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Trial record 59 of 137 for:    "Connective Tissue Disease" | "Abatacept"

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

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ClinicalTrials.gov Identifier: NCT02557100
Recruitment Status : Active, not recruiting
First Posted : September 23, 2015
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Abatacept Drug: Adalimumab Drug: Methotrexate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
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
Actual Study Start Date : November 19, 2015
Actual Primary Completion Date : July 26, 2018
Estimated Study Completion Date : April 5, 2019

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Arm Intervention/treatment
Experimental: Abatacept in combination with methotrexate
Abatacept subcutaneous (SC) injection, 125 mg, weekly for 24 weeks. 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. Open-label Abatacept subcutaneous (SC) injection, 125 mg, weekly and maintain the enrollment dose of MTX unless toxicity or intolerability occurs during the study.
Drug: Abatacept
Other Name: Orencia

Drug: Methotrexate
Active Comparator: Adalimumab in combination with methotrexate
Adalimumab SC injection, 40 mg, once every two weeks for 24 weeks, 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. Open-label Abatacept subcutaneous (SC) injection, 125 mg, weekly and maintain the enrollment dose of MTX unless toxicity or intolerability occurs during the study.
Drug: Abatacept
Other Name: Orencia

Drug: Adalimumab
Other Name: Humira

Drug: Methotrexate



Primary Outcome Measures :
  1. Efficacy of abatacept based on changes to autoantibody levels [ Time Frame: 24 weeks ]
  2. Efficacy of abatacept based on changes to cytokines [ Time Frame: 24 weeks ]
  3. Efficacy of abatacept based on changes to percentages of immune cell subsets [ Time Frame: 24 weeks ]
  4. Efficacy of abatacept based on changes to activation states of immune cell subsets [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   18 Years and older   (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:

  • 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


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): NCT02557100


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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02557100     History of Changes
Other Study ID Numbers: IM101-567
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
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Connective Tissue Diseases
Abatacept
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Adalimumab
Antirheumatic Agents
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
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents