Biomarkers of Anti-TNF-α Therapy Efficacy in Rheumatoid Arthritis to Define Unresponsive Patients
NCT ID: NCT01211678
Last Updated: 2014-06-09
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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COMPLETED
301 participants
OBSERVATIONAL
2010-06-30
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Are willing and able to provide informed consent..
* Meet the ACR criteria for RA as determined by a rheumatologist who is board certified in Rheumatology or a member of the ACR.
* Have 4 or more tender and 4 or more swollen joints out of 28 joints as assessed by their treating rheumatologist or a trained joint assessor.
* Subjects are not taking any of the following treatments and/or have washed out for the minimum duration as defined below. If subjects are currently taking these treatments, must have been on a stable dosing regimen for the minimum duration as defined below:
* Oral DMARDs (MTX, hydroxychloroquine, sulfasalazine, leflunomide, cyclosporine, azathioprine): on drug for at least 3 months and washed out or stable for at least 6 weeks prior to baseline sample collection.
* Oral corticosteroids: washed out or stable AND ≤10 mg/day of prednisone equivalent for at least 4 weeks prior to baseline sample collection.
* Intraarticular or parenteral corticosteroids: Washed out or stable for at least 4 weeks prior to baseline sample collection.
* NSAIDs: Washed out or stable for at least 2 weeks prior to baseline sample collection.
* Are about to start treatment with an anti-TNF agent approved for the treatment of RA for the first time OR Have not, in the opinion of the treating rheumatologist, achieved or maintained an adequate response to treatment with their first anti-TNF agent (any anti-TNF agent approved for the treatment of RA), and have been prescribed a different anti TNF agent. Subjects who switch for any reason other than lack of efficacy will be excluded.
Exclusion Criteria
* Previous participation in the present study as a subject in the anti-TNF-naïve group.
* Prior exposure to 2 or more anti-TNF agents.
* Prior exposure to Orencia (abatacept, or CTLA4-Ig) and/or Rituxan (anti CD20), or other biologic therapy for RA or other diseases.
18 Years
ALL
No
Sponsors
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Crescendo Biosciences
UNKNOWN
Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Murrieta, California, United States
Research Site
Longmont, Colorado, United States
Research Site
Lewes, Delaware, United States
Research Site
Dunedin, Florida, United States
Research Site
Ocala, Florida, United States
Research Site
Orange Park, Florida, United States
Research Site
Morton Grove, Illinois, United States
Research Site
Baltimore, Maryland, United States
Research Site
Plymouth, Massachusetts, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Reno, Nevada, United States
Research Site
Berkeley Heights, New Jersey, United States
Research Site
Summit, New Jersey, United States
Research Site
Floral Park, New York, United States
Research Site
Orchard Park, New York, United States
Research Site
Smithtown, New York, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Wilmington, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Mayfield Village, Ohio, United States
Research Site
Middleburg Heights, Ohio, United States
Research Site
Edmund, Oklahoma, United States
Research Site
Duncansville, Pennsylvania, United States
Research Site
Mrytle Beach, South Carolina, United States
Research Site
Dallas, Texas, United States
Research Site
San Anotnio, Texas, United States
Research Site
Burke, Virginia, United States
Research Site
Seattle, Washington, United States
Research Site
Spokane, Washington, United States
Research Site
Franklin, Wisconsin, United States
Countries
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Other Identifiers
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999RA002
Identifier Type: -
Identifier Source: org_study_id
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