Spacing of TNF-blocker Injections in Rheumatoid Arthritis Study (STRASS)

This study has been completed.
Sponsor:
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
  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 :

  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 22, 2014