Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis
A Randomized, Head-to-Head, Single-Blinded Study to Assess Changes in the Immune Profile in Response to Treatment With Subcutaneous Abatacept in Combination With Methotrexate Versus Subcutaneous Adalimumab in Combination With Methotrexate in Adults With Early Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs
1 other identifier
interventional
80
3 countries
28
Brief Summary
The purpose of this study is to examine changes in immune cells and proteins in response to treatment with two approved therapies for Rheumatoid arthritis (RA), abatacept versus adalimumab, both given in combination with methotrexate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 rheumatoid-arthritis
Started Nov 2015
Typical duration for phase_4 rheumatoid-arthritis
28 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
September 4, 2015
CompletedFirst Posted
Study publicly available on registry
September 23, 2015
CompletedStudy Start
First participant enrolled
November 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2019
CompletedResults Posted
Study results publicly available
September 3, 2020
CompletedSeptember 3, 2020
August 1, 2020
3.4 years
September 4, 2015
April 20, 2020
August 19, 2020
Conditions
Outcome Measures
Primary Outcomes (7)
Percentage of Adverse Events (AEs)
Percentage of participants who experienced an AE
up to 85 days post last dose, approximately 40 weeks
Percentage of Participants With an Serious Adverse Events (SAEs)
Percentage of participants who experienced an SAEs
up to 85 days post last dose, approximately 40 weeks
Percentage of Participants With Adverse Events Leading to Discontinuation (AEsDc)
Percentage of participants who experienced an (AEsDc)
up to 85 days post last dose, approximately 40 weeks
Percentage of Serious Adverse Events Leading to Discontinuation (SAEsDc)
Percentage of participants who experienced an (SAEsDc)
up to 85 days post last dose, approximately 40 weeks
Percentage of Drug Related Adverse Events (DRAEs)
Percentage of participants who experienced an DRAEs
up to 85 days post last dose, approximately 40 weeks
Percentage of Drug Related Serious Adverse Events (DRSAEs)
Percentage of participants who experienced an DRSAEs
up to 85 days post last dose, approximately 40 weeks
Number of Deaths
Number of participants who experienced Death
up to 85 days post last dose, approximately 40 weeks
Study Arms (3)
Treatment A
EXPERIMENTALAbatacept Single Blind Treatment Period
Treatment B
ACTIVE COMPARATORAdalimumab Single Blind Treatment Period
Treatment C
ACTIVE COMPARATORAbatacept Cumulative Treatment Period
Interventions
Eligibility Criteria
You may qualify if:
- Symptoms of RA for no more than 12 months prior to enrollment
- Meet American College of Rheumatology/European League against Rheumatism (ACR/EULAR) 2010 criteria for classification of RA
- Treated with Methotrexate (MTX) for at least 12 weeks prior to randomization with a stable oral dose for at least 4 weeks, Subjects must randomize on the maximum tolerated dose of oral methotrexate (minimum of 15 mg and maximum of 25 mg per week), dose of MTX \< 15 mg/week but ≥ 7.5 mg/week is permitted if subjects are intolerant to higher doses
- At least 3 tender \& 3 swollen joints
- Anti-cyclic citrullinated peptide (CCP) \> 3X the upper limit of normal and positive rheumatoid factor
You may not qualify if:
- History of other autoimmune diseases (eg, psoriasis, systemic lupus, erythematosus, etc)
- Prior use of non-biologic therapy other than methotrexate
- Prior use of biologic and targeted synthetic disease-modifying anti-rheumatic drugs (DMARD) therapy
- Subjects with chronic or recent acute serious infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
University Of Alabama At Birmingham
Birmingham, Alabama, 35294-7201, United States
Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama, 35801, United States
Clinical And Translational Research Center Of Alabama, Pc
Tuscaloosa, Alabama, 35406, United States
Arizona Arthritis & Rheumatology Research PLLC
Glendale, Arizona, 85306, United States
Arizona Arthritis & Rheumatology Research PLLC
Phoenix, Arizona, 85037, United States
St. Joseph Heritage Medical Group
Fullerton, California, 92835, United States
Desert Medical Advances
Palm Desert, California, 92260, United States
University Of Colorado Health Sciences Center
Aurora, Colorado, 80045, United States
Medical Faculty Associates,Inc.
Washington D.C., District of Columbia, 20037, United States
Howard University Hospital
Washington D.C., District of Columbia, 20060, United States
Integral Rheumatology & Immunology Specialists
Plantation, Florida, 33324, United States
Marietta Rheumatology
Marietta, Georgia, 30060, United States
The Center For Rheumatology And Bone Research
Wheaton, Maryland, 20902, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01605, United States
Aa Mrc Llc
Grand Blanc, Michigan, 48439, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Oregon Health & Science University (Ohsu)
Portland, Oregon, 97239, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635-8406, United States
Carolina Health Specialists
Myrtle Beach, South Carolina, 29572, United States
West Tennessee Research Institute
Jackson, Tennessee, 38305, United States
Arthritis Clinic Of Northern Virginia, P.C.
Arlington, Virginia, 22205, United States
Dr. Anil K Gupta Med Prof Corp
Toronto, Ontario, M9V 4B4, Canada
Essex County Medical Society
Windsor, Ontario, N8X 5A6, Canada
Institut De Rhumatologie De Montreal
Montreal, Quebec, H2L 1S6, Canada
Centre De Recherche Musculo-Squelettique
Trois-Rivières, Quebec, G8Z 1Y2, Canada
Clinica de Investigacion en Reumatologia y Obesidad S.C.
Guadalajara, Jalisco, 44650, Mexico
CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.
Mexico City, Mexico City, 11850, Mexico
Clinica Integral en Osteoporosis y Artritis CLINOSAR Mexico S.A. de C.V.
Mexico City, 06760, Mexico
Related Publications (1)
Rigby W, Buckner JH, Louis Bridges S Jr, Nys M, Gao S, Polinsky M, Ray N, Bykerk V. HLA-DRB1 risk alleles for RA are associated with differential clinical responsiveness to abatacept and adalimumab: data from a head-to-head, randomized, single-blind study in autoantibody-positive early RA. Arthritis Res Ther. 2021 Sep 18;23(1):245. doi: 10.1186/s13075-021-02607-7.
PMID: 34537057DERIVED
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 Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2015
First Posted
September 23, 2015
Study Start
November 19, 2015
Primary Completion
March 28, 2019
Study Completion
March 28, 2019
Last Updated
September 3, 2020
Results First Posted
September 3, 2020
Record last verified: 2020-08