A study to check if the drug Rituximab is safe, well tolerated and shows good results in patients of Wegeners Granulomatosis

AN OPEN LABEL, PROSPECTIVE, POST MARKETING STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFICACY OF RITUXIMAB WITH GLUCOCORTICOIDS IN ADULT PATIENTS WITH WEGENERâ??S GRANULOMATOSIS (GRANULOMATOSIS WITH POLYANGIITIS - GPA) OR MICROSCOPIC POLYANGIITIS

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/01/004354

Enrollment

Registered

2014-01-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- WEGENERâ??S GRANULOMATOSIS (GRANULOMATOSIS WITH POLYANGIITIS - GPA) OR MICROSCOPIC POLYANGIITIS

Interventions

Intervention1: Rituximab: Intravenous infusion 375 mg/m2 body surface area Intervention2: Rituximab: intravenous infusion in a dose of 375 mg/m2 body surface area. 4 doses- 1 dose/week Control Interve

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
â?¢ Percentage of patients with Wegenerâ??s Granulomatosis (Granulomatosis with Polyangiitis - GPA) and Microscopic polyangiitis achieving BVAS/WG score of 0 and successful completion of the prednisone taper at 6 months after starting Rituximab therapy. â?¢ Incidence of adverse events (AEs) and serious adverse events (SAEs) during the observation period of 6 months after starting Rituximab therapy.Timepoint: 6 months after starting Rituximab therapy.	—

Measure

Time frame

â?¢ Percentage of patients with Wegenerâ??s Granulomatosis (Granulomatosis with Polyangiitis - GPA) and Microscopic polyangiitis achieving BVAS/WG score of 0 and successful completion of the prednisone taper at 6 months after starting Rituximab therapy. â?¢ Incidence of adverse events (AEs) and serious adverse events (SAEs) during the observation period of 6 months after starting Rituximab therapy.Timepoint: 6 months after starting Rituximab therapy.

—

Secondary

Measure	Time frame
â?¢ Percentage of incidence of adverse events (AEs) and serious adverse events (SAEs) during the observation period of 6 months after starting Rituximab therapy.Timepoint: 6 months after Rituximab therapy	—

Countries

India

Contacts

Public ContactPriyanka Bhattacharya

Roche Products India Pvt. Ltd

raeesuddin.syed@roche.com022-50457300

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026