Trial Outcomes & Findings for A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis (RA) (NCT NCT02265705)
NCT ID: NCT02265705
Last Updated: 2019-09-11
Results Overview
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) \* 100.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
290 participants
Primary outcome timeframe
Week 12
Results posted on
2019-09-11
Participant Flow
Participants who did not respond (nonresponders) to study drug were eligible for rescue treatment (Tx) 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 Treatment Period Week 0-24
Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
|
4 Milligrams (mg) Baricitinib Treatment Period Week 0-24
4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
|
Rescue Treatment Period Week 16-52
All participants who are non-responders (both baricitinib and placebo arms) will receive rescue therapy at Week 16.
|
Placebo to Baricitinib Treatment Period Week 24 - 52
At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
|
4 mg Baricitinib Treatment Period Week 24-52
4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
|
Placebo Follow-up Period
Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
|
4 mg Baricitinib Follow-up Period
4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Treatment Period Week 0-24
STARTED
|
145
|
145
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period Week 0-24
Received at Least One Dose of Study Drug
|
145
|
145
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period Week 0-24
Rescued
|
59
|
17
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period Week 0-24
COMPLETED
|
133
|
136
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period Week 0-24
NOT COMPLETED
|
12
|
9
|
0
|
0
|
0
|
0
|
0
|
|
Rescue Period
STARTED
|
0
|
0
|
77
|
0
|
0
|
0
|
0
|
|
Rescue Period
COMPLETED
|
0
|
0
|
74
|
0
|
0
|
0
|
0
|
|
Rescue Period
NOT COMPLETED
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Open Label Period
STARTED
|
0
|
0
|
0
|
74
|
120
|
0
|
0
|
|
Open Label Period
COMPLETED
|
0
|
0
|
0
|
72
|
115
|
0
|
0
|
|
Open Label Period
NOT COMPLETED
|
0
|
0
|
0
|
2
|
5
|
0
|
0
|
|
Follow-up Period
STARTED
|
0
|
0
|
0
|
0
|
0
|
2
|
58
|
|
Follow-up Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
47
|
|
Follow-up Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
11
|
Reasons for withdrawal
| Measure |
Placebo Treatment Period Week 0-24
Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
|
4 Milligrams (mg) Baricitinib Treatment Period Week 0-24
4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
|
Rescue Treatment Period Week 16-52
All participants who are non-responders (both baricitinib and placebo arms) will receive rescue therapy at Week 16.
|
Placebo to Baricitinib Treatment Period Week 24 - 52
At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
|
4 mg Baricitinib Treatment Period Week 24-52
4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
|
Placebo Follow-up Period
Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
|
4 mg Baricitinib Follow-up Period
4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Treatment Period Week 0-24
Adverse Event
|
3
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period Week 0-24
Entry Criteria Not Met
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period Week 0-24
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period Week 0-24
Withdrawal by Subject
|
7
|
5
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period Week 0-24
Lack of Efficacy
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Rescue Period
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Rescue Period
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Rescue Period
Lack of Efficacy
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Open Label Period
Adverse Event
|
0
|
0
|
0
|
2
|
2
|
0
|
0
|
|
Open Label Period
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Open Label Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Follow-up Period
Sponsor Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
6
|
|
Follow-up Period
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Follow-up Period
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Follow-up Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis (RA)
Baseline characteristics by cohort
| Measure |
Placebo
n=145 Participants
Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
Participants will continue to take background MTX therapy throughout study. Other background therapies, including NSAIDs and low dose oral corticosteroids, are permitted during the study for participants who are on stable doses of these treatments at baseline.
Placebo: Administered orally
|
Baricitinib
n=145 Participants
4 milligrams (mg) baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
Participants will continue to take background methotrexate (MTX) therapy throughout study. Other background therapies, including non-steroidal anti-inflammatory drugs (NSAIDs) and low dose oral corticosteroids, are permitted during the study for participants who are on stable doses of these treatments at baseline.
Baricitinib: Administered orally
|
Total
n=290 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.9 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
49.5 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
49.2 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
115 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
115 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
115 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Duration of Rheumatoid Arthritis
|
9.1 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
10.7 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
9.9 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Tender Joint Count of 68 Evaluable Joints
|
25.2 Tender Joints
STANDARD_DEVIATION 14.7 • n=5 Participants
|
23.3 Tender Joints
STANDARD_DEVIATION 13.6 • n=7 Participants
|
24.2 Tender Joints
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
Swollen Joint Count of 66 Evaluable Joints
|
14.8 Swollen Joints
STANDARD_DEVIATION 9.5 • n=5 Participants
|
14.6 Swollen Joints
STANDARD_DEVIATION 8.6 • n=7 Participants
|
14.7 Swollen Joints
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
High Sensitivity C-Reactive Protein (hsCRP)
|
26.48 milligrams per liter (mg/L)
STANDARD_DEVIATION 31.27 • n=5 Participants
|
25.59 milligrams per liter (mg/L)
STANDARD_DEVIATION 23.53 • n=7 Participants
|
26.04 milligrams per liter (mg/L)
STANDARD_DEVIATION 27.63 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: All randomized participants who received at least one dose of the study drug.
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) \* 100.
Outcome measures
| Measure |
Placebo
n=145 Participants
Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
|
Baricitinib
n=145 Participants
4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20)
|
28.3 percentage of participants
|
58.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least one dose of the study drug and had an evaluable score at Week 12.
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 HAQ-DI scores, 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=145 Participants
Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
|
Baricitinib
n=144 Participants
4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
|
|---|---|---|
|
Change From Baseline to Week 12 in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score
|
-0.35 units on a scale
Standard Deviation 0.52
|
-0.57 units on a scale
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least one dose of study drug and had an evaluable score at Week 12.
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). 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 from 1.0-9.4, where lower scores indicated less disease activity, and remission was DAS28-CRP \<2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Outcome measures
| Measure |
Placebo
n=144 Participants
Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
|
Baricitinib
n=144 Participants
4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
|
|---|---|---|
|
Change From Baseline to Week 12 in Disease Activity Score Modified to Include the 28 Diarthroidal Joint Count (DAS28)-High Sensitivity C-Reactive Protein (hsCRP)
|
-0.94 units on a scale
Standard Deviation 1.04
|
-1.89 units on a scale
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least one dose of study drug.
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=145 Participants
Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
|
Baricitinib
n=145 Participants
4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
|
|---|---|---|
|
Proportion of Participants Achieving a Simplified Disease Activity Index (SDAI) Score < or Equal to 3.3
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least one dose of study drug and had an evaluable score at Week 12.
Participants recorded the duration of their morning joint stiffness (MJS) in hours and minutes into paper diaries daily. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit was calculated. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
Outcome measures
| Measure |
Placebo
n=145 Participants
Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
|
Baricitinib
n=144 Participants
4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
|
|---|---|---|
|
Median Duration of Morning Joint Stiffness in the 7 Days Prior to Week 12
|
47.6 minutes
Interval 30.0 to 67.9
|
24.3 minutes
Interval 15.0 to 30.6
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least one dose of study drug and had an evaluable score at Week 12.
Participants rated the severity of their morning joint stiffness by selecting a number from 0 to 10 that best described their overall level of morning joint stiffness from the time they woke up, where 0 represents "no joint stiffness" and 10 represents "joint stiffness as bad as you can imagine". Participants reported their severity daily in paper diaries. The average value across the 7 days preceding each visit was calculated.
Outcome measures
| Measure |
Placebo
n=145 Participants
Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
|
Baricitinib
n=144 Participants
4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
|
|---|---|---|
|
Mean Severity of Morning Joint Stiffness in the 7 Days Prior to Week 12
|
4.3 units on a scale
Standard Deviation 2.3
|
3.5 units on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least one dose of study drug and had an evaluable score at Week 12.
Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents "no tiredness" and 10 represents "as bad as you can imagine". Participants reported their worst tiredness in paper diaries. The average value across the 7 days preceding each visit is calculated.
Outcome measures
| Measure |
Placebo
n=145 Participants
Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
|
Baricitinib
n=144 Participants
4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
|
|---|---|---|
|
Mean Worst Tiredness Numeric Rating Scale (NRS) in the 7 Days Prior to Week 12
|
4.4 units on a scale
Standard Deviation 2.0
|
3.7 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least one dose of study drug and had evaluable score at Week 12.
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 paper diaries. The average value across the 7 days preceding each visit was calculated.
Outcome measures
| Measure |
Placebo
n=145 Participants
Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
|
Baricitinib
n=144 Participants
4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
|
|---|---|---|
|
Mean Worst Pain NRS in the 7 Days Prior to Week 12
|
5.0 units on a scale
Standard Deviation 1.8
|
4.1 units on a scale
Standard Deviation 1.9
|
Adverse Events
Placebo Treatment Period Week 0-24
Serious events: 4 serious events
Other events: 72 other events
Deaths: 0 deaths
4 Milligrams (mg) Baricitinib Treatment Period Week 0-24
Serious events: 4 serious events
Other events: 94 other events
Deaths: 0 deaths
Rescue Treatment Period Week 16-52
Serious events: 3 serious events
Other events: 38 other events
Deaths: 1 deaths
Placebo to Baricitinib Treatment Period Week 24 - 52
Serious events: 7 serious events
Other events: 31 other events
Deaths: 0 deaths
4 mg Baricitinib Treatment Period Week 24-52
Serious events: 3 serious events
Other events: 41 other events
Deaths: 0 deaths
Placebo Follow-up Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
4 mg Baricitinib Follow-up Period
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Treatment Period Week 0-24
n=145 participants at risk
Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
|
4 Milligrams (mg) Baricitinib Treatment Period Week 0-24
n=145 participants at risk
4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
|
Rescue Treatment Period Week 16-52
n=77 participants at risk
All participants who are non-responders (both baricitinib and placebo arms) will receive rescue therapy at Week 16.
|
Placebo to Baricitinib Treatment Period Week 24 - 52
n=74 participants at risk
At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
|
4 mg Baricitinib Treatment Period Week 24-52
n=120 participants at risk
4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
|
Placebo Follow-up Period
n=2 participants at risk
Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
|
4 mg Baricitinib Follow-up Period
n=58 participants at risk
4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.69%
1/145 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
1.4%
1/74 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Eye disorders
Cataract
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.83%
1/120 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
1.4%
1/74 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.69%
1/145 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Hypertrophic anal papilla
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
1.3%
1/77 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.69%
1/145 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.69%
1/145 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.83%
1/120 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Infections and infestations
Lung infection
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
1.4%
1/74 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
1.3%
1/77 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
1.4%
1/74 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.83%
1/120 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.69%
1/145 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Infections and infestations
Viral infection
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
1.4%
1/74 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
1.7%
1/58 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.69%
1/145 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.69%
1/145 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.69%
1/145 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.69%
1/145 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
1.4%
1/74 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
1.4%
1/74 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/106 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.79%
1/127 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
1.7%
1/58 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
1.3%
1/77 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.83%
1/120 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Renal and urinary disorders
Renal tubular acidosis
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
1.4%
1/74 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
Other adverse events
| Measure |
Placebo Treatment Period Week 0-24
n=145 participants at risk
Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
|
4 Milligrams (mg) Baricitinib Treatment Period Week 0-24
n=145 participants at risk
4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
|
Rescue Treatment Period Week 16-52
n=77 participants at risk
All participants who are non-responders (both baricitinib and placebo arms) will receive rescue therapy at Week 16.
|
Placebo to Baricitinib Treatment Period Week 24 - 52
n=74 participants at risk
At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
|
4 mg Baricitinib Treatment Period Week 24-52
n=120 participants at risk
4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
|
Placebo Follow-up Period
n=2 participants at risk
Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
|
4 mg Baricitinib Follow-up Period
n=58 participants at risk
4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.7%
14/145 • Number of events 18 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
8.3%
12/145 • Number of events 13 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.7%
2/74 • Number of events 2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.83%
1/120 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.4%
2/145 • Number of events 2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.1%
3/145 • Number of events 4 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.6%
2/77 • Number of events 3 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
3/145 • Number of events 10 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.69%
1/145 • Number of events 3 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.69%
1/145 • Number of events 2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.1%
3/145 • Number of events 3 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.6%
2/77 • Number of events 2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
2/145 • Number of events 2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.1%
3/145 • Number of events 3 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.7%
2/74 • Number of events 2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
1.7%
2/120 • Number of events 2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.7%
2/74 • Number of events 2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
3.4%
5/145 • Number of events 5 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.6%
2/77 • Number of events 2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.5%
3/120 • Number of events 3 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
General disorders
Asthenia
|
2.1%
3/145 • Number of events 3 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
General disorders
Pain
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.6%
2/77 • Number of events 2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
2.1%
3/145 • Number of events 3 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.69%
1/145 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.6%
2/77 • Number of events 2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.5%
3/120 • Number of events 3 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
4.1%
3/74 • Number of events 3 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
1.7%
2/120 • Number of events 2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.6%
2/77 • Number of events 3 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.5%
3/120 • Number of events 3 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.7%
2/74 • Number of events 2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.83%
1/120 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Infections and infestations
Nasopharyngitis
|
4.1%
6/145 • Number of events 9 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
6.9%
10/145 • Number of events 11 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
7.8%
6/77 • Number of events 6 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
5.4%
4/74 • Number of events 6 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
3.3%
4/120 • Number of events 5 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
15.2%
22/145 • Number of events 24 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
19.3%
28/145 • Number of events 37 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
9.1%
7/77 • Number of events 8 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
6.8%
5/74 • Number of events 5 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
9.2%
11/120 • Number of events 12 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Infections and infestations
Urinary tract infection
|
3.4%
5/145 • Number of events 5 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
9.0%
13/145 • Number of events 14 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
13.0%
10/77 • Number of events 11 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
5.4%
4/74 • Number of events 4 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.5%
3/120 • Number of events 3 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
6.2%
9/145 • Number of events 11 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
6.5%
5/77 • Number of events 5 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
6.8%
5/74 • Number of events 5 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
1.7%
2/120 • Number of events 2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Investigations
Blood pressure increased
|
0.69%
1/145 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.1%
3/145 • Number of events 3 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.8%
4/145 • Number of events 4 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.6%
2/77 • Number of events 2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.8%
4/145 • Number of events 4 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
3.4%
5/145 • Number of events 5 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
3.9%
3/77 • Number of events 3 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.5%
8/145 • Number of events 9 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
11.0%
16/145 • Number of events 16 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
7.8%
6/77 • Number of events 6 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
4.1%
3/74 • Number of events 3 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
7.5%
9/120 • Number of events 9 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.8%
4/145 • Number of events 5 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.1%
3/145 • Number of events 3 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.7%
2/74 • Number of events 2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.83%
1/120 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
9/145 • Number of events 9 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.6%
2/77 • Number of events 5 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
1.4%
1/74 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.5%
3/120 • Number of events 3 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
5.2%
3/58 • Number of events 3 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.1%
3/145 • Number of events 3 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Dizziness
|
3.4%
5/145 • Number of events 7 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.8%
4/145 • Number of events 4 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Headache
|
5.5%
8/145 • Number of events 20 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
3.4%
5/145 • Number of events 8 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.7%
2/74 • Number of events 2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/145 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/22 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
7.1%
1/14 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
2/145 • Number of events 2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
6.2%
9/145 • Number of events 9 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
3.9%
3/77 • Number of events 3 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.7%
2/74 • Number of events 2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.83%
1/120 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.69%
1/145 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.1%
3/145 • Number of events 3 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.69%
1/145 • Number of events 1 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
2.1%
3/145 • Number of events 3 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/77 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/74 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/120 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
|
Vascular disorders
Hypertension
|
5.5%
8/145 • Number of events 8 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
4.8%
7/145 • Number of events 7 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
5.2%
4/77 • Number of events 4 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
4.1%
3/74 • Number of events 4 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
5.0%
6/120 • Number of events 6 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/2 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
0.00%
0/58 • Start of treatment to end of study (Up To 52 Weeks)
All randomized participants who received at least one dose of the study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60