Trial Outcomes & Findings for A Study in Moderate to Severe Rheumatoid Arthritis Participants (NCT NCT01721057)
NCT ID: NCT01721057
Last Updated: 2019-09-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
684 participants
Primary outcome timeframe
Week 12
Results posted on
2019-09-18
Participant Flow
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.
Participant milestones
| Measure |
Placebo
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
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Rescue
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
|
Placebo-Follow Up
No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
|
Baricitinib 2 mg- Follow Up
No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
|
Baricitinib 4 mg- Follow Up
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.
|
|---|---|---|---|---|---|---|---|
|
Treatment Period
STARTED
|
228
|
229
|
227
|
0
|
0
|
0
|
0
|
|
Treatment Period
Received at Least 1 Dose of Study Drug
|
228
|
229
|
227
|
0
|
0
|
0
|
0
|
|
Treatment Period
Rescued
|
55
|
21
|
15
|
0
|
0
|
0
|
0
|
|
Treatment Period
COMPLETED
|
200
|
210
|
204
|
0
|
0
|
0
|
0
|
|
Treatment Period
NOT COMPLETED
|
28
|
19
|
23
|
0
|
0
|
0
|
0
|
|
Rescue Period
STARTED
|
0
|
0
|
0
|
91
|
0
|
0
|
0
|
|
Rescue Period
COMPLETED
|
0
|
0
|
0
|
88
|
0
|
0
|
0
|
|
Rescue Period
NOT COMPLETED
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Follow Up
STARTED
|
0
|
0
|
0
|
0
|
17
|
19
|
22
|
|
Follow Up
COMPLETED
|
0
|
0
|
0
|
0
|
17
|
19
|
22
|
|
Follow Up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
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
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Rescue
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
|
Placebo-Follow Up
No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
|
Baricitinib 2 mg- Follow Up
No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
|
Baricitinib 4 mg- Follow Up
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.
|
|---|---|---|---|---|---|---|---|
|
Treatment Period
Withdrawal by Subject
|
11
|
5
|
8
|
0
|
0
|
0
|
0
|
|
Treatment Period
Adverse Event
|
7
|
10
|
12
|
0
|
0
|
0
|
0
|
|
Treatment Period
Lack of Efficacy
|
7
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period
Physician Decision
|
0
|
1
|
3
|
0
|
0
|
0
|
0
|
|
Treatment Period
Death
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Rescue Period
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Rescue Period
Lack of Efficacy
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Placebo
n=228 Participants
Placebo administered orally (PO) once daily (QD) through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 2 mg
n=229 Participants
Baricitinib 2 mg PO QD through week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
n=227 Participants
Baricitinib 4 mg PO QD through week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Total
n=684 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 12.5 • n=228 Participants
|
52.2 years
STANDARD_DEVIATION 12.3 • n=229 Participants
|
51.8 years
STANDARD_DEVIATION 12.1 • n=227 Participants
|
51.8 years
STANDARD_DEVIATION 12.3 • n=684 Participants
|
|
Sex: Female, Male
Female
|
189 Participants
n=228 Participants
|
184 Participants
n=229 Participants
|
187 Participants
n=227 Participants
|
560 Participants
n=684 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=228 Participants
|
45 Participants
n=229 Participants
|
40 Participants
n=227 Participants
|
124 Participants
n=684 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=228 Participants
|
15 Participants
n=229 Participants
|
17 Participants
n=227 Participants
|
44 Participants
n=684 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=228 Participants
|
43 Participants
n=229 Participants
|
43 Participants
n=227 Participants
|
131 Participants
n=684 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
171 Participants
n=228 Participants
|
171 Participants
n=229 Participants
|
167 Participants
n=227 Participants
|
509 Participants
n=684 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=228 Participants
|
2 Participants
n=229 Participants
|
9 Participants
n=227 Participants
|
14 Participants
n=684 Participants
|
|
Race (NIH/OMB)
Asian
|
60 Participants
n=228 Participants
|
61 Participants
n=229 Participants
|
59 Participants
n=227 Participants
|
180 Participants
n=684 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=228 Participants
|
0 Participants
n=229 Participants
|
0 Participants
n=227 Participants
|
1 Participants
n=684 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=228 Participants
|
9 Participants
n=229 Participants
|
9 Participants
n=227 Participants
|
28 Participants
n=684 Participants
|
|
Race (NIH/OMB)
White
|
153 Participants
n=228 Participants
|
156 Participants
n=229 Participants
|
148 Participants
n=227 Participants
|
457 Participants
n=684 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=228 Participants
|
1 Participants
n=229 Participants
|
1 Participants
n=227 Participants
|
3 Participants
n=684 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=228 Participants
|
0 Participants
n=229 Participants
|
1 Participants
n=227 Participants
|
1 Participants
n=684 Participants
|
|
Region of Enrollment
Argentina
|
25 Participants
n=228 Participants
|
21 Participants
n=229 Participants
|
18 Participants
n=227 Participants
|
64 Participants
n=684 Participants
|
|
Region of Enrollment
Australia
|
8 Participants
n=228 Participants
|
1 Participants
n=229 Participants
|
6 Participants
n=227 Participants
|
15 Participants
n=684 Participants
|
|
Region of Enrollment
Belgium
|
1 Participants
n=228 Participants
|
4 Participants
n=229 Participants
|
6 Participants
n=227 Participants
|
11 Participants
n=684 Participants
|
|
Region of Enrollment
Canada
|
10 Participants
n=228 Participants
|
10 Participants
n=229 Participants
|
8 Participants
n=227 Participants
|
28 Participants
n=684 Participants
|
|
Region of Enrollment
Croatia
|
0 Participants
n=228 Participants
|
2 Participants
n=229 Participants
|
2 Participants
n=227 Participants
|
4 Participants
n=684 Participants
|
|
Region of Enrollment
Czech Republic
|
7 Participants
n=228 Participants
|
5 Participants
n=229 Participants
|
3 Participants
n=227 Participants
|
15 Participants
n=684 Participants
|
|
Region of Enrollment
Germany
|
4 Participants
n=228 Participants
|
2 Participants
n=229 Participants
|
3 Participants
n=227 Participants
|
9 Participants
n=684 Participants
|
|
Region of Enrollment
Hungary
|
7 Participants
n=228 Participants
|
8 Participants
n=229 Participants
|
5 Participants
n=227 Participants
|
20 Participants
n=684 Participants
|
|
Region of Enrollment
India
|
19 Participants
n=228 Participants
|
19 Participants
n=229 Participants
|
20 Participants
n=227 Participants
|
58 Participants
n=684 Participants
|
|
Region of Enrollment
Italy
|
3 Participants
n=228 Participants
|
3 Participants
n=229 Participants
|
4 Participants
n=227 Participants
|
10 Participants
n=684 Participants
|
|
Region of Enrollment
Japan
|
8 Participants
n=228 Participants
|
6 Participants
n=229 Participants
|
7 Participants
n=227 Participants
|
21 Participants
n=684 Participants
|
|
Region of Enrollment
Korea, Republic of
|
6 Participants
n=228 Participants
|
7 Participants
n=229 Participants
|
4 Participants
n=227 Participants
|
17 Participants
n=684 Participants
|
|
Region of Enrollment
Mexico
|
3 Participants
n=228 Participants
|
8 Participants
n=229 Participants
|
11 Participants
n=227 Participants
|
22 Participants
n=684 Participants
|
|
Region of Enrollment
Poland
|
18 Participants
n=228 Participants
|
13 Participants
n=229 Participants
|
20 Participants
n=227 Participants
|
51 Participants
n=684 Participants
|
|
Region of Enrollment
Portugal
|
2 Participants
n=228 Participants
|
2 Participants
n=229 Participants
|
1 Participants
n=227 Participants
|
5 Participants
n=684 Participants
|
|
Region of Enrollment
Romania
|
1 Participants
n=228 Participants
|
3 Participants
n=229 Participants
|
2 Participants
n=227 Participants
|
6 Participants
n=684 Participants
|
|
Region of Enrollment
Russian Federation
|
4 Participants
n=228 Participants
|
10 Participants
n=229 Participants
|
6 Participants
n=227 Participants
|
20 Participants
n=684 Participants
|
|
Region of Enrollment
Slovakia
|
3 Participants
n=228 Participants
|
5 Participants
n=229 Participants
|
3 Participants
n=227 Participants
|
11 Participants
n=684 Participants
|
|
Region of Enrollment
Spain
|
14 Participants
n=228 Participants
|
10 Participants
n=229 Participants
|
10 Participants
n=227 Participants
|
34 Participants
n=684 Participants
|
|
Region of Enrollment
Taiwan
|
26 Participants
n=228 Participants
|
28 Participants
n=229 Participants
|
28 Participants
n=227 Participants
|
82 Participants
n=684 Participants
|
|
Region of Enrollment
United Kingdom
|
1 Participants
n=228 Participants
|
4 Participants
n=229 Participants
|
0 Participants
n=227 Participants
|
5 Participants
n=684 Participants
|
|
Region of Enrollment
United States
|
58 Participants
n=228 Participants
|
58 Participants
n=229 Participants
|
60 Participants
n=227 Participants
|
176 Participants
n=684 Participants
|
|
Duration of Rheumatoid Arthritis
|
7.2 years
STANDARD_DEVIATION 7.5 • n=228 Participants • 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.
|
7.6 years
STANDARD_DEVIATION 7.6 • n=225 Participants • 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.
|
7.7 years
STANDARD_DEVIATION 7.9 • n=225 Participants • 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.
|
7.5 years
STANDARD_DEVIATION 7.6 • n=678 Participants • 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
|
24.3 Number of Joints
STANDARD_DEVIATION 15.0 • n=228 Participants
|
23.5 Number of Joints
STANDARD_DEVIATION 14.1 • n=229 Participants
|
24.3 Number of Joints
STANDARD_DEVIATION 14.0 • n=227 Participants
|
24.0 Number of Joints
STANDARD_DEVIATION 14.3 • n=684 Participants
|
|
Swollen Joint Count of 66 Evaluable Joints
|
13.1 Number of Joints
STANDARD_DEVIATION 7.2 • n=228 Participants
|
13.6 Number of Joints
STANDARD_DEVIATION 8.7 • n=229 Participants
|
13.5 Number of Joints
STANDARD_DEVIATION 6.9 • n=227 Participants
|
13.4 Number of Joints
STANDARD_DEVIATION 7.6 • n=684 Participants
|
|
High Sensitivity C-Reactive Protein (hsCRP)
|
17.7 milligram per Liter (mg/L)
STANDARD_DEVIATION 20.4 • n=228 Participants
|
18.2 milligram per Liter (mg/L)
STANDARD_DEVIATION 21.5 • n=229 Participants
|
14.2 milligram per Liter (mg/L)
STANDARD_DEVIATION 14.5 • n=227 Participants
|
16.7 milligram per Liter (mg/L)
STANDARD_DEVIATION 19.1 • n=684 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: 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).
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.
Outcome measures
| Measure |
Placebo
n=228 Participants
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
n=229 Participants
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
n=227 Participants
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)
|
39.5 percentage of participants
|
65.9 percentage of participants
|
61.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: 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).
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.
Outcome measures
| Measure |
Placebo
n=228 Participants
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
n=229 Participants
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
n=227 Participants
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
|---|---|---|---|
|
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
|
-0.30 units on a scale
Standard Deviation 0.45
|
-0.52 units on a scale
Standard Deviation 0.59
|
-0.52 units on a scale
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=228 Participants
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
n=229 Participants
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
n=227 Participants
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
|---|---|---|---|
|
Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)
|
-1.05 units on a scale
Standard Deviation 1.23
|
-1.83 units on a scale
Standard Deviation 1.22
|
-1.91 units on a scale
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=228 Participants
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
n=229 Participants
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
n=227 Participants
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
|---|---|---|---|
|
Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) ≤3.3
|
0.9 percentage of participants
|
9.2 percentage of participants
|
8.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=221 Participants
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
n=223 Participants
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
n=222 Participants
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
|---|---|---|---|
|
Mean Duration of Morning Joint Stiffness(MJS) in the Prior 7 Days as Collected in Electronic Daily Diaries
|
60.0 minutes
Interval 50.7 to 76.7
|
44.4 minutes
Interval 30.0 to 60.0
|
34.6 minutes
Interval 23.7 to 51.4
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=221 Participants
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
n=223 Participants
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
n=222 Participants
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
|---|---|---|---|
|
Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries
|
4.2 units on a scale
Standard Deviation 2.3
|
3.5 units on a scale
Standard Deviation 2.5
|
3.4 units on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=221 Participants
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
n=223 Participants
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
n=222 Participants
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
|---|---|---|---|
|
Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries
|
4.5 units on a scale
Standard Deviation 2.2
|
4.0 units on a scale
Standard Deviation 2.5
|
4.0 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=221 Participants
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
n=223 Participants
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
n=222 Participants
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
|---|---|---|---|
|
Mean Worst Joint Pain Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries
|
4.7 units on a scale
Standard Deviation 2.2
|
3.9 units on a scale
Standard Deviation 2.5
|
3.8 units on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Week 12, Week 24Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=228 Participants
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
n=229 Participants
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
n=227 Participants
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Week 12
|
12.7 percentage of participants
|
33.6 percentage of participants
|
33.5 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Week 24
|
21.5 percentage of participants
|
41.5 percentage of participants
|
44.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12, Week 24Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=228 Participants
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
n=229 Participants
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
n=227 Participants
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Week 12
|
3.1 percentage of participants
|
17.9 percentage of participants
|
18.1 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Week 24
|
7.9 percentage of participants
|
25.3 percentage of participants
|
24.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: 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) .
• 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.
Outcome measures
| Measure |
Placebo
n=218 Participants
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
n=224 Participants
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
n=219 Participants
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
|---|---|---|---|
|
Change From Baseline in Measures of Clinical Disease Activity Index (CDAI) Score
|
-14.29 units on a scale
Standard Deviation 16.04
|
-20.99 units on a scale
Standard Deviation 14.48
|
-23.18 units on a scale
Standard Deviation 13.47
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=218 Participants
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
n=224 Participants
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
n=219 Participants
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
|---|---|---|---|
|
Change From Baseline in Measures of Simplified Disease Activity Index (SDAI) Score
|
-14.55 units on a scale
Standard Deviation 16.37
|
-21.87 units on a scale
Standard Deviation 14.99
|
-23.78 units on a scale
Standard Deviation 13.94
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=220 Participants
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
n=226 Participants
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
n=221 Participants
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
|---|---|---|---|
|
Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (DAS28-ESR)
|
-1.16 units on a scale
Standard Deviation 1.27
|
-1.89 units on a scale
Standard Deviation 1.23
|
-1.97 units on a scale
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=228 Participants
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
n=229 Participants
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
n=227 Participants
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission - Boolean Remission
|
0.4 percentage of participants
|
7.0 percentage of participants
|
6.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline Week 24Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=216 Participants
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
n=227 Participants
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
n=216 Participants
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
|---|---|---|---|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores.
Week 24
|
7.8 units on a scale
Standard Deviation 11.0
|
9.2 units on a scale
Standard Deviation 10.7
|
9.7 units on a scale
Standard Deviation 10.8
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores.
Week 12
|
7.6 units on a scale
Standard Deviation 10.3
|
8.7 units on a scale
Standard Deviation 11.1
|
8.8 units on a scale
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline, Week 24Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=218 Participants
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
n=229 Participants
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
n=219 Participants
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
|---|---|---|---|
|
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)
Week 12, MCS
|
3.3 units on a scale
Standard Deviation 10.6
|
3.6 units on a scale
Standard Deviation 10.5
|
3.3 units on a scale
Standard Deviation 11.0
|
|
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)
Week 24, MCS
|
2.7 units on a scale
Standard Deviation 11.5
|
3.0 units on a scale
Standard Deviation 10.4
|
3.3 units on a scale
Standard Deviation 11.3
|
|
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)
Week 12, PCS
|
4.1 units on a scale
Standard Deviation 7.3
|
7.7 units on a scale
Standard Deviation 8.5
|
7.0 units on a scale
Standard Deviation 8.3
|
|
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)
Week 24, PCS
|
4.9 units on a scale
Standard Deviation 8.0
|
8.5 units on a scale
Standard Deviation 9.0
|
8.6 units on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Baseline Week 12; Baseline Week 24Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=216 Participants
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
n=227 Participants
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
n=216 Participants
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
|---|---|---|---|
|
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores
Index Score (US Algorithm) Week 12
|
0.054 units on a scale
Standard Deviation 0.155
|
0.117 units on a scale
Standard Deviation 0.151
|
0.109 units on a scale
Standard Deviation 0.165
|
|
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores
Index Score (US Algorithm) Week 24
|
0.051 units on a scale
Standard Deviation 0.149
|
0.113 units on a scale
Standard Deviation 0.172
|
0.129 units on a scale
Standard Deviation 0.173
|
|
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores
Index Score (UK Algorithm) Week 12
|
0.074 units on a scale
Standard Deviation 0.230
|
0.167 units on a scale
Standard Deviation 0.221
|
0.159 units on a scale
Standard Deviation 0.237
|
|
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores
Index Score (UK Algorithm) Week 24
|
0.075 units on a scale
Standard Deviation 0.218
|
0.162 units on a scale
Standard Deviation 0.254
|
0.185 units on a scale
Standard Deviation 0.250
|
SECONDARY outcome
Timeframe: Baseline Week 12; Baseline Week 24Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=216 Participants
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
n=227 Participants
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
n=216 Participants
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
|---|---|---|---|
|
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
Self-Perceived Health, Week 12
|
5.7 mm
Standard Deviation 23.8
|
13.4 mm
Standard Deviation 21.8
|
11.5 mm
Standard Deviation 25.2
|
|
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
Self-Perceived Health, Week 24
|
8.4 mm
Standard Deviation 25.1
|
13.1 mm
Standard Deviation 25.8
|
10.4 mm
Standard Deviation 28.8
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline, Week 24Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=228 Participants
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
n=229 Participants
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
n=227 Participants
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
|---|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
Absenteeism Week 12
|
2.6 percentage of impairment
Standard Deviation 23.5
|
-6.3 percentage of impairment
Standard Deviation 26.5
|
2.5 percentage of impairment
Standard Deviation 24.7
|
|
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
Absenteeism Week 24
|
-2.1 percentage of impairment
Standard Deviation 13.9
|
-3.8 percentage of impairment
Standard Deviation 28.2
|
4.0 percentage of impairment
Standard Deviation 27.2
|
|
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
Presenteeism Week 12
|
-8 percentage of impairment
Standard Deviation 26
|
-17 percentage of impairment
Standard Deviation 25
|
-15 percentage of impairment
Standard Deviation 27
|
|
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
Presenteeism Week 24
|
-17 percentage of impairment
Standard Deviation 26
|
-20 percentage of impairment
Standard Deviation 23
|
-17 percentage of impairment
Standard Deviation 21
|
|
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
Work Productivity Loss Week 12
|
-4.2 percentage of impairment
Standard Deviation 27.7
|
-17.6 percentage of impairment
Standard Deviation 30.4
|
-9.9 percentage of impairment
Standard Deviation 23.7
|
|
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
Work Producivity Loss Week 24
|
-15.9 percentage of impairment
Standard Deviation 26.1
|
-19.6 percentage of impairment
Standard Deviation 25.0
|
-14.3 percentage of impairment
Standard Deviation 23.0
|
|
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
Activity Impairment Week 12
|
-13 percentage of impairment
Standard Deviation 25
|
-19 percentage of impairment
Standard Deviation 27
|
-19 percentage of impairment
Standard Deviation 25
|
|
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
Activity Impairment Week 24
|
-18 percentage of impairment
Standard Deviation 27
|
-23 percentage of impairment
Standard Deviation 28
|
-21 percentage of impairment
Standard Deviation 27
|
SECONDARY outcome
Timeframe: Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24:predosePopulation: All randomized participants who received at least 1 dose of study drug with evaluable PK data.
Outcome measures
| Measure |
Placebo
n=246 Participants
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
n=245 Participants
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
|---|---|---|---|
|
Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104
|
70.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 26.2
|
138 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 25.7
|
—
|
SECONDARY outcome
Timeframe: Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24; predosePopulation: All randomized participants who received at least 1 dose of study drug with evaluable PK data.
Outcome measures
| Measure |
Placebo
n=246 Participants
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
n=245 Participants
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 mg
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
|---|---|---|---|
|
Population PK: Maximum Concentration at Steady State of Dosing (AUC,ss) of LY3009104
|
637 nanograms per mL per hour (ng/mL*h)
Geometric Coefficient of Variation 44.5
|
1210 nanograms per mL per hour (ng/mL*h)
Geometric Coefficient of Variation 47
|
—
|
Adverse Events
Placebo-Treatment Period
Serious events: 13 serious events
Other events: 105 other events
Deaths: 0 deaths
Baricitinib 2 Mg-Treatment Period
Serious events: 6 serious events
Other events: 108 other events
Deaths: 0 deaths
Baricitinib 4 Mg-Treatment Period
Serious events: 12 serious events
Other events: 127 other events
Deaths: 0 deaths
Rescue
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo-Follow Up
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Baricitinib 2 mg- Follow Up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Baricitinib 4 mg- Follow Up
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo-Treatment Period
n=228 participants at risk
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-Treatment Period
n=229 participants at risk
Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 Mg-Treatment Period
n=227 participants at risk
Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Rescue
n=91 participants at risk
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
|
Placebo-Follow Up
n=17 participants at risk
No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
|
Baricitinib 2 mg- Follow Up
n=19 participants at risk
No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
|
Baricitinib 4 mg- Follow Up
n=22 participants at risk
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.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.44%
1/228 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/227 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/229 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.44%
1/228 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.44%
1/228 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.44%
1/228 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/227 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.44%
1/228 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/227 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
5.9%
1/17 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/227 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.44%
1/228 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
1.1%
1/91 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/227 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/229 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/227 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
5.9%
1/17 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.88%
2/228 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/229 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/227 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/227 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.44%
1/228 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
1.1%
1/91 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Viral infection
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/227 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.44%
1/228 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/227 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.88%
2/228 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.44%
1/228 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/227 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.44%
1/228 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.44%
1/228 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/227 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/227 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/227 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Polymyositis
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
5.9%
1/17 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.44%
1/228 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/227 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.44%
1/228 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/229 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.44%
1/228 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.44%
1/228 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/229 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
0.44%
1/228 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.44%
1/228 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/229 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/229 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic bronchitis
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/227 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/227 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/227 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/227 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/229 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/227 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.44%
1/228 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Placebo-Treatment Period
n=228 participants at risk
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-Treatment Period
n=229 participants at risk
Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Baricitinib 4 Mg-Treatment Period
n=227 participants at risk
Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
|
Rescue
n=91 participants at risk
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
|
Placebo-Follow Up
n=17 participants at risk
No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
|
Baricitinib 2 mg- Follow Up
n=19 participants at risk
No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
|
Baricitinib 4 mg- Follow Up
n=22 participants at risk
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.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.6%
6/228 • Number of events 6
All randomized participants who received at least 1 dose of study drug.
|
2.6%
6/229 • Number of events 6
All randomized participants who received at least 1 dose of study drug.
|
1.8%
4/227 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
2.2%
5/229 • Number of events 5
All randomized participants who received at least 1 dose of study drug.
|
1.3%
3/227 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.44%
1/228 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
2.2%
5/229 • Number of events 5
All randomized participants who received at least 1 dose of study drug.
|
1.8%
4/227 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
1.3%
3/228 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
3.1%
7/229 • Number of events 7
All randomized participants who received at least 1 dose of study drug.
|
2.2%
5/227 • Number of events 5
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.4%
10/228 • Number of events 11
All randomized participants who received at least 1 dose of study drug.
|
4.4%
10/229 • Number of events 11
All randomized participants who received at least 1 dose of study drug.
|
1.8%
4/227 • Number of events 5
All randomized participants who received at least 1 dose of study drug.
|
2.2%
2/91 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
5.9%
1/17 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.88%
2/228 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/229 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
2.2%
5/227 • Number of events 5
All randomized participants who received at least 1 dose of study drug.
|
2.2%
2/91 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.2%
5/228 • Number of events 5
All randomized participants who received at least 1 dose of study drug.
|
0.87%
2/229 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/227 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
2.2%
2/91 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lip disorder
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
2.2%
5/229 • Number of events 6
All randomized participants who received at least 1 dose of study drug.
|
1.3%
3/227 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
3.5%
8/228 • Number of events 9
All randomized participants who received at least 1 dose of study drug.
|
3.1%
7/229 • Number of events 7
All randomized participants who received at least 1 dose of study drug.
|
2.2%
5/227 • Number of events 5
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
4/228 • Number of events 5
All randomized participants who received at least 1 dose of study drug.
|
3.1%
7/229 • Number of events 7
All randomized participants who received at least 1 dose of study drug.
|
1.8%
4/227 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
2.2%
2/91 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
2.2%
5/228 • Number of events 5
All randomized participants who received at least 1 dose of study drug.
|
0.87%
2/229 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
2.2%
5/227 • Number of events 5
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
2.6%
6/228 • Number of events 6
All randomized participants who received at least 1 dose of study drug.
|
1.3%
3/229 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
1.3%
3/227 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.88%
2/228 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/229 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
2.2%
5/227 • Number of events 7
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
5.9%
1/17 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
4.8%
11/228 • Number of events 12
All randomized participants who received at least 1 dose of study drug.
|
2.6%
6/229 • Number of events 7
All randomized participants who received at least 1 dose of study drug.
|
3.1%
7/227 • Number of events 8
All randomized participants who received at least 1 dose of study drug.
|
2.2%
2/91 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.44%
1/228 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
1.7%
4/229 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
4.0%
9/227 • Number of events 9
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
7.9%
18/228 • Number of events 19
All randomized participants who received at least 1 dose of study drug.
|
4.4%
10/229 • Number of events 10
All randomized participants who received at least 1 dose of study drug.
|
7.9%
18/227 • Number of events 22
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
1.3%
3/228 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
2.6%
6/229 • Number of events 6
All randomized participants who received at least 1 dose of study drug.
|
3.5%
8/227 • Number of events 8
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
5.9%
1/17 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
2.6%
6/228 • Number of events 6
All randomized participants who received at least 1 dose of study drug.
|
1.3%
3/229 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
1.8%
4/227 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.9%
18/228 • Number of events 19
All randomized participants who received at least 1 dose of study drug.
|
6.1%
14/229 • Number of events 16
All randomized participants who received at least 1 dose of study drug.
|
10.6%
24/227 • Number of events 26
All randomized participants who received at least 1 dose of study drug.
|
2.2%
2/91 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.8%
4/228 • Number of events 5
All randomized participants who received at least 1 dose of study drug.
|
5.2%
12/229 • Number of events 13
All randomized participants who received at least 1 dose of study drug.
|
4.0%
9/227 • Number of events 9
All randomized participants who received at least 1 dose of study drug.
|
3.3%
3/91 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.88%
2/228 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
2.2%
5/229 • Number of events 6
All randomized participants who received at least 1 dose of study drug.
|
2.2%
5/227 • Number of events 6
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.44%
1/228 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
1.3%
3/229 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
2.6%
6/227 • Number of events 7
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
3.5%
8/229 • Number of events 8
All randomized participants who received at least 1 dose of study drug.
|
6.6%
15/227 • Number of events 17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
5.9%
1/17 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.88%
2/228 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
2.2%
5/229 • Number of events 5
All randomized participants who received at least 1 dose of study drug.
|
4.0%
9/227 • Number of events 9
All randomized participants who received at least 1 dose of study drug.
|
4.4%
4/91 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.88%
2/228 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.87%
2/229 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
2.6%
6/227 • Number of events 6
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
3/228 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
2.6%
6/229 • Number of events 8
All randomized participants who received at least 1 dose of study drug.
|
2.6%
6/227 • Number of events 6
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.4%
10/228 • Number of events 10
All randomized participants who received at least 1 dose of study drug.
|
3.9%
9/229 • Number of events 9
All randomized participants who received at least 1 dose of study drug.
|
2.2%
5/227 • Number of events 5
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
1.8%
4/228 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
1.3%
3/229 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
3.1%
7/227 • Number of events 9
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
3.5%
8/228 • Number of events 10
All randomized participants who received at least 1 dose of study drug.
|
6.6%
15/229 • Number of events 17
All randomized participants who received at least 1 dose of study drug.
|
4.0%
9/227 • Number of events 10
All randomized participants who received at least 1 dose of study drug.
|
3.3%
3/91 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
3.1%
7/228 • Number of events 7
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/227 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/45
All randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/13
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/6
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/4
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/3
All randomized participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/189
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/184
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/187
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/78
All randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
3/228 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
3.9%
9/229 • Number of events 11
All randomized participants who received at least 1 dose of study drug.
|
4.0%
9/227 • Number of events 10
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.88%
2/228 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
1.7%
4/229 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
4.0%
9/227 • Number of events 9
All randomized participants who received at least 1 dose of study drug.
|
3.3%
3/91 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
2.2%
2/91 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.8%
4/228 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
0.44%
1/229 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
2.6%
6/227 • Number of events 6
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/228
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/229
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/227
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
5.9%
1/17 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.88%
2/228 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
4.4%
10/229 • Number of events 10
All randomized participants who received at least 1 dose of study drug.
|
2.6%
6/227 • Number of events 6
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/91
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/22
All randomized participants who received at least 1 dose of study drug.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60