Trial record 5 of 1259 for:
TNF
Spacing of TNF-blocker Injections in Rheumatoid Arthritis Study (STRASS)
This study has been completed.
Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborator:
French Society of Rheumatology
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00780793
First received: October 27, 2008
Last updated: February 1, 2012
Last verified: October 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: progressive spacing of TNF-blocker injections Drug: DMARD maintenance |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Effect of TNF-blocker Injections Spacing on Rheumatoid Arthritis Inflammatory Activity in Patients in Clinical Remission or Low Disease Activity |
Resource links provided by NLM:
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- RA inflammatory activity over 18 months based on repeated DAS28 measures [ Time Frame: over 18 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- RA inflammatory activity over 18 months estimated by DAS44 repeated measures [ Time Frame: over 18 months ] [ Designated as safety issue: No ]
- Cost - Effectiveness ratio calculated as: (CostMaintenance - CostSpacing) / (EfficacyMaintenance - EfficacySpacing); [ Time Frame: during the study ] [ Designated as safety issue: No ]
- Relapse rate over 18 months based on Kaplan Meier survival analysis [ Time Frame: over 18 months ] [ Designated as safety issue: No ]
- Functional impairment based on HAQ index [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
- Health-related quality of life on SF-36 [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
- Utility based on EQ-5D instrument [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
- Structural damage progression over 18 months assessed with the van der HEIJDE-modified Sharp score (SHS) [ Time Frame: over 18 months ] [ Designated as safety issue: Yes ]
- Determinants of maintained remission or relapse after TNF-blocker injection spacing [ Time Frame: during teh study ] [ Designated as safety issue: No ]
| Enrollment: | 250 |
| Study Start Date: | September 2008 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1-M : Maintenance
Usual care
|
Drug: DMARD maintenance
DMARD maintenance
Other Name: DMARD maintenance
|
|
Experimental: 2 -S : Spacing of TNF-blocker injections
Spacing of TNF-blocker injections
|
Drug: progressive spacing of TNF-blocker injections
Experimental arm Progressive spacing of TNF-blocker injections according to the following algorithm :
Step 0 (inclusion) :
Step 1 :
Step 2 :
Step 3 :
Step 4 :
Other Name: Spacing (S)
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780793
Locations
| France | |
| Service de rhumatologie / Groupe hospitalier Pitié Salpêtrière | |
| Paris, France, 75013 | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
French Society of Rheumatology
Investigators
| Principal Investigator: | Bruno Fautrel, MD, PhD | Assistance Publique - Hôpitaux de Paris |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00780793 History of Changes |
| Other Study ID Numbers: | AOM 07127 |
| Study First Received: | October 27, 2008 |
| Last Updated: | February 1, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Rheumatoid arthritis Remission Therapeutic strategy DMARDs Biological agents |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Antirheumatic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013