BIIB057 in Subjects With Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic Drugs
NCT ID: NCT01652937
Last Updated: 2013-09-16
Study Results
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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WITHDRAWN
PHASE2
INTERVENTIONAL
2012-08-31
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo + Background Therapy
Background therapy including DMARD(s) approved by protocol
Placebo
Oral
BIIB057 Dose 1 + Background Therapy
Background therapy including DMARD(s) approved by protocol
BIIB057
Oral
BIIB057 Dose 2 + Background Therapy
Background therapy including DMARD(s) approved by protocol
BIIB057
Oral
BIIB057 Dose 3 + Background Therapy
Background therapy including DMARD(s) approved by protocol
BIIB057
Oral
Interventions
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BIIB057
Oral
Placebo
Oral
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Locations
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Research Site
Winnipeg, Manitoba, Canada
Research Site
Quispamsis, New Brunswick, Canada
Research Site
Toronto, Ontario, Canada
Countries
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Other Identifiers
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227RA201
Identifier Type: -
Identifier Source: org_study_id
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