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

NCT ID: NCT01652937

Last Updated: 2013-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-03-31

Brief Summary

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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

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Conditions

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Rheumatoid Arthritis

Keywords

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Rheumatoid Arthritis DMARD-IR

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo + Background Therapy

Background therapy including DMARD(s) approved by protocol

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral

BIIB057 Dose 1 + Background Therapy

Background therapy including DMARD(s) approved by protocol

Group Type EXPERIMENTAL

BIIB057

Intervention Type DRUG

Oral

BIIB057 Dose 2 + Background Therapy

Background therapy including DMARD(s) approved by protocol

Group Type EXPERIMENTAL

BIIB057

Intervention Type DRUG

Oral

BIIB057 Dose 3 + Background Therapy

Background therapy including DMARD(s) approved by protocol

Group Type EXPERIMENTAL

BIIB057

Intervention Type DRUG

Oral

Interventions

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BIIB057

Oral

Intervention Type DRUG

Placebo

Oral

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Winnipeg, Manitoba, Canada

Site Status

Research Site

Quispamsis, New Brunswick, Canada

Site Status

Research Site

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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227RA201

Identifier Type: -

Identifier Source: org_study_id