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NCT01613599 · ClinicalTrials.gov registry record
An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
A clinical trial, sponsored by Genentech.
- Completed
- Registry status
- 100
- Enrollment target
NCT01613599: Completed study, sponsored by Genentech.
NCT01613599 is a clinical trial that has completed, run by Genentech. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01613599 has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
Study 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.
Primary Outcome
A serious infection was defined as an infection that was a serious adverse event (SAE) or a non-SAE infection that required treatment with intravenous antimicrobials. A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was life-threatening •Required in-patient hospitalization or prolongation of existing hospitalization •Resulted in persistent or significant disability/incapacity •Was a congenital anomaly/birth defect •Was m
Interventions
- DRUG Rituximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2012-06-20 |
| Est. Completion | 2017-04-28 |
What the finished NCT01613599 record still lists
NCT01613599 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Rituximab is the first listed.
NCT01613599 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01613599 about?
NCT01613599 is a clinical study titled "An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis". 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 thera...
What is the current status of trial NCT01613599?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2012-06-20. Estimated completion is 2017-04-28.
What interventions are being tested in trial NCT01613599?
The interventions under investigation include: Rituximab (DRUG).
Who is sponsoring clinical trial NCT01613599?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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