Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of this study is to determine whether the study drug, BMS-986142, is safe and effective in treating moderate to severe rheumatoid arthritis in subjects with an inadequate response to methotrexate or methotrexate and up to 2 tumour necrosis factor (TNF) Inhibitors. Patients who qualify will be randomized to either one of 3 doses of BMS-986142 or placebo in 1:1:1 randomization for 12 weeks. Disease activity and safety will be assessed over the course of the study.

Key facts

Study ID

NCT02638948

Run by

Bristol-Myers Squibb

People needed

508

Starts

2016-02-16

Expected to finish

2018-05-03

Last updated by the study team

2019-05-28

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female age 18 and above
• Diagnosed with active rheumatoid arthritis (RA) by standard criteria at least 16 weeks before screening, have functional ACR class I-III
• Have an inadequate response to methotrexate
• In addition to an inadequate response to methotrexate have an inadequate response or intolerance to 1 but not more than 2 TNF inhibitors
• Have a minimum of 6 swollen and 6 tender joints (from 66/68 joint count)
• Have hsCRP of ≥ 0.8 mg/dL (8mg/L) [by central laboratory values] or an ESR ≥ 28 mm/hr
• Willing to use effective birth control for the entire length of the study

You may not qualify if…

• Diagnosed with juvenile Rheumatoid Arthritis
• Have been treated with other biologic treatment than a TNF inhibitor
• Active systemic bacterial, viral or fungal infection or evidence of prior or current Hepatitis B or C infection or HIV infection, latent bacterial, viral or fungal infections
• Have been treated with Intramuscular or Intra-articular glucocorticosteroids within 4 weeks of randomization
• Taking Oral steroids at dose above 10 mg/day of prednisone (or prednisone equivalents)
• Have other autoimmune disease other than RA like lupus, multiple sclerosis
• Have significant concurrent medical condition at the time of screening or baseline visit

Where it is running

• St. Joseph Heritage Medical Group — Fullerton, California, United States
• C.V Mehta M.D Medical Corp — Hemet, California, United States
• HCP Clinical Research, LLC — Huntington Beach, California, United States
• Leon Medical Research — Miami, Florida, United States
• San Marcus Research Clinic, Inc. — Miami, Florida, United States
• Coral Research Clinic Corp — Miami, Florida, United States
• Precision Research Organization — Miami Lakes, Florida, United States
• The Arthritis Center — Palm Harbor, Florida, United States
• Vizae Clinical Trials Management — Pembroke Pines, Florida, United States
• Integral Rheumatology & Immunology Specialists — Plantation, Florida, United States
• North Georgia Rheumatology Group — Lawrenceville, Georgia, United States
• Arthritis And Diabetes Clinic — Monroe, Louisiana, United States
• Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
• Aa Mrc Llc — Grand Blanc, Michigan, United States
• Albuquerque Center For Rheumatology — Albuquerque, New Mexico, United States
• Albuquerque Clinical Trials — Albuquerque, New Mexico, United States
• Paramount Medical Research & Consulting, Llc — Middleburg Heights, Ohio, United States
• East Penn Rheumatology — Bethlehem, Pennsylvania, United States
• Altoona Center For Clinical Research — Duncansville, Pennsylvania, United States
• Advanced Rheumatology & Arthritis Research Center, P.C — Wexford, Pennsylvania, United States
• Local Institution — Wyomissing, Pennsylvania, United States
• West Tennessee Research Institute — Jackson, Tennessee, United States
• Pharma Tex Research — Amarillo, Texas, United States
• Tekton Research Inc — Austin, Texas, United States
• Rheumatology Associates Of North Alabama, P.C. — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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