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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01610947

Acronym

SPACING

Enrollment

398

Registered

2012-06-04

Start date

2012-05-14

Completion date

2018-10-18

Last updated

2021-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondyloarthritis

Keywords

Spondyloarthritis, Anti-TNF, Adalimumab, Etanercept, Infliximab

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.

Interventions

DRUGAdalimumab, Etanercept, Golimumab or infliximab

Continuation of usual treatment with fixed intervals according to standard recommendations

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Proportion of patients remaining in low disease activity	12 months

Secondary

Measure	Time frame	Description
Medico-economic comparison of arms	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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026