BIIB057 in Subjects With Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic Drugs
- Registration Number
- NCT01652937
- Lead Sponsor
- Biogen
- Brief Summary
Phase II study designed to evaluate the safety and efficacy of BIIB057 in Subjects with Rheumatoid Arthritis who have experienced an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
- Adult onset RA satisfying 2010 Revised ACR Criteria for the Classification of RA with a disease history of at least 6 months
- Active RA as defined by: at least 4 swollen joints (based on 28-joint count), at least 4 tender joints (based on 28-joint count), and high-sensitivity CRP (hsCRP) 10mg/L or greater
- No prior treatment with biologics
- Receiving a DMARD therapy for at least 3 months, using a regimen that has been stable for at least 28 days prior to screening
Exclusion Criteria
- History of inflammatory joint disease other than RA
- Abnormal chest X-ray consistent with tuberculosis, malignancy, or infection
- History of malignancy, carcinoma in situ, or high-grade dysplasia
- History of opportunistic infection, infection requiring treatment, serious local infection, recent fever, active herpes zoster or Epstein-Barr virus, or diagnosis or family history of Creutzfeldt-Jakob disease.
- Clinically significant cardiac disease
- Treatment with prednisone >10 mg orally daily
- Intra-articular steroid injection within 28 days before screening
- Clinically significant abnormality in hematology or blood chemistry values at screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + Background Therapy Placebo Background therapy including DMARD(s) approved by protocol BIIB057 Dose 1 + Background Therapy BIIB057 Background therapy including DMARD(s) approved by protocol BIIB057 Dose 2 + Background Therapy BIIB057 Background therapy including DMARD(s) approved by protocol BIIB057 Dose 3 + Background Therapy BIIB057 Background therapy including DMARD(s) approved by protocol
- Primary Outcome Measures
Name Time Method Proportion of subjects achieving an ACR20 response (ACR20 = American College of Rheumatology 20% response criteria change from baseline) Week 12
- Secondary Outcome Measures
Name Time Method Assess the safety and tolerability of BIIB057 by measuring the incidence of AEs, SAEs and changes in laboratory test results during the study Up to 16 weeks Proportion of subjects with 28-joint count Disease Activity Score with C-reactive protein (DAS28-CRP) <3.2, <2.6, and <2.32 Week 12 Proportion of subjects achieving ACR50 and ACR70 response Week 12
Trial Locations
- Locations (1)
Research Site
🇨🇦Toronto, Ontario, Canada