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

This study has been withdrawn prior to enrollment.

Sponsor:

Collaborators:

Biogen Idec Research Ltd.

Biogen Idec MA Inc.

Information provided by (Responsible Party):

Biogen Idec

ClinicalTrials.gov Identifier:

NCT01652937

First received: July 19, 2012

Last updated: November 1, 2012

Last verified: November 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 19, 2012
Last Updated Date	November 1, 2012
Start Date ^ICMJE	August 2012
Estimated Primary Completion Date	February 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 26, 2012)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01652937 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 26, 2012)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	BIIB057 in Subjects With Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic Drugs
Official Title ^ICMJE	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
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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Rheumatoid Arthritis
Intervention ^ICMJE	Drug: BIIB057 Oral Drug: Placebo Oral
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Enrollment ^ICMJE	0
Estimated Completion Date	March 2014
Estimated Primary Completion Date	February 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT01652937
Other Study ID Numbers ^ICMJE	227RA201
Has Data Monitoring Committee	Yes
Responsible Party	Biogen Idec
Study Sponsor ^ICMJE	Biogen Idec
Collaborators ^ICMJE	Biogen Idec Research Ltd. Biogen Idec MA Inc.
Investigators ^ICMJE	Not Provided
Information Provided By	Biogen Idec
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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