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

Rheumatoid Arthritis Clinical Trial

— COMEDRA  

Official title:

Evaluation of the Usefulness of a Center Specialized in the Standardized Management of Rheumatoid Arthritis: The COMEDRA Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01315652
• Other study ID #: P100113
• Secondary ID: P140101
• Status: Completed
• Phase: N/A
• First received: March 9, 2011
• Last updated: July 5, 2016
• Start date: March 2011
• Est. completion date: January 2016

Study information

• 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

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Behavioral:
• Comorbidities treatment
" Comorbidities treatment":Number of actions initiated in order to treat or prevent Rheumatoid Arthritis comorbidities during the 6 months follow-up
• Auto-DAS
"Auto-DAS"Number of patients with a modification in their treatment between baseline and 6 months visits

Locations

Country	Name	City	State
France	Hôpital Cochin	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	French Society of Rheumatology, Roche Chugai

Country where clinical trial is conducted

France, 

Outcome

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