Status:
COMPLETED
Gene Expression Profiling in PBMCs as a Tool for Prediction of Anakinra Responsiveness in Rheumatoid Arthritis
Lead Sponsor:
University Hospital, Rouen
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
The objective of the study is to identify and validate predictive markers of anakinra responsiveness in RA patients by a transcriptomic approach. Patients with active RA (ACR criteria) were given sub...
Eligibility Criteria
Inclusion
- Is age 18 years old or older Satisfies the 1987 American College of Rheumatology revised criteria for Rheumatoid arthritis Has active disease at the time of randomization as indicated by a DAS28\> 5.1 Has a disease at least refractory to DMARDs whose methotrexate or leflunomide Is capable of understanding and signing an informed consent form Agrees to use a medically accepted form of contraception during the study
Exclusion
- Is pregnant or breast-feeding or without contraception Has significant concurrent medical diseases including cancer or a history of cancer within 5 years of entering the study, uncompensated congestive heart failure, significant active infection or any underlying diseases that could predispose subjects to infections (whose tuberculosis) Has renal disease (creatinin clearance level \< 30 ml/min) Has allergy to anakinra Has leukopenia (white blood cells \< 1.5 x 109 /l
Key Trial Info
Start Date :
June 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
341 Patients enrolled
Trial Details
Trial ID
NCT00213538
Start Date
June 1 2003
End Date
December 1 2016
Last Update
June 14 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU de rouen - Hôpitaux de Rouen
Rouen, France, 76031