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

NCT03043846 | Completed

• 1 other identifier: 2016-A00564-47
• Study Type: observational
• Target: 163
• Locations: 3 countries
• Sites: 18

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.

Conditions

Axial Spondyloarthritis

Keywords

Treat to Target approach

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

Study Arms (2)

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.

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

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

Interventions

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

Tight control and Treat to Target arm; Usual care arm

Follow-up every month to follow the pre-defined strategy OTHER

Tight control and Treat to Target arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Association de Recherche Clinique en Rhumatologie: lead
• RCTs: collaborator

Study Sites (18)

UZ GENT

Ghent, Belgium

Location

Jessa Ziekenhuis

Hasselt, Belgium

Location

Reumatologie Medizorg

Merksem, Belgium

Location

AZ Alma

Sijsele, Belgium

Location

Chu Gabriel Montpied

Clermont-Ferrand, France

Location

Chu Grenoble

Grenoble, France

Location

Chu Le Mans

Le Mans, France

Location

Hopital Lapeyronnie

Montpellier, France

Location

Ch Mulhouse

Mulhouse, France

Location

Hopital Cochin

Paris, France

Location

Hopital de La Pitie Salpetriere

Paris, France

Location

Hopital Henri Mondor

Paris, France

Location

Chu Rouen

Rouen, France

Location

Chu Toulouse

Toulouse, France

Location

UMCG

Groningen, Netherlands

Location

Zuyderland MC

Heerlen, Netherlands

Location

LUMC

Leiden, Netherlands

Location

Maastricht UMC

Maastricht, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 33958325 DERIVED

MeSH Terms

Conditions

Axial Spondyloarthritis

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 6, 2017
• Study Start: November 30, 2016
• Primary Completion: June 18, 2019
• Study Completion: June 18, 2019
• Last Updated: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10); BE (4); NL (4)