Rheumatoid Arthritis Clinical Trial
— STRASSOfficial title:
Effect of TNF-blocker Injections Spacing on Rheumatoid Arthritis Inflammatory Activity in Patients in Clinical Remission or Low Disease Activity
Verified date | October 2008 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 250 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Service de rhumatologie / Groupe hospitalier Pitié Salpêtrière | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | French Society of Rheumatology |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | RA inflammatory activity over 18 months based on repeated DAS28 measures | over 18 months | No | |
Secondary | RA inflammatory activity over 18 months estimated by DAS44 repeated measures | over 18 months | No | |
Secondary | Cost - Effectiveness ratio calculated as: (CostMaintenance - CostSpacing) / (EfficacyMaintenance - EfficacySpacing); | during the study | No | |
Secondary | Relapse rate over 18 months based on Kaplan Meier survival analysis | over 18 months | No | |
Secondary | Functional impairment based on HAQ index | during the study | Yes | |
Secondary | Health-related quality of life on SF-36 | during the study | Yes | |
Secondary | Utility based on EQ-5D instrument | during the study | Yes | |
Secondary | Structural damage progression over 18 months assessed with the van der HEIJDE-modified Sharp score (SHS) | over 18 months | Yes | |
Secondary | Determinants of maintained remission or relapse after TNF-blocker injection spacing | during teh study | No |
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