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

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ClinicalTrials.gov Identifier: NCT03043846
Recruitment Status : Completed
First Posted : February 6, 2017
Last Update Posted : September 27, 2019
Sponsor:
Collaborator:
RCTs
Information provided by (Responsible Party):
Association de Recherche Clinique en Rhumatologie

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.

Condition or disease Intervention/treatment
Axial Spondyloarthritis Other: Follow-up every 3 months during 1 year (data collection in eCRF) Other: Follow-up every month to follow the pre-defined strategy

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.

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Study Type : Observational
Actual Enrollment : 163 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treat to Target Trial in Axial Spondylo Arthritis : The TICOSPA (Tight Control in Spondyloarthritis)
Actual Study Start Date : November 30, 2016
Actual Primary Completion Date : June 18, 2019
Actual Study Completion Date : June 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Group/Cohort Intervention/treatment
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)



Primary Outcome Measures :
  1. 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 ]

    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".



Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. To compare the change in the ASDAS over one year follow-up in the 2 groups. [ Time Frame: After a one year follow-up ]
  5. To compare the change in the BASDAI over one year follow-up in the 2 groups. [ Time Frame: After a one year follow-up ]
  6. 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 ]
  7. To compare the WPAI after a one year follow-up in the 2 groups. [ Time Frame: After a one year follow-up ]
  8. To compare the EQ5D after a one year follow-up in the 2 groups. [ Time Frame: After a one year follow-up ]
  9. 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 ]
  10. 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 ]
  11. To compare the treatment effect (...) within the T2T depending on the compliance to the T2T treatment. [ Time Frame: After a one year follow-up ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03043846


Locations
Show Show 18 study locations
Sponsors and Collaborators
Association de Recherche Clinique en Rhumatologie
RCTs
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Responsible Party: Association de Recherche Clinique en Rhumatologie
ClinicalTrials.gov Identifier: NCT03043846    
Other Study ID Numbers: 2016-A00564-47
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Association de Recherche Clinique en Rhumatologie:
Treat to Target approach
Additional relevant MeSH terms:
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Spondylarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Spondylitis
Spinal Diseases
Bone Diseases