NCT03043846

Treat to Target Trial in Axial Spondylo Arthritis : The TICOSPA (Tight Control in Spondyloarthritis)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 163 (actual)
• Sponsor: Association de Recherche Clinique en Rhumatologie · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a not interventional, pragmatic, prospective, randomized (cluster) study to evaluate the potential benefit of a Treat to Target approach in comparison to routine treatment (i.e. usual care) in patients with axial spondyloarthritis.

Detailed description

This study is reflecting the usual care either in accordance to the treating rheumatologist (arm: usual care) or in accordance to the international scientific recommendations (arm: T2T) The tight control means that as soon as a treatment is initiated in a patient, the time permitting to evaluate its potential efficacy/safety has to be determined. In terms of safety, such time frame can be very short based on the occurrence of adverse events. In terms of efficacy it is usually recommended to evaluate an NSAIDs after 2 to 4 weeks of treatment intake and the TNF blockers after 12 to 16 weeks. The Treat to Target means that there is an a priori decision of the target to reach while initiating a treatment and more importantly an a priori decision to intensify the treatment in case such target is not achieved. There will be 2 arms in the study (tight control and treat to target arm and usual care arm). 160 patients (80 patients per arm) will be included during one year by 18 centers (10 in France, 4 in Belgium and 4 in Netherlands). Patients will be followed during 1 year.

Conditions

• Axial Spondyloarthritis

Interventions

Type	Name	Description
OTHER	Follow-up every 3 months during 1 year (data collection in eCRF)
OTHER	Follow-up every month to follow the pre-defined strategy

Timeline

• Start date: 2016-11-30
• Primary completion: 2019-06-18
• Completion: 2019-06-18
• First posted: 2017-02-06
• Last updated: 2019-09-27

Locations

18 sites across 3 countries: Belgium, France, Netherlands