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

Not Applicable

Completed

• Conditions: Spondyloarthritis
• Interventions: Drug: Adalimumab, Etanercept, Golimumab or infliximab

• Registration Number: NCT01610947
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-14
• Study First Submitted: 2012-05-24
• Study First Submitted QC: 2012-05-30
• Study First Posted: 2012-06-04
• Primary Completion: 2018-10-18
• Study Completion: 2018-10-18
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-18
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 398

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spacing	Adalimumab, Etanercept, Golimumab or infliximab	Progressive spacing of injections according to disease activity observed during follow-up and predefined protocol.
Maintain	Adalimumab, Etanercept, Golimumab or infliximab	Continuation of usual treatment with fixed intervals according to standard recommendations

Primary Outcome Measures

Name	Time	Method
Proportion of patients remaining in low disease activity	12 months

Secondary Outcome Measures

Name	Time	Method
Medico-economic comparison of arms	12 months	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).

Trial Locations

Locations (1)

Lapeyronie Hospital; 🇫🇷 Montpellier, France