NCT03543527: START

Study of Refractory and/or Relapsing TAkayasu aRTeritis

Status unknown Last updated 26 June 2018

What this trial tests

trial testing no intervention in Systemic Vasculitis in 150 participants. Status unknown.

Timeline

20 June 2018

Primary endpoint
1 June 2020

1 June 2024

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	150
Start date	20 June 2018
Primary completion	1 June 2020
Estimated completion	1 June 2024
Sites	1 location across France

Drugs / interventions tested

• no intervention

Conditions studied

• Systemic Vasculitis — all drugs for Systemic Vasculitis →
• Arteritis, Takayasu — all drugs for Arteritis, Takayasu →
• Arteritis — all drugs for Arteritis →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Eligibility, any sex, with Systemic Vasculitis or Arteritis, Takayasu. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.