Clinical trial NCT02886689: C.O.R.P.U.S.: Observational Cohort of Adult and Child Inflammatory Arthritis in France
Official title: C.O.R.P.U.S. : Observational Cohort of Active Rheumatoid Arthritis, Spondylarthropathy and Idiopathic Juvenile Arthritis in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Spondylitis, Ankylosing
Arthritis, Psoriatic
Arthitis, Juvenile Idiopathic
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 5400
Sex: ALL
Minimum age (years): 3
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering rheumatoid arthritis, spondyloarthropathy or idiopathic juvenile arthritis, recruited with rheumatologist in public and private practice

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.

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.

Eligibility 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

Primary outcomes:
measure: Drug consumption
timeFrame: first year
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Central Hospital, Nancy
Study officials:
affiliation: Central Hospital, Nancy, France
name: Francis Guillemin, MD, PhD
role: STUDY_CHAIR
affiliation: CHU, Rouen, France
name: Jacques Benichou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de la Cavale Blanche, Brest, France
name: Alain Sasraux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Cochin, Paris, France
name: Loic Guillevin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Hautepierre, Strasbourg, France
name: Jean Sibilia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Necker, Paris , France
name: Anne Marie Prieur, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Minioz, Besançon, France
name: Daniel Wendling, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: