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NCT00278538 · ClinicalTrials.gov registry record · Phase 2
Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus
A Phase 2 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT00278538: Completed Phase 2 study, sponsored by Northwestern University.
NCT00278538 is a Phase 2 study that has completed, run by Northwestern University. The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00278538, a Phase 2 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study Summary
This study is designed to examine whether treating patients with lupus with high dose cyclophosphamide together with rATG/rituximab (drugs which reduce the function of the immune system), followed by return of their previously collected stem cells will result in improvement in the disease. Stem cells are undeveloped cells that have the capacity to grow into mature blood cells, which normally circulate in the blood stream. The purpose of the intense chemotherapy is to destroy the cells in the immune system which may be causing this disease. The purpose of the stem cell infusion is to produce a normal immune system that will no longer attack body. The study purpose is to examine whether this treatment will result in improvement in the lupus disease.
Primary Outcome
The primary efficacy outcome is overall survival.
Interventions
- BIOLOGICAL Hematopoietic stem cell transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2005-09-23 |
| Est. Completion | 2019-05 |
| Phase | Phase 2 |
What the finished NCT00278538 record still lists
NCT00278538 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 1 intervention - of which Hematopoietic stem cell transplantation is the first listed.
NCT00278538 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00278538 about?
NCT00278538 is a clinical study titled "Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus". This study is designed to examine whether treating patients with lupus with high dose cyclophosphamide together with rATG/rituximab (drugs which reduce the function of the immune system), followed by return of their previously collected stem cells will result in improvement in the disease. Stem cell...
What is the current status of trial NCT00278538?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2005-09-23. Estimated completion is 2019-05.
What interventions are being tested in trial NCT00278538?
The interventions under investigation include: Hematopoietic stem cell transplantation (BIOLOGICAL).
Who is sponsoring clinical trial NCT00278538?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00278538's enrollment target sits among peer trials
32 1563rd of 2000 higher than 423 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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