Takayasu Arteritis
Conditions
Interventions
investigational material(s)
Generic name etc : tocilizumab (MRA-SC)
INN of investigational material : tocilizumab
Therapeutic category code : 639 Other biological preparations
Dosage and Administratio
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Takayasu Arteritis in accordance with the diagnosis guideline of Arteritis syndrome ( JCS2008) (2) Relapse of Takayasu Arteritis within 12 weeks prior to enrollment in spite of treatment with oral corticosteroid above 0.2 mg/kg/day.
Exclusion criteria
Exclusion criteria: (1) Patients with hyper sensitivity against the ingredients of IMP (2) Patients who received anti-TNF treatment within 12 weeks prior to IMP administration as well as other biological drugs (3) Patients who have been administrated with tocilizumab in the past (4) Patients who received treatment with MTX within 4 weeks of the initial administration of IMP (5) Patients who have active hepatitis B or C at tests at enrollment or have a history of hepatitis B
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Time to relapse of Takayasu Arteritis Time to relapse of Takayasu Arteritis is compared between the group of patients who received MRA-SC 162 mg QW and the group of patients who received placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy (1) Time to relapse of Takayasu Arteritis (Kerr-s Definition) (2) Time to relapse of Takayasu Arteritis (clinical symptoms) (3) Dose of CS as of relapse or as of the end of the study Time to relapse of Takayasu Arteritis (Kerr Definition, clinical symptoms) is compared between the group of patients who received MRA-SC 162 mg QW and the group of patients who received placebo QW. Dose of CS is compared between both group. | — |
Countries
Japan
Outcome results
None listed