Study of Refractory and/or Relapsing TAkayasu aRTeritis

NCT03543527 | Unknown

• 1 other identifier: START_001
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• incidence of relapse

  6 months

• incidence of relapse

  12 months

• incidence of treatment failure

  6 months

• incidence of treatment failure

  12 months

• incidence of revascularization procedures

  6 months

Study Arms (1)

Takayashu

Other: no intervention

Interventions

no intervention OTHER

no intervention

Takayashu

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Takayasu Patients

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

La pitié Salpétrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Systemic Vasculitis; Takayasu Arteritis; Arteritis

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Aortic Arch Syndromes; Aortic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

David SAADOUN, MD PhD

CONTACT

142178088; david.saadoun@psl.aphp.fr

Matthieu RESCHE-RIGON, MD PhD

CONTACT

142499742; matthieu.resche-rigon@univ-paris-diderot.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 1, 2018
• Study Start: June 20, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2024
• Last Updated: June 26, 2018

Record last verified: 2018-05

Locations

FR (1)