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

• Status: Completed
• Trial end date: 2018-05-03
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Methotrexate

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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