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

Rheumatoid Arthritis Clinical Trial

— EMBRACE  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01652937
• Other study ID #: 227RA201
• Status: Withdrawn
• Phase: Phase 2
• First received: July 19, 2012
• Last updated: September 12, 2013
• Start date: August 2012
• Est. completion date: March 2014

Study information

• Verified date: October 2012
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Department of HealthCanada: Health Canada
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• BIIB057
Oral
• Placebo
Oral

Locations

Country	Name	City	State
Canada	Research Site	Quispamsis	New Brunswick
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects achieving an ACR20 response (ACR20 = American College of Rheumatology 20% response criteria change from baseline)		Week 12	No
Secondary	Assess the safety and tolerability of BIIB057 by measuring the incidence of AEs, SAEs and changes in laboratory test results during the study		Up to 16 weeks	Yes
Secondary	Proportion of subjects with 28-joint count Disease Activity Score with C-reactive protein (DAS28-CRP) <3.2, <2.6, and <2.32		Week 12	No
Secondary	Proportion of subjects achieving ACR50 and ACR70 response		Week 12	No