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Completed

NCT Number: NCT01315652

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

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).

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Cochin

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comorbidities treatment

Behavioral

" Comorbidities treatment":Number of actions initiated in order to treat or prevent Rheumatoid Arthritis comorbidities during the 6 months follow-up

Auto-DAS

Behavioral

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

Primary outcomes

  1. Comorbidities treatment

    Time frame: 6 months later

    Number of actions initiated I order to treat or prevent Rheumatoid Arthritis comorbidities

  2. Auto-DAS: Patient education to calculate his Disease Activity Score

    Time frame: 6 months after

    Number of patients with a modification in their treatment between baseline and 6 months visits

Secondary outcomes

  1. Frequency of comorbidities in Rheumatoid Arthritis

    Time frame: 6 months later

  2. Adhesion to the current recommendations concerning the prevention of co-morbidities

    Time frame: 6 months later

  3. Compliance and satisfaction of the patients concerning the DAS educational program

    Time frame: 6 months later

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • French Society of Rheumatology
  • Roche Chugai
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: COMEDRA

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Mar 15, 2011
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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