Rheumatoid Arthritis Clinical Trial
Official title:
Effect of TNF-blocker Injections Spacing on Rheumatoid Arthritis Inflammatory Activity in Patients in Clinical Remission or Low Disease Activity
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.
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, the maintenance of such treatments - highly efficacious but expensive and
potentially toxic - is debated. To date, no reliable data are available to estimate the risk
- benefice ratio associated with either their maintenance or their tapering.
Objectives:
In RA patients in remission, the study aims:
1. To compare RA inflammatory activity based on repeated measures of the Disease Activity
Score (DAS) depending on 2 therapeutic schemes: (M) maintenance of unchanged
TNF-blockers or (S) tapering of TNF-blocker doses by progressive spacing of
subcutaneous injections according to a predefined algorithm;
2. To estimate the cost - effectiveness ratio of TNF-blocker spacing as compared to
TNF-blocker maintenance.
Inclusion criteria:
- Patients aged 18 or more, diagnosed with RA according to the 1987 ACR classification
criteria;
- RA treated with subcutaneous TNF-blockers (etanercept 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.
Sample size calculation: 250 patients, 125 for each arm.
Centers: 22 inclusion centers in France.
Research duration: 3 years. Participation duration for each patient: 18 months. Inclusion
period duration: 18 months (Sep 2008 - Feb 2010).
Methods:
Equivalence trial, prospective, randomized, controlled versus usual care, patients remaining
blinded of the tested hypotheses.
Investigators assessing disease activity remain blind of the protocol arm. The statistical
analysis will be based on a mixed linear model taking into account repeated data.
Randomization:
Computer-assisted randomization (CleanWeb software) by blocks of unequal size, stratified on
inclusion centers and TNF-blocker molecule.
Primary endpoint:
RA inflammatory activity over 18 months estimated by DAS28 repeated measures.
Secondary endpoints:
- RA inflammatory activity over 18 months estimated by DAS44 repeated measures;
- Cost - Effectiveness ratio calculated as: (CostMaintenance - CostSpacing) /
(EfficacyMaintenance - EfficacySpacing);
- Relapse rate over 18 months based on Kaplan Meier survival analysis;
- Functional impairment based on HAQ index;
- Health-related quality of life on SF-36;
- Utility based on EQ-5D instrument;
- Structural damage progression over 18 months assessed with the van der HEIJDE-modified
Sharp score (SHS);
- Safety;
- Determinants of maintained remission or relapse after TNF-blocker injection spacing.
Research time sheet:
Clinical, biological and imaging follow-up is based on guidelines-recommended RA follow-up.
Biological work-ups specifically dedicated to the research represent 80 mL. The others are
part of usual care and may be performed in non-hospital laboratories.
Expected results and perspectives:
The trial aims to test the feasibility and the risk - benefit ratio of a step-down strategy
for TNF-blockers in the course of RA.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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