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INTOReTAK - Multicentre, randomized, prospective trial evaluating the efficacy and safety of Infliximab to tocilizumab in refractory or relapsing Takayasu arteritis - INTOReTAK : INfliximab and TOcilizumab in Refractory/relapsing TAKayasu arteritis

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512229-10-00
Acronym
P160909
Enrollment
50
Registered
2024-09-16
Start date
2021-02-04
Completion date
Unknown
Last updated
2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Takayasu arteritis

Brief summary

Proportion at 6 months after Day1 of treatment, of patients with prednisone (or the prednisolone) ≤ 0.1mg/kg per day and sustained inactive disease from M3 to M6 and same biological therapy from Day1 of treatment among the randomized patients in the same arm.

Detailed description

 Incidence of relapse as defined by the NIH criteria between M3 and M6 after Day1 of treatment.,  Incidence of traitement failure at M3 after Day1 of treatment i.e disease still active according to the NIH criteria,  Proportion at 6 months after Day1 of treatment of patients with prednisone (or the prednisolone) ≤ 0.1mg/kg per day and sustained inactive disease (modified NIH score (without criterion 3) ≤ 1) from M3 to M6 and same biological therapy from Day1 of treatment among the randomized patients in the same arm.,  Incidence of relapse as defined by the modified NIH criteria (without criterion 3) ≥2 between M3 and M6 after Day1 of treatment.,  incidence of traitement failure at M3 after Day1 of treatment i.e disease still active according to the modified NIH criteria (without criterion 3) ≥2,  Incidence of revascularization procedures (endovascular or surgical) from Day1 of treatment to M6 and M12 after Day1 of treatment,  Cumulative doses of prednisone (or the prednisolone) in each arm at M6 and M12 after Day1 of treatment,  Incidence of adverse events of grades III or IV at M6 and M12 after Day1 of treatment,  Mean change in the quality of life questionnaire SF-36 from D1 of treatment to M6 and M12 after treatment,  Proportion of new vascular lesions at M6 and M12 after Day1 of treatment assessed by angio-CT or MR angiography

Interventions

DRUGINFLIXIMAB
DRUGRoActemra 20 mg/mL concentrate for solution for infusion

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion at 6 months after Day1 of treatment, of patients with prednisone (or the prednisolone) ≤ 0.1mg/kg per day and sustained inactive disease from M3 to M6 and same biological therapy from Day1 of treatment among the randomized patients in the same arm.

Secondary

MeasureTime frame
 Incidence of relapse as defined by the NIH criteria between M3 and M6 after Day1 of treatment.,  Incidence of traitement failure at M3 after Day1 of treatment i.e disease still active according to the NIH criteria,  Proportion at 6 months after Day1 of treatment of patients with prednisone (or the prednisolone) ≤ 0.1mg/kg per day and sustained inactive disease (modified NIH score (without criterion 3) ≤ 1) from M3 to M6 and same biological therapy from Day1 of treatment among the randomized patients in the same arm.,  Incidence of relapse as defined by the modified NIH criteria (without criterion 3) ≥2 between M3 and M6 after Day1 of treatment.,  incidence of traitement failure at M3 after Day1 of treatment i.e disease still active according to the modified NIH criteria (without criterion 3) ≥2,  Incidence of revascularization procedures (endovascular or surgical) from Day1 of treatment to M6 and M12 after Day1 of treatment,  Cumulative doses of prednisone (or the prednisolo

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026