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Spacing of TNF-blocker Injections in Rheumatoid Arthritis Study

NCT00780793 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2012-02-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

progressive spacing of TNF-blocker injections

Experimental arm Progressive spacing of TNF-blocker injections according to the following algorithm : * if DAS28 ≤ 2.6 at trimestrial assessment: go for step N+1 * if DAS28 \> 2.6 and DAS28 change ≤ 0.6: continue at step N * if DAS28 \> 2.6 and DAS28 change \> 0.6 : return to step N-1 (relapse as defined by the European expert consensus). Step 0 (inclusion) : * Adalimumab 40 mg / 14 days * Etanercept 50 mg / 7 days Step 1 : * Adalimumab 40 mg / 21 days * Etanercept 50 mg / 10 days Step 2 : * Adalimumab 40 mg / 28 days * Etanercept 50 mg / 14 days Step 3 : * Adalimumab 40 mg / 42 days * Etanercept 50 mg / 21 days Step 4 : * TNF-blocker stop

DRUG

DMARD maintenance

DMARD maintenance

Sponsors & Collaborators

  • French Society of Rheumatology

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Bruno Fautrel, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00780793 on ClinicalTrials.gov