Spacing of TNF-blocker Injections in Rheumatoid Arthritis Study

NCT00780793 | Completed Phase 4 DMC

• 1 other identifier: AOM 07127
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; Remission; Therapeutic strategy; DMARDs; Biological agents

Outcome Measures

Primary Outcomes (1)

• RA inflammatory activity over 18 months based on repeated DAS28 measures

  over 18 months

Secondary Outcomes (8)

• RA inflammatory activity over 18 months estimated by DAS44 repeated measures

  over 18 months

• Cost - Effectiveness ratio calculated as: (CostMaintenance - CostSpacing) / (EfficacyMaintenance - EfficacySpacing);

  during the study

• Relapse rate over 18 months based on Kaplan Meier survival analysis

  over 18 months

• Functional impairment based on HAQ index

  during the study

• Health-related quality of life on SF-36

  during the study

Study Arms (2)

1-M : Maintenance

ACTIVE COMPARATOR

Usual care

Drug: DMARD maintenance

2 -S : Spacing of TNF-blocker injections

EXPERIMENTAL

Spacing of TNF-blocker injections

Drug: progressive spacing of TNF-blocker injections

Interventions

progressive spacing of TNF-blocker injections DRUG

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

Also known as: Spacing (S)

2 -S : Spacing of TNF-blocker injections

DMARD maintenance DRUG

DMARD maintenance

1-M : Maintenance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• French Society of Rheumatology: collaborator

Study Sites (1)

Service de rhumatologie / Groupe hospitalier Pitié Salpêtrière

Paris, 75013, France

Location

Related Publications (1)

• Fautrel B, Pham T, Alfaiate T, Gandjbakhch F, Foltz V, Morel J, Dernis E, Gaudin P, Brocq O, Solau-Gervais E, Berthelot JM, Balblanc JC, Mariette X, Tubach F. Step-down strategy of spacing TNF-blocker injections for established rheumatoid arthritis in remission: results of the multicentre non-inferiority randomised open-label controlled trial (STRASS: Spacing of TNF-blocker injections in Rheumatoid ArthritiS Study). Ann Rheum Dis. 2016 Jan;75(1):59-67. doi: 10.1136/annrheumdis-2014-206696. Epub 2015 Jun 23.

  PMID: 26103979 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bruno Fautrel, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2008
• First Posted: October 28, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 2, 2012

Record last verified: 2008-10

Locations

FR (1)