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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02557100
• Date of registration: 04/09/2015
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis
• Scientific 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
• Date of first enrolment: November 19, 2015
• Target sample size: 80
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02557100
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Single (Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Algeria, Canada, Mexico, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Adalimumab

Drug: Methotrexate

Drug: Abatacept

Primary Outcome(s)

Percentage of Drug Related Adverse Events (DRAEs) [Time Frame: 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]

Number of Deaths [Time Frame: 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 Adverse Events (AEs) [Time Frame: 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 Serious Adverse Events Leading to Discontinuation (SAEsDc) [Time Frame: up to 85 days post last dose, approximately 40 weeks]

Secondary ID(s)

IM101-567

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/09/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02557100