Status:
COMPLETED
Biomarkers of Anti-TNF-α Therapy Efficacy in Rheumatoid Arthritis to Define Unresponsive Patients
Lead Sponsor:
Biogen
Collaborating Sponsors:
Crescendo Biosciences
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of this study was to validate the ability of an 8-gene biomarker set to differentiate between participants who met or did not meet European League Against Rheumatism (EULAR) Dise...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria
- To be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of enrollment:
- 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.
- Key Exclusion Criteria
- Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of enrollment:
- Any medical condition that would preclude safe use of an anti-TNF agent for at least 14 weeks.
- 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.
- Note: Other protocol defined inclusion/exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT01211678
Start Date
June 1 2010
End Date
July 1 2013
Last Update
June 9 2014
Active Locations (30)
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1
Research Site
Murrieta, California, United States
2
Research Site
Longmont, Colorado, United States
3
Research Site
Lewes, Delaware, United States
4
Research Site
Dunedin, Florida, United States