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

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.

Study Overview

• Status: Recruiting
• Conditions: Arteritis; Systemic Vasculitis; Arteritis, Takayasu
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: David SAADOUN, MD PhD; Phone Number: +33 142178088; Email: david.saadoun@psl.aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • La Pitié Salpêtrière
    • Contact: David Saadoun, MD PhD; Phone Number: +33 142178009; Email: dsaadoun@wanadoo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Takayasu Patients

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Takayashu	Other: no intervention; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of relapse	incidence of relapse	6 months
incidence of relapse	incidence of relapse	12 months
incidence of treatment failure	incidence of treatment failure	6 months
incidence of treatment failure	incidence of treatment failure	12 months
incidence of revascularization procedures	incidence of revascularization procedures	6 months
incidence of revascularization procedures	incidence of revascularization procedures	12 months
incidence of adverse events of treatments received	incidence of adverse events of treatments received	6 months
incidence of adverse events of treatments received	incidence of adverse events of treatments received	12 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2018
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: May 18, 2018
• First Submitted That Met QC Criteria: May 18, 2018
• First Posted (Actual): June 1, 2018

Study Record Updates

• Last Update Posted (Actual): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 25, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Diseases, Vascular; Aortic Diseases; Arteritis; Vasculitis; Takayasu Arteritis; Aortic Arch Syndromes; Systemic Vasculitis
• Other Study ID Numbers: START_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No