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

This study has suspended participant recruitment.
(pending regulatory autoristions for substantial modifications)
Sponsor:
Collaborators:
1 French Society of Rheumatology
2 ROCHE-CHUGAI France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01315652
First received: March 9, 2011
Last updated: August 2, 2013
Last verified: July 2013
  Purpose

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).


Condition Intervention
Rheumatoid Arthritis
Behavioral: Comorbidities treatment
Behavioral: Auto-DAS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Evaluation of the Usefulness of a Center Specialized in the Standardized Management of Rheumatoid Arthritis: The COMEDRA Trial

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Comorbidities treatment [ Time Frame: 6 months later ] [ Designated as safety issue: No ]
    Number of actions initiated I order to treat or prevent Rheumatoid Arthritis comorbidities

  • Auto-DAS: Patient education to calculate his Disease Activity Score [ Time Frame: 6 months after ] [ Designated as safety issue: No ]
    Number of patients with a modification in their treatment between baseline and 6 months visits


Secondary Outcome Measures:
  • Frequency of comorbidities in Rheumatoid Arthritis [ Time Frame: 6 months later ] [ Designated as safety issue: No ]
  • Adhesion to the current recommendations concerning the prevention of co-morbidities [ Time Frame: 6 months later ] [ Designated as safety issue: No ]
  • Compliance and satisfaction of the patients concerning the DAS educational program [ Time Frame: 6 months later ] [ Designated as safety issue: No ]

Enrollment: 970
Study Start Date: March 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Auto-DAS
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
Other Name: Comorbidities 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315652

Locations
France
Hôpital Cochin
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
1 French Society of Rheumatology
2 ROCHE-CHUGAI France
Investigators
Principal Investigator: Maxime Dougados, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01315652     History of Changes
Other Study ID Numbers: P100113
Study First Received: March 9, 2011
Last Updated: August 2, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
1 Rheumatoid arthritis
2 Education
3 Co-morbidities
4 Nurse

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014