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:
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

March 9, 2011
August 2, 2013
March 2011
December 2014   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01315652 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Interest of a Standardized Monitoring of Rheumatoid Arthritis: The COMEDRA Trial
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).

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Rheumatoid Arthritis
  • 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
  • Behavioral: Auto-DAS
    "Auto-DAS"Number of patients with a modification in their treatment between baseline and 6 months visits
    Other Name: Auto-DAS
  • Experimental: Auto DAS
    "Auto-DAS"Number of patients with a modification in their treatment between baseline and 6 months visits
    Intervention: Behavioral: Auto-DAS
  • Active Comparator: Comorbidities treatment
    Intervention: Behavioral: Comorbidities treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
970
July 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01315652
P100113
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
  • French Society of Rheumatology
  • 2 ROCHE-CHUGAI France
Principal Investigator: Maxime Dougados, MD, PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP