Comparative Analysis of Two Therapeutic Strategies in Patients With Spondyloarthritis Treated With Anti-tnf Biologics

Study Overview
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Brief Summary
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The objective of the study is to evaluate two therapeutic strategies: early switch or therapeutic intensification in patients with spondyloarthritis in case of secondary treatment failure suspicion to a first monoclonal antibodies anti-TNF definite by increase of ASDAS and positivity to ADAb. Patients and Methods: Multicentric randomized prospective study. Duration of inclusion 30 months. Duration of follow-up 24 months. 104 patients with spondyloarthritis treated with infliximab or adalimumab will be included if their ADAb dosage is positive, and they will be randomized (1:1) in two groups : early switch where treatment will be change to another anti-TNF, or therapeutic intensification where interval between two injections will be shortened. Patients will be evaluated clinically (ASDAS) and biologically (ADAb) at 12 weeks then at 24 weeks. Principal outcome will be the variation of ASDAS between baseline and end of the study. Number of patients to be included has been determined statistically from a preliminary study (power >98% for ASDAS variation of 20% on week 24). Expected results: On week 24, we expect a better response and a greater proportion of patients in remission in the early switch arm compare to the therapeutic intensification arm.

Official Title
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Comparative Analysis of Two Therapeutic Strategies: Early Switch Versus Therapeutic Intensification in Patients With Spondyloarthritis Treated With Anti-tnf Biologics, in Case of Secondary Treatment Failure Suspicion.

Conditions
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Spondyloarthritis

Intervention / Treatment
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* Biological: anti drug antibodies dosage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Spondyloarthritis positive for the ASAS criteria, treated with a first biologic : infliximab ( 5mg/kg intravenously every 8 weeks) or adalimumab (40mg subcutaneously every 2 weeks) Active spondyloarthritis definite by ASDAS-CRP > 2.1 at two successive evaluations while patient was previously responder (ASDAS<2.1 at least once in the 6th months after beginning of treatment) Positivity to anti-drug antibodies (ADAb) Consent of the patient No contra-indication to another anti-tnf biologic affiliation to health insurance woman of childbearing age must use an appropriate mean of contraception Exclusion Criteria: Pregnant or breastfeeding woman contra-indication to anti-tnf biologic patient with known hypersensitivity to any of the excipients Severe and uncontrolled opportunistic infection , includins septicemia, tuberculosis, abcess and opportunistic infection Evolutive infection, including chronic or localised infection Patient with moderate to severe heart failure (NYHA class III/IV)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: early switch<br>early switch of monoclonal antibodies anti-TNF anti drug antibodies dosage | Biological: anti drug antibodies dosage<br>* anti drug antibodies dosage<br>|
| Experimental: therapeutic intensification<br>therapeutic intensification of monoclonal antibodies anti-TNF anti drug antibodies dosage | Biological: anti drug antibodies dosage<br>* anti drug antibodies dosage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of ASDAS between inclusion and 24 weeks of treatment | ASDAS will be measured at week 24 and will be compared to day 1 | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of patients with ASDAS < 2.1 | Frequency of patients with ASDAS < 2.1 at week 24 ASDAS < 2.1 is considered as remission | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spondyloarthritis, monoclonal antibodies anti-TNF, secondary treatment failure