Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    IM006-016
Previous Study | Return to List | Next Study

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 27, 2019
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: BMS-986142 Drug: Placebo Drug: Methotrexate Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 508 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 16, 2016
Actual Primary Completion Date : May 3, 2018
Actual Study Completion Date : May 3, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo + Methotrexate dose as specified
Drug: Placebo
Placebo of BMS-986142 specific dose on specific days

Drug: Methotrexate
Methotrexate specific dose on specific days

Experimental: Dose Level 1
BMS-986142 at dose level 1+ Methotrexate as specified
Drug: BMS-986142
BMS986142 specific dose on specific days

Drug: Methotrexate
Methotrexate specific dose on specific days

Experimental: Dose Level 2
BMS-986142 at dose level 2 + Methotrexate as specified
Drug: BMS-986142
BMS986142 specific dose on specific days

Drug: Methotrexate
Methotrexate specific dose on specific days




Primary Outcome Measures :
  1. Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 [ Time Frame: 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

  2. Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12 [ Time Frame: 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 :
  1. Percentage of Participants Achieving American College of Rheumatology 20% Response Over Time From Baseline to Week 12 [ Time Frame: Baseline, Day 15, Day 29, Day 57, Day 85 ]
    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

  2. Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Over Time From Baseline to Week 12 [ Time Frame: Baseline, Day 15, Day 29, Day 57, Day 85 ]
    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

  3. Percentage of Participants Achieving American College of Rheumatology 70% Response Over Time From Baseline to Week 12 [ Time Frame: Baseline, Day 15, Day 29, Day 57, Day 85 ]
    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

  4. Percentage of Participants Achieving < 2.6 Response in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score at Week 12 [ Time Frame: 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.

  5. Percentage of Participants Achieving < 2.6 Response in Disease Activity Score for 28 Joints Erythrocyte Sedimentation Rate (DAS28--ESR) Score at Week 12 [ Time Frame: 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.

  6. Percentage of Participants Achieving <= 2.8 Response in Clinical Disease Activity Index (CDAI) Score at Week 12 [ Time Frame: 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.

  7. Percentage of Participants Achieving <= 3.3 Response in Simple Disease Activity Index (SDAI) Score at Week 12 [ Time Frame: 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.

  8. Percentage of Participants Achieving Boolean Remission Criteria at Week 12 [ Time Frame: 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.

  9. Change From Baseline in DAS28-CRP Score Over Time up to Week 12 [ Time Frame: Baseline, Day 85 (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.

  10. Change From Baseline in DAS28-ESR Score Over Time up to Week 12 [ Time Frame: Baseline, 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.

  11. Change From Baseline in CDAI Score Over Time up to Week 12 [ Time Frame: Baseline, 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.

  12. Change From Baseline in SDAI Score Over Time up to Week 12 [ Time Frame: Baseline, 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.

  13. Number of Participants With Adverse Events (AEs), and Serious AEs (SAEs) [ Time Frame: Up to 30 days after treatment discontinuation ]
    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.

  14. Trough Observed Plasma Concentration (Ctrough) of BMS-986142 [ Time Frame: Week 4, 8, and 12 ]
    Ctrough was defined as trough observed plasma concentration.

  15. Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Synovitis at Week 4 and 12 [ Time Frame: Week 4 and Week 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.

  16. Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Osteitis at Week 4 and 12 [ Time Frame: Week 4, and Week 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.

  17. Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Bone Erosion at Week 4 and 12 [ Time Frame: Week 4 and Week 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.

  18. Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Cartilage Loss at Week 4 and 12 [ Time Frame: Week 4, and Week12 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638948


  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama, United States, 35801
United States, California
St. Joseph Heritage Medical Group
Fullerton, California, United States, 92835
C.V Mehta M.D Medical Corp
Hemet, California, United States, 92543
HCP Clinical Research, LLC
Huntington Beach, California, United States, 92646
United States, Florida
Precision Research Organization
Miami Lakes, Florida, United States, 33016
Leon Medical Research
Miami, Florida, United States, 33015
San Marcus Research Clinic, Inc.
Miami, Florida, United States, 33015
Coral Research Clinic Corp
Miami, Florida, United States, 33175
The Arthritis Center
Palm Harbor, Florida, United States, 34684
Vizae Clinical Trials Management
Pembroke Pines, Florida, United States, 33026
Integral Rheumatology & Immunology Specialists
Plantation, Florida, United States, 33324
United States, Georgia
North Georgia Rheumatology Group
Lawrenceville, Georgia, United States, 30046
United States, Louisiana
Arthritis And Diabetes Clinic
Monroe, Louisiana, United States, 71203
United States, Massachusetts
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States, 01605
United States, Michigan
Aa Mrc Llc
Grand Blanc, Michigan, United States, 48439
United States, New Mexico
Albuquerque Center For Rheumatology
Albuquerque, New Mexico, United States, 87102
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States, 87102
United States, Ohio
Paramount Medical Research & Consulting, Llc
Middleburg Heights, Ohio, United States, 44130
United States, Pennsylvania
East Penn Rheumatology
Bethlehem, Pennsylvania, United States, 18015
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States, 16635-8406
Advanced Rheumatology & Arthritis Research Center, P.C
Wexford, Pennsylvania, United States, 15090
Local Institution
Wyomissing, Pennsylvania, United States, 19610
United States, Tennessee
West Tennessee Research Institute
Jackson, Tennessee, United States, 38305
United States, Texas
Pharma Tex Research
Amarillo, Texas, United States, 79106
Tekton Research Inc
Austin, Texas, United States, 78745
Southwest Rheumatology Research LLC
Mesquite, Texas, United States, 75150
Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina, 1015
Aprillus Asistencia e Investigacion
Capital Federal, Buenos Aires, Argentina
Instituto De Rehabilitacion Psicofisica
Buenos Aires, Argentina, 1428
Instituto Reumatologico Strusberg
Cordoba, Argentina, 5000
Austria
Universitaetsklinik Fuer Innere Medizin 3
Wien, Austria, 1090
Brazil
Local Institution
Goiania, Goias, Brazil, 74110-120
Local Institution
Juiz de Fora, Minas Gerais, Brazil, 36010570
Local Institution
Curitiba, Parana, Brazil, 80030-110
Local Institution
Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
Local Institution
Porto Alegre, RIO Grande DO SUL, Brazil, 90480-000
Local Institution
Santo Andre, SAO Paulo, Brazil, 09190510
Local Institution
Sao Paulo, Brazil, 04032-060
Local Institution
Sao Paulo, Brazil, 04266-010
Canada, Ontario
Aggarwal And Associates
Brampton, Ontario, Canada, L6T 0G1
Dr. Anil K Gupta Med Prof Corp
Toronto, Ontario, Canada, M9V 4B4
France
Local Institution
Corbeil Essonnes, France, 91100
Local Institution
Montpellier Cedex 5, France, 34295
Local Institution
Orleans cedex 2, France, 45067
Local Institution
Strasbourg Cedex, France, 67098
Germany
Asklepios Gesundheitszentrum
Elmshorn, Germany
Medizinsche Universitaetsklinik Freiburg
Freiburg, Germany, 79106
Smo.Md Gmbh
Magdeburg, Germany, 39120
Italy
Local Institution
Firenze, Italy, 50139
Local Institution
Padova, Italy, 35128
Japan
Local Institution
Nagoya-shi, Aichi, Japan, 4578511
Local Institution
Fukuoka-shi, Fukuoka, Japan, 8108563
Local Institution
Kitakyushu-shi, Fukuoka, Japan, 8078555
Local Institution
Sapporo-shi, Hokkaido, Japan, 0608604
Local Institution
Sapporo-shi, Hokkaido, Japan, 0608648
Local Institution
Sapporo-shi, Hokkaido, Japan, 0630811
Local Institution
Kato-shi, Hyogo, Japan, 6731462
Local Institution
Sagamihara-shi, Kanagawa, Japan, 2520392
Local Institution
Kumamoto-shi, Kumamoto, Japan, 8620976
Local Institution
Sendai-shi, Miyagi, Japan, 9808574
Local Institution
Sasebo-shi, Nagasaki, Japan, 8571195
Local Institution
Kawachinagano, Osaka, Japan, 5868521
Local Institution
Osaka-shi, Osaka, Japan, 5458586
Local Institution
Iruma-gun, Saitama, Japan, 3500495
Local Institution
Kawagoe-shi, Saitama, Japan, 3508550
Local Institution
Hamamatsu-shi, Shizuoka, Japan, 4308558
Local Institution
Chuo-ku, Tokyo, Japan, 1048560
Local Institution
Itabashi-ku, Tokyo, Japan, 1738610
Local Institution
Meguro-ku, Tokyo, Japan, 1538515
Local Institution
Shinjuku-Ku, Tokyo, Japan, 1608582
Local Institution
Osaki-shi, Japan, 9896183
Korea, Republic of
Local Institution
Daegu, Korea, Republic of, 41931
Local Institution
Seoul, Korea, Republic of, 03080
Mexico
CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.
Mexico City, Distrito Fededral, Mexico, 11850
Consultorio Privado de Especialidad
Guadalajara, Jalisco, Mexico, 42650
Clinica de Investigacion en Reumatologia y Obesidad S.C.
Guadalajara, Jalisco, Mexico, 44650
Local Institution
Monterrey, Nuevo LEON, Mexico, 64460
Local Institution
Villahermosa, Tabasco, Mexico, 86190
Unidad Reumatologica Las Americas, S.C. P.
Merida, Yucatan, Mexico, 97000
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.
Distrito Federal, Mexico, 03100
Netherlands
Maasstad Ziekenhuis Rotterdam
Rotterdam, Netherlands, 3079 DZ
Poland
Nzoz Osteo-Medic S.C. A. Racewicz, J.Supronik
Bialystok, Poland, 15-351
Local Institution
Bialystok, Poland, 15-879
Centrum Badan Klinicznych JCI Life Science Park
Krakow, Poland, 30-348
Local Institution
Lublin, Poland, 20-954
Local Institution
Nadarzyn, Poland, 05-830
Local Institution
Poznan, Poland, 60-218
Local Institution
Warszawa, Poland, 00-465
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warszawa, Poland, 02-637
Local Institution
Warszawa, Poland, 02-691
Russian Federation
Local Institution
Moscow, Russian Federation, 119049
Local Institution
Moscow, Russian Federation, 121374
Local Institution
Saint-Petersburg, Russian Federation, 194356
Local Institution
St Petersburg, Russian Federation, 191124
Local Institution
Tolyatti, Russian Federation, 445039
South Africa
Local Institution
Benoni, Gauteng, South Africa, 1500
Local Institution
Cape Town, Western CAPE, South Africa, 7500
Local Institution
George, Western CAPE, South Africa, 6529
Local Institution
Somerset West, Western CAPE, South Africa, 7129
Spain
Local Institution
A Coruna, Spain, 15006
Fundacion Jimenez Diaz
Madrid, Spain, 28040
Local Institution
Santiago Compostela, Spain, 15702
Taiwan
Local Institution
Taichung, Taiwan, 402
Local Institution
Taipei, Taiwan, 11031
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] October 29, 2017
Statistical Analysis Plan  [PDF] December 4, 2015


Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02638948     History of Changes
Other Study ID Numbers: IM006-016
2015-002887-17 ( EudraCT Number )
First Posted: December 23, 2015    Key Record Dates
Results First Posted: May 27, 2019
Last Update Posted: May 27, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors