Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis
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
2 other identifiers
interventional
508
17 countries
104
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
Started Feb 2016
Typical duration for phase_2 rheumatoid-arthritis
104 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2015
CompletedFirst Posted
Study publicly available on registry
December 23, 2015
CompletedStudy Start
First participant enrolled
February 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 3, 2018
CompletedResults Posted
Study results publicly available
May 28, 2019
CompletedMay 28, 2019
May 1, 2019
2.2 years
December 21, 2015
May 1, 2019
May 2, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
Week 12
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
Week 12
Secondary Outcomes (18)
Percentage of Participants Achieving American College of Rheumatology 20% Response Over Time From Baseline to Week 12
Baseline, Day 15, Day 29, Day 57, Day 85
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Over Time From Baseline to Week 12
Baseline, Day 15, Day 29, Day 57, Day 85
Percentage of Participants Achieving American College of Rheumatology 70% Response Over Time From Baseline to Week 12
Baseline, Day 15, Day 29, Day 57, Day 85
Percentage of Participants Achieving < 2.6 Response in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score at Week 12
Week 12
Percentage of Participants Achieving < 2.6 Response in Disease Activity Score for 28 Joints Erythrocyte Sedimentation Rate (DAS28--ESR) Score at Week 12
Week 12
- +13 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo + Methotrexate dose as specified
Dose Level 1
EXPERIMENTALBMS-986142 at dose level 1+ Methotrexate as specified
Dose Level 2
EXPERIMENTALBMS-986142 at dose level 2 + Methotrexate as specified
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (104)
Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama, 35801, United States
St. Joseph Heritage Medical Group
Fullerton, California, 92835, United States
C.V Mehta M.D Medical Corp
Hemet, California, 92543, United States
HCP Clinical Research, LLC
Huntington Beach, California, 92646, United States
Leon Medical Research
Miami, Florida, 33015, United States
San Marcus Research Clinic, Inc.
Miami, Florida, 33015, United States
Coral Research Clinic Corp
Miami, Florida, 33175, United States
Precision Research Organization
Miami Lakes, Florida, 33016, United States
The Arthritis Center
Palm Harbor, Florida, 34684, United States
Vizae Clinical Trials Management
Pembroke Pines, Florida, 33026, United States
Integral Rheumatology & Immunology Specialists
Plantation, Florida, 33324, United States
North Georgia Rheumatology Group
Lawrenceville, Georgia, 30046, United States
Arthritis And Diabetes Clinic
Monroe, Louisiana, 71203, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01605, United States
Aa Mrc Llc
Grand Blanc, Michigan, 48439, United States
Albuquerque Center For Rheumatology
Albuquerque, New Mexico, 87102, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102, United States
Paramount Medical Research & Consulting, Llc
Middleburg Heights, Ohio, 44130, United States
East Penn Rheumatology
Bethlehem, Pennsylvania, 18015, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635-8406, United States
Advanced Rheumatology & Arthritis Research Center, P.C
Wexford, Pennsylvania, 15090, United States
Local Institution
Wyomissing, Pennsylvania, 19610, United States
West Tennessee Research Institute
Jackson, Tennessee, 38305, United States
Pharma Tex Research
Amarillo, Texas, 79106, United States
Tekton Research Inc
Austin, Texas, 78745, United States
Southwest Rheumatology Research LLC
Mesquite, Texas, 75150, United States
Local Institution
Capital Federal, Buenos Aires, 1015, Argentina
Aprillus Asistencia e Investigacion
Capital Federal, Buenos Aires, Argentina
Instituto De Rehabilitacion Psicofisica
Buenos Aires, 1428, Argentina
Instituto Reumatologico Strusberg
Córdoba, 5000, Argentina
Universitaetsklinik Fuer Innere Medizin 3
Vienna, 1090, Austria
Local Institution
Goiânia, Goiás, 74110-120, Brazil
Local Institution
Juiz de Fora, Minas Gerais, 36010570, Brazil
Local Institution
Curitiba, Paraná, 80030-110, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, 90480-000, Brazil
Local Institution
Santo André, São Paulo, 09190510, Brazil
Local Institution
São Paulo, 04032-060, Brazil
Local Institution
São Paulo, 04266-010, Brazil
Aggarwal And Associates
Brampton, Ontario, L6T 0G1, Canada
Dr. Anil K Gupta Med Prof Corp
Toronto, Ontario, M9V 4B4, Canada
Local Institution
Corbeil-Essonnes, 91100, France
Local Institution
Montpellier, 34295, France
Local Institution
Orléans, 45067, France
Local Institution
Strasbourg, 67098, France
Asklepios Gesundheitszentrum
Elmshorn, Germany
Medizinsche Universitaetsklinik Freiburg
Freiburg im Breisgau, 79106, Germany
Smo.Md Gmbh
Magdeburg, 39120, Germany
Local Institution
Florence, 50139, Italy
Local Institution
Padua, 35128, Italy
Local Institution
Nagoya, Aichi-ken, 4578511, Japan
Local Institution
Fukuoka, Fukuoka, 8108563, Japan
Local Institution
Kitakyushu-shi, Fukuoka, 8078555, Japan
Local Institution
Sapporo, Hokkaido, 0608604, Japan
Local Institution
Sapporo, Hokkaido, 0608648, Japan
Local Institution
Sapporo, Hokkaido, 0630811, Japan
Local Institution
Kato-shi, Hyōgo, 6731462, Japan
Local Institution
Sagamihara-shi, Kanagawa, 2520392, Japan
Local Institution
Kumamoto, Kumamoto, 8620976, Japan
Local Institution
Sendai, Miyagi, 9808574, Japan
Local Institution
Sasebo-shi, Nagasaki, 8571195, Japan
Local Institution
Kawachi-Nagano, Osaka, 5868521, Japan
Local Institution
Osaka, Osaka, 5458586, Japan
Local Institution
Iruma-gun, Saitama, 3500495, Japan
Local Institution
Kawagoe-shi, Saitama, 3508550, Japan
Local Institution
Hamamatsu, Shizuoka, 4308558, Japan
Local Institution
Chuo-ku, Tokyo, 1048560, Japan
Local Institution
Itabashi-ku, Tokyo, 1738610, Japan
Local Institution
Meguro-ku, Tokyo, 1538515, Japan
Local Institution
Shinjuku-Ku, Tokyo, 1608582, Japan
Local Institution
Osaki-shi, 9896183, Japan
CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.
Mexico City, Distrito Fededral, 11850, Mexico
Consultorio Privado de Especialidad
Guadalajara, Jalisco, 42650, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S.C.
Guadalajara, Jalisco, 44650, Mexico
Local Institution
Monterrey, Nuevo León, 64460, Mexico
Local Institution
Villahermosa, Tabasco, 86190, Mexico
Unidad Reumatologica Las Americas, S.C. P.
Mérida, Yucatán, 97000, Mexico
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.
Distrito Federal, 03100, Mexico
Maasstad Ziekenhuis Rotterdam
Rotterdam, 3079 DZ, Netherlands
Nzoz Osteo-Medic S.C. A. Racewicz, J.Supronik
Bialystok, 15-351, Poland
Local Institution
Bialystok, 15-879, Poland
Centrum Badan Klinicznych JCI Life Science Park
Krakow, 30-348, Poland
Local Institution
Lublin, 20-954, Poland
Local Institution
Nadarzyn, 05-830, Poland
Local Institution
Poznan, 60-218, Poland
Local Institution
Warsaw, 00-465, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw, 02-637, Poland
Local Institution
Warsaw, 02-691, Poland
Local Institution
Moscow, 119049, Russia
Local Institution
Moscow, 121374, Russia
Local Institution
Saint Petersburg, 191124, Russia
Local Institution
Saint Petersburg, 194356, Russia
Local Institution
Tolyatti, 445039, Russia
Local Institution
Benoni, Gauteng, 1500, South Africa
Local Institution
Cape Town, Western Cape, 7500, South Africa
Local Institution
George, Western Cape, 6529, South Africa
Local Institution
Somerset West, Western Cape, 7129, South Africa
Local Institution
Daegu, 41931, South Korea
Local Institution
Seoul, 03080, South Korea
Local Institution
A Coruña, 15006, Spain
Fundacion Jimenez Diaz
Madrid, 28040, Spain
Local Institution
Santiago Compostela, 15702, Spain
Local Institution
Taichung, 402, Taiwan
Local Institution
Taipei, 11031, Taiwan
Related Publications (1)
Conaghan PG, Nowak M, Du S, Luo Y, Landis J, Pachai C, Fura A, Catlett IM, Grasela DM, Ostergaard M. Evaluation of BMS-986142, a reversible Bruton's tyrosine kinase inhibitor, for the treatment of rheumatoid arthritis: a phase 2, randomised, double-blind, dose-ranging, placebo-controlled, adaptive design study. Lancet Rheumatol. 2023 May;5(5):e263-e273. doi: 10.1016/S2665-9913(23)00089-9.
PMID: 38251590DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb Study Director
Study Officials
- STUDY DIRECTOR
Bristol Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2015
First Posted
December 23, 2015
Study Start
February 16, 2016
Primary Completion
May 3, 2018
Study Completion
May 3, 2018
Last Updated
May 28, 2019
Results First Posted
May 28, 2019
Record last verified: 2019-05