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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 November 2021
• Main ID: NCT01610947
• Date of registration: 24/05/2012
• Prospective Registration: No
• Primary sponsor: University Hospital, Montpellier
• Public title: Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity SPACING
• Scientific title: Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity: a Randomized Controlled Trial
• Date of first enrolment: May 14, 2012
• Target sample size: 398
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01610947
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Spondyloarthritis

Intervention(s)

Drug: Adalimumab, Etanercept, Golimumab or infliximab

Primary Outcome(s)

Proportion of patients remaining in low disease activity [Time Frame: 12 months]

Secondary Outcome(s)

Medico-economic comparison of arms [Time Frame: 12 months]

Secondary ID(s)

8785

Source(s) of Monetary Support

Please refer to primary and secondary sponsors