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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01610947
Date of registration: 24/05/2012
Prospective Registration: Yes
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
Contacts
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
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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