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

NCT02886689 | Completed DMC

• 1 other identifier: PCv1.6-12-11-05
• Study Type: observational
• Target: 5,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Arthitis, Juvenile Idiopathic

Outcome Measures

Primary Outcomes (1)

• Drug consumption

  first year

Study Arms (2)

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.

Interventions

TNF-alpha antagonist and other biotherapy DRUG

1

Eligibility Criteria

• Age: 3 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Central Hospital, Nancy

Nancy, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Study Officials

• Francis Guillemin, MD, PhD

  Central Hospital, Nancy, France

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 1, 2016
• Study Start: January 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: September 1, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)