Study of Refractory and/or Relapsing TAkayasu aRTeritis

Systemic Vasculitis Clinical Trial

— START  

Official title:

Observational Multicenter Study of Refractory and/or Relapsing Takayasu Arteritis START: Study of Refractory and/or Relapsing TAkayasu aRTeritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03543527
• Other study ID #: START_001
• Status: Recruiting
• Start date: June 20, 2018
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: David SAADOUN, MD PhD
• Phone: 142178088
• Email: david.saadoun[@]psl.aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Arteritis
• Arteritis, Takayasu
• Systemic Vasculitis
• Takayasu Arteritis
• Vasculitis

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
France	La pitié Salpétrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	incidence of relapse	incidence of relapse	6 months
Secondary	incidence of relapse	incidence of relapse	12 months
Secondary	incidence of treatment failure	incidence of treatment failure	6 months
Secondary	incidence of treatment failure	incidence of treatment failure	12 months
Secondary	incidence of revascularization procedures	incidence of revascularization procedures	6 months
Secondary	incidence of revascularization procedures	incidence of revascularization procedures	12 months
Secondary	incidence of adverse events of treatments received	incidence of adverse events of treatments received	6 months
Secondary	incidence of adverse events of treatments received	incidence of adverse events of treatments received	12 months