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Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02638948
Recruitment Status : Completed
First Posted : December 23, 2015
Results First Posted : May 28, 2019
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: BMS-986142
Drug: Placebo
Drug: Methotrexate
Enrollment 508
Recruitment Details  
Pre-assignment Details Out of 508 participants who signed the informed consent form and were enrolled in the study; 248 participants were randomized, and 247 participants were administered study drug (1 participant did not take any double-blind study medication).
Arm/Group Title Placebo BMS 100mg BMS 200mg BMS 350mg
Hide Arm/Group Description Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks. Oral dose of BMS-986142 100mg was administered daily for 12 weeks. Oral dose of BMS-986142 200mg was administered daily for 12 weeks. Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
Period Title: Overall Study
Started 75 73 73 26
Completed 66 62 66 18
Not Completed 9 11 7 8
Reason Not Completed
Withdrawal by Subject             4             5             3             1
Administrative Reason by Sponsor             0             1             0             4
Adverse Event             0             0             1             1
Lack of Efficacy             1             1             0             0
Lost to Follow-up             0             0             1             1
Poor/Non-Compliance             0             2             1             0
Participant no longer met study criteria             0             1             0             0
Other than specified above             4             1             1             1
Arm/Group Title Placebo BMS 100mg BMS 200mg BMS 350mg Total
Hide Arm/Group Description Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks. Oral dose of BMS-986142 100mg was administered daily for 12 weeks. Oral dose of BMS-986142 200mg was administered daily for 12 weeks. Oral dose of BMS-986142 350mg was administered daily for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 75 73 73 26 247
Hide Baseline Analysis Population Description
All randomized and treated participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 73 participants 73 participants 26 participants 247 participants
58.6  (11.61) 57.6  (13.01) 55.2  (13.13) 52.9  (13.16) 56.7  (12.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 73 participants 73 participants 26 participants 247 participants
Female
64
  85.3%
67
  91.8%
62
  84.9%
21
  80.8%
214
  86.6%
Male
11
  14.7%
6
   8.2%
11
  15.1%
5
  19.2%
33
  13.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 73 participants 73 participants 26 participants 247 participants
Hispanic or Latino
22
  29.3%
24
  32.9%
28
  38.4%
10
  38.5%
84
  34.0%
Not Hispanic or Latino
27
  36.0%
24
  32.9%
25
  34.2%
8
  30.8%
84
  34.0%
Unknown or Not Reported
26
  34.7%
25
  34.2%
20
  27.4%
8
  30.8%
79
  32.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 73 participants 73 participants 26 participants 247 participants
White
52
  69.3%
54
  74.0%
58
  79.5%
24
  92.3%
188
  76.1%
Black or African American
6
   8.0%
9
  12.3%
5
   6.8%
1
   3.8%
21
   8.5%
Asian
14
  18.7%
8
  11.0%
8
  11.0%
1
   3.8%
31
  12.6%
Other
3
   4.0%
2
   2.7%
2
   2.7%
0
   0.0%
7
   2.8%
1.Primary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Hide Description ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: tender joint count (TJC); swollen joint count (SJC); levels of an acute phase reactant C-reactive Protein levels (CRP); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by health assessment questionnaire disability index (HAQ-DI). ACR20 is defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR20 = (number of participants with measure/event of interest)/(number of particpants in the analysis)*100
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA).
Arm/Group Title Placebo BMS 100mg BMS 200mg BMS 350mg
Hide Arm/Group Description:
Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
Overall Number of Participants Analyzed 75 73 73 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
30.7
(20.2 to 41.1)
35.6
(24.6 to 46.6)
42.5
(31.1 to 53.8)
30.8
(13.0 to 48.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BMS 100mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5224
Comments Threshold for significance = 0.05
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of Difference (%)
Estimated Value 4.9
Confidence Interval (2-Sided) 95%
-10.2 to 20.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, BMS 200mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1360
Comments Threshold for significance = 0.05
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of Difference (%)
Estimated Value 11.8
Confidence Interval (2-Sided) 95%
-3.6 to 27.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, BMS 350mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9922
Comments Threshold for significance = 0.05
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of Difference (%)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-20.5 to 20.7
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12
Hide Description ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ--DI. ACR70 is defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR70 = (number of participants with measure/event of interest)/(number of particpants in the analysis)*100
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA)
Arm/Group Title Placebo BMS 100mg BMS 200mg BMS 350mg
Hide Arm/Group Description:
Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
Overall Number of Participants Analyzed 75 73 73 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
4.0
(0.8 to 11.2)
4.1
(0.9 to 11.5)
9.6
(2.8 to 16.3)
3.8
(0.1 to 19.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BMS 100mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments Threshold for significance = 0.05
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of Difference (%)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-16.0 to 16.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, BMS 200mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2058
Comments Threshold for significance = 0.05
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of Difference (%)
Estimated Value 5.6
Confidence Interval (2-Sided) 95%
-10.5 to 21.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, BMS 350mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments Threshold for significance = 0.05
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of Difference (%)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-22.5 to 22.2
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20% Response Over Time From Baseline to Week 12
Hide Description ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: tender joint count (TJC); swollen joint count (SJC); levels of an acute phase reactant C-reactive Protein levels (CRP); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by health assessment questionnaire disability index (HAQ-DI). ACR20 is defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR20 = (number of participants with measure/event of interest)/(number of particpants in the analysis)*100
Time Frame Baseline, Day 15, Day 29, Day 57, Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA)
Arm/Group Title Placebo BMS 100mg BMS 200mg BMS 350mg
Hide Arm/Group Description:
Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
Overall Number of Participants Analyzed 75 73 73 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Baseline (Day 1)
0.0 [1] 
(NA to NA)
0.0 [1] 
(NA to NA)
0.0 [1] 
(NA to NA)
0.0 [1] 
(NA to NA)
Day 15
10.7
(3.7 to 17.7)
13.7
(5.8 to 21.6)
24.7
(14.8 to 34.5)
15.4
(4.4 to 34.9)
Day 29
18.7
(9.8 to 27.5)
23.3
(13.6 to 33.0)
21.9
(12.4 to 31.4)
26.9
(9.9 to 44.0)
Day 57
28.0
(17.8 to 38.2)
41.1
(29.8 to 52.4)
39.7
(28.5 to 51.0)
15.4
(4.4 to 34.9)
Day 85
30.7
(20.2 to 41.1)
35.6
(24.6 to 46.6)
42.5
(31.1 to 53.8)
30.8
(13.0 to 48.5)
[1]
Here 'NA' signifies not estimable (NE): number of participants with ACR20% response was zero due to which 95% confidence interval was NE
4.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Over Time From Baseline to Week 12
Hide Description ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ--DI. ACR70 is defined as achieving at least 50% improvement in both TJC and SJC, and at least 50% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR50 = (number of participants with measure/event of interest)/(number of particpants in the analysis)*100
Time Frame Baseline, Day 15, Day 29, Day 57, Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA)
Arm/Group Title Placebo BMS 100mg BMS 200mg BMS 350mg
Hide Arm/Group Description:
Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
Overall Number of Participants Analyzed 75 73 73 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Baseline (Day 1)
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
Day 15
2.7
(0.3 to 9.3)
4.1
(0.9 to 11.5)
5.5
(1.5 to 13.4)
3.8
(0.1 to 19.6)
Day 29
2.7
(0.3 to 9.3)
4.1
(0.9 to 11.5)
6.8
(1.1 to 12.6)
7.7
(0.9 to 25.1)
Day 57
9.3
(2.7 to 15.9)
12.3
(4.8 to 19.9)
13.7
(5.8 to 21.6)
7.7
(0.9 to 25.1)
Day 85
9.3
(2.7 to 15.9)
13.7
(5.8 to 21.6)
16.4
(7.9 to 24.9)
11.5
(2.4 to 30.2)
[1]
Here 'NA' signifies not estimable (NE): number of participants with ACR50% response was zero due to which 95% confidence interval was NE
5.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 70% Response Over Time From Baseline to Week 12
Hide Description ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ--DI. ACR70 is defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR70 = (number of participants with measure/event of interest)/(number of particpants in the analysis)*100
Time Frame Baseline, Day 15, Day 29, Day 57, Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA)
Arm/Group Title Placebo BMS 100mg BMS 200mg BMS 350mg
Hide Arm/Group Description:
Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
Overall Number of Participants Analyzed 75 73 73 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Baseline (Day 1)
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
Day 15
1.3
(0.0 to 7.2)
0.0
(0.0 to 4.9)
1.4
(0.0 to 7.4)
0.0
(0.0 to 13.2)
Day 29
0.0 [2] 
(NA to NA)
0.0 [3] 
(NA to NA)
0.0 [3] 
(NA to NA)
0.0 [3] 
(NA to NA)
Day 57
1.3
(0.0 to 7.2)
5.5
(1.5 to 13.4)
5.5
(1.5 to 13.4)
3.8
(0.1 to 19.6)
Day 85
4.0
(0.8 to 11.2)
4.1
(0.9 to 11.5)
9.6
(2.8 to 16.3)
3.8
(0.1 to 19.6)
[1]
Here 'NA' signifies not estimable (NE): number of participants with ACR70% response was zero due to which 95% confidence interval was NE
[2]
Here 'NA' signifies not estimable (NE): number of participants with ACR70% response was zero due to which 95% confidence interval was NE.
[3]
Here 'NA' signifies NE: number of participants with ACR70% response was zero due to which 95% confidence interval was NE.
6.Secondary Outcome
Title Percentage of Participants Achieving < 2.6 Response in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score at Week 12
Hide Description DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the ACR rheumatoid arthritis (RA) core set questionnaire (participant global assessment) in 100 mm visual analog scale (VAS). Marker of inflammation assessed by the high sensitivity C-reactive protein (hs-CRP) in mg/L. The DAS28 score provides a number indicating the current disease activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA)
Arm/Group Title Placebo BMS 100mg BMS 200mg BMS 350mg
Hide Arm/Group Description:
Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
Overall Number of Participants Analyzed 75 73 73 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
6.7
(1.0 to 12.3)
9.6
(2.8 to 16.3)
11.0
(3.8 to 18.1)
0.0
(0.0 to 13.2)
7.Secondary Outcome
Title Percentage of Participants Achieving < 2.6 Response in Disease Activity Score for 28 Joints Erythrocyte Sedimentation Rate (DAS28--ESR) Score at Week 12
Hide Description DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA)
Arm/Group Title Placebo BMS 100mg BMS 200mg BMS 350mg
Hide Arm/Group Description:
Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
Overall Number of Participants Analyzed 75 73 73 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.0
(0.0 to 4.8)
6.8
(1.1 to 12.6)
1.4
(0.0 to 7.4)
0.0
(0.0 to 13.2)
8.Secondary Outcome
Title Percentage of Participants Achieving <= 2.8 Response in Clinical Disease Activity Index (CDAI) Score at Week 12
Hide Description CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: TJC (28 joints), SJC (28 joints), Participant's Global Assessment of Disease Activity VAS (in cm), and Physician's Global Assessment of Disease VAS (in cm). Total scores ranges from 0 to 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA)
Arm/Group Title Placebo BMS 100mg BMS 200mg BMS 350mg
Hide Arm/Group Description:
Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
Overall Number of Participants Analyzed 75 73 73 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.0
(0.0 to 4.8)
6.8
(1.1 to 12.6)
6.8
(1.1 to 12.6)
0.0
(0.0 to 13.2)
9.Secondary Outcome
Title Percentage of Participants Achieving <= 3.3 Response in Simple Disease Activity Index (SDAI) Score at Week 12
Hide Description The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on a VAS scale ranging from 0 to 10 cm, where higher scores indicate greater affection due to disease activity, and CRP measured in terms of milligram per deciliter (mg/dL). SDAI total score ranges from 0 to 86. SDAI <= 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA)
Arm/Group Title Placebo BMS 100mg BMS 200mg BMS 350mg
Hide Arm/Group Description:
Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
Overall Number of Participants Analyzed 75 73 73 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.0
(0.0 to 4.8)
6.8
(1.1 to 12.6)
6.8
(1.1 to 12.6)
0.0
(0.0 to 13.2)
10.Secondary Outcome
Title Percentage of Participants Achieving Boolean Remission Criteria at Week 12
Hide Description Boolean remission criteria was defined as: tender joint count28 <= 1; swollen joint count28 <= 1; physician's global assessment <= 1; and CRP <= 1 mg/deciliter.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA)
Arm/Group Title Placebo BMS 100mg BMS 200mg BMS 350mg
Hide Arm/Group Description:
Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
Overall Number of Participants Analyzed 75 73 73 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
1.3
(0.0 to 7.2)
4.1
(0.9 to 11.5)
4.1
(0.9 to 11.5)
0.0
(0.0 to 13.2)
11.Secondary Outcome
Title Change From Baseline in DAS28-CRP Score Over Time up to Week 12
Hide Description DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the ACR rheumatoid arthritis (RA) core set questionnaire (participant global assessment) in 100 mm visual analog scale (VAS). Marker of inflammation assessed by the high sensitivity C-reactive protein (hs-CRP) in mg/L. The DAS28 score provides a number indicating the current disease activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission.
Time Frame Baseline, Day 85 (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here 'N' signifies number of participants analyzed who were evaluable for this outcome measure.
Arm/Group Title Placebo BMS 100mg BMS 200mg BMS 350mg
Hide Arm/Group Description:
Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
Overall Number of Participants Analyzed 64 63 64 15
Mean (Standard Error)
Unit of Measure: Units on a scale
-1.1  (0.141) -1.1  (0.176) -1.4  (0.168) -1.4  (0.194)
12.Secondary Outcome
Title Change From Baseline in DAS28-ESR Score Over Time up to Week 12
Hide Description DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here 'N' signifies number of participants analyzed who were evaluable for this outcome measure.
Arm/Group Title Placebo BMS 100mg BMS 200mg BMS 350mg
Hide Arm/Group Description:
Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
Overall Number of Participants Analyzed 64 63 65 14
Mean (Standard Error)
Unit of Measure: Units on a scale
-1.1  (0.149) -1.1  (0.166) -1.4  (0.161) -1.5  (0.247)
13.Secondary Outcome
Title Change From Baseline in CDAI Score Over Time up to Week 12
Hide Description CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: TJC (28 joints), SJC (28 joints), Participant's Global Assessment of Disease Activity VAS (in cm), and Physician's Global Assessment of Disease VAS (in cm). Total scores ranges from 0 to 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here 'N' signifies number of participants analyzed who were evaluable for this outcome measure.
Arm/Group Title Placebo BMS 100mg BMS 200mg BMS 350mg
Hide Arm/Group Description:
Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
Overall Number of Participants Analyzed 65 61 68 16
Mean (Standard Error)
Unit of Measure: Units on a scale
-14.9  (1.591) -13.6  (2.030) -16.0  (1.828) -17.6  (2.519)
14.Secondary Outcome
Title Change From Baseline in SDAI Score Over Time up to Week 12
Hide Description The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores indicate greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score ranges from 0 to 86. SDAI <= 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here 'N' signifies number of participants analyzed who were evaluable for this outcome measure.
Arm/Group Title Placebo BMS 100mg BMS 200mg BMS 350mg
Hide Arm/Group Description:
Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
Overall Number of Participants Analyzed 64 61 64 15
Mean (Standard Error)
Unit of Measure: Units on a scale
-14.8  (1.628) -13.9  (2.090) -16.6  (1.954) -18.9  (3.218)
15.Secondary Outcome
Title Number of Participants With Adverse Events (AEs), and Serious AEs (SAEs)
Hide Description An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, or a congenital anomaly, or a medically important event.
Time Frame Up to 30 days after treatment discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants.
Arm/Group Title Placebo BMS 100mg BMS 200mg BMS 350mg
Hide Arm/Group Description:
Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
Overall Number of Participants Analyzed 75 73 73 26
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
36
  48.0%
39
  53.4%
39
  53.4%
19
  73.1%
SAEs
4
   5.3%
2
   2.7%
0
   0.0%
0
   0.0%
16.Secondary Outcome
Title Trough Observed Plasma Concentration (Ctrough) of BMS-986142
Hide Description Ctrough was defined as trough observed plasma concentration.
Time Frame Week 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on pharmacokinetic population which included all participants who received BMS-986142 and had any available concentration-time data.
Arm/Group Title BMS 100mg BMS 200mg BMS 350mg
Hide Arm/Group Description:
Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
Overall Number of Participants Analyzed 73 73 26
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram/mL
Week 4 Number Analyzed 60 participants 61 participants 16 participants
47.9
(119.0%)
111.8
(101.7%)
195.9
(91.9%)
Week 8 Number Analyzed 54 participants 60 participants 18 participants
41.2
(95.3%)
92.2
(124.5%)
283.0
(133.3%)
Week 12 Number Analyzed 55 participants 52 participants 13 participants
28.4
(123.0%)
75.6
(155.4%)
169.5
(83.2%)
17.Secondary Outcome
Title Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Synovitis at Week 4 and 12
Hide Description Synovitis is assessed in 3 wrist regions (A. the distal radioulnar joint; B. the radiocarpal joint; C. the intercarpal and carpometacarpophalangeal, CMC, joints) and in each MCP joint. For each wrist region, possible score ranges from 0-3, with 0=normal, 1=mild, 2=moderate, and 3=severe damage. The total synovitis score per wrist=the sum of the individual scores for the 3 wrist regions. Minimum score per wrist ranges from 0, indicating no damage, to 9 (score of 3*3 wrist regions), indicating most severe damage. A negative change from baseline indicates improvement.
Time Frame Week 4 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here number analyzed = number of randomized and treated participants with non-missing value at each time point
Arm/Group Title Placebo BMS 100mg BMS 200mg BMS 350mg
Hide Arm/Group Description:
Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
Overall Number of Participants Analyzed 75 73 73 26
Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 4 Number Analyzed 68 participants 66 participants 70 participants 23 participants
0.1  (0.226) -0.2  (0.202) 0.1  (0.182) 0.1  (0.558)
Week 12 Number Analyzed 68 participants 66 participants 70 participants 23 participants
0.7  (0.467) -0.0  (0.315) -0.3  (0.263) 0.9  (1.163)
18.Secondary Outcome
Title Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Osteitis at Week 4 and 12
Hide Description Osteitis was assessed at a total of 23 anatomic locations: 15 in 1 wrist and 8 in the hand of the same side. Each site is scored in 1.0 increments from 0 to 3, indicating involvement of original articular bone. The total score for the hands/wrists is the sum of the individual scores for each location. Thus the maximum score achievable per hand/wrist is 23 (total number of anatomic locations) * 3 (maximum per joint)=69. Minimum score=0, indicating normal. Increasing score=greater severity. A negative change from baseline indicates improvement.
Time Frame Week 4, and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here number analyzed = number of randomized and treated participants with non-missing value at each time point
Arm/Group Title Placebo BMS 100mg BMS 200mg BMS 350mg
Hide Arm/Group Description:
Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
Overall Number of Participants Analyzed 75 73 73 26
Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 4 Number Analyzed 64 participants 65 participants 69 participants 22 participants
0.1  (0.223) 0.2  (0.262) 0.1  (0.148) -0.1  (0.249)
Week 12 Number Analyzed 64 participants 65 participants 69 participants 22 participants
0.4  (0.574) 0.5  (0.451) 0.0  (0.257) 0.2  (0.654)
19.Secondary Outcome
Title Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Bone Erosion at Week 4 and 12
Hide Description Bone erosion assessed at a total of 23 anatomic locations: 15 in 1 wrist and 8 in the hand of the same side. Each site is scored in 1.0 increments from 0 (no damage) to 10 (severe damage) according to erosion of the original articular bone (each unit=10% loss of articular bone). The total erosion score for the hands/wrists is the sum of the individual scores for each location. Thus the maximum score achievable per hand/wrist is 230. Increasing score=greater severity.A negative change from baseline indicates improvement.
Time Frame Week 4 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here number analyzed = number of randomized and treated participants with non-missing value at each time point
Arm/Group Title Placebo BMS 100mg BMS 200mg BMS 350mg
Hide Arm/Group Description:
Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
Overall Number of Participants Analyzed 75 73 73 26
Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 4 Number Analyzed 69 participants 67 participants 70 participants 23 participants
0.1  (0.048) 0.1  (0.089) -0.0  (0.036) 0.0  (0.030)
Week 12 Number Analyzed 69 participants 67 participants 70 participants 23 participants
0.1  (0.048) 0.3  (0.248) 0.0  (0.046) 0.1  (0.072)
20.Secondary Outcome
Title Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Cartilage Loss at Week 4 and 12
Hide Description Cartilage loss was assessed by MRI. Scans of 25 joints were read and scored for each participant by assessors. Scores for each location ranged 0-4 on a 9-point scale, with 0= no cartilage loss and 4= complete cartilage loss. Total score was the sum of the 25 individual scores and ranged 0-100 with 0= no cartilage loss and 100= most severe cartilage loss. A negative change from baseline indicates improvement.
Time Frame Week 4, and Week12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here number analyzed = number of randomized and treated participants with non-missing value at each time point
Arm/Group Title Placebo BMS 100mg BMS 200mg BMS 350mg
Hide Arm/Group Description:
Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
Oral dose of BMS-986142 100mg was administered daily for 12 weeks.
Oral dose of BMS-986142 200mg was administered daily for 12 weeks.
Oral dose of BMS-986142 350mg was administered daily for 12 weeks.
Overall Number of Participants Analyzed 75 73 73 26
Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 4 Number Analyzed 69 participants 67 participants 70 participants 23 participants
0.1  (0.105) 0.0  (0.064) -0.0  (0.079) 0.4  (0.169)
Week 12 Number Analyzed 69 participants 67 participants 70 participants 23 participants
0.0  (0.116) 0.3  (0.139) 0.0  (0.111) 0.5  (0.294)
Time Frame All Adverse Events were collected from signature of the informed consent until 30 days after last treatment administration. (Approximately 26 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BMS-986142 100mg BMS-986142 200mg BMS-986142 350mg Placebo
Hide Arm/Group Description Oral dose of BMS-986142 100mg was administered daily for 12 weeks. Oral dose of BMS-986142 200mg was administered daily for 12 weeks. Oral dose of BMS-986142 350mg was administered daily for 12 weeks. Oral dose of matching placebo for BMS-986142 was administered daily for 12 weeks.
All-Cause Mortality
BMS-986142 100mg BMS-986142 200mg BMS-986142 350mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/73 (0.00%)   0/73 (0.00%)   0/26 (0.00%)   0/75 (0.00%) 
Hide Serious Adverse Events
BMS-986142 100mg BMS-986142 200mg BMS-986142 350mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/73 (2.74%)   0/73 (0.00%)   0/26 (0.00%)   4/75 (5.33%) 
Cardiac disorders         
Angina pectoris  1  1/73 (1.37%)  0/73 (0.00%)  0/26 (0.00%)  0/75 (0.00%) 
Gastrointestinal disorders         
Intestinal obstruction  1  1/73 (1.37%)  0/73 (0.00%)  0/26 (0.00%)  0/75 (0.00%) 
Mouth ulceration  1  0/73 (0.00%)  0/73 (0.00%)  0/26 (0.00%)  1/75 (1.33%) 
Injury, poisoning and procedural complications         
Open globe injury  1  0/73 (0.00%)  0/73 (0.00%)  0/26 (0.00%)  1/75 (1.33%) 
Musculoskeletal and connective tissue disorders         
Rheumatoid arthritis  1  0/73 (0.00%)  0/73 (0.00%)  0/26 (0.00%)  1/75 (1.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Endometrial adenocarcinoma  1  0/73 (0.00%)  0/73 (0.00%)  0/26 (0.00%)  1/75 (1.33%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BMS-986142 100mg BMS-986142 200mg BMS-986142 350mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/73 (16.44%)   17/73 (23.29%)   14/26 (53.85%)   11/75 (14.67%) 
Blood and lymphatic system disorders         
Anaemia  1  1/73 (1.37%)  3/73 (4.11%)  2/26 (7.69%)  1/75 (1.33%) 
Infections and infestations         
Nasopharyngitis  1  4/73 (5.48%)  3/73 (4.11%)  0/26 (0.00%)  2/75 (2.67%) 
Urinary tract infection  1  5/73 (6.85%)  6/73 (8.22%)  5/26 (19.23%)  1/75 (1.33%) 
Investigations         
Alanine aminotransferase increased  1  0/73 (0.00%)  1/73 (1.37%)  5/26 (19.23%)  3/75 (4.00%) 
Aspartate aminotransferase increased  1  0/73 (0.00%)  1/73 (1.37%)  2/26 (7.69%)  2/75 (2.67%) 
Blood alkaline phosphatase increased  1  0/73 (0.00%)  0/73 (0.00%)  4/26 (15.38%)  0/75 (0.00%) 
Metabolism and nutrition disorders         
Dyslipidaemia  1  1/73 (1.37%)  3/73 (4.11%)  6/26 (23.08%)  2/75 (2.67%) 
Nervous system disorders         
Headache  1  2/73 (2.74%)  4/73 (5.48%)  2/26 (7.69%)  2/75 (2.67%) 
1
Term from vocabulary, MedDRA 21.0
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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period <=60 days from submitting for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb Study Director
Phone: Please email
EMail: clinical.trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02638948    
Other Study ID Numbers: IM006-016
2015-002887-17 ( EudraCT Number )
First Submitted: December 21, 2015
First Posted: December 23, 2015
Results First Submitted: May 1, 2019
Results First Posted: May 28, 2019
Last Update Posted: May 28, 2019