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

A Phase IIa, International, Multicenter, Open-Label, Uncontrolled Study to Evaluate the Safety and Pharmacokinetics of 4× 375 mg/m2 Intravenous Rituximab in Pediatric Patients with Severe Granulomatosis with Polyangiitis (Wegener’s) or Microscopic Polyangiitis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002062-13-GB

Enrollment

Registered

2012-08-23

Start date

2013-01-18

Completion date

Unknown

Last updated

2020-07-20

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

Conditions

granulomatosis with polyangiitis (Wegener’s) and microscopic polyangiitis MedDRA version: 19.0 Level: LLT Classification code 10047888 Term: Wegener's granulomatosis System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.0 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders

Interventions

Trade Name: MabThera® Product Code: RO0452294/V01 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Current Sponsor code: RO0452294 Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age at screening between =2 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Primary end point(s): - to evaluate safety and PK parameters. The primary PK parameters will be clearance and volume of distribution estimated from population PK model. The safety outcome measures are frequency, nature and severity of adverse events, and frequency of laboratory abnormalities.;Timepoint(s) of evaluation of this end point: PK is evaluated up to month 6. Safety is assessed throughout the trial.;Main Objective: To evaluate the safety, tolerability and pharmacokinetic parameters of rituximab in pediatric patients with severe granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).;Secondary Objective: To explore the efficacy of rituximab for the induction of remission in pediatric patients with severe GPA or MPA; to explore the pharmacodynamics parameters of rituximab in pediatric patients with GPA or MPA	—

Measure

Time frame

Primary end point(s): - to evaluate safety and PK parameters. The primary PK parameters will be clearance and volume of distribution estimated from population PK model. The safety outcome measures are frequency, nature and severity of adverse events, and frequency of laboratory abnormalities.;Timepoint(s) of evaluation of this end point: PK is evaluated up to month 6. Safety is assessed throughout the trial.;Main Objective: To evaluate the safety, tolerability and pharmacokinetic parameters of rituximab in pediatric patients with severe granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).;Secondary Objective: To explore the efficacy of rituximab for the induction of remission in pediatric patients with severe GPA or MPA; to explore the pharmacodynamics parameters of rituximab in pediatric patients with GPA or MPA

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Secondary

Measure	Time frame
Secondary end point(s): - Exploratory efficacy outcomes including induction of remission, numbers of major or minor BVAS/WG/PVAS relapses/flares, cumulative glucocorticoid dose, Exploratory pharmacodynamic outcome measures include circulating CD19-positive B cell counts. Other exploratory measures include patient reported outcomes, and vasculitis damage. - Number of patients with disease progression prior to remission ;Timepoint(s) of evaluation of this end point: Key time-points for exploratory efficacy evaluations include months 6, 12 and 18.	—

Measure

Time frame

Secondary end point(s): - Exploratory efficacy outcomes including induction of remission, numbers of major or minor BVAS/WG/PVAS relapses/flares, cumulative glucocorticoid dose, Exploratory pharmacodynamic outcome measures include circulating CD19-positive B cell counts. Other exploratory measures include patient reported outcomes, and vasculitis damage. - Number of patients with disease progression prior to remission ;Timepoint(s) of evaluation of this end point: Key time-points for exploratory efficacy evaluations include months 6, 12 and 18.

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Countries

Canada, France, Germany, Italy, Serbia, Turkey, United Kingdom, United States

Contacts

Public ContactTrial Information Support Line-TISL

F.Hoffmann-La Roche Ltd.

global.rochegenentechtrials@roche.com+4161 688 1111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 19, 2026