Interest of a Standardized Monitoring of Rheumatoid Arthritis: The COMEDRA Trial
This study is ongoing, but not recruiting participants.
Sponsor:
Assistance Publique - Hôpitaux de Paris
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: July 25, 2012
Last verified: July 2012
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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: | September 2012 |
| Primary Completion Date: | June 2012 (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: | July 25, 2012 |
| 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 May 22, 2013