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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03543527
Other study ID # START_001
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


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
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