Evaluation of the Usefulness of a Center Specialized in the Standardized Management of Rheumatoid Arthritis: The COMEDRA Trial
18 Years
N/A
Both
Rheumatoid Arthritis
Trial Information
Evaluation of the Usefulness of a Center Specialized in the Standardized Management of Rheumatoid Arthritis: The COMEDRA Trial
Patients with a stable definite Rheumatoid Arthritis will be invited by their
rheumatologists to participate at this study in 20 centers in France. After written informed
consent will be obtained, the patients will be randomized in two arms:
- comorbidities
- auto-DAS The patients will be seen again in the same center six months later in order
to collect the outcome measures.
Inclusion Criteria:
- Rheumatoid Arthritis
- Stable (no change in therapy)
- Adult
- Able to collaborate
Exclusion criteria
- Pregnant woman
- Change of the therapy for 3 months before the inclusion
- Alcoholism, toxicomania, psychological problem, sever co morbidity which could
invalid the consent or limit the protocol compliance
- No social coverage affiliate
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Outcome Measure:
Comorbidities treatment
Outcome Description:
Number of actions initiated I order to treat or prevent Rheumatoid Arthritis comorbidities
Outcome Time Frame:
6 months later
Safety Issue:
No
Principal Investigator
Maxime Dougados, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Assistance Publique - Hôpitaux de Paris
Authority:
France: Ministry of Health
Study ID:
P100113
NCT ID:
NCT01315652
Start Date:
March 2011
Completion Date:
September 2012
Related Keywords:
- Rheumatoid Arthritis
- 1 Rheumatoid arthritis
- 2 Education
- 3 Co-morbidities
- 4 Nurse
- Arthritis
- Arthritis, Rheumatoid
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