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

August 29, 2016 updated by: GUILLEMIN Francis, MD, Central Hospital, Nancy, France

C.O.R.P.U.S. : Observational Cohort of Active Rheumatoid Arthritis, Spondylarthropathy and Idiopathic Juvenile Arthritis in France

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 :

  1. to determine the impact of biotherapy prescription in 3 category of diseases assessed on articular, functional and quality of life outcomes, as well as other drug consumption, and to monitor adverse events
  2. to determine the place of biotherapy in the sequence of treatments of patients

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

  • Exposed patients will be those receiving any biotherapy
  • Non-exposed patients will be those not receiving biotherapy : non indication, refusal, contraindication.

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.

Study Type

Observational

Enrollment (Actual)

5400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France
        • Central Hospital, Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients suffering rheumatoid arthritis, spondyloarthropathy or idiopathic juvenile arthritis, recruited with rheumatologist in public and private practice

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Drug consumption
Time Frame: first year
first year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • 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, Hôpital 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

August 29, 2016

First Posted (Estimate)

September 1, 2016

Study Record Updates

Last Update Posted (Estimate)

September 1, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCv1.6-12-11-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

open to partnership

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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