Treat to Target Trial in Axial Spondylo Arthritis : The TICOSPA (Tight Control in Spondyloarthritis)
NCT ID: NCT03043846
Last Updated: 2019-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
163 participants
OBSERVATIONAL
2016-11-30
2019-06-18
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Tight control and Treat to Target arm
For this group, the treating rheumatologist will agree to monitor very closely (at least every 4 weeks) and also to treat their patients in accordance with a pre-defined strategy.
Follow-up every 3 months during 1 year (data collection in eCRF)
Follow-up every month to follow the pre-defined strategy
Usual care arm
For this arm, the treating rheumatologists will continue to manage the enrolled patients in accordance to their usual care.
Follow-up every 3 months during 1 year (data collection in eCRF)
Interventions
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Follow-up every 3 months during 1 year (data collection in eCRF)
Follow-up every month to follow the pre-defined strategy
Eligibility Criteria
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Inclusion Criteria
* With a diagnosis of axial spondyloarthritis according to the axial ASAS criteria AND the opinion of the treating rheumatologist.
* Active disease defined as an ASDAS ≥ 2.1
* Predominant axial disease meaning that:
* Patients with non-spinal rheumatological symptoms and/or extra-rheumatological manifestations requiring at baseline the initiation of a specific treatment will be excluded.
* Patients with a past history and/or a current well controlled non-spinal rheumatological or extra-rheumatological features will be eligible for the study.
* Non-optimally treated with NSAIDs (i.e. who have not received at least 2 NSAIDS, daily during at least 2 weeks at full dose, during the last year). Annex II summarizes the list of commonly used NSAIDs and the definition of a "full" use.
* With available pelvic X-rays, B27 and MRI of the sacro-iliac joints (performed at any time since symptoms onset)
* With no contraindication to the use of a NSAID
* With no intake of apremilast during the previous 3 months
* Able to understand the objectives of the study and to fill the questionnaires
* Written informed consent.
18 Years
65 Years
ALL
No
Sponsors
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RCTs
INDUSTRY
Association de Recherche Clinique en Rhumatologie
OTHER
Responsible Party
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Locations
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UZ GENT
Ghent, , Belgium
Jessa Ziekenhuis
Hasselt, , Belgium
Reumatologie Medizorg
Merksem, , Belgium
AZ Alma
Sijsele, , Belgium
Chu Gabriel Montpied
Clermont-Ferrand, , France
Chu Grenoble
Grenoble, , France
Chu Le Mans
Le Mans, , France
Hopital Lapeyronnie
Montpellier, , France
Ch Mulhouse
Mulhouse, , France
Hopital Cochin
Paris, , France
Hopital de La Pitie Salpetriere
Paris, , France
Hopital Henri Mondor
Paris, , France
Chu Rouen
Rouen, , France
Chu Toulouse
Toulouse, , France
UMCG
Groningen, , Netherlands
Zuyderland MC
Heerlen, , Netherlands
LUMC
Leiden, , Netherlands
Maastricht UMC
Maastricht, , Netherlands
Countries
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References
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Molto A, Lopez-Medina C, Van den Bosch FE, Boonen A, Webers C, Dernis E, van Gaalen FA, Soubrier M, Claudepierre P, Baillet A, Starmans-Kool M, Spoorenberg A, Jacques P, Carron P, Joos R, Lenaerts J, Gossec L, Pouplin S, Ruyssen-Witrand A, Sparsa L, van Tubergen A, van der Heijde D, Dougados M. Efficacy of a tight-control and treat-to-target strategy in axial spondyloarthritis: results of the open-label, pragmatic, cluster-randomised TICOSPA trial. Ann Rheum Dis. 2021 Nov;80(11):1436-1444. doi: 10.1136/annrheumdis-2020-219585. Epub 2021 May 6.
Other Identifiers
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2016-A00564-47
Identifier Type: -
Identifier Source: org_study_id
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