Randomized, placebo-controlled, double-blind, parallel-group clinical study of GGS in patients with microscopic polyangiitis (MPA) (Phase 3 study)

TEIJIN PHARMA LIMITED0 个研究点目标入组 36 人开始时间: 2013年12月25日最近更新: 2023年10月17日

适应症

试验速览

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•Patients with microscopic polyangiitis associated with neuropathy
•Main Inclusion Criteria
•1.Patients diagnosed as definite or probable according to Diagnostic Criteria of Microscopic Polyangiitis (MPA) specified in the Guideline for management of vasculitis syndrome (JCS 2008)
•2. Patients who have underwent the following steroid therapy for MPA
•A: Patients who have underwent the following steroid therapy as remission induction therapy
•1) Treatment with corticosteroid at 40 mg/day (or 0.6 mg/kg/day) as prednisolone for at least 2 weeks
•2) Treatment with corticosteroid at 20 mg/day or higher for 8 weeks or longer including the above 1) following the above 1)
•B: After the tapering following A, treatment with corticosteroid at a constant dose of 2.5 mg/day or higher and 15 mg/day or lower as prednisolone for at least 4 weeks until the day of consent
•3. Patients for whom the presence of clinical symptoms of peripheral neuropathy (muscle weakness, pain, and numbness of the extremities, etc.) during remission induction therapy for MPA can be confirmed in medical records

•Main Exclusion Criteria
•1. Patients with a history of shock or hypersensitivity to any human immunoglobulin preparation
•2. Patients with IgA deficiency
•3. Patients with hemolytic/blood loss anemia
•4. Patients with reduced cardiac function
•5. Patients with end-stage renal disease
•6. Patients with cerebrovascular or cardiovascular disorder
•7. Patients with a high risk of thromboembolism
•8. Patients with immunodeficiency or under immunosuppression
•9. Pregnant, potentially pregnant, or lactating patients
•10. Patients who are being treated in other clinical study

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