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

NCT01610947 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 398

Last updated 2021-10-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-14
Primary Completion
2018-10-18
Completion
2018-10-18

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01610947 on ClinicalTrials.gov