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

September 12, 2013 updated by: Biogen

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

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 3J5
        • Research Site
    • New Brunswick
      • Quispamsis, New Brunswick, Canada, E2E 4J8
        • Research Site
    • Ontario
      • Toronto, Ontario, Canada, M9W 4L6
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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
Time Frame: Up to 16 weeks
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
Time Frame: Week 12
Week 12
Proportion of subjects achieving ACR50 and ACR70 response
Time Frame: Week 12
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

July 19, 2012

First Submitted That Met QC Criteria

July 26, 2012

First Posted (Estimate)

July 30, 2012

Study Record Updates

Last Update Posted (Estimate)

September 16, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 227RA201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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