C.O.R.P.U.S.: Observational Cohort of Adult and Child Inflammatory Arthritis in France
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|ClinicalTrials.gov Identifier: NCT02886689|
Recruitment Status : Completed
First Posted : September 1, 2016
Last Update Posted : September 1, 2016
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.
|Condition or disease||Intervention/treatment|
|Arthritis, Rheumatoid Spondylitis, Ankylosing Arthritis, Psoriatic Arthitis, Juvenile Idiopathic||Drug: TNF-alpha antagonist and other biotherapy|
|Study Type :||Observational|
|Actual Enrollment :||5400 participants|
|Official Title:||C.O.R.P.U.S. : Observational Cohort of Active Rheumatoid Arthritis, Spondylarthropathy and Idiopathic Juvenile Arthritis in France|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2011|
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02886689
|Central Hospital, Nancy|
|Study Chair:||Francis Guillemin, MD, PhD||Central Hospital, Nancy, France|
|Principal Investigator:||Jacques Benichou, MD, PhD||CHU, Rouen, France|
|Principal Investigator:||Alain Sasraux, MD, PhD||CHU de la Cavale Blanche, Brest, France|
|Principal Investigator:||Loic Guillevin, MD, PhD||Hopital Cochin, Paris, France|
|Principal Investigator:||Jean Sibilia, MD, PhD||CHU Hautepierre, Strasbourg, France|
|Principal Investigator:||Anne Marie Prieur, MD, PhD||Hopital Necker, Paris , France|
|Principal Investigator:||Daniel Wendling, MD, PhD||CHU Minioz, Besançon, France|