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Study of Refractory and/or Relapsing TAkayasu aRTeritis (START)

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ClinicalTrials.gov Identifier: NCT03543527
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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). 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.

Condition or disease Intervention/treatment
Systemic Vasculitis Arteritis, Takayasu Arteritis Other: no intervention

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Multicenter Study of Refractory and/or Relapsing Takayasu Arteritis START: Study of Refractory and/or Relapsing TAkayasu aRTeritis
Actual Study Start Date : June 20, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Group/Cohort Intervention/treatment
Takayashu Other: no intervention
no intervention




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. incidence of relapse [ Time Frame: 6 months ]
    incidence of relapse

  2. incidence of relapse [ Time Frame: 12 months ]
    incidence of relapse

  3. incidence of treatment failure [ Time Frame: 6 months ]
    incidence of treatment failure

  4. incidence of treatment failure [ Time Frame: 12 months ]
    incidence of treatment failure

  5. incidence of revascularization procedures [ Time Frame: 6 months ]
    incidence of revascularization procedures

  6. incidence of revascularization procedures [ Time Frame: 12 months ]
    incidence of revascularization procedures

  7. incidence of adverse events of treatments received [ Time Frame: 6 months ]
    incidence of adverse events of treatments received

  8. incidence of adverse events of treatments received [ Time Frame: 12 months ]
    incidence of adverse events of treatments received



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Takayasu Patients
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

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): NCT03543527


Contacts
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Contact: David SAADOUN, MD PhD 142178088 ext +33 david.saadoun@psl.aphp.fr
Contact: Matthieu RESCHE-RIGON, MD PhD 142499742 ext +33 matthieu.resche-rigon@univ-paris-diderot.fr

Locations
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France
La pitié Salpétrière Recruiting
Paris, France, 75013
Contact: David Saadoun, MD PhD    142178009 ext +33    dsaadoun@wanadoo.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03543527     History of Changes
Other Study ID Numbers: START_001
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vasculitis
Arteritis
Takayasu Arteritis
Aortic Arch Syndromes
Systemic Vasculitis
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Skin Diseases, Vascular
Skin Diseases