An international, randomised, open label trial comparing a rituxmab based regimen with a standard cyclophosphamide/azathioprine regimen in the treatment of active, 'generalised' ANCA associated vasculitis

An international, randomised, open label trial comparing a rituxmab based regimen with a standard cyclophosphamide/azathioprine regimen in the treatment of active, 'generalised' ANCA associated vasculitis - Rituxvas Clinical Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29858

Enrollment

Registered

2006-08-14

Start date

2006-12-23

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

Wegener granulomatosis

Interventions

1.3 Rituximab Rituximab is an anti CD 20 chimeric mouse/human monoclonal antibody, with human IgG1 constant regions and murine light/heavy chain variable regions (7). CD 20 is a ligand which exists

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Active ANCA-associated vasculitis

Exclusion criteria

Exclusion criteria: Pregnancy and malignancy

Design outcomes

Primary

Measure	Time frame
Endpoints Primary end points will be assessed upon trial completion at 2 years. However interim analyses will be performed when 30 patients have completed 6 weeks, to assess efficacy (treatment response) and safety (severe adverse events). 40 patients have completed 6 months to assess efficacy (remission rates) and safety (severe adverse events). i Primary Sustained remission (BVAS = 0 at 6 months and sustained for 6 months). Severe adverse events (CTCAE grade >= 3) at 2 years.	—

Measure

Time frame

Endpoints Primary end points will be assessed upon trial completion at 2 years. However interim analyses will be performed when 30 patients have completed 6 weeks, to assess efficacy (treatment response) and safety (severe adverse events). 40 patients have completed 6 months to assess efficacy (remission rates) and safety (severe adverse events). i Primary Sustained remission (BVAS = 0 at 6 months and sustained for 6 months). Severe adverse events (CTCAE grade >= 3) at 2 years.

—

Secondary

Measure	Time frame
ii Secondary Efficacy Response rate at 6 weeks (BVAS = 3) at 6 weeks and 6 months All adverse events Death Prednisolone cumulative dose Cyclophosphamide cumulative dose iii Tertiary Human anti-chimeric antibody testing Correlation of B cells with disease activity Change in ANCA and disease activity Histopathology predictors of outcome	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)