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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03043846
• Date of registration: 31/01/2017
• Prospective Registration: No
• Primary sponsor: Association de Recherche Clinique en Rhumatologie
• Public title: Treat to Target Trial in Axial Spondylo Arthritis : The TICOSPA (Tight Control in Spondyloarthritis) TICOSPA
• Scientific title: Treat to Target Trial in Axial Spondylo Arthritis : The TICOSPA (Tight Control in Spondyloarthritis)
• Date of first enrolment: November 30, 2016
• Target sample size: 163
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03043846
• Study type: Observational

Countries of recruitment

Belgium, France, Netherlands

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Axial Spondyloarthritis

Intervention(s)

Other: Follow-up every 3 months during 1 year (data collection in eCRF)

Other: Follow-up every month to follow the pre-defined strategy

Primary Outcome(s)

To compare the changes in ASASHI-NRS over the one year of follow-up in the 2 groups [Time Frame: After a one year follow-up]

Secondary Outcome(s)

To compare the change in the ASAS-NSAID score over one year follow-up in the 2 groups. [Time Frame: After a one year follow-up]

To compare the change in the ASDAS over one year follow-up in the 2 groups. [Time Frame: After a one year follow-up]

To compare the change in the BASDAI over one year follow-up in the 2 groups. [Time Frame: 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. [Time Frame: 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. [Time Frame: After a one year follow-up]

To compare the percentage of patients reaching an ASDAS major improvement after a one year follow-up in the 2 groups. [Time Frame: After a one year follow-up]

To compare the WPAI after a one year follow-up in the 2 groups. [Time Frame: After a one year follow-up]

To compare the EQ5D after a one year follow-up in the 2 groups. [Time Frame: 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. [Time Frame: 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. [Time Frame: After a one year follow-up]

To compare the treatment effect (...) within the T2T depending on the compliance to the T2T treatment. [Time Frame: After a one year follow-up]

Secondary ID(s)

2016-A00564-47

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

RCTs