Interest of a Standardized Monitoring of Rheumatoid Arthritis: The COMEDRA Trial
NCT ID: NCT01315652
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
970 participants
INTERVENTIONAL
2011-03-31
2016-01-31
Brief Summary
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Detailed Description
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* comorbidities
* auto-DAS The patients will be seen again in the same center six months later in order to collect the outcome measures.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Auto DAS
"Auto-DAS"Number of patients with a modification in their treatment between baseline and 6 months visits
Auto-DAS
"Auto-DAS"Number of patients with a modification in their treatment between baseline and 6 months visits
Comorbidities treatment
Comorbidities treatment
" Comorbidities treatment":Number of actions initiated in order to treat or prevent Rheumatoid Arthritis comorbidities during the 6 months follow-up
Interventions
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Comorbidities treatment
" Comorbidities treatment":Number of actions initiated in order to treat or prevent Rheumatoid Arthritis comorbidities during the 6 months follow-up
Auto-DAS
"Auto-DAS"Number of patients with a modification in their treatment between baseline and 6 months visits
Eligibility Criteria
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Inclusion Criteria
* Stable (no change in therapy)
* Adult
* Able to collaborate
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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1 French Society of Rheumatology
UNKNOWN
Roche Chugai
INDUSTRY
URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Maxime Dougados, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital Cochin
Paris, , France
Countries
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References
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Gossec L, Soubrier M, Foissac F, Molto A, Richette P, Beauvais C, Ruyssen-Witrand A, Perdriger A, Chary-Valckenaere I, Mouterde G, Dernis E, Euller-Ziegler L, Flipo RM, Gilson M, Guis S, Mariette X, Pouplin S, Marhadour T, Schaeverbeke T, Sordet C, Fayet F, Dougados M. Screening for and management of comorbidities after a nurse-led program: results of a 3-year longitudinal study in 769 established rheumatoid arthritis patients. RMD Open. 2019 Jun 14;5(2):e000914. doi: 10.1136/rmdopen-2019-000914. eCollection 2019.
Gossec L, Fayet F, Soubrier M, Foissac F, Molto A, Richette P, Beauvais C, Ruyssen-Witrand A, Perdriger A, Chary-Valckenaere I, Mouterde G, Dernis E, Euller-Ziegler L, Flipo RM, Gilson M, Balandraud N, Mariette X, Pouplin S, Marhadour T, Schaeverbeke T, Sordet C, Dougados M. Is self-assessment by patients of disease activity acceptable over the long term in rheumatoid arthritis? A 3-year follow-up of 771 patients. Rheumatology (Oxford). 2019 Aug 1;58(8):1498-1499. doi: 10.1093/rheumatology/kez094. No abstract available.
Tournadre A, Pereira B, Gossec L, Soubrier M, Dougados M. Impact of comorbidities on fatigue in rheumatoid arthritis patients: Results from a nurse-led program for comorbidities management (COMEDRA). Joint Bone Spine. 2019 Jan;86(1):55-60. doi: 10.1016/j.jbspin.2018.06.010. Epub 2018 Jul 17.
Ferreira RJO, Dougados M, Kirwan JR, Duarte C, de Wit M, Soubrier M, Fautrel B, Kvien TK, da Silva JAP, Gossec L; CoimbRA investigators, RAID investigators and COMEDRA investigators. Drivers of patient global assessment in patients with rheumatoid arthritis who are close to remission: an analysis of 1588 patients. Rheumatology (Oxford). 2017 Sep 1;56(9):1573-1578. doi: 10.1093/rheumatology/kex211.
Dougados M, Soubrier M, Perrodeau E, Gossec L, Fayet F, Gilson M, Cerato MH, Pouplin S, Flipo RM, Chabrefy L, Mouterde G, Euller-Ziegler L, Schaeverbeke T, Fautrel B, Saraux A, Chary-Valckenaere I, Chales G, Dernis E, Richette P, Mariette X, Berenbaum F, Sibilia J, Ravaud P. Impact of a nurse-led programme on comorbidity management and impact of a patient self-assessment of disease activity on the management of rheumatoid arthritis: results of a prospective, multicentre, randomised, controlled trial (COMEDRA). Ann Rheum Dis. 2015 Sep;74(9):1725-33. doi: 10.1136/annrheumdis-2013-204733. Epub 2014 May 28.
Other Identifiers
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P140101
Identifier Type: OTHER
Identifier Source: secondary_id
P100113
Identifier Type: -
Identifier Source: org_study_id
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