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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01652937

Acronym

EMBRACE

Enrollment

Registered

2012-07-30

Start date

2012-08-31

Completion date

2014-03-31

Last updated

2013-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, DMARD-IR

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).

Interventions

DRUGBIIB057

Oral

DRUGPlacebo

Oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Proportion of subjects achieving an ACR20 response (ACR20 = American College of Rheumatology 20% response criteria change from baseline)	Week 12

Secondary

Measure	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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026