Rheumatoid Arthritis Clinical Trial
— COMEDRAOfficial title:
Evaluation of the Usefulness of a Center Specialized in the Standardized Management of Rheumatoid Arthritis: The COMEDRA Trial
Verified date | July 2016 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
The two objectives of this trial are :1 To evaluate the impact of a visit with a nurse checking the preventive modalities and/or the presence of comorbidities such as infections ( e.g. vaccinations), cardiovascular-diseases (e.g. Indication to statin, antiaggregant,anti-hypertensive treatment…), cancers (e.g.mammography,…), osteoporosis (e.g. bone densitometry,..) in patients suffering from Rheumatoid Arthritis 2 To evaluate the impact of an educational program aimed at permitting rheumatoid arthritis patients to auto-evaluate their disease activity by collecting the Disease Activity Score (DAS28-ESR).
Status | Completed |
Enrollment | 970 |
Est. completion date | January 2016 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
France | Hôpital Cochin | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | French Society of Rheumatology, Roche Chugai |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comorbidities treatment | Number of actions initiated I order to treat or prevent Rheumatoid Arthritis comorbidities | 6 months later | No |
Primary | Auto-DAS: Patient education to calculate his Disease Activity Score | Number of patients with a modification in their treatment between baseline and 6 months visits | 6 months after | No |
Secondary | Frequency of comorbidities in Rheumatoid Arthritis | 6 months later | No | |
Secondary | Adhesion to the current recommendations concerning the prevention of co-morbidities | 6 months later | No | |
Secondary | Compliance and satisfaction of the patients concerning the DAS educational program | 6 months later | No |
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