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Completed

NCT Number: NCT02557100

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dr. Anil K Gupta Med Prof Corp, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abatacept

Drug

Other names: Orencia

Adalimumab

Drug

Other names: Humira

methotrexate

Drug

Primary outcomes

  1. Percentage of Adverse Events (AEs)

    Time frame: up to 85 days post last dose, approximately 40 weeks

    Percentage of participants who experienced an AE

  2. 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

  3. 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)

  4. 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)

  5. 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

  6. 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

  7. Number of Deaths

    Time frame: up to 85 days post last dose, approximately 40 weeks

    Number of participants who experienced Death

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 23, 2015
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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