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

NCT01315652 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 970

Last updated 2025-09-05

No results posted yet for this study

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).

Conditions

Interventions

BEHAVIORAL

Comorbidities treatment

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

BEHAVIORAL

Auto-DAS

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

Sponsors & Collaborators

  • 1 French Society of Rheumatology

    collaborator UNKNOWN

  • Roche Chugai

    collaborator INDUSTRY

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Maxime Dougados, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2015-10-31
Completion
2016-01-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01315652 on ClinicalTrials.gov