A study to check if the drug Rituximab is safe, well tolerated and shows good results in patients of Wegeners Granulomatosis
Phase 4
- Conditions
- Health Condition 1: null- WEGENERâ??S GRANULOMATOSIS (GRANULOMATOSIS WITH POLYANGIITIS - GPA) OR MICROSCOPIC POLYANGIITIS
- Registration Number
- CTRI/2014/01/004354
- Lead Sponsor
- Roche Products India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Male or non-pregnant, non-nursing female,Patients diagnosed with Wegenerâ??s Granulomatosis (Granulomatosis with Polyangiitis - GPA) or Microscopic polyangiitis according to the definitions of the Chapel Hill Consensus Conference,•Patients with either newly diagnosed or relapsing disease, Patients must be positive for either PR3-ANCA or MPO-ANCA at the screening
Exclusion Criteria
Patients with any previous treatment with Rituximab, History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies, Patients with severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease,•Patients having active severe infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method