Study of Refractory and/or Relapsing TAkayasu aRTeritis

NCT ID: NCT03543527

Last Updated: 2018-06-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-20
• Study Completion Date: 2024-06-01

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.

Conditions

Systemic Vasculitis; Arteritis, Takayasu; Arteritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Takayashu

no intervention

Intervention Type: OTHER

no intervention

Interventions

no intervention

no intervention

Intervention Type: OTHER

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

La pitié Salpétrière

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

David SAADOUN, MD PhD

Role: CONTACT

david.saadoun@psl.aphp.fr

142178088 ext. +33

Matthieu RESCHE-RIGON, MD PhD

Role: CONTACT

matthieu.resche-rigon@univ-paris-diderot.fr

142499742 ext. +33

Facility Contacts

David Saadoun, MD PhD

Role: primary

dsaadoun@wanadoo.fr

142178009 ext. +33

Other Identifiers

START_001

Identifier Type: -

Identifier Source: org_study_id