Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Adalimumab, Etanercept, Golimumab or infliximab
- Conditions
- Spondyloarthritis
- Sponsor
- University Hospital, Montpellier
- Enrollment
- 398
- Locations
- 1
- Primary Endpoint
- Proportion of patients remaining in low disease activity
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Maintain
Continuation of usual treatment with fixed intervals according to standard recommendations
Intervention: Adalimumab, Etanercept, Golimumab or infliximab
Spacing
Progressive spacing of injections according to disease activity observed during follow-up and predefined protocol.
Intervention: Adalimumab, Etanercept, Golimumab or infliximab
Outcomes
Primary Outcomes
Proportion of patients remaining in low disease activity
Time Frame: 12 months
Secondary Outcomes
- Medico-economic comparison of arms(12 months)