CClinicalTrials.gg
CompletedNCT01315652COMEDRAUpdated Sep 5, 2025

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

An interventional study of Comorbidities treatment and Auto-DAS in Rheumatoid Arthritis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-05.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
970
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

Read the 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.
02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • 1 Rheumatoid arthritis
  • 2 Education
  • 3 Co-morbidities
  • 4 Nurse
03

In context

Arthritis, Rheumatoid

2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.

This study's enrollment of 970 is above the median of 94 across 1,984 interventional studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Rheumatoid Arthritis
  • Stable (no change in therapy)
  • Adult
  • Able to collaborate

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
970 participants (actual)

Study arms

  • Experimental
    Auto DAS

    "Auto-DAS"Number of patients with a modification in their treatment between baseline and 6 months visits

    Behavioral: Auto-DAS

  • Active comparator
    Comorbidities treatment

    Behavioral: Comorbidities treatment

Interventions

  • BehavioralComorbidities treatment

    " Comorbidities treatment":Number of actions initiated in order to treat or prevent Rheumatoid Arthritis comorbidities during the 6 months follow-up

  • BehavioralAuto-DAS

    "Auto-DAS"Number of patients with a modification in their treatment between baseline and 6 months visits

06

What researchers measure

Primary outcomes

  1. Comorbidities treatment

    Number of actions initiated I order to treat or prevent Rheumatoid Arthritis comorbidities

    Time frame: 6 months later

  2. Auto-DAS: Patient education to calculate his Disease Activity Score

    Number of patients with a modification in their treatment between baseline and 6 months visits

    Time frame: 6 months after

Secondary outcomes

  1. Frequency of comorbidities in Rheumatoid Arthritis

    Time frame: 6 months later

  2. Adhesion to the current recommendations concerning the prevention of co-morbidities

    Time frame: 6 months later

  3. Compliance and satisfaction of the patients concerning the DAS educational program

    Time frame: 6 months later

07

Study locations

1 site
  • Hôpital Cochin
    Paris, 75014, France
08

References and documents

Publications

  • 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. PubMed 31275607 ↗
  • 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. PubMed 30915463 ↗
  • 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. PubMed 30025953 ↗
  • 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. PubMed 28859325 ↗
  • 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. PubMed 24872377 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01315652
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
French Society of Rheumatology, Roche Chugai, URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Mar 15, 2011
Start date
Mar 2011
Primary completion
Oct 2015
Completion
Jan 2016
Last update
Sep 5, 2025

Study contacts

Maxime Dougados, MD, PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion