BIIB057 in Subjects With Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic Drugs (EMBRACE)
This study has been withdrawn prior to enrollment.
Sponsor:
Biogen Idec
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
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: BIIB057 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Biogen Idec:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 0 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 Idec
Biogen Idec Research Ltd.
Biogen Idec MA Inc.
More Information
No publications provided
| Responsible Party: | Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT01652937 History of Changes |
| Other Study ID Numbers: | 227RA201 |
| Study First Received: | July 19, 2012 |
| Last Updated: | November 1, 2012 |
| Health Authority: | South Africa: Department of Health Canada: Health Canada |
Keywords provided by Biogen Idec:
|
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 Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013