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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01652937
First received: July 19, 2012
Last updated: September 12, 2013
Last verified: October 2012

July 19, 2012
September 12, 2013
August 2012
February 2014   (final data collection date for primary outcome measure)
Proportion of subjects achieving an ACR20 response (ACR20 = American College of Rheumatology 20% response criteria change from baseline) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01652937 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving ACR50 and ACR70 response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: BIIB057
    Oral
  • Drug: Placebo
    Oral
  • Placebo Comparator: Placebo + Background Therapy
    Background therapy including DMARD(s) approved by protocol
    Intervention: Drug: Placebo
  • Experimental: BIIB057 Dose 1 + Background Therapy
    Background therapy including DMARD(s) approved by protocol
    Intervention: Drug: BIIB057
  • Experimental: BIIB057 Dose 2 + Background Therapy
    Background therapy including DMARD(s) approved by protocol
    Intervention: Drug: BIIB057
  • Experimental: BIIB057 Dose 3 + Background Therapy
    Background therapy including DMARD(s) approved by protocol
    Intervention: Drug: BIIB057
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2014
February 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01652937
227RA201
Yes
Biogen Idec
Biogen Idec
Not Provided
Not Provided
Biogen Idec
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP