An observational study in Arthritis, Rheumatoid, Spondylitis, Ankylosing and Arthritis, Psoriatic, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged 3 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-09-01.
Sponsored by Central Hospital, Nancy, France · Observational
C.O.R.P.U.S. is the first French observatory of care practices in active inflammatory rheumatism of children and adults: rheumatoid arthritis, spondylarthropathy, and idiopathic juvenile arthritis, established under the auspices of national health authorities.
Its goal is to document safety, effectiveness in routine practice of various therapy, including biotherapy, of prescription or non-prescription over 5 years.
A cohort will be constituted including any new case of active disease (DAS 28 > 3,2, BASDAI > 4, failure of methotrexate), without previous prescription of biotherapy. Therefore, it will be possible to have patients non exposed to biotherapy (non indication, refusal, contraindication) compared to patients exposed to biotherapy, and to monitor adverse events occurrence as well as effectiveness in routine practice over time, according to prescription, maintenance or switch of various therapies.
Rational:
Biotherapies, including anti-TNF alpha have demonstrated effectiveness by several randomized clinical trials. The long-term use in clinical practice raise several questions regarding their safety, the risk-benefit ratio, and the actual advantage of such treatment in real life routine practice. Moreover such practice may considerably change, as far as increasing number of therapies are made available on the market.
On request form national health authorities in France, this phase 4 study will help monitor the changing strategies of prescription, the effectiveness and safety of these drugs.
Objectives :
Study design:
an open cohort study to include patients over 3 years continuously, and to last at least 5 years form study start, with annual prospective follow-up. C.O.R.P.U.S. will be the first French observatory of prescription (or non-prescription) practices of biotherapy in first or switch treatment.
Sample:
Patients will be recruited by French network of private rheumatologist, and 40 university hospital rheumatology ward.
Data collected:
Socio-demographic, clinical parameters, function and quality of life know to have prognostic value
Outcomes:
radiographic joint lesions, function, adverse events, maintenance rate, drug consumption.
Sample size:
a sample of 1200 RA, 350 SPA and 300 IJA will be recruited every year for the first 3 years.
Adverse events:
Any adverse events will be reported to the national centre for pharmacovigilance.
IRB:
this protocol has been accepted by the CCTIRS and the CNIL.
Study monitoring:
A scientific committee has been constituted and is in charge of respect of any aspects of the protocol, particularly regarding safety A steering committee has been constituted and includes any drug company representative marketing such therapy, as well as representative of Inserm.
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's enrollment of 5,400 is above the median of 202 across 256 observational studies indexed under Spondylitis.
Browse Spondylitis studies →Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients suffering rheumatoid arthritis, spondyloarthropathy or idiopathic juvenile arthritis, recruited with rheumatologist in public and private practice
Diagnosis by rheumatologist of rheumatoid arthritis
Exclusion Criteria:
patients will be those receiving any biotherapy
Drug: TNF-alpha antagonist and other biotherapy
patients will be those not receiving biotherapy : non indication, refusal, contraindication.
Drug consumption
Time frame: first year
Plan to share: Yes — open to partnership
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France