Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity

Study Overview
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Brief Summary
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Patients with spondyloarthritis, already treated by TNF blocker (adalimumab, etanercept or infliximab), and in stable low disease activity for at least 6 months, will be randomized into 2 groups: either keeping on their usual treatment with stable doses or progressive spacing of injections of their treatment. Follow-up will be done every 3 months during 12 months, with regular monitoring of disease activity and, in patients from the group spacing, modification of the rhythm of injections according to health state and predefined protocol.

Official Title
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Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity: a Randomized Controlled Trial

Conditions
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Spondyloarthritis

Intervention / Treatment
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* Drug: Adalimumab, Etanercept, Golimumab or infliximab
* Drug: Adalimumab, Etanercept, Golimumab or infliximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with spondyloarthritis according to ASAS criteria Stable low disease activity for at least 6 months Already treated by TNF blocking drug (adalimumab, etanercept or infliximab) Exclusion Criteria: Raised acute phase reactants participation in another clinical trial Structural progression of peripheral joint damage Scheduled surgery within 12 months pregnancy

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: Maintain<br>Continuation of usual treatment with fixed intervals according to standard recommendations | Drug: Adalimumab, Etanercept, Golimumab or infliximab<br>* Continuation of usual treatment with fixed intervals according to standard recommendations<br>|
| Active Comparator: Spacing<br>Progressive spacing of injections according to disease activity observed during follow-up and predefined protocol. | Drug: Adalimumab, Etanercept, Golimumab or infliximab<br>* Progressive spacing of injections according to disease activity observed during follow-up and predefined protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients remaining in low disease activity |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medico-economic comparison of arms | The cost-efficacy ratio will be compared between the 2 arms (maintain and spacing). The objective is to see if the spacing of the treatments will allow a better tolerance and reduce the cost due to the treatments.To assess this cost-efficacy ratio, questionnaires will be used (quality of life SF36, medico-economic Euroqol). | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spondyloarthritis, Anti-TNF, Adalimumab, Etanercept, Infliximab