N/A
Completed N=97
An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
Source: ClinicalTrials.gov NCT01613599 ↗Enrolled (actual)
97
Serious AEs
39.2%
Results posted
Aug 2016
Primary outcomePrimary: Incidence Rate of Serious Infections — 7.11 events per 100 patient year
Summary
This prospective observational study will evaluate the long-term safety of MabThera/Rituxan (rituximab) in participants with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis. Data will be collected for a maximum of 4 years from participants initiated on MabThera/Rituxan therapy by their physician according to prescribing information.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Serious Infections |
7.11 | — |
| SECONDARY Percentage of Participants With a Serious Infusion-related Reaction |
— | — |
| SECONDARY Incidence Rate of Serious Cardiac Adverse Events |
5.03 | — |
| SECONDARY Percentage of Participants With Any Serious Adverse Events During or Within 24 Hours After Any Rituximab Infusion |
— | — |
| SECONDARY Incidence Rate of Serious Vascular Adverse Events |
2.37 | — |
| SECONDARY Incidence Rate of Malignancy, Excluding Non-melanoma Skin Cancer |
0.89 | — |
| SECONDARY Incidence Rate of Serious Adverse Events |
27.84 | — |
| SECONDARY Incidence Rate of Adverse Events With Fatal Outcomes |
2.67 | — |
| SECONDARY Incidence Rate of Serious Adverse Events in Participants Who Received Re-treatment With MabThera/Rituximab |
23.90 | — |
| SECONDARY Incidence Rate of Serious Infections in Participants Who Received Re-treatment With MabThera/Rituximab |
6.07 | — |
Eligibility Criteria
Inclusion Criteria
- Adult participants, >/= 18 years of age
- Granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), according to Chapel Hill Consensus Conference Definitions for MPA and American College of Rheumatology (ACR) Criteria for the Classification of GPA
- Disease severity requiring rituximab treatment per the investigator's assessment
Exclusion Criteria
- Prior use of rituximab (except if received within 4 weeks of screening)
- Known hypersensitivity to rituximab, to any component of the product, or to murine proteins
- Pregnant or breastfeeding women
- Diagnosis of Churg-Strauss syndrome
Data sourced from ClinicalTrials.gov (NCT01613599). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.