Interest of a Standardized Monitoring of Rheumatoid Arthritis: The COMEDRA Trial

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Behavioral: Comorbidities treatment; Behavioral: Auto-DAS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01315652

P140101 (Other Identifier)

P100113

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 970 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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970 participants in 2 patient groups

Auto DAS

Experimental group

Description:

"Auto-DAS"Number of patients with a modification in their treatment between baseline and 6 months visits

Treatment:

Behavioral: Auto-DAS

Comorbidities treatment

Active Comparator group

Treatment:

Behavioral: Comorbidities treatment