A phase IIa, international, multicenter, open-label, uncontrolled study to evaluate the safety and pharmacokinetics of 4 x 375 mg/m2 Intravenous rituximab in pediatric patients with severe granulomatosis with polyangiitis (Wegener’s) or microscopic polyangiitis

Phase 1

• Conditions: granulomatosis with polyangiitis (Wegener’s) and microscopic polyangiitis; MedDRA version: 19.0Level: LLTClassification code 10047888Term: Wegener's granulomatosisSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 19.0Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-002062-13-DE
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-13
• Last Update Posted: 21 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Age at screening between =2 and < 18 years
• Diagnosis of GPA (EULAR/PRINTO/PRES 2008, Ankara criteria for childhood WG [Özen et al. 2010]) or diagnosis of MPA (according to the Chapel Hill Consensus Conference [Jennette 1994])
• Newly diagnosed patients or patients with relapsing disease according to the following definition:
- The recurrence or new onset of potentially organ- or life-threatening disease (i.e., one or more major BVAS/WG items or disease severe enough to require treatment with cyclophosphamide).

Are the trial subjects under 18? yes
Number of subjects for this age range: 25
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Diagnosis of Churg?Strauss Syndrome, as defined by the Chapel Hill Consensus Conference (Jennette 1994)
• Limited disease that would not normally be treated with cyclophosphamide
• Severe disease requiring mechanical ventilation due to alveolar hemorrhage
• Requirement for plasmapheresis or dialysis at screening
•Evidence of active tuberculosis (patients receiving chemoprophylaxis for latent tuberculosis infection are eligible for the study)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified