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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-986142
Placebo
Methotrexate
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Male and female age 18 and above
  • Diagnosed with active rheumatoid arthritis (RA) by standard criteria at least 16 weeks before screening, have functional ACR class I-III
  • Have an inadequate response to methotrexate
  • In addition to an inadequate response to methotrexate have an inadequate response or intolerance to 1 but not more than 2 TNF inhibitors
  • Have a minimum of 6 swollen and 6 tender joints (from 66/68 joint count)
  • Have hsCRP of ≥ 0.8 mg/dL (8mg/L) [by central laboratory values] or an ESR ≥ 28 mm/hr
  • Willing to use effective birth control for the entire length of the study

Exclusion Criteria:

  • Diagnosed with juvenile Rheumatoid Arthritis
  • Have been treated with other biologic treatment than a TNF inhibitor
  • Active systemic bacterial, viral or fungal infection or evidence of prior or current Hepatitis B or C infection or HIV infection, latent bacterial, viral or fungal infections
  • Have been treated with Intramuscular or Intra-articular glucocorticosteroids within 4 weeks of randomization
  • Taking Oral steroids at dose above 10 mg/day of prednisone (or prednisone equivalents)
  • Have other autoimmune disease other than RA like lupus, multiple sclerosis
  • Have significant concurrent medical condition at the time of screening or baseline visit

Sites / Locations

  • Rheumatology Associates Of North Alabama, P.C.
  • St. Joseph Heritage Medical Group
  • C.V Mehta M.D Medical Corp
  • HCP Clinical Research, LLC
  • Precision Research Organization
  • Leon Medical Research
  • San Marcus Research Clinic, Inc.
  • Coral Research Clinic Corp
  • The Arthritis Center
  • Vizae Clinical Trials Management
  • Integral Rheumatology & Immunology Specialists
  • North Georgia Rheumatology Group
  • Arthritis And Diabetes Clinic
  • Clinical Pharmacology Study Group
  • Aa Mrc Llc
  • Albuquerque Center For Rheumatology
  • Albuquerque Clinical Trials
  • Paramount Medical Research & Consulting, Llc
  • East Penn Rheumatology
  • Altoona Center For Clinical Research
  • Advanced Rheumatology & Arthritis Research Center, P.C
  • Local Institution
  • West Tennessee Research Institute
  • Pharma Tex Research
  • Tekton Research Inc
  • Southwest Rheumatology Research LLC
  • Local Institution
  • Aprillus Asistencia e Investigacion
  • Instituto De Rehabilitacion Psicofisica
  • Instituto Reumatologico Strusberg
  • Universitaetsklinik Fuer Innere Medizin 3
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Aggarwal And Associates
  • Dr. Anil K Gupta Med Prof Corp
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Asklepios Gesundheitszentrum
  • Medizinsche Universitaetsklinik Freiburg
  • Smo.Md Gmbh
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.
  • Consultorio Privado de Especialidad
  • Clinica de Investigacion en Reumatologia y Obesidad S.C.
  • Local Institution
  • Local Institution
  • Unidad Reumatologica Las Americas, S.C. P.
  • Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.
  • Maasstad Ziekenhuis Rotterdam
  • Nzoz Osteo-Medic S.C. A. Racewicz, J.Supronik
  • Local Institution
  • Centrum Badan Klinicznych JCI Life Science Park
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Fundacion Jimenez Diaz
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Dose Level 1

Dose Level 2

Arm Description

Placebo + Methotrexate dose as specified

BMS-986142 at dose level 1+ Methotrexate as specified

BMS-986142 at dose level 2 + Methotrexate as specified

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
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
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12
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

Secondary Outcome Measures

Percentage of Participants Achieving American College of Rheumatology 20% Response Over Time From Baseline to Week 12
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
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Over Time From Baseline to Week 12
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
Percentage of Participants Achieving American College of Rheumatology 70% Response Over Time From Baseline to Week 12
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
Percentage of Participants Achieving < 2.6 Response in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score at Week 12
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.
Percentage of Participants Achieving < 2.6 Response in Disease Activity Score for 28 Joints Erythrocyte Sedimentation Rate (DAS28--ESR) Score at Week 12
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.
Percentage of Participants Achieving <= 2.8 Response in Clinical Disease Activity Index (CDAI) Score at Week 12
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.
Percentage of Participants Achieving <= 3.3 Response in Simple Disease Activity Index (SDAI) Score at Week 12
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.
Percentage of Participants Achieving Boolean Remission Criteria at Week 12
Boolean remission criteria was defined as: tender joint count28 <= 1; swollen joint count28 <= 1; physician's global assessment <= 1; and CRP <= 1 mg/deciliter.
Change From Baseline in DAS28-CRP Score Over Time up to Week 12
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.
Change From Baseline in DAS28-ESR Score Over Time up to Week 12
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.
Change From Baseline in CDAI Score Over Time up to Week 12
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.
Change From Baseline in SDAI Score Over Time up to Week 12
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.
Number of Participants With Adverse Events (AEs), and Serious AEs (SAEs)
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.
Trough Observed Plasma Concentration (Ctrough) of BMS-986142
Ctrough was defined as trough observed plasma concentration.
Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Synovitis at Week 4 and 12
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.
Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Osteitis at Week 4 and 12
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.
Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Bone Erosion at Week 4 and 12
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.
Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Cartilage Loss at Week 4 and 12
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.

Full Information

First Posted
December 21, 2015
Last Updated
May 2, 2019
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02638948
Brief Title
Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis
Official Title
Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis With an Inadequate Response to Methotrexate With or Without TNF Inhibitors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 16, 2016 (Actual)
Primary Completion Date
May 3, 2018 (Actual)
Study Completion Date
May 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether the study drug, BMS-986142, is safe and effective in treating moderate to severe rheumatoid arthritis in subjects with an inadequate response to methotrexate or methotrexate and up to 2 tumour necrosis factor (TNF) Inhibitors. Patients who qualify will be randomized to either one of 3 doses of BMS-986142 or placebo in 1:1:1 randomization for 12 weeks. Disease activity and safety will be assessed over the course of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
508 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo + Methotrexate dose as specified
Arm Title
Dose Level 1
Arm Type
Experimental
Arm Description
BMS-986142 at dose level 1+ Methotrexate as specified
Arm Title
Dose Level 2
Arm Type
Experimental
Arm Description
BMS-986142 at dose level 2 + Methotrexate as specified
Intervention Type
Drug
Intervention Name(s)
BMS-986142
Intervention Description
BMS986142 specific dose on specific days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo of BMS-986142 specific dose on specific days
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Methotrexate specific dose on specific days
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
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
Title
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12
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
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving American College of Rheumatology 20% Response Over Time From Baseline to Week 12
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
Title
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Over Time From Baseline to Week 12
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
Title
Percentage of Participants Achieving American College of Rheumatology 70% Response Over Time From Baseline to Week 12
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
Title
Percentage of Participants Achieving < 2.6 Response in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score at Week 12
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
Title
Percentage of Participants Achieving < 2.6 Response in Disease Activity Score for 28 Joints Erythrocyte Sedimentation Rate (DAS28--ESR) Score at Week 12
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
Title
Percentage of Participants Achieving <= 2.8 Response in Clinical Disease Activity Index (CDAI) Score at Week 12
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
Title
Percentage of Participants Achieving <= 3.3 Response in Simple Disease Activity Index (SDAI) Score at Week 12
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
Title
Percentage of Participants Achieving Boolean Remission Criteria at Week 12
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
Title
Change From Baseline in DAS28-CRP Score Over Time up to Week 12
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)
Title
Change From Baseline in DAS28-ESR Score Over Time up to Week 12
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
Title
Change From Baseline in CDAI Score Over Time up to Week 12
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
Title
Change From Baseline in SDAI Score Over Time up to Week 12
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
Title
Number of Participants With Adverse Events (AEs), and Serious AEs (SAEs)
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
Title
Trough Observed Plasma Concentration (Ctrough) of BMS-986142
Description
Ctrough was defined as trough observed plasma concentration.
Time Frame
Week 4, 8, and 12
Title
Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Synovitis at Week 4 and 12
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
Title
Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Osteitis at Week 4 and 12
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
Title
Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Bone Erosion at Week 4 and 12
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
Title
Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Cartilage Loss at Week 4 and 12
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Male and female age 18 and above Diagnosed with active rheumatoid arthritis (RA) by standard criteria at least 16 weeks before screening, have functional ACR class I-III Have an inadequate response to methotrexate In addition to an inadequate response to methotrexate have an inadequate response or intolerance to 1 but not more than 2 TNF inhibitors Have a minimum of 6 swollen and 6 tender joints (from 66/68 joint count) Have hsCRP of ≥ 0.8 mg/dL (8mg/L) [by central laboratory values] or an ESR ≥ 28 mm/hr Willing to use effective birth control for the entire length of the study Exclusion Criteria: Diagnosed with juvenile Rheumatoid Arthritis Have been treated with other biologic treatment than a TNF inhibitor Active systemic bacterial, viral or fungal infection or evidence of prior or current Hepatitis B or C infection or HIV infection, latent bacterial, viral or fungal infections Have been treated with Intramuscular or Intra-articular glucocorticosteroids within 4 weeks of randomization Taking Oral steroids at dose above 10 mg/day of prednisone (or prednisone equivalents) Have other autoimmune disease other than RA like lupus, multiple sclerosis Have significant concurrent medical condition at the time of screening or baseline visit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Rheumatology Associates Of North Alabama, P.C.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
St. Joseph Heritage Medical Group
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
C.V Mehta M.D Medical Corp
City
Hemet
State/Province
California
ZIP/Postal Code
92543
Country
United States
Facility Name
HCP Clinical Research, LLC
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92646
Country
United States
Facility Name
Precision Research Organization
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Leon Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
San Marcus Research Clinic, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Coral Research Clinic Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
The Arthritis Center
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Vizae Clinical Trials Management
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Integral Rheumatology & Immunology Specialists
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
North Georgia Rheumatology Group
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Arthritis And Diabetes Clinic
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Aa Mrc Llc
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
Albuquerque Center For Rheumatology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Albuquerque Clinical Trials
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Paramount Medical Research & Consulting, Llc
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
East Penn Rheumatology
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Altoona Center For Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635-8406
Country
United States
Facility Name
Advanced Rheumatology & Arthritis Research Center, P.C
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States
Facility Name
Local Institution
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Pharma Tex Research
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Tekton Research Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Southwest Rheumatology Research LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1015
Country
Argentina
Facility Name
Aprillus Asistencia e Investigacion
City
Capital Federal
State/Province
Buenos Aires
Country
Argentina
Facility Name
Instituto De Rehabilitacion Psicofisica
City
Buenos Aires
ZIP/Postal Code
1428
Country
Argentina
Facility Name
Instituto Reumatologico Strusberg
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Universitaetsklinik Fuer Innere Medizin 3
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution
City
Goiania
State/Province
Goias
ZIP/Postal Code
74110-120
Country
Brazil
Facility Name
Local Institution
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36010570
Country
Brazil
Facility Name
Local Institution
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80030-110
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90480-000
Country
Brazil
Facility Name
Local Institution
City
Santo Andre
State/Province
SAO Paulo
ZIP/Postal Code
09190510
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
04032-060
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
Aggarwal And Associates
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Facility Name
Dr. Anil K Gupta Med Prof Corp
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9V 4B4
Country
Canada
Facility Name
Local Institution
City
Corbeil Essonnes
ZIP/Postal Code
91100
Country
France
Facility Name
Local Institution
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Local Institution
City
Orleans cedex 2
ZIP/Postal Code
45067
Country
France
Facility Name
Local Institution
City
Strasbourg Cedex
ZIP/Postal Code
67098
Country
France
Facility Name
Asklepios Gesundheitszentrum
City
Elmshorn
Country
Germany
Facility Name
Medizinsche Universitaetsklinik Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Smo.Md Gmbh
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Local Institution
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Local Institution
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4578511
Country
Japan
Facility Name
Local Institution
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
8108563
Country
Japan
Facility Name
Local Institution
City
Kitakyushu-shi
State/Province
Fukuoka
ZIP/Postal Code
8078555
Country
Japan
Facility Name
Local Institution
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
0608604
Country
Japan
Facility Name
Local Institution
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
0608648
Country
Japan
Facility Name
Local Institution
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
0630811
Country
Japan
Facility Name
Local Institution
City
Kato-shi
State/Province
Hyogo
ZIP/Postal Code
6731462
Country
Japan
Facility Name
Local Institution
City
Sagamihara-shi
State/Province
Kanagawa
ZIP/Postal Code
2520392
Country
Japan
Facility Name
Local Institution
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
8620976
Country
Japan
Facility Name
Local Institution
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Facility Name
Local Institution
City
Sasebo-shi
State/Province
Nagasaki
ZIP/Postal Code
8571195
Country
Japan
Facility Name
Local Institution
City
Kawachinagano
State/Province
Osaka
ZIP/Postal Code
5868521
Country
Japan
Facility Name
Local Institution
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
5458586
Country
Japan
Facility Name
Local Institution
City
Iruma-gun
State/Province
Saitama
ZIP/Postal Code
3500495
Country
Japan
Facility Name
Local Institution
City
Kawagoe-shi
State/Province
Saitama
ZIP/Postal Code
3508550
Country
Japan
Facility Name
Local Institution
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
4308558
Country
Japan
Facility Name
Local Institution
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
1048560
Country
Japan
Facility Name
Local Institution
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
1738610
Country
Japan
Facility Name
Local Institution
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
1538515
Country
Japan
Facility Name
Local Institution
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
1608582
Country
Japan
Facility Name
Local Institution
City
Osaki-shi
ZIP/Postal Code
9896183
Country
Japan
Facility Name
Local Institution
City
Daegu
ZIP/Postal Code
41931
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.
City
Mexico City
State/Province
Distrito Fededral
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Consultorio Privado de Especialidad
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
42650
Country
Mexico
Facility Name
Clinica de Investigacion en Reumatologia y Obesidad S.C.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Local Institution
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Local Institution
City
Villahermosa
State/Province
Tabasco
ZIP/Postal Code
86190
Country
Mexico
Facility Name
Unidad Reumatologica Las Americas, S.C. P.
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.
City
Distrito Federal
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Maasstad Ziekenhuis Rotterdam
City
Rotterdam
ZIP/Postal Code
3079 DZ
Country
Netherlands
Facility Name
Nzoz Osteo-Medic S.C. A. Racewicz, J.Supronik
City
Bialystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Local Institution
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Centrum Badan Klinicznych JCI Life Science Park
City
Krakow
ZIP/Postal Code
30-348
Country
Poland
Facility Name
Local Institution
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Local Institution
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Facility Name
Local Institution
City
Poznan
ZIP/Postal Code
60-218
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
00-465
Country
Poland
Facility Name
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
City
Warszawa
ZIP/Postal Code
02-637
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
02-691
Country
Poland
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
121374
Country
Russian Federation
Facility Name
Local Institution
City
Saint-Petersburg
ZIP/Postal Code
194356
Country
Russian Federation
Facility Name
Local Institution
City
St Petersburg
ZIP/Postal Code
191124
Country
Russian Federation
Facility Name
Local Institution
City
Tolyatti
ZIP/Postal Code
445039
Country
Russian Federation
Facility Name
Local Institution
City
Benoni
State/Province
Gauteng
ZIP/Postal Code
1500
Country
South Africa
Facility Name
Local Institution
City
Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Local Institution
City
George
State/Province
Western CAPE
ZIP/Postal Code
6529
Country
South Africa
Facility Name
Local Institution
City
Somerset West
State/Province
Western CAPE
ZIP/Postal Code
7129
Country
South Africa
Facility Name
Local Institution
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Local Institution
City
Santiago Compostela
ZIP/Postal Code
15702
Country
Spain
Facility Name
Local Institution
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
11031
Country
Taiwan

12. IPD Sharing Statement

Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

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