Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Registration Number
- jRCT2080223262
- Lead Sponsor
- Bristol-Myers Squibb K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 408
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 not less than 0.8 mg/dL (8mg/L) [by central laboratory values] or an ESR not less than 28 mm/hr Willing to use effective birth control for the entire length of the study
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
Study & Design
- Study Type
- Interventional
- Study Design
- Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
- Primary Outcome Measures
Name Time Method ACR70 response rate At week 12 Proportion of subjects who achieve ACR70 response rate
ACR20 response rate At week 12 Proportion of subjects who achieve ACR20 response rate
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Japan/Asia except Japan/North America/South America/Europe/Oceania
Location not specified
Japan/Asia except Japan/North America/South America/Europe/Oceania