  (27)
Work Productivity Loss Week 12 (n=147,160,113) -10.4  (24.3) -21.6  (28.0) -14.0  (25.6)
Work Productivity Loss Week 24 (n=110,134,99) -9.0  (24.9) -22.1  (30.2) -21.4  (27.2)
Work Productivity Loss Week 52 (n=0,119,88) NA [1]   (NA) -24.4  (30.1) -24.6  (29.8)
Activity Impairment Week 12 (n=458,474,315) -11  (25) -25  (26) -20  (25)
Activity Impairment Week 24 (n=333,430,272) -16  (26) -28  (27) -26  (26)
Activity Impairment Week 52 (n=0,396,240) NA [1]   (NA) -30  (27) -28  (27)
[1]
NA= No data available. There is no Placebo Arm at week 52.
18.Secondary Outcome
Title Change From Baseline in Joint Space Narrowing (JSN) 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, 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 Placebo Baricitinib Adalimumab
Hide Arm/Group Description:

Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.

At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.

Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Baricitinib: Administered orally

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Participants continued to take background MTX therapy throughout study.

Overall Number of Participants Analyzed 452 473 312
Mean (Standard Deviation)
Unit of Measure: units on a scale
Joint Space Narrowing Week 24 (n= 452, 470, 312) 0.27  (1.15) 0.10  (0.74) 0.09  (0.52)
Joint Space Narrowing Week 52 (n= 452, 473, 312) 0.56  (2.33) 0.18  (1.02) 0.17  (1.00)
Bone Erosion Score Week 24 (n=452, 470, 312) 0.57  (1.58) 0.25  (1.12) 0.20  (1.08)
Bone Erosion Score Week 52 (n= 452, 473, 312) 1.15  (3.21) 0.42  (1.91) 0.34  (2.00)
19.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 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
Overall Number of Participants Analyzed 635
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanomole/Liter (nmol/L)
143
(19.7%)
20.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 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
Overall Number of Participants Analyzed 635
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanomole*hr/Liter (nmol*hr/L)
1220
(45.8%)
Time Frame [Not Specified]
Adverse Event Reporting Description All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
 
Arm/Group Title Placebo Treatment A Baricitinib Treatment A Adalimumab Treatment A Placebo Treatment B BaricitinibTreatment B Adalimumab Treatment B Rescue Placebo Follow-up Baricitinib Follow-up Adalimumab Follow-up
Hide Arm/Group Description

Placebo Treatment A (week 0-24).

Placebo administered orally (PO) once daily (QD) through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50.

At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Baricitinib Treatment A (week 0-24).

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.

Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.

Adalimumab Treatment A (week 0-24).

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Placebo Treatment B (week 24-52).

Placebo administered orally (PO) once daily (QD) through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50.

At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Baricitinib Treatment B (week 24-52).

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.

Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.

Adalimumab Treatment B (week 24-52).

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Baricitinib 4 mg administered PO QD through Week 52 (Week 16-52). 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. Participants who were rescued or switched to Baricitinib 4 mg. No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
All-Cause Mortality
Placebo Treatment A Baricitinib Treatment A Adalimumab Treatment A Placebo Treatment B BaricitinibTreatment B Adalimumab Treatment B Rescue Placebo Follow-up Baricitinib Follow-up Adalimumab Follow-up
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) 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 A Baricitinib Treatment A Adalimumab Treatment A Placebo Treatment B BaricitinibTreatment B Adalimumab Treatment B Rescue Placebo Follow-up Baricitinib Follow-up Adalimumab 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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/488 (5.33%)      26/487 (5.34%)      7/330 (2.12%)      12/306 (3.92%)      16/424 (3.77%)      9/267 (3.37%)      17/227 (7.49%)      2/33 (6.06%)      0/76 (0.00%)      0/20 (0.00%)    
Blood and lymphatic system disorders                     
Anaemia  1  0/488 (0.00%)  0 2/487 (0.41%)  2 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 2/227 (0.88%)  2 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Lymphocytosis  1  0/488 (0.00%)  0 1/487 (0.21%)  1 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Neutropenia  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 1/424 (0.24%)  1 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Cardiac disorders                     
Cardiac failure  1  1/488 (0.20%)  1 1/487 (0.21%)  1 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Myocardial infarction  1  0/488 (0.00%)  0 1/487 (0.21%)  1 0/330 (0.00%)  0 0/306 (0.00%)  0 1/424 (0.24%)  1 1/267 (0.37%)  1 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Sinus bradycardia  1  0/488 (0.00%)  0 1/487 (0.21%)  1 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Acute myocardial infarction  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 1/424 (0.24%)  1 0/267 (0.00%)  0 1/227 (0.44%)  1 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Supraventricular tachycardia  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Eye disorders                     
Cataract  1  0/488 (0.00%)  0 0/487 (0.00%)  0 1/330 (0.30%)  1 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Macular fibrosis  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 1/267 (0.37%)  1 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Retinal detachment  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 1/267 (0.37%)  1 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Glaucoma  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 1/227 (0.44%)  1 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Gastrointestinal disorders                     
Duodenal ulcer haemorrhage  1  0/488 (0.00%)  0 1/487 (0.21%)  1 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Gastric ulcer  1  0/488 (0.00%)  0 1/487 (0.21%)  1 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Gastrointestinal haemorrhage  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 1/306 (0.33%)  1 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Large intestine polyp  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Pancreatitis acute  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Diarrhoea  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 1/424 (0.24%)  1 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Jejunal ulcer  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 1/424 (0.24%)  1 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Enterocolitis  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 2/227 (0.88%)  2 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Inguinal hernia  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 1/227 (0.44%)  1 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
General disorders                     
Non-cardiac chest pain  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 1/227 (0.44%)  1 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Hepatobiliary disorders                     
Bile duct stone  1  2/488 (0.41%)  2 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Cholangitis sclerosing  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Cholelithiasis  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 1/227 (0.44%)  1 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Drug-induced liver injury  1  0/488 (0.00%)  0 1/487 (0.21%)  1 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Infections and infestations                     
Arthritis infective  1  0/488 (0.00%)  0 0/487 (0.00%)  0 1/330 (0.30%)  1 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Bronchitis  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Cellulitis  1  0/488 (0.00%)  0 2/487 (0.41%)  2 0/330 (0.00%)  0 0/306 (0.00%)  0 1/424 (0.24%)  1 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Disseminated tuberculosis  1  0/488 (0.00%)  0 0/487 (0.00%)  0 1/330 (0.30%)  1 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Epiglottitis  1  0/488 (0.00%)  0 1/487 (0.21%)  1 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Gastroenteritis  1  2/488 (0.41%)  2 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Herpes zoster  1  0/488 (0.00%)  0 2/487 (0.41%)  2 0/330 (0.00%)  0 1/306 (0.33%)  1 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Kidney infection  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Muscle abscess  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Pneumonia  1  0/488 (0.00%)  0 1/487 (0.21%)  1 0/330 (0.00%)  0 1/306 (0.33%)  1 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 1/33 (3.03%)  1 0/76 (0.00%)  0 0/20 (0.00%)  0
Pyelonephritis  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Urinary tract infection  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 2/424 (0.47%)  2 0/267 (0.00%)  0 1/227 (0.44%)  1 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Atypical pneumonia  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 1/424 (0.24%)  1 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Bacteraemia  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 1/424 (0.24%)  1 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Cholecystitis infective  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 1/267 (0.37%)  1 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Cystitis  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 1/306 (0.33%)  1 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Escherichia sepsis  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 1/267 (0.37%)  1 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Necrotising fasciitis  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 1/424 (0.24%)  1 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Pneumonia pseudomonal  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 1/267 (0.37%)  1 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Pyelonephritis acute  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 1/306 (0.33%)  1 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Viral infection  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 1/306 (0.33%)  1 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Arthritis bacterial  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 1/227 (0.44%)  1 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Sepsis  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 1/227 (0.44%)  1 1/33 (3.03%)  1 0/76 (0.00%)  0 0/20 (0.00%)  0
Soft tissue infection  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 1/227 (0.44%)  1 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Tuberculosis  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 1/227 (0.44%)  1 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Injury, poisoning and procedural complications                     
Ankle fracture  1  0/488 (0.00%)  0 1/487 (0.21%)  1 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Femoral neck fracture  1  0/488 (0.00%)  0 1/487 (0.21%)  1 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Humerus fracture  1  0/488 (0.00%)  0 1/487 (0.21%)  1 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Joint injury  1  0/488 (0.00%)  0 0/487 (0.00%)  0 1/330 (0.30%)  1 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Ulna fracture  1  0/488 (0.00%)  0 1/487 (0.21%)  1 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Fall  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 2/306 (0.65%)  2 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Femur fracture  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 1/306 (0.33%)  1 1/424 (0.24%)  1 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Laceration  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 1/306 (0.33%)  1 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Post concussion syndrome  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 1/306 (0.33%)  1 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Radius fracture  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 1/306 (0.33%)  1 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Road traffic accident  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 1/306 (0.33%)  1 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Spinal compression fracture  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 1/424 (0.24%)  1 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Spinal fracture  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 1/306 (0.33%)  1 0/424 (0.00%)  0 0/267 (0.00%)  0 1/227 (0.44%)  1 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Investigations                     
Alanine aminotransferase increased  1  0/488 (0.00%)  0 1/487 (0.21%)  1 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Aspartate aminotransferase increased  1  0/488 (0.00%)  0 1/487 (0.21%)  1 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Metabolism and nutrition disorders                     
Dehydration  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 1/306 (0.33%)  1 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Diabetes mellitus  1  1/488 (0.20%)  1 1/487 (0.21%)  1 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Hypoproteinaemia  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 1/306 (0.33%)  1 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Diabetes mellitus inadequate control  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 1/227 (0.44%)  1 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Musculoskeletal and connective tissue disorders                     
Arthralgia  1  0/488 (0.00%)  0 0/487 (0.00%)  0 1/330 (0.30%)  1 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Back pain  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Chondrocalcinosis pyrophosphate  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Intervertebral disc protrusion  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 1/306 (0.33%)  1 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Osteoporosis  1  1/488 (0.20%)  1 1/487 (0.21%)  1 0/330 (0.00%)  0 1/306 (0.33%)  1 1/424 (0.24%)  1 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Rheumatoid arthritis  1  4/488 (0.82%)  4 1/487 (0.21%)  1 0/330 (0.00%)  0 0/306 (0.00%)  0 1/424 (0.24%)  1 0/267 (0.00%)  0 0/227 (0.00%)  0 1/33 (3.03%)  1 0/76 (0.00%)  0 0/20 (0.00%)  0
Bursitis  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 1/267 (0.37%)  1 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Myositis  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 1/306 (0.33%)  1 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Osteoarthritis  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 1/227 (0.44%)  1 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                     
Breast cancer  1  0/488 (0.00%)  0 1/487 (0.21%)  1 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Lung squamous cell carcinoma stage III  1  0/488 (0.00%)  0 1/487 (0.21%)  1 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Ovarian cancer  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Uterine leiomyoma  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Clear cell renal cell carcinoma  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 1/424 (0.24%)  1 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Lymphoproliferative disorder  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 1/227 (0.44%)  1 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Squamous cell carcinoma of lung  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 1/227 (0.44%)  1 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Nervous system disorders                     
Transient ischaemic attack  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Cerebrovascular accident  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 1/227 (0.44%)  1 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Psychiatric disorders                     
Insomnia  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Confusional state  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 1/306 (0.33%)  1 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Generalised anxiety disorder  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 1/424 (0.24%)  1 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Renal and urinary disorders                     
Acute kidney injury  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Calculus urinary  1  0/488 (0.00%)  0 0/487 (0.00%)  0 1/330 (0.30%)  1 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Nephrosclerosis  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 1/227 (0.44%)  1 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Renal impairment  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Reproductive system and breast disorders                     
Metrorrhagia  1  0/488 (0.00%)  0 1/487 (0.21%)  1 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                     
Chronic obstructive pulmonary disease  1  0/488 (0.00%)  0 1/487 (0.21%)  1 1/330 (0.30%)  1 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Interstitial lung disease  1  0/488 (0.00%)  0 1/487 (0.21%)  1 0/330 (0.00%)  0 1/306 (0.33%)  1 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Nasal septum perforation  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Acute respiratory failure  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 1/267 (0.37%)  1 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Pleurisy  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 1/267 (0.37%)  1 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Pneumonia aspiration  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 1/424 (0.24%)  1 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Pneumonitis  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 1/424 (0.24%)  1 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Respiratory failure  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 1/33 (3.03%)  1 0/76 (0.00%)  0 0/20 (0.00%)  0
Skin and subcutaneous tissue disorders                     
Dermatitis allergic  1  0/488 (0.00%)  0 1/487 (0.21%)  1 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Surgical and medical procedures                     
Hysterectomy  1  1/488 (0.20%)  1 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Bladder repair  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 1/306 (0.33%)  1 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Fracture treatment  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 1/306 (0.33%)  1 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Knee arthroplasty  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 1/306 (0.33%)  1 0/424 (0.00%)  0 1/267 (0.37%)  1 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Vascular disorders                     
Circulatory collapse  1  0/488 (0.00%)  0 1/487 (0.21%)  1 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Hypotension  1  0/488 (0.00%)  0 0/487 (0.00%)  0 1/330 (0.30%)  1 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Thrombophlebitis  1  0/488 (0.00%)  0 1/487 (0.21%)  1 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (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%
Placebo Treatment A Baricitinib Treatment A Adalimumab Treatment A Placebo Treatment B BaricitinibTreatment B Adalimumab Treatment B Rescue Placebo Follow-up Baricitinib Follow-up Adalimumab 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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   177/488 (36.27%)      196/487 (40.25%)      132/330 (40.00%)      58/306 (18.95%)      70/424 (16.51%)      38/267 (14.23%)      46/227 (20.26%)      3/33 (9.09%)      0/76 (0.00%)      3/20 (15.00%)    
Blood and lymphatic system disorders                     
Anaemia  1  15/488 (3.07%)  16 16/487 (3.29%)  16 4/330 (1.21%)  4 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 8/227 (3.52%)  9 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Eye disorders                     
Blepharitis  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  1/33 (3.03%)  1 0/76 (0.00%)  0 0/20 (0.00%)  0
Gastrointestinal disorders                     
Diarrhoea  1  14/488 (2.87%)  16 11/487 (2.26%)  12 8/330 (2.42%)  10 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Dyspepsia  1  7/488 (1.43%)  7 9/487 (1.85%)  9 8/330 (2.42%)  8 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Nausea  1  6/488 (1.23%)  7 14/487 (2.87%)  15 9/330 (2.73%)  9 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Constipation  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 5/227 (2.20%)  6 1/33 (3.03%)  1 0/76 (0.00%)  0 0/20 (0.00%)  0
Infections and infestations                     
Bronchitis  1  14/488 (2.87%)  14 19/487 (3.90%)  22 8/330 (2.42%)  8 11/306 (3.59%)  12 12/424 (2.83%)  12 5/267 (1.87%)  5 6/227 (2.64%)  7 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Influenza  1  4/488 (0.82%)  5 12/487 (2.46%)  12 5/330 (1.52%)  5 3/306 (0.98%)  3 10/424 (2.36%)  10 1/267 (0.37%)  1 5/227 (2.20%)  5 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Nasopharyngitis  1  35/488 (7.17%)  39 37/487 (7.60%)  41 34/330 (10.30%)  40 15/306 (4.90%)  19 24/424 (5.66%)  26 14/267 (5.24%)  15 9/227 (3.96%)  11 2/33 (6.06%)  2 0/76 (0.00%)  0 0/20 (0.00%)  0
Pharyngitis  1  14/488 (2.87%)  14 12/487 (2.46%)  13 12/330 (3.64%)  12 10/306 (3.27%)  12 4/424 (0.94%)  4 7/267 (2.62%)  7 5/227 (2.20%)  10 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Upper respiratory tract infection  1  14/488 (2.87%)  15 15/487 (3.08%)  17 13/330 (3.94%)  16 10/306 (3.27%)  10 13/424 (3.07%)  13 4/267 (1.50%)  4 6/227 (2.64%)  7 0/33 (0.00%)  0 0/76 (0.00%)  0 2/20 (10.00%)  2
Urinary tract infection  1  16/488 (3.28%)  16 21/487 (4.31%)  25 13/330 (3.94%)  14 5/306 (1.63%)  5 10/424 (2.36%)  10 5/267 (1.87%)  6 5/227 (2.20%)  6 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Investigations                     
Alanine aminotransferase increased  1  5/488 (1.02%)  5 8/487 (1.64%)  9 9/330 (2.73%)  9 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Blood creatine phosphokinase increased  1  3/488 (0.61%)  3 13/487 (2.67%)  15 2/330 (0.61%)  2 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 5/227 (2.20%)  5 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Metabolism and nutrition disorders                     
Hypercholesterolaemia  1  7/488 (1.43%)  7 15/487 (3.08%)  15 2/330 (0.61%)  2 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Hyperlipidaemia  1  2/488 (0.41%)  2 10/487 (2.05%)  11 3/330 (0.91%)  3 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Musculoskeletal and connective tissue disorders                     
Back pain  1  8/488 (1.64%)  8 9/487 (1.85%)  9 10/330 (3.03%)  13 7/306 (2.29%)  7 9/424 (2.12%)  9 4/267 (1.50%)  4 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Rheumatoid arthritis  1  14/488 (2.87%)  15 5/487 (1.03%)  6 4/330 (1.21%)  5 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Nervous system disorders                     
Headache  1  12/488 (2.46%)  12 14/487 (2.87%)  17 13/330 (3.94%)  16 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Reproductive system and breast disorders                     
Erectile dysfunction  1  0/488 (0.00%)  0 0/487 (0.00%)  0 2/79 (2.53%)  2 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Benign prostatic hyperplasia  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 1/47 (2.13%)  1 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Calculus prostatic  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 1/47 (2.13%)  1 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Ovarian cyst  1  0/488 (0.00%)  0 0/487 (0.00%)  0 0/330 (0.00%)  0 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders                     
Cough  1  8/488 (1.64%)  9 7/487 (1.44%)  7 7/330 (2.12%)  7 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Skin and subcutaneous tissue disorders                     
Rash  1  5/488 (1.02%)  6 3/487 (0.62%)  3 7/330 (2.12%)  7 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (0.00%)  0
Vascular disorders                     
Hypertension  1  13/488 (2.66%)  13 9/487 (1.85%)  9 11/330 (3.33%)  11 0/306 (0.00%)  0 0/424 (0.00%)  0 0/267 (0.00%)  0 0/227 (0.00%)  0 0/33 (0.00%)  0 0/76 (0.00%)  0 0/20 (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
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):