Spacing of TNF-blocker Injections in Rheumatoid Arthritis Study

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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 therapeutic maintenance or progressive DMARD tapering (with a non quantified risk of disease flare).

STRASS is a 2-arm randomized controlled trial aiming to compare these 2 strategies (DMARD maintenance or progressive spacing of TNF-blocker injections) in terms of remission maintenance, relapse risk, safety issues and economic consequences during 18 months.

The inclusion period is 18 months, between September 2008 and February 2010.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: French Society of Rheumatology
• Treatments: Tumor Necrosis Factor Inhibitors

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.