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

Spondyloarthritis Clinical Trial

— SPACING  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610947
• Other study ID #: 8785
• Status: Completed
• Phase: N/A
• Start date: May 14, 2012
• Est. completion date: October 18, 2018

Study information

• Verified date: October 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: October 18, 2018
• Est. primary completion date: October 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing
• Spondyloarthritis

Intervention

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

Locations

Country	Name	City	State
France	Lapeyronie Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients remaining in low disease activity		12 months
Secondary	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