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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Axial Spondyloarthritis

Intervention / Treatment
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* Other: Follow-up every 3 months during 1 year (data collection in eCRF)
* Other: Follow-up every month to follow the pre-defined strategy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tight control and Treat to Target arm<br>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. | Other: Follow-up every 3 months during 1 year (data collection in eCRF)<br> <br> Other: Follow-up every month to follow the pre-defined strategy<br> <br> |
| Usual care arm<br>For this arm, the treating rheumatologists will continue to manage the enrolled patients in accordance to their usual care. | Other: Follow-up every 3 months during 1 year (data collection in eCRF)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the changes in ASASHI-NRS over the one year of follow-up in the 2 groups | In the original protocol, the main objective was to compare the percentage of patients with a significant improvement in the ASAS-HI score after a one year follow-up in the 2 groups. However, after further research on the methodology to better assess the treatment effect on a pragmatic cluster-based strategy trial, we propose to change the primary objective for two reasons in order to: Calculate a significant improvement of the ASAS-HI, we would need to be aware of the minimally clinically important difference, and this threshold has not been yet defined for the regular ASAS-HI nor for the ASAS-HI NRS. Account for the reduced heterogeneity induced by the fact that patients are clustered, a multilevel analysis (e.g. mixed models with two random effects, the subject and the cluster or center) has been proposed as the most appropriate method. Therefore, we have amended the main objective to: To compare the changes in ASASHI-NRS over the one year of follow-up in the 2 groups. | After a one year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the percentage of patients reaching an ASDAS major improvement after a one year follow-up in the 2 groups. |  | After a one year follow-up | 
| To compare the percentage of patients reaching an ASDAS clinically important improvement after a one year follow-up in the 2 groups. |  | After a one year follow-up | 
| To compare the percentage of patients reaching a BASDAI 50 after a one year follow-up in the 2 groups. |  | After a one year follow-up | 
| To compare the change in the ASDAS over one year follow-up in the 2 groups. |  | After a one year follow-up | 
| To compare the change in the BASDAI over one year follow-up in the 2 groups. |  | After a one year follow-up | 
| To compare the change in the ASAS-NSAID score over one year follow-up in the 2 groups. |  | After a one year follow-up | 
| To compare the WPAI after a one year follow-up in the 2 groups. |  | After a one year follow-up | 
| To compare the EQ5D after a one year follow-up in the 2 groups. |  | After a one year follow-up | 
| To compare the self-report questionnaire on health resource utilization after a one year follow-up in the 2 groups. |  | After a one year follow-up | 
| To compare the number and type of adverse events occuring over one year follow-up in the 2 groups. |  | After a one year follow-up | 
| To compare the treatment effect (...) within the T2T depending on the compliance to the T2T treatment. |  | After a one year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treat to Target approach