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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 : Recruiting
First Posted : February 6, 2017
Last Update Posted : February 6, 2017
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.


Study Type : Observational
Estimated Enrollment : 160 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
Estimated Primary Completion Date : January 31, 2018
Estimated Study Completion Date : January 31, 2018

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. The percentage of patients with a significant improvement in the ASAS-HI score after a one year follow-up in the 2 groups. [ Time Frame: At one year follow-up ]

Secondary Outcome Measures :
  1. The percentage of patients reaching an ASDAS clinically important improvement after a one year follow-up in the 2 groups. [ Time Frame: At one year follow-up ]
  2. The percentage of patients reaching a BASDAI 50 after a one year follow-up in the 2 groups. [ Time Frame: Over one year follow-up ]
  3. To compare the change in the BASDAI over one year follow-up in the 2 groups. [ Time Frame: Over one year follow-up ]
  4. The change in the ASAS-NSAID score over one year follow-up in the 2 groups. [ Time Frame: Over one year follow-up ]
  5. The change in WPAI results after a one year follow-up in the 2 groups. [ Time Frame: After a one year follow-up ]
  6. The evolution of EuroQOL after a one year follow-up in the 2 groups. [ Time Frame: After a one year follow-up ]
  7. The changes in 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 ]


Information from the National Library of Medicine

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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). Annex III 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


Contacts
Contact: Anna MOLTO anna.molto@aphp.fr
Contact: Maxime DOUDAGOS maxime.dougados@aphp.fr

Locations
Belgium
UZ GENT Not yet recruiting
Gent, Belgium
Contact: Peggy JACQUES         
Principal Investigator: Peggy JACQUES         
Jessa Ziekenhuis Not yet recruiting
Hasselt, Belgium
Contact: Jan LENAERTS         
Principal Investigator: Jan LENAERTS         
Reumatologie Medizorg Not yet recruiting
Merksem, Belgium
Contact: Rik JOOS         
Principal Investigator: Rik JOOS         
AZ Alma Not yet recruiting
Sijsele, Belgium
Contact: Philippe CARRON         
Principal Investigator: Philippe CARRON         
France
Chu Gabriel Montpied Not yet recruiting
Clermont-ferrand, France
Contact: Martin SOUBRIER         
Principal Investigator: Martin Soubrier         
Chu Grenoble Not yet recruiting
Grenoble, France
Contact: Athan BAILLET         
Principal Investigator: Athan BAILLET         
Chu Le Mans Not yet recruiting
Le Mans, France
Contact: Emmanuelle DERNIS         
Principal Investigator: Emmanuelle DERNIS         
Hopital Lapeyronnie Not yet recruiting
Montpellier, France
Contact: Cédric LUKAS         
Principal Investigator: Cédric LUKAS         
Ch Mulhouse Recruiting
Mulhouse, France
Contact: Laetitia SPARSA         
Principal Investigator: Laetitia SPARSA         
Hopital Cochin Not yet recruiting
Paris, France
Contact: Minh NGUYEN         
Principal Investigator: Minh NGUYEN         
Hopital de La Pitie Salpetriere Not yet recruiting
Paris, France
Contact: Laure GOSSEC         
Principal Investigator: Laure GOSSEC         
Hopital Henri Mondor Not yet recruiting
Paris, France
Contact: Pascal CLAUDEPIERRE         
Principal Investigator: Pascal CLAUDEPIERRE         
Chu Rouen Not yet recruiting
Rouen, France
Contact: Sophie POUPLIN         
Principal Investigator: Sophie POUPLIN         
Chu Toulouse Not yet recruiting
Toulouse, France
Contact: Adeline RUYSSEN-WITRAND         
Principal Investigator: Adeline RUYSSEN-WITRAND         
Netherlands
UMCG Not yet recruiting
Groningen, Netherlands
Contact: Anneke SPOORENBERG         
Principal Investigator: Anneke SPOORENBERG         
Zuyderland MC Not yet recruiting
Heerlen, Netherlands
Contact: Mirian STARMANS-KOOL         
Principal Investigator: Mirian STARMANS-KOOL         
LUMC Not yet recruiting
Leiden, Netherlands
Contact: Floris van GAALEN         
Principal Investigator: Floris van GAALEN         
Maastricht UMC Not yet recruiting
Maastricht, Netherlands
Contact: Astrid van TUBERGEN         
Principal Investigator: Astrid van TUBERGEN         
Sponsors and Collaborators
Association de Recherche Clinique en Rhumatologie
RCTs

Responsible Party: Association de Recherche Clinique en Rhumatologie
ClinicalTrials.gov Identifier: NCT03043846     History of Changes
Other Study ID Numbers: 2016-A00564-47
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases