NCT01610947

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 398 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spondyloarthritis

Interventions

Type	Name	Description
DRUG	Adalimumab, Etanercept, Golimumab or infliximab	Continuation of usual treatment with fixed intervals according to standard recommendations
DRUG	Adalimumab, Etanercept, Golimumab or infliximab	Progressive spacing of injections according to disease activity observed during follow-up and predefined protocol

Timeline

• Start date: 2012-05-14
• Primary completion: 2018-10-18
• Completion: 2018-10-18
• First posted: 2012-06-04
• Last updated: 2021-10-19

Locations

1 site across 1 country: France