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Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Abatacept
Adalimumab
Methotrexate
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Rheumatoid Arthritis

Eligibility Criteria

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

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Other protocol defined inclusion/exclusion criteria could apply

Sites / Locations

  • University Of Alabama At Birmingham
  • Rheumatology Associates Of North Alabama, P.C.
  • Clinical And Translational Research Center Of Alabama, Pc
  • Arizona Arthritis & Rheumatology Research PLLC
  • Arizona Arthritis & Rheumatology Research PLLC
  • St. Joseph Heritage Medical Group
  • Desert Medical Advances
  • University Of Colorado Health Sciences Center
  • Medical Faculty Associates,Inc.
  • Howard University Hospital
  • Integral Rheumatology & Immunology Specialists
  • Marietta Rheumatology
  • The Center For Rheumatology And Bone Research
  • Clinical Pharmacology Study Group
  • Aa Mrc Llc
  • Dartmouth-Hitchcock Medical Center
  • Oregon Health & Science University (Ohsu)
  • Altoona Center For Clinical Research
  • Carolina Health Specialists
  • West Tennessee Research Institute
  • Arthritis Clinic Of Northern Virginia, P.C.
  • Dr. Anil K Gupta Med Prof Corp
  • Essex County Medical Society
  • Institut De Rhumatologie De Montreal
  • Centre De Recherche Musculo-Squelettique
  • CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.
  • Clinica de Investigacion en Reumatologia y Obesidad S.C.
  • Clinica Integral en Osteoporosis y Artritis CLINOSAR Mexico S.A. de C.V.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Treatment A

Treatment B

Treatment C

Arm Description

Abatacept Single Blind Treatment Period

Adalimumab Single Blind Treatment Period

Abatacept Cumulative Treatment Period

Outcomes

Primary Outcome Measures

Percentage of Adverse Events (AEs)
Percentage of participants who experienced an AE
Percentage of Participants With an Serious Adverse Events (SAEs)
Percentage of participants who experienced an SAEs
Percentage of Participants With Adverse Events Leading to Discontinuation (AEsDc)
Percentage of participants who experienced an (AEsDc)
Percentage of Serious Adverse Events Leading to Discontinuation (SAEsDc)
Percentage of participants who experienced an (SAEsDc)
Percentage of Drug Related Adverse Events (DRAEs)
Percentage of participants who experienced an DRAEs
Percentage of Drug Related Serious Adverse Events (DRSAEs)
Percentage of participants who experienced an DRSAEs
Number of Deaths
Number of participants who experienced Death

Secondary Outcome Measures

Full Information

First Posted
September 4, 2015
Last Updated
August 19, 2020
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02557100
Brief Title
Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 19, 2015 (Actual)
Primary Completion Date
March 28, 2019 (Actual)
Study Completion Date
March 28, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

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
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment A
Arm Type
Experimental
Arm Description
Abatacept Single Blind Treatment Period
Arm Title
Treatment B
Arm Type
Active Comparator
Arm Description
Adalimumab Single Blind Treatment Period
Arm Title
Treatment C
Arm Type
Active Comparator
Arm Description
Abatacept Cumulative Treatment Period
Intervention Type
Drug
Intervention Name(s)
Abatacept
Other Intervention Name(s)
Orencia
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Primary Outcome Measure Information:
Title
Percentage of Adverse Events (AEs)
Description
Percentage of participants who experienced an AE
Time Frame
up to 85 days post last dose, approximately 40 weeks
Title
Percentage of Participants With an Serious Adverse Events (SAEs)
Description
Percentage of participants who experienced an SAEs
Time Frame
up to 85 days post last dose, approximately 40 weeks
Title
Percentage of Participants With Adverse Events Leading to Discontinuation (AEsDc)
Description
Percentage of participants who experienced an (AEsDc)
Time Frame
up to 85 days post last dose, approximately 40 weeks
Title
Percentage of Serious Adverse Events Leading to Discontinuation (SAEsDc)
Description
Percentage of participants who experienced an (SAEsDc)
Time Frame
up to 85 days post last dose, approximately 40 weeks
Title
Percentage of Drug Related Adverse Events (DRAEs)
Description
Percentage of participants who experienced an DRAEs
Time Frame
up to 85 days post last dose, approximately 40 weeks
Title
Percentage of Drug Related Serious Adverse Events (DRSAEs)
Description
Percentage of participants who experienced an DRSAEs
Time Frame
up to 85 days post last dose, approximately 40 weeks
Title
Number of Deaths
Description
Number of participants who experienced Death
Time Frame
up to 85 days post last dose, approximately 40 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: 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 Exclusion Criteria: 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 Other protocol defined inclusion/exclusion criteria could apply
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
University Of Alabama At Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-7201
Country
United States
Facility Name
Rheumatology Associates Of North Alabama, P.C.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Clinical And Translational Research Center Of Alabama, Pc
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35406
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research PLLC
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research PLLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85037
Country
United States
Facility Name
St. Joseph Heritage Medical Group
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Desert Medical Advances
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
University Of Colorado Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Medical Faculty Associates,Inc.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Howard University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Integral Rheumatology & Immunology Specialists
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Marietta Rheumatology
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
The Center For Rheumatology And Bone Research
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
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
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Oregon Health & Science University (Ohsu)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
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
Carolina Health Specialists
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Arthritis Clinic Of Northern Virginia, P.C.
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
Dr. Anil K Gupta Med Prof Corp
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9V 4B4
Country
Canada
Facility Name
Essex County Medical Society
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 5A6
Country
Canada
Facility Name
Institut De Rhumatologie De Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 1S6
Country
Canada
Facility Name
Centre De Recherche Musculo-Squelettique
City
Trois-rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Facility Name
CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
11850
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
Clinica Integral en Osteoporosis y Artritis CLINOSAR Mexico S.A. de C.V.
City
Mexico D.F.
ZIP/Postal Code
06760
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
34537057
Citation
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.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis

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