Clinical Trials Logo

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). Between 20 and 50% of cases respond to CS alone, with subsequent resolution of symptoms and stabilization of vascular abnormalities. Although second-line agents (methotrexate, azathioprine, mercaptopurine, mycophenolate mofetil) may result in initial remission, relapses remain common when prednisone is tapered. Thus, 50% of CS-resistant or relapsing TA patients may achieve sustained remission with the addition of methotrexate. 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. Tocilizumab, an anti-IL-6 has given similar results with 68% of sustained remission in refractory TA. Irrespective of classical cardiovascular risk factors, the systemic inflammation and CS use play a pivotal role in the occurrence of cardiovascular thrombotic events (CVEs). As CVEs overlap with TA complications it is primordial to drastically taper CS in that vasculitis. We therefore hypothesize that Infliximab or Tocilizumab can achieve a remission in more than 70% of refractory/relapsing TA cases to CS associated to a second-line agent. INTOReTAK, first randomized prospective study in TA, has an original design testing Infliximab and Tocilizumab propensity to achieve over 70% of sustained remission in refractory/relapsing TA and evaluating jointly the 2 arms. The primary objective of this study is to obtain, by arm, ≥ 70% of patients at 6 months after randomization with prednisone ≤ 0.1mg/kg per day and inactive disease (NIH score ≤ 1) during the last 3 months.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04564001
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Tristan MIRAULT
Phone +33156093051
Email tristan.mirault@aphp.fr
Status Not yet recruiting
Phase Phase 2
Start date September 2020
Completion date September 2023

See also
  Status Clinical Trial Phase
Terminated NCT04882072 - A Study of Ustekinumab in Participants With Takayasu Arteritis (TAK) Phase 3
Completed NCT03750929 - Aerobic Capacity and Strength Exercise in Takayasu's Arteritis N/A
Recruiting NCT04137614 - Drug-coated Balloon for Takayasu Arteritis Associated Renal Artery Stenosis N/A
Recruiting NCT02967068 - VCRC Tissue Repository
Recruiting NCT05102448 - Comparison of Tofacitinib and Methotrexate in Takayasu's Arteritis Phase 4
Recruiting NCT03893136 - The Registry Study of Takayasu Arteritis in East China
Active, not recruiting NCT00006055 - Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases N/A
Completed NCT03096275 - Comparison of Mycophenolate Mofetil and Cyclophosphamide for Active Takayasu's Arteritis Phase 3
Recruiting NCT04299971 - Efficiency of Methotrexate and Tofacitinib in Mild and Moderate Patients Phase 4
Recruiting NCT04300686 - A Pilot Study in Severe Patients With Takayasu Arteritis. Phase 4
Recruiting NCT03192878 - Infliximab Biosimilar in Takayasu's Arteritis N/A
Active, not recruiting NCT04071691 - PET Imaging of Giant Cell and Takayasu Arteritis
Recruiting NCT05904301 - Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases
Completed NCT02101333 - Efficacy and Tolerance of Tocilizumab In Takayasu Arteritis Phase 3
Not yet recruiting NCT03550781 - Anti-inflammatory Treatment for Inactive Takayasu Arteritis Phase 2/Phase 3
Active, not recruiting NCT05168475 - Biologics in Refractory Vasculitis Phase 2
Completed NCT03956394 - Takayasu Arteritis Activity Evaluation by Ultrafast Ultrasound Imaging N/A
Recruiting NCT05151848 - Comparison of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis Phase 4
Completed NCT03430388 - Yellow Fever Vaccine in Patients With Rheumatic Diseases N/A
Completed NCT02925351 - Fluorine F 18 Clofarabine PET/CT in Imaging Patients With Autoimmune or Inflammatory Diseases Early Phase 1