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

Primary Purpose

Spondyloarthritis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Adalimumab, Etanercept, Golimumab or infliximab
Adalimumab, Etanercept, Golimumab or infliximab
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondyloarthritis focused on measuring Spondyloarthritis, Anti-TNF, Adalimumab, Etanercept, Infliximab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lapeyronie Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Maintain

Spacing

Arm Description

Continuation of usual treatment with fixed intervals according to standard recommendations

Progressive spacing of injections according to disease activity observed during follow-up and predefined protocol.

Outcomes

Primary Outcome Measures

Proportion of patients remaining in low disease activity

Secondary Outcome Measures

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).

Full Information

First Posted
May 24, 2012
Last Updated
October 18, 2021
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT01610947
Brief Title
Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity
Acronym
SPACING
Official Title
Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 14, 2012 (Actual)
Primary Completion Date
October 18, 2018 (Actual)
Study Completion Date
October 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthritis
Keywords
Spondyloarthritis, Anti-TNF, Adalimumab, Etanercept, Infliximab

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
398 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maintain
Arm Type
Active Comparator
Arm Description
Continuation of usual treatment with fixed intervals according to standard recommendations
Arm Title
Spacing
Arm Type
Active Comparator
Arm Description
Progressive spacing of injections according to disease activity observed during follow-up and predefined protocol.
Intervention Type
Drug
Intervention Name(s)
Adalimumab, Etanercept, Golimumab or infliximab
Intervention Description
Continuation of usual treatment with fixed intervals according to standard recommendations
Intervention Type
Drug
Intervention Name(s)
Adalimumab, Etanercept, Golimumab or infliximab
Intervention Description
Progressive spacing of injections according to disease activity observed during follow-up and predefined protocol
Primary Outcome Measure Information:
Title
Proportion of patients remaining in low disease activity
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Medico-economic comparison of arms
Description
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).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Lapeyronie Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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