Study of Refractory and/or Relapsing TAkayasu aRTeritis

• Conditions: Arteritis, Takayasu; Arteritis; Systemic Vasculitis
• Interventions: Other: no intervention

• Registration Number: NCT03543527
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-05
• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2018-05-18
• Study First Posted: 2018-06-01
• Study Start: 2018-06-20
• Last Update Submitted: 2018-06-25
• Last Update Posted: 2018-06-26
• Primary Completion: 2020-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Takayashu	no intervention	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients with prednisone ≤ 0.1mg/kg per day and sustained inactive disease.	6 months	Proportion of patients with prednisone ≤ 0.1mg/kg per day and sustained inactive disease.

Secondary Outcome Measures

Name	Time	Method
incidence of revascularization procedures	12 months	incidence of revascularization procedures
incidence of relapse	12 months	incidence of relapse
incidence of treatment failure	12 months	incidence of treatment failure
incidence of adverse events of treatments received	12 months	incidence of adverse events of treatments received

Trial Locations

Locations (1)

La pitié Salpétrière; 🇫🇷 Paris, France