Status:
COMPLETED
Spacing of TNF-blocker Injections in Rheumatoid Arthritis Study
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
French Society of Rheumatology
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Remission is nowadays the recommended therapeutic objective in rheumatoid arthritis. Once this objective is achieved thanks to TNF-blockers, the optimal therapeutic strategy remains unclear, either th...
Detailed Description
Rationale: Clinical remission is the therapeutic objective in rheumatoid arthritis, as recommended by professional practice guidelines. Once this objective is achieved with subcutaneous TNF-blockers,...
Eligibility Criteria
Inclusion
- Patients aged 18 or more, diagnosed with RA according to the 1987 ACR classification criteria;
- RA treated with subcutaneous TNF-blockers (étanercept or adalimumab) at stable and standard dosage for 1 year or more, as monotherapy or associated with stable conventional DMARD;
- RA in clinical remission, defined as a stable DAS28 ≤ 2.6 for 6 months or more, without any structural damage progression on X-rays (local reading by the treating rheumatologist);
Exclusion
- Treatment with steroids;
- progressing disease on X-rays during the year preceding the trial;
- surgery planed in the 18 coming months;
- pregnancy;
- on-going neoplastic disease;
- other auto-immune disorders different from RA;
- inability to speak or understand French;
- absence of signed informed consent;
- absence of medical insurance coverage.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00780793
Start Date
September 1 2008
End Date
September 1 2011
Last Update
February 2 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Service de rhumatologie / Groupe hospitalier Pitié Salpêtrière
Paris, France, 75013