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

October 18, 2021 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

398

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Lapeyronie Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Maintain
Continuation of usual treatment with fixed intervals according to standard recommendations
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
ACTIVE_COMPARATOR: Spacing
Progressive spacing of injections according to disease activity observed during follow-up and predefined protocol.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients remaining in low disease activity
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medico-economic comparison of arms
Time Frame: 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).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 14, 2012

Primary Completion (ACTUAL)

October 18, 2018

Study Completion (ACTUAL)

October 18, 2018

Study Registration Dates

First Submitted

May 24, 2012

First Submitted That Met QC Criteria

May 30, 2012

First Posted (ESTIMATE)

June 4, 2012

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2021

Last Update Submitted That Met QC Criteria

October 18, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8785 (DUMC old IRB number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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