Phase 3 study of GGS in patients with CSS/AGA

Phase 3

• Conditions: Churg-Strauss Syndrome (CSS) / Allergic Granulomatous Angiitis (AGA)

• Registration Number: JPRN-jRCT2080220238
• Lead Sponsor: TEIJIN PHARMA LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Patients with CSS/AGA associated with neuropathy responding poorly to traditional therapy (steroid therapy, etc.)
Main Inclusion Criteria
1.Patients with a diagnosis of definite CSS/AGA according to Diagnostic criteria for allergic granulomatosus angiitis (Churg-Strauss Syndrome) proposed by the Research Committee of Intractable Vasculitis, Ministry of Health and Welfare, Japan (1998)
2.Patients who have underwent the following steroid therapy for CSS/AGA
A:Treatment with corticosteroid at 40 mg/day as prednisolone for at least 4 weeks as remission induction therapy
B:After the tapering following A, treatment with corticosteroid at a constant dose of 5 mg/day or higher and 20 mg/day or lower as prednisolone for at least 4 weeks
3.Patients who have at least one impaired site with a manual muscle testing (MMT) score of not more than 3 and have a MMT sum score of not more than 130

Exclusion Criteria

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 serious renal disorder
4.Patients with cerebrovascular or cardiovascular disorder or its history
5.Patients with a high risk of thromboembolism
6.Patients with hemolytic/blood loss anemia
7.Patients with reduced cardiac function
8.Patients with immunodeficiency or under immunosuppression
9.Pregnant, potentially pregnant, or lactating patients
10.Patients who are being treated in other clinical study or who complete other clinical study within the last 4 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
europathy<br>Manual muscle test (MMT)

Secondary Outcome Measures

Name	Time	Method
Main secondary endpoints<br>Efficacy<br>1. Neuropathy<br><br>Safety<br>1. Subjective symptoms<br>2. Objective findings<br>3. Clinical laboratory tests<br>Manual muscle test (MMT), Modified Barthel Index, VAS (Visual Analogue Scale)