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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

Tracking Information
First Submitted Date May 18, 2018
First Posted Date June 1, 2018
Last Update Posted Date June 26, 2018
Actual Study Start Date June 20, 2018
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 18, 2018)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03543527 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 18, 2018)
  • incidence of relapse [ Time Frame: 6 months ]
    incidence of relapse
  • incidence of relapse [ Time Frame: 12 months ]
    incidence of relapse
  • incidence of treatment failure [ Time Frame: 6 months ]
    incidence of treatment failure
  • incidence of treatment failure [ Time Frame: 12 months ]
    incidence of treatment failure
  • incidence of revascularization procedures [ Time Frame: 6 months ]
    incidence of revascularization procedures
  • incidence of revascularization procedures [ Time Frame: 12 months ]
    incidence of revascularization procedures
  • incidence of adverse events of treatments received [ Time Frame: 6 months ]
    incidence of adverse events of treatments received
  • incidence of adverse events of treatments received [ Time Frame: 12 months ]
    incidence of adverse events of treatments received
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Refractory and/or Relapsing TAkayasu aRTeritis
Official Title Observational Multicenter Study of Refractory and/or Relapsing Takayasu Arteritis START: Study of Refractory and/or Relapsing TAkayasu aRTeritis
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Takayasu Patients
Condition
  • Systemic Vasculitis
  • Arteritis, Takayasu
  • Arteritis
Intervention Other: no intervention
no intervention
Study Groups/Cohorts Takayashu
Intervention: Other: no intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 18, 2018)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2024
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03543527
Other Study ID Numbers START_001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators Not Provided
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date May 2018