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

July 5, 2016 updated by: Assistance Publique - Hôpitaux de Paris

Evaluation of the Usefulness of a Center Specialized in the Standardized Management 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

970

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Hopital Cochin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Auto DAS
"Auto-DAS"Number of patients with a modification in their treatment between baseline and 6 months visits
Behavioral: Auto-DAS
"Auto-DAS"Number of patients with a modification in their treatment between baseline and 6 months visits
Active Comparator: Comorbidities treatment
Behavioral: Comorbidities treatment
" Comorbidities treatment":Number of actions initiated in order to treat or prevent Rheumatoid Arthritis comorbidities during the 6 months follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comorbidities treatment
Time Frame: 6 months later
Number of actions initiated I order to treat or prevent Rheumatoid Arthritis comorbidities
6 months later
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
6 months after

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of comorbidities in Rheumatoid Arthritis
Time Frame: 6 months later
6 months later
Adhesion to the current recommendations concerning the prevention of co-morbidities
Time Frame: 6 months later
6 months later
Compliance and satisfaction of the patients concerning the DAS educational program
Time Frame: 6 months later
6 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

French Society of Rheumatology
Roche Chugai

Investigators

  • Principal Investigator: Maxime DOUGADOS, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

March 9, 2011

First Submitted That Met QC Criteria

March 14, 2011

First Posted (Estimate)

March 15, 2011

Study Record Updates

Last Update Posted (Estimate)

July 6, 2016

Last Update Submitted That Met QC Criteria

July 5, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P100113
  • P140101 (Other Identifier: AP-HP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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