Clinical trial NCT03043846: Treat to Target Trial in Axial Spondylo Arthritis : The TICOSPA (Tight Control in Spondyloarthritis)
Official title: Treat to Target Trial in Axial Spondylo Arthritis : The TICOSPA (Tight Control in Spondyloarthritis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Axial Spondyloarthritis
Keywords: Treat to Target approach
Lead sponsor: Association de Recherche Clinique en Rhumatologie
Sponsor class: OTHER
Collaborators: name: RCTs
First posted: 2017-02-06
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with a diagnosis of predominant axial spondyloarthritis according to the axial ASAS criteria AND the opinion of the treating rheumatologist, and an active disease defined as an (ASDAS ≥ 2.1), and non-optimally treated with NSAIDs.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Adults (between 18 and 65 years old)
* 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.

Primary outcomes:
measure: To compare the changes in ASASHI-NRS over the one year of follow-up in the 2 groups
timeFrame: After a one year follow-up
Secondary outcomes:
measure: To compare the percentage of patients reaching an ASDAS major improvement after a one year follow-up in the 2 groups.
timeFrame: After a one year follow-up
measure: To compare the percentage of patients reaching an ASDAS clinically important improvement after a one year follow-up in the 2 groups.
timeFrame: After a one year follow-up
measure: To compare the percentage of patients reaching a BASDAI 50 after a one year follow-up in the 2 groups.
timeFrame: After a one year follow-up
measure: To compare the change in the ASDAS over one year follow-up in the 2 groups.
timeFrame: After a one year follow-up
measure: To compare the change in the BASDAI over one year follow-up in the 2 groups.
timeFrame: After a one year follow-up
measure: To compare the change in the ASAS-NSAID score over one year follow-up in the 2 groups.
timeFrame: After a one year follow-up
measure: To compare the WPAI after a one year follow-up in the 2 groups.
timeFrame: After a one year follow-up
measure: To compare the EQ5D after a one year follow-up in the 2 groups.
timeFrame: After a one year follow-up
measure: To compare the self-report questionnaire on health resource utilization after a one year follow-up in the 2 groups.
timeFrame: After a one year follow-up
measure: To compare the number and type of adverse events occuring over one year follow-up in the 2 groups.
timeFrame: After a one year follow-up
measure: To compare the treatment effect (...) within the T2T depending on the compliance to the T2T treatment.
timeFrame: After a one year follow-up
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: UZ GENT
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Merksem
country: Belgium
facility: Reumatologie Medizorg
city: Sijsele
country: Belgium
facility: AZ Alma
city: Clermont-ferrand
country: France
facility: Chu Gabriel Montpied
city: Grenoble
country: France
facility: Chu Grenoble
city: Le Mans
country: France
facility: Chu Le Mans
city: Montpellier
country: France
facility: Hopital Lapeyronnie
city: Mulhouse
country: France
facility: Ch Mulhouse
city: Paris
country: France
facility: Hopital Cochin
city: Paris
country: France
facility: Hopital de La Pitie Salpetriere
city: Paris
country: France
facility: Hopital Henri Mondor
city: Rouen
country: France
facility: Chu Rouen
city: Toulouse
country: France
facility: Chu Toulouse
city: Groningen
country: Netherlands
facility: UMCG
city: Heerlen
country: Netherlands
facility: Zuyderland MC
city: Leiden
country: Netherlands
facility: LUMC
city: Maastricht
country: Netherlands
facility: Maastricht UMC
Study officials:
References:
citation: 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.