Systemic VasculitisSTARTNCT03543527
Study of Refractory and/or Relapsing TAkayasu aRTeritis
An observational study of Systemic Vasculitis and Arteritis, Takayasu, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Takayasu arteritis (TA) is a vasculitis of unknown origin, resulting in progressive thickening and stenosis of large and medium arteries (the aorta and its major branches, and the pulmonary arteries). First line therapy of TA consists of high dose corticosteroids (CS) (Mukhtyar et al, 2009). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Systemic Vasculitis, Arteritis, Takayasu, Arteritis
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2018to 1 Jun 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Takayasu Patients
Who may be able to join
- Diagnosis of Takayasu arteritis according to the international criteria of the American College of Rheumatology (ACR) (Arend et al, 1990) and/or Ishikawa criteria modified by Sharma.
- Active disease according to the international criteria of the National Institute of Health (NIH) (Kerr et al, 1994)
- Able and willing to give informed consent and comply with the requirements of the study protocol
Who cannot join
- Aortitis of other cause (i.e. infectious, ANCA vasculitis, histiocytosis, cancer..)
- Lack of affiliation to a social security benefit plan (as a beneficiary or assignee)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
La pitié Salpétrière
Paris, 75013
David Saadoun, MD PhD, 142178009 ext. +33, dsaadoun@wanadoo.fr
About this study
Official title: Observational Multicenter Study of Refractory and/or Relapsing Takayasu Arteritis START: Study of Refractory and/or Relapsing TAkayasu aRTeritis
Takayasu arteritis (TA) is a vasculitis of unknown origin, resulting in progressive thickening and stenosis of large and medium arteries (the aorta and its major branches, and the pulmonary arteries). First line therapy of TA consists of high dose corticosteroids (CS) (Mukhtyar et al, 2009). Between 20 and 50% of cases respond to CS alone, with subsequent resolution of symptoms and stabilization of vascular abnormalities (Shelhamer et al, 1985; Maksimowicz-McKinnon et al, 2007). Although second-line agents (methotrexate, azathioprine, mycophenolate mofetil, cyclophosphamide) may result in initial remission, relapses remain common when prednisone is tapered (Maksimowicz-McKinnon et al, 2007). Thus, 50% of CS-resistant or relapsing TA patients may achieve sustained remission with the addition of methotrexate (Hoffman et al, 1994). During the last decade, biologics such as anti-tumor necrosis factor alpha (anti-TNFα) and anti-interleukin-6 (anti-IL-6) have been used as third-line treatment in refractory or relapsing TA. Almost 90% of CS-methotrexate resistant TA cases responded to infliximab, an anti-TNFα, and sustained remission was obtained in 37 to 76% of the cases (Schmidt et al, 2012; Comarmond et al, 2012; Mekinian et al, 2012). Tocilizumab, an anti-IL-6 has given similar results with 68% of sustained remission in refractory TA (Abisror et al, 2013). Irrespective of classical cardiovascular risk factors, the systemic inflammation and CS use play a pivotal role in the occurrence of cardiovascular thrombotic events (CVEs) (Roubille et al, 2015). As CVEs overlap with TA complications it is primordial to drastically taper CS in that vasculitis. We therefore aim to analyses prospectively the long term outcome of refractory/relapsing TA patients.
- Conditions
- Systemic Vasculitis, Arteritis, Takayasu, Arteritis
- Being tested
- no intervention
- Medical subject headings
- Systemic Vasculitis, Takayasu Arteritis, Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Takayashu | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with prednisone ≤ 0.1mg/kg per day and sustained inactive disease.
Proportion of patients with prednisone ≤ 0.1mg/kg per day and sustained inactive disease.
Measured: 6 months
Secondary outcomes (8)
incidence of relapse
incidence of relapse
Measured: 6 months
incidence of relapse
incidence of relapse
Measured: 12 months
incidence of treatment failure
incidence of treatment failure
Measured: 6 months
incidence of treatment failure
incidence of treatment failure
Measured: 12 months
incidence of revascularization procedures
incidence of revascularization procedures
Measured: 6 months
incidence of revascularization procedures
incidence of revascularization procedures
Measured: 12 months
incidence of adverse events of treatments received
incidence of adverse events of treatments received
Measured: 6 months
incidence of adverse events of treatments received
incidence of adverse events of treatments received
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start20 Jun 2018
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic VasculitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543527
- Sponsor's protocol ID
- START_001
- Acronym
- START
- Status last verified
- May 2018
- First submitted
- 18 May 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Multicenter Study of Refractory and/or Relapsing Takayasu Arteritis START: Study of Refractory and/or Relapsing TAkayasu aRTeritis
- ClinicalTrials.gov ID
- NCT03543527
- Acronym / sponsor ID
- START / START_001
- Conditions
- Systemic Vasculitis, Arteritis, Takayasu, Arteritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 1 Jun 2018 (actual)
- 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.
Takayasu arteritis (TA) is a vasculitis of unknown origin, resulting in progressive thickening and stenosis of large and medium arteries (the aorta and its major branches, and the pulmonary arteries). First line therapy of TA consists of high dose corticosteroids (CS) (Mukhtyar et al, 2009). Between 20 and 50% of cases respond to CS alone, with subsequent resolution of symptoms and stabilization of vascular abnormalities (Shelhamer et al, 1985; Maksimowicz-McKinnon et al, 2007). Although second-line agents (methotrexate, azathioprine, mycophenolate mofetil, cyclophosphamide) may result in initial remission, relapses remain common when prednisone is tapered (Maksimowicz-McKinnon et al, 2007). Thus, 50% of CS-resistant or relapsing TA patients may achieve sustained remission with the addition of methotrexate (Hoffman et al, 1994). During the last decade, biologics such as anti-tumor necrosis factor alpha (anti-TNFα) and anti-interleukin-6 (anti-IL-6) have been used as third-line treatment in refractory or relapsing TA. Almost 90% of CS-methotrexate resistant TA cases responded to infliximab, an anti-TNFα, and sustained remission was obtained in 37 to 76% of the cases (Schmidt et al, 2012; Comarmond et al, 2012; Mekinian et al, 2012). Tocilizumab, an anti-IL-6 has given similar results with 68% of sustained remission in refractory TA (Abisror et al, 2013). Irrespective of classical cardiovascular risk factors, the systemic inflammation and CS use play a pivotal role in the occurrence of cardiovascular thrombotic events (CVEs) (Roubille et al, 2015). As CVEs overlap with TA complications it is primordial to drastically taper CS in that vasculitis. We therefore aim to analyses prospectively the long term outcome of refractory/relapsing TA patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Takayashu | – | Other: no intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Takayasu Patients
Key inclusion criteria (3 listed)
- Diagnosis of Takayasu arteritis according to the international criteria of the American College of Rheumatology (ACR) (Arend et al, 1990) and/or Ishikawa criteria modified by Sharma.
- Active disease according to the international criteria of the National Institute of Health (NIH) (Kerr et al, 1994)
- Able and willing to give informed consent and comply with the requirements of the study protocol
Key exclusion criteria (2 listed)
- Aortitis of other cause (i.e. infectious, ANCA vasculitis, histiocytosis, cancer..)
- Lack of affiliation to a social security benefit plan (as a beneficiary or assignee)
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 |
|---|---|---|
| no interventionno intervention | Other | Takayashu |
Primary outcome
Proportion of patients with prednisone ≤ 0.1mg/kg per day and sustained inactive disease.
Time frame: 6 months
Proportion of patients with prednisone ≤ 0.1mg/kg per day and sustained inactive disease.
8 secondary outcomes
incidence of relapse
Time frame: 6 months
incidence of relapse
Time frame: 12 months
incidence of treatment failure
Time frame: 6 months
incidence of treatment failure
Time frame: 12 months
incidence of revascularization procedures
Time frame: 6 months
incidence of revascularization procedures
Time frame: 12 months
incidence of adverse events of treatments received
Time frame: 6 months
incidence of adverse events of treatments received
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Vasculitis and Arteritis, Takayasu, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David SAADOUN, MD PhD (142178088 ext. +33, david.saadoun@psl.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with prednisone ≤ 0.1mg/kg per day and sustained inactive disease. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2018.