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Trial record 34 of 62 for:    Baricitinib

A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis (RA)

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ClinicalTrials.gov Identifier: NCT02265705
Recruitment Status : Completed
First Posted : October 16, 2014
Results First Posted : March 13, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Baricitinib
Drug: Placebo
Enrollment 290
Recruitment Details  
Pre-assignment Details

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.

Arm/Group Title Placebo Treatment Period Week 0-24 4 Milligrams (mg) Baricitinib Treatment Period Week 0-24 Rescue Treatment Period Week 16-52 Placebo to Baricitinib Treatment Period Week 24 - 52 4 mg Baricitinib Treatment Period Week 24-52 Placebo Follow-up Period 4 mg Baricitinib Follow-up Period
Hide Arm/Group Description 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 administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks. All participants who are non-responders (both baricitinib and placebo arms) will receive rescue therapy at Week 16. 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 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 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 administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
Period Title: Treatment Period Week 0-24
Started 145 145 0 0 0 0 0
Received at Least One Dose of Study Drug 145 145 0 0 0 0 0
Rescued 59 17 0 0 0 0 0
Completed 133 [1] 136 [1] 0 0 0 0 0
Not Completed 12 9 0 0 0 0 0
Reason Not Completed
Adverse Event             3             2             0             0             0             0             0
Entry Criteria Not Met             1             1             0             0             0             0             0
Physician Decision             1             0             0             0             0             0             0
Withdrawal by Subject             7             5             0             0             0             0             0
Lack of Efficacy             0             1             0             0             0             0             0
[1]
"Completers" include rescued participants.
Period Title: Rescue Period
Started 0 [1] 0 [1] 77 [2] 0 0 0 0
Completed 0 0 74 0 0 0 0
Not Completed 0 0 3 0 0 0 0
Reason Not Completed
Withdrawal by Subject             0             0             1             0             0             0             0
Death             0             0             1             0             0             0             0
Lack of Efficacy             0             0             1             0             0             0             0
[1]
Participants who were nonresponders based on tender/swollen joint count entered into rescue group.
[2]
Participants who were determined to be nonresponders based on tender/swollen joint count.
Period Title: Open Label Period
Started 0 0 0 74 [1] 120 [1] 0 0
Completed 0 0 0 72 115 0 0
Not Completed 0 0 0 2 5 0 0
Reason Not Completed
Adverse Event             0             0             0             2             2             0             0
Physician Decision             0             0             0             0             1             0             0
Withdrawal by Subject             0             0             0             0             2             0             0
[1]
Completed Wk 24 w/o rescue Tx, switched to or remained on active Tx, and entered Open Label Period.
Period Title: Follow-up Period
Started 0 0 0 0 0 2 [1] 58 [2]
Completed 0 0 0 0 0 1 47
Not Completed 0 0 0 0 0 1 11
Reason Not Completed
Sponsor Decision             0             0             0             0             0             1             6
Adverse Event             0             0             0             0             0             0             3
Physician Decision             0             0             0             0             0             0             1
Withdrawal by Subject             0             0             0             0             0             0             1
[1]
Participants from placebo who never rescued or switched and entered post-treatment follow-up period.
[2]
Participants who ever took baricitinib and entered the post-treatment follow-up period.
Arm/Group Title Placebo Baricitinib Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 145 145 290
Hide Baseline Analysis Population Description
Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least one dose of the study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 145 participants 145 participants 290 participants
48.9  (12.7) 49.5  (10.6) 49.2  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 145 participants 290 participants
Female 106 127 233
Male 39 18 57
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 145 participants 290 participants
Hispanic or Latino 0 0 0
Not Hispanic or Latino 115 116 231
Unknown or Not Reported 30 29 59
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 145 participants 290 participants
American Indian or Alaska Native 1 5 6
Asian 115 116 231
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 3 0 3
White 26 24 50
More than one race 0 0 0
Unknown or Not Reported 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 145 participants 290 participants
Argentina
22
  15.2%
21
  14.5%
43
  14.8%
China
115
  79.3%
116
  80.0%
231
  79.7%
Brazil
8
   5.5%
8
   5.5%
16
   5.5%
Duration of Rheumatoid Arthritis   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 145 participants 145 participants 290 participants
9.1  (7.0) 10.7  (8.3) 9.9  (7.7)
[1]
Measure Description: Time from symptom onset of Rheumatoid Arthritis.
Tender Joint Count of 68 Evaluable Joints   [1] 
Mean (Standard Deviation)
Unit of measure:  Tender Joints
Number Analyzed 145 participants 145 participants 290 participants
25.2  (14.7) 23.3  (13.6) 24.2  (14.2)
[1]
Measure Description: TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy.
Swollen Joint Count of 66 Evaluable Joints   [1] 
Mean (Standard Deviation)
Unit of measure:  Swollen Joints
Number Analyzed 145 participants 145 participants 290 participants
14.8  (9.5) 14.6  (8.6) 14.7  (9.1)
[1]
Measure Description: SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint.
High Sensitivity C-Reactive Protein (hsCRP)   [1] 
Mean (Standard Deviation)
Unit of measure:  Milligrams per liter (mg/L)
Number Analyzed 145 participants 145 participants 290 participants
26.48  (31.27) 25.59  (23.53) 26.04  (27.63)
[1]
Measure Description: hsCRP is a laboratory analyte that is an indicator of inflammation. Decreases in hsCRP represent reductions in inflammation.
1.Primary Outcome
Title Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20)
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of the study drug.
Arm/Group Title Placebo Baricitinib
Hide Arm/Group Description:
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 administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
Overall Number of Participants Analyzed 145 145
Measure Type: Number
Unit of Measure: percentage of participants
28.3 58.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Baricitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.1
Confidence Interval (2-Sided) 95%
2.5 to 6.9
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to Week 12 in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score
Hide Description The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of the study drug and had an evaluable score at Week 12.
Arm/Group Title Placebo Baricitinib
Hide Arm/Group Description:
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 administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
Overall Number of Participants Analyzed 145 144
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.35  (0.52) -0.57  (0.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Baricitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.31 to -0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.056
Estimation Comments [Not Specified]
3.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had an evaluable score at Week 12.
Arm/Group Title Placebo Baricitinib
Hide Arm/Group Description:
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 administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
Overall Number of Participants Analyzed 144 144
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.94  (1.04) -1.89  (1.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Baricitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.02
Confidence Interval (2-Sided) 95%
-1.25 to -0.79
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.116
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Proportion of Participants Achieving a Simplified Disease Activity Index (SDAI) Score < or Equal to 3.3
Hide Description SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Participant's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Placebo Baricitinib
Hide Arm/Group Description:
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 administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
Overall Number of Participants Analyzed 145 145
Measure Type: Count of Participants
Unit of Measure: Participants
0 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Baricitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-0.5 to 3.3
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Median Duration of Morning Joint Stiffness in the 7 Days Prior to Week 12
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had an evaluable score at Week 12.
Arm/Group Title Placebo Baricitinib
Hide Arm/Group Description:
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 administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
Overall Number of Participants Analyzed 145 144
Median (95% Confidence Interval)
Unit of Measure: minutes
47.6
(30.0 to 67.9)
24.3
(15.0 to 30.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Baricitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -12.9
Confidence Interval (2-Sided) 95%
-28.0 to -2.9
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Mean Severity of Morning Joint Stiffness in the 7 Days Prior to Week 12
Hide Description Participants rated the severity of their morning joint stiffness by selecting a number from 0 to 10 that best described their overall level of morning joint stiffness from the time they woke up, where 0 represents "no joint stiffness" and 10 represents "joint stiffness as bad as you can imagine". Participants reported their severity daily in paper diaries. The average value across the 7 days preceding each visit was calculated.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had an evaluable score at Week 12.
Arm/Group Title Placebo Baricitinib
Hide Arm/Group Description:
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 administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
Overall Number of Participants Analyzed 145 144
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.3  (2.3) 3.5  (2.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Baricitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-1.2 to -0.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Mean Worst Tiredness Numeric Rating Scale (NRS) in the 7 Days Prior to Week 12
Hide Description Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents "no tiredness" and 10 represents "as bad as you can imagine". Participants reported their worst tiredness in paper diaries. The average value across the 7 days preceding each visit is calculated.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had an evaluable score at Week 12.
Arm/Group Title Placebo Baricitinib
Hide Arm/Group Description:
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 administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
Overall Number of Participants Analyzed 145 144
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.4  (2.0) 3.7  (1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Baricitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-1.2 to -0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.20
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Mean Worst Pain NRS in the 7 Days Prior to Week 12
Hide Description Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents "no pain" and 10 represents "pain as bad as you can imagine". Participants reported their worst joint pain in daily paper diaries. The average value across the 7 days preceding each visit was calculated.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable score at Week 12.
Arm/Group Title Placebo Baricitinib
Hide Arm/Group Description:
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 administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
Overall Number of Participants Analyzed 145 144
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.0  (1.8) 4.1  (1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Baricitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-1.3 to -0.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.20
Estimation Comments [Not Specified]
Time Frame Start of treatment to end of study (Up To 52 Weeks)
Adverse Event Reporting Description All randomized participants who received at least one dose of the study drug.
 
Arm/Group Title Placebo Treatment Period Week 0-24 4 Milligrams (mg) Baricitinib Treatment Period Week 0-24 Rescue Treatment Period Week 16-52 Placebo to Baricitinib Treatment Period Week 24 - 52 4 mg Baricitinib Treatment Period Week 24-52 Placebo Follow-up Period 4 mg Baricitinib Follow-up Period
Hide Arm/Group Description 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 administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks. All participants who are non-responders (both baricitinib and placebo arms) will receive rescue therapy at Week 16. 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 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 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 administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
All-Cause Mortality
Placebo Treatment Period Week 0-24 4 Milligrams (mg) Baricitinib Treatment Period Week 0-24 Rescue Treatment Period Week 16-52 Placebo to Baricitinib Treatment Period Week 24 - 52 4 mg Baricitinib Treatment Period Week 24-52 Placebo Follow-up Period 4 mg Baricitinib Follow-up Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/145 (0.00%)      0/145 (0.00%)      1/77 (1.30%)      0/74 (0.00%)      0/120 (0.00%)      0/2 (0.00%)      0/58 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Treatment Period Week 0-24 4 Milligrams (mg) Baricitinib Treatment Period Week 0-24 Rescue Treatment Period Week 16-52 Placebo to Baricitinib Treatment Period Week 24 - 52 4 mg Baricitinib Treatment Period Week 24-52 Placebo Follow-up Period 4 mg Baricitinib Follow-up Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/145 (2.76%)      4/145 (2.76%)      3/77 (3.90%)      7/74 (9.46%)      3/120 (2.50%)      0/2 (0.00%)      1/58 (1.72%)    
Blood and lymphatic system disorders               
Anaemia  1  0/145 (0.00%)  0 1/145 (0.69%)  1 0/77 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Cardiac disorders               
Angina unstable  1  0/145 (0.00%)  0 0/145 (0.00%)  0 0/77 (0.00%)  0 1/74 (1.35%)  1 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Eye disorders               
Cataract  1  0/145 (0.00%)  0 0/145 (0.00%)  0 0/77 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/2 (0.00%)  0 0/58 (0.00%)  0
Gastrointestinal disorders               
Enteritis  1  0/145 (0.00%)  0 0/145 (0.00%)  0 0/77 (0.00%)  0 1/74 (1.35%)  1 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Gastric perforation  1  1/145 (0.69%)  1 0/145 (0.00%)  0 0/77 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Hypertrophic anal papilla  1  0/145 (0.00%)  0 0/145 (0.00%)  0 1/77 (1.30%)  1 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Infections and infestations               
Diverticulitis  1  0/145 (0.00%)  0 1/145 (0.69%)  1 0/77 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Herpes zoster  1  0/145 (0.00%)  0 1/145 (0.69%)  1 0/77 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/2 (0.00%)  0 0/58 (0.00%)  0
Lung infection  1  0/145 (0.00%)  0 0/145 (0.00%)  0 0/77 (0.00%)  0 1/74 (1.35%)  1 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Pneumonia  1  0/145 (0.00%)  0 0/145 (0.00%)  0 1/77 (1.30%)  1 1/74 (1.35%)  1 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Soft tissue infection  1  0/145 (0.00%)  0 0/145 (0.00%)  0 0/77 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/2 (0.00%)  0 0/58 (0.00%)  0
Upper respiratory tract infection  1  1/145 (0.69%)  1 0/145 (0.00%)  0 0/77 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Viral infection  1  0/145 (0.00%)  0 0/145 (0.00%)  0 0/77 (0.00%)  0 1/74 (1.35%)  1 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Injury, poisoning and procedural complications               
Subarachnoid haemorrhage  1  0/145 (0.00%)  0 0/145 (0.00%)  0 0/77 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 1/58 (1.72%)  1
Musculoskeletal and connective tissue disorders               
Arthralgia  1  1/145 (0.69%)  1 0/145 (0.00%)  0 0/77 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Gouty arthritis  1  1/145 (0.69%)  1 0/145 (0.00%)  0 0/77 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Intervertebral disc protrusion  1  0/145 (0.00%)  0 1/145 (0.69%)  1 0/77 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Rheumatoid arthritis  1  1/145 (0.69%)  1 0/145 (0.00%)  0 0/77 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Spinal disorder  1  0/145 (0.00%)  0 0/145 (0.00%)  0 0/77 (0.00%)  0 1/74 (1.35%)  1 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Lung adenocarcinoma  1  0/145 (0.00%)  0 0/145 (0.00%)  0 0/77 (0.00%)  0 1/74 (1.35%)  1 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Uterine leiomyoma  1  0/106 (0.00%)  0 1/127 (0.79%)  1 0/77 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Nervous system disorders               
Intracranial aneurysm  1  0/145 (0.00%)  0 0/145 (0.00%)  0 0/77 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 1/58 (1.72%)  1
Ischaemic stroke  1  0/145 (0.00%)  0 0/145 (0.00%)  0 1/77 (1.30%)  1 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Renal and urinary disorders               
Acute kidney injury  1  0/145 (0.00%)  0 0/145 (0.00%)  0 0/77 (0.00%)  0 0/74 (0.00%)  0 1/120 (0.83%)  1 0/2 (0.00%)  0 0/58 (0.00%)  0
Renal tubular acidosis  1  0/145 (0.00%)  0 0/145 (0.00%)  0 0/77 (0.00%)  0 1/74 (1.35%)  1 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Treatment Period Week 0-24 4 Milligrams (mg) Baricitinib Treatment Period Week 0-24 Rescue Treatment Period Week 16-52 Placebo to Baricitinib Treatment Period Week 24 - 52 4 mg Baricitinib Treatment Period Week 24-52 Placebo Follow-up Period 4 mg Baricitinib Follow-up Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   72/145 (49.66%)      94/145 (64.83%)      38/77 (49.35%)      31/74 (41.89%)      41/120 (34.17%)      0/2 (0.00%)      3/58 (5.17%)    
Blood and lymphatic system disorders               
Anaemia  1  14/145 (9.66%)  18 12/145 (8.28%)  13 0/77 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Leukopenia  1  0/145 (0.00%)  0 0/145 (0.00%)  0 0/77 (0.00%)  0 2/74 (2.70%)  2 1/120 (0.83%)  1 0/2 (0.00%)  0 0/58 (0.00%)  0
Lymphopenia  1  2/145 (1.38%)  2 3/145 (2.07%)  4 2/77 (2.60%)  3 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Gastrointestinal disorders               
Abdominal pain  1  3/145 (2.07%)  10 1/145 (0.69%)  3 0/77 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Abdominal pain upper  1  1/145 (0.69%)  2 3/145 (2.07%)  3 2/77 (2.60%)  2 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Diarrhoea  1  2/145 (1.38%)  2 3/145 (2.07%)  3 0/77 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Gastritis  1  0/145 (0.00%)  0 0/145 (0.00%)  0 0/77 (0.00%)  0 2/74 (2.70%)  2 2/120 (1.67%)  2 0/2 (0.00%)  0 0/58 (0.00%)  0
Hiatus hernia  1  0/145 (0.00%)  0 0/145 (0.00%)  0 0/77 (0.00%)  0 2/74 (2.70%)  2 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Toothache  1  0/145 (0.00%)  0 5/145 (3.45%)  5 2/77 (2.60%)  2 0/74 (0.00%)  0 3/120 (2.50%)  3 0/2 (0.00%)  0 0/58 (0.00%)  0
General disorders               
Asthenia  1  3/145 (2.07%)  3 0/145 (0.00%)  0 0/77 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Pain  1  0/145 (0.00%)  0 0/145 (0.00%)  0 2/77 (2.60%)  2 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Hepatobiliary disorders               
Hepatic function abnormal  1  3/145 (2.07%)  3 1/145 (0.69%)  1 2/77 (2.60%)  2 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Liver injury  1  0/145 (0.00%)  0 0/145 (0.00%)  0 0/77 (0.00%)  0 0/74 (0.00%)  0 3/120 (2.50%)  3 0/2 (0.00%)  0 0/58 (0.00%)  0
Infections and infestations               
Bronchitis  1  0/145 (0.00%)  0 0/145 (0.00%)  0 0/77 (0.00%)  0 3/74 (4.05%)  3 2/120 (1.67%)  2 0/2 (0.00%)  0 0/58 (0.00%)  0
Gastroenteritis  1  0/145 (0.00%)  0 0/145 (0.00%)  0 2/77 (2.60%)  3 0/74 (0.00%)  0 3/120 (2.50%)  3 0/2 (0.00%)  0 0/58 (0.00%)  0
Influenza  1  0/145 (0.00%)  0 0/145 (0.00%)  0 0/77 (0.00%)  0 2/74 (2.70%)  2 1/120 (0.83%)  1 0/2 (0.00%)  0 0/58 (0.00%)  0
Nasopharyngitis  1  6/145 (4.14%)  9 10/145 (6.90%)  11 6/77 (7.79%)  6 4/74 (5.41%)  6 4/120 (3.33%)  5 0/2 (0.00%)  0 0/58 (0.00%)  0
Upper respiratory tract infection  1  22/145 (15.17%)  24 28/145 (19.31%)  37 7/77 (9.09%)  8 5/74 (6.76%)  5 11/120 (9.17%)  12 0/2 (0.00%)  0 0/58 (0.00%)  0
Urinary tract infection  1  5/145 (3.45%)  5 13/145 (8.97%)  14 10/77 (12.99%)  11 4/74 (5.41%)  4 3/120 (2.50%)  3 0/2 (0.00%)  0 0/58 (0.00%)  0
Investigations               
Blood creatine phosphokinase increased  1  0/145 (0.00%)  0 9/145 (6.21%)  11 5/77 (6.49%)  5 5/74 (6.76%)  5 2/120 (1.67%)  2 0/2 (0.00%)  0 0/58 (0.00%)  0
Blood pressure increased  1  1/145 (0.69%)  1 3/145 (2.07%)  3 0/77 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Lymphocyte count decreased  1  0/145 (0.00%)  0 4/145 (2.76%)  4 2/77 (2.60%)  2 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Metabolism and nutrition disorders               
Hypercholesterolaemia  1  4/145 (2.76%)  4 5/145 (3.45%)  5 3/77 (3.90%)  3 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Hyperlipidaemia  1  8/145 (5.52%)  9 16/145 (11.03%)  16 6/77 (7.79%)  6 3/74 (4.05%)  3 9/120 (7.50%)  9 0/2 (0.00%)  0 0/58 (0.00%)  0
Hyperuricaemia  1  4/145 (2.76%)  5 3/145 (2.07%)  3 0/77 (0.00%)  0 2/74 (2.70%)  2 1/120 (0.83%)  1 0/2 (0.00%)  0 0/58 (0.00%)  0
Musculoskeletal and connective tissue disorders               
Arthralgia  1  9/145 (6.21%)  9 0/145 (0.00%)  0 2/77 (2.60%)  5 1/74 (1.35%)  1 3/120 (2.50%)  3 0/2 (0.00%)  0 3/58 (5.17%)  3
Joint swelling  1  3/145 (2.07%)  3 0/145 (0.00%)  0 0/77 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Nervous system disorders               
Dizziness  1  5/145 (3.45%)  7 4/145 (2.76%)  4 0/77 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Headache  1  8/145 (5.52%)  20 5/145 (3.45%)  8 0/77 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Hypoaesthesia  1  0/145 (0.00%)  0 0/145 (0.00%)  0 0/77 (0.00%)  0 2/74 (2.70%)  2 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Reproductive system and breast disorders               
Benign prostatic hyperplasia  1  0/145 (0.00%)  0 0/145 (0.00%)  0 0/77 (0.00%)  0 0/22 (0.00%)  0 1/14 (7.14%)  1 0/2 (0.00%)  0 0/58 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Cough  1  2/145 (1.38%)  2 9/145 (6.21%)  9 3/77 (3.90%)  3 2/74 (2.70%)  2 1/120 (0.83%)  1 0/2 (0.00%)  0 0/58 (0.00%)  0
Oropharyngeal pain  1  1/145 (0.69%)  1 3/145 (2.07%)  3 0/77 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Skin and subcutaneous tissue disorders               
Dermatitis allergic  1  1/145 (0.69%)  1 3/145 (2.07%)  3 0/77 (0.00%)  0 0/74 (0.00%)  0 0/120 (0.00%)  0 0/2 (0.00%)  0 0/58 (0.00%)  0
Vascular disorders               
Hypertension  1  8/145 (5.52%)  8 7/145 (4.83%)  7 4/77 (5.19%)  4 3/74 (4.05%)  4 6/120 (5.00%)  6 0/2 (0.00%)  0 0/58 (0.00%)  0
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: ClinicalTrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02265705     History of Changes
Other Study ID Numbers: 14875
I4V-CR-JAGS ( Other Identifier: Eli Lilly and Company )
First Submitted: October 13, 2014
First Posted: October 16, 2014
Results First Submitted: May 15, 2018
Results First Posted: March 13, 2019
Last Update Posted: September 11, 2019