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

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ClinicalTrials.gov Identifier: NCT00780793
Recruitment Status : Completed
First Posted : October 28, 2008
Last Update Posted : February 2, 2012
French Society of Rheumatology
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: progressive spacing of TNF-blocker injections Drug: DMARD maintenance Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : September 2008
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1-M : Maintenance
Usual care
Drug: DMARD maintenance
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)

Primary Outcome Measures :
  1. RA inflammatory activity over 18 months based on repeated DAS28 measures [ Time Frame: over 18 months ]

Secondary Outcome Measures :
  1. RA inflammatory activity over 18 months estimated by DAS44 repeated measures [ Time Frame: over 18 months ]
  2. Cost - Effectiveness ratio calculated as: (CostMaintenance - CostSpacing) / (EfficacyMaintenance - EfficacySpacing); [ Time Frame: during the study ]
  3. Relapse rate over 18 months based on Kaplan Meier survival analysis [ Time Frame: over 18 months ]
  4. Functional impairment based on HAQ index [ Time Frame: during the study ]
  5. Health-related quality of life on SF-36 [ Time Frame: during the study ]
  6. Utility based on EQ-5D instrument [ Time Frame: during the study ]
  7. Structural damage progression over 18 months assessed with the van der HEIJDE-modified Sharp score (SHS) [ Time Frame: over 18 months ]
  8. Determinants of maintained remission or relapse after TNF-blocker injection spacing [ Time Frame: during teh study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00780793

Service de rhumatologie / Groupe hospitalier Pitié Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
French Society of Rheumatology
Principal Investigator: Bruno Fautrel, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00780793     History of Changes
Other Study ID Numbers: AOM 07127
First Posted: October 28, 2008    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: October 2008

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Rheumatoid arthritis
Therapeutic strategy
Biological agents

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases