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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01315652
First Posted: March 15, 2011
Last Update Posted: July 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
French Society of Rheumatology
Roche Chugai
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    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 ]
  • Adhesion to the current recommendations concerning the prevention of co-morbidities [ Time Frame: 6 months later ]
  • Compliance and satisfaction of the patients concerning the DAS educational program [ Time Frame: 6 months later ]

Enrollment: 970
Study Start Date: March 2011
Study Completion Date: January 2016
Primary Completion Date: October 2015 (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
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315652


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01315652     History of Changes
Other Study ID Numbers: P100113
P140101 ( Other Identifier: AP-HP )
First Submitted: March 9, 2011
First Posted: March 15, 2011
Last Update Posted: July 6, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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