NCT01315652

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
970

participants targeted

Target at P75+ for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

4.6 years

First QC Date

March 9, 2011

Last Update Submit

August 29, 2025

Conditions

Rheumatoid Arthritis

Keywords

1 Rheumatoid arthritis2 Education3 Co-morbidities4 Nurse

Outcome Measures

Primary Outcomes (2)

  • Comorbidities treatment

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

    6 months later

  • 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

    6 months after

Secondary Outcomes (3)

  • Frequency of comorbidities in Rheumatoid Arthritis

    6 months later

  • Adhesion to the current recommendations concerning the prevention of co-morbidities

    6 months later

  • Compliance and satisfaction of the patients concerning the DAS educational program

    6 months later

Study Arms (2)

Auto DAS

EXPERIMENTAL

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

Behavioral: Auto-DAS

Comorbidities treatment

ACTIVE COMPARATOR
Behavioral: Comorbidities treatment

Interventions

Comorbidities treatmentBEHAVIORAL

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

Comorbidities treatment
Auto-DASBEHAVIORAL

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

Auto DAS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnant woman
  • Alcoholism, toxicomania, psychological problem, sever co morbidity which could invalid the consent or limit the protocol compliance
  • No social coverage affiliate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cochin

Paris, 75014, France

Location

Related Publications (5)

  • 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.

    PMID: 31275607BACKGROUND

  • 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.

    PMID: 30915463BACKGROUND

  • 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.

    PMID: 30025953DERIVED

  • 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.

    PMID: 28859325DERIVED

  • 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.

    PMID: 24872377DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Maxime Dougados, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2011

First Posted

March 15, 2011

Study Start

March 1, 2011

Primary Completion

October 1, 2015

Study Completion

January 1, 2016

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)