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

August 19, 2020 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M9V 4B4
        • Dr. Anil K Gupta Med Prof Corp
      • Windsor, Ontario, Canada, N8X 5A6
        • Essex County Medical Society
    • Quebec
      • Montreal, Quebec, Canada, H2L 1S6
        • Institut de Rhumatologie de Montreal
      • Trois-rivieres, Quebec, Canada, G8Z 1Y2
        • Centre de Recherche Musculo-Squelettique
  • Mexico
      • Mexico D.F., Mexico, 06760
        • Clinica Integral en Osteoporosis y Artritis CLINOSAR Mexico S.A. de C.V.
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 11850
        • CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Clinica de Investigacion en Reumatologia y Obesidad S.C.
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-7201
        • University of Alabama at Birmingham
      • Huntsville, Alabama, United States, 35801
        • Rheumatology Associates Of North Alabama, P.C.
      • Tuscaloosa, Alabama, United States, 35406
        • Clinical and Translational Research Center of Alabama, PC
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Arizona Arthritis & Rheumatology Research PLLC
      • Phoenix, Arizona, United States, 85037
        • Arizona Arthritis & Rheumatology Research PLLC
    • California
      • Fullerton, California, United States, 92835
        • St. Joseph Heritage Medical Group
      • Palm Desert, California, United States, 92260
        • Desert Medical Advances
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Health Sciences Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Howard University Hospital
      • Washington, District of Columbia, United States, 20037
        • Medical Faculty Associates,Inc.
    • Florida
      • Plantation, Florida, United States, 33324
        • Integral Rheumatology & Immunology Specialists
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Marietta Rheumatology
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • The Center For Rheumatology And Bone Research
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Clinical Pharmacology Study Group
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Aa Mrc Llc
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University (OHSU)
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635-8406
        • Altoona Center for Clinical Research
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Health Specialists
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • West Tennessee Research Institute
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Arthritis Clinic Of Northern Virginia, P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment A
Abatacept Single Blind Treatment Period
Drug: Methotrexate
Drug: Abatacept
Other Names:
  • Orencia
Active Comparator: Treatment B
Adalimumab Single Blind Treatment Period
Drug: Methotrexate
Drug: Adalimumab
Other Names:
  • Humira
Drug: Abatacept
Other Names:
  • Orencia
Active Comparator: Treatment C
Abatacept Cumulative Treatment Period
Drug: Abatacept
Other Names:
  • Orencia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Adverse Events (AEs)
Time Frame: up to 85 days post last dose, approximately 40 weeks
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)
Time Frame: up to 85 days post last dose, approximately 40 weeks
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)
Time Frame: up to 85 days post last dose, approximately 40 weeks
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)
Time Frame: up to 85 days post last dose, approximately 40 weeks
Percentage of participants who experienced an (SAEsDc)
up to 85 days post last dose, approximately 40 weeks
Percentage of Drug Related Adverse Events (DRAEs)
Time Frame: up to 85 days post last dose, approximately 40 weeks
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)
Time Frame: up to 85 days post last dose, approximately 40 weeks
Percentage of participants who experienced an DRSAEs
up to 85 days post last dose, approximately 40 weeks
Number of Deaths
Time Frame: up to 85 days post last dose, approximately 40 weeks
Number of participants who experienced Death
up to 85 days post last dose, approximately 40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 28, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 28, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IM101-567

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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