Axial SpondyloarthritisTICOSPANCT03043846
Treat to Target Trial in Axial Spondylo Arthritis : The TICOSPA (Tight Control in Spondyloarthritis)
An observational study of Axial Spondyloarthritis, run by Association de Recherche Clinique en Rhumatologie at 18 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- Follow-up every 3 months during 1 year (data collection in eCRF) and Follow-up every month to follow the pre-defined strategy
- How many people
- 163 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 30 Nov 2016to 18 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
France10 sites
Chu Gabriel Montpied
Clermont-Ferrand
Chu Grenoble
Grenoble
Chu Le Mans
Le Mans
Hopital Lapeyronnie
Montpellier
Ch Mulhouse
Mulhouse
Hopital Cochin
Paris
Hopital de La Pitie Salpetriere
Paris
Hopital Henri Mondor
Paris
Chu Rouen
Rouen
Chu Toulouse
Toulouse
Belgium4 sites
UZ GENT
Ghent
Jessa Ziekenhuis
Hasselt
Reumatologie Medizorg
Merksem
AZ Alma
Sijsele
Netherlands4 sites
UMCG
Groningen
Zuyderland MC
Heerlen
LUMC
Leiden
Maastricht UMC
Maastricht
About this study
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.
Read the 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.
- Conditions
- Axial Spondyloarthritis
- Being tested
- Follow-up every 3 months during 1 year (data collection in eCRF), Follow-up every month to follow the pre-defined strategy
- Keywords
- Treat to Target approach
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up every 3 months during 1 year (data collection in eCRF)Other
Follow-up every month to follow the pre-defined strategyOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Follow-up every 3 months during 1 year (data collection in eCRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After a one year follow-up
To compare the change in the ASDAS over one year follow-up in the 2 groups.
Measured: After a one year follow-up
To compare the change in the BASDAI over one year follow-up in the 2 groups.
Measured: After a one year follow-up
To compare the change in the ASAS-NSAID score over one year follow-up in the 2 groups.
Measured: After a one year follow-up
To compare the WPAI after a one year follow-up in the 2 groups.
Measured: After a one year follow-up
To compare the EQ5D after a one year follow-up in the 2 groups.
Measured: 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.
Measured: 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.
Measured: After a one year follow-up
To compare the treatment effect (...) within the T2T depending on the compliance to the T2T treatment.
Measured: After a one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start30 Nov 2016
- Primary completion18 Jun 2019
- Study completion18 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association de Recherche Clinique en Rhumatologie
- Sponsor type
- University, hospital or other
- Collaborators
- RCTs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043846
- Sponsor's protocol ID
- 2016-A00564-47
- Acronym
- TICOSPA
- Status last verified
- Sep 2019
- First submitted
- 31 Jan 2017
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33958325
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treat to Target Trial in Axial Spondylo Arthritis : The TICOSPA (Tight Control in Spondyloarthritis)
- ClinicalTrials.gov ID
- NCT03043846
- Acronym / sponsor ID
- TICOSPA / 2016-A00564-47
- Conditions
- Axial Spondyloarthritis
- Keywords
- Treat to Target approach
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Association de Recherche Clinique en RhumatologieUniversity, hospital or other
- Collaborators
- RCTs
- Study start
- 30 Nov 2016 (actual)
- Primary completion
- 18 Jun 2019 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 6 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tight control and Treat to Target arm | – | Other: Follow-up every 3 months during 1 year (data collection in eCRF), Other: Follow-up every month to follow the pre-defined strategyFor 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. |
| Usual care arm | – | Other: Follow-up every 3 months during 1 year (data collection in eCRF)For this arm, the treating rheumatologists will continue to manage the enrolled patients in accordance to their usual care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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:
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
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".
11 secondary outcomes
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 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 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 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 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 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 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 treatment effect (...) within the T2T depending on the compliance to the T2T treatment.
Time frame: After a one year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Derived from this study: PubMed 33958325Molto 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.
- Individual participant dataSharing planned: No
Related trials for Axial Spondyloarthritis
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Identification of Serum Level of Glutathione Peroxidase 4
Spondyloarthropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Axial Spondyloarthritis, run by Association de Recherche Clinique en Rhumatologie at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03043846, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.