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C.O.R.P.U.S.: Observational Cohort of Adult and Child Inflammatory Arthritis in France

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02886689
Recruitment Status : Completed
First Posted : September 1, 2016
Last Update Posted : September 1, 2016
Sponsor:
Information provided by (Responsible Party):
GUILLEMIN Francis, MD, Central Hospital, Nancy, France

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 5400 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
1
patients will be those receiving any biotherapy
Drug: TNF-alpha antagonist and other biotherapy
2
patients will be those not receiving biotherapy : non indication, refusal, contraindication.



Primary Outcome Measures :
  1. Drug consumption [ Time Frame: first year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering rheumatoid arthritis, spondyloarthropathy or idiopathic juvenile arthritis, recruited with rheumatologist in public and private practice
Criteria

Inclusion Criteria:

Diagnosis by rheumatologist of rheumatoid arthritis

  • DAS score > 3.2,
  • any age of onset
  • hand and feet x-ray within the past 3 months
  • never received any biotherapy Diagnosis by rheumatologist of spondylarthropathy (ankylosing spondylitis, psoriasic arthritis)
  • active disease
  • hand and feet (peripheral) or spine (axial) x-ray within the past 3 months Diagnosis by rheumatologist of idiopathic juvenile arthritis
  • failure or intolerance to methotrexate
  • x-ray within the past 3 months

Exclusion Criteria:

  • received previous biotherapy
  • other spondylarthropathy than ankylosing spondylitis, psoriasic arthritis

Information from the National Library of Medicine

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


Locations
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France
Central Hospital, Nancy
Nancy, France
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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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

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Responsible Party: GUILLEMIN Francis, MD, Professor, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02886689    
Other Study ID Numbers: PCv1.6-12-11-05
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: open to partnership
Additional relevant MeSH terms:
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Spondylitis
Arthritis
Arthritis, Rheumatoid
Arthritis, Psoriatic
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spondylarthropathies
Spondylarthritis
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ankylosis