Skip to main content
OpenTrials
Completed

NCT Number: NCT01610947

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spondyloarthritis Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lapeyronie Hospital

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adalimumab, Etanercept, Golimumab or infliximab

Drug

Continuation of usual treatment with fixed intervals according to standard recommendations

Primary outcomes

  1. Proportion of patients remaining in low disease activity

    Time frame: 12 months

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: SPACING

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Jun 4, 2012
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.