Phase 3 study of GGS in patients with microscopic polyangiitis (MPA)
- Conditions
- Microscopic polyangiitis (MPA)
- Registration Number
- JPRN-jRCT2080222344
- Lead Sponsor
- TEIJIN PHARMA LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 36
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Primary endopoint<br>Neuropathy<br><br>Evaluation method<br>Manual muscle test (MMT)
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Main secondary endpoints<br>Efficacy<br>1. Neuropathy<br>2. Angiitis symptoms<br><br>Safety<br>1. Adverse events<br>2. Vital signs<br>3. Clinical laboratory tests<br><br>Evaluation method<br>Manual muscle test (MMT), BVAS (Birmingham Vasculitis Activity Score)