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NCT02260934 · ClinicalTrials.gov registry record · Phase 2
Rituximab and Belimumab for Lupus Nephritis
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT02260934: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02260934 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02260934, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study Summary
In this experimental study, researchers will try to find out if treatment of lupus nephritis with a combination of rituximab and cyclophosphamide (CTX), or a combination of rituximab and CTX followed by treatment with belimumab is safe and if this drug combination can block the immune system attacks.
Primary Outcome
The percentage of participants who experienced at least one Grade 3 or higher treatment-emergent infectious adverse event. The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010). Treatment-emergent AEs are those: * with an onset date on or after the first dose of study medication, * with onset before first dose but that worsened in severity after first dose, and * for which t
Interventions
- DRUG Cyclophosphamide
- DRUG Prednisone
- BIOLOGICAL Rituximab
- DRUG Methylprednisolone
- DRUG Diphenhydramine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2015-07-09 |
| Est. Completion | 2019-02-08 |
| Phase | Phase 2 |
What the finished NCT02260934 record still lists
NCT02260934 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02260934 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02260934 about?
NCT02260934 is a clinical study titled "Rituximab and Belimumab for Lupus Nephritis". In this experimental study, researchers will try to find out if treatment of lupus nephritis with a combination of rituximab and cyclophosphamide (CTX), or a combination of rituximab and CTX followed by treatment with belimumab is safe and if this drug combination can block the immune system attacks...
What is the current status of trial NCT02260934?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2015-07-09. Estimated completion is 2019-02-08.
What interventions are being tested in trial NCT02260934?
The interventions under investigation include: Cyclophosphamide (DRUG), Prednisone (DRUG), Rituximab (BIOLOGICAL), Methylprednisolone (DRUG), Diphenhydramine (DRUG).
Who is sponsoring clinical trial NCT02260934?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02260934's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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