Takayasu arteritis
Conditions
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
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time 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
| Measure | Time 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