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

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ClinicalTrials.gov Identifier: NCT01652937
Recruitment Status : Withdrawn
First Posted : July 30, 2012
Last Update Posted : September 16, 2013
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: BIIB057 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2012
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Proportion of subjects achieving an ACR20 response (ACR20 = American College of Rheumatology 20% response criteria change from baseline) [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Proportion of subjects achieving ACR50 and ACR70 response [ Time Frame: Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01652937


Locations
Canada, Manitoba
Research Site
Winnipeg, Manitoba, Canada, R3C 3J5
Canada, New Brunswick
Research Site
Quispamsis, New Brunswick, Canada, E2E 4J8
Canada, Ontario
Research Site
Toronto, Ontario, Canada, M9W 4L6
Sponsors and Collaborators
Biogen

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01652937     History of Changes
Other Study ID Numbers: 227RA201
First Posted: July 30, 2012    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: October 2012

Keywords provided by Biogen:
Rheumatoid Arthritis
DMARD-IR

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents