BIIB057 in Subjects With Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic Drugs

Study Overview
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Brief Summary
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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).

Official Title
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A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of BIIB057 in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Disease-Modifying Antirheumatic Drugs

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: BIIB057
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo + Background Therapy<br>Background therapy including DMARD(s) approved by protocol | Drug: Placebo<br>* Oral<br>|
| Experimental: BIIB057 Dose 1 + Background Therapy<br>Background therapy including DMARD(s) approved by protocol | Drug: BIIB057<br>* Oral<br>|
| Experimental: BIIB057 Dose 2 + Background Therapy<br>Background therapy including DMARD(s) approved by protocol | Drug: BIIB057<br>* Oral<br>|
| Experimental: BIIB057 Dose 3 + Background Therapy<br>Background therapy including DMARD(s) approved by protocol | Drug: BIIB057<br>* Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving an ACR20 response (ACR20 = American College of Rheumatology 20% response criteria change from baseline) |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, DMARD-IR