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

Biogen

Status and phase: Withdrawn; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: BIIB057; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01652937

227RA201

Details and patient eligibility

About

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).

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 4 patient groups, including a placebo group

Placebo + Background Therapy

Placebo Comparator group

Description:

Background therapy including DMARD(s) approved by protocol

Treatment:

Drug: Placebo

BIIB057 Dose 1 + Background Therapy

Experimental group

Description:

Background therapy including DMARD(s) approved by protocol

Treatment:

Drug: BIIB057

BIIB057 Dose 2 + Background Therapy

Experimental group

Description:

Background therapy including DMARD(s) approved by protocol

Treatment:

Drug: BIIB057

BIIB057 Dose 3 + Background Therapy

Experimental group

Description:

Background therapy including DMARD(s) approved by protocol

Treatment:

Drug: BIIB057