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NCT00282412 · ClinicalTrials.gov registry record · Phase 1
Rheumatoid Arthritis:Tolerance Induction by Mixed Chimerism
A Phase 1 study, sponsored by Northwestern University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT00282412 is a Phase 1 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 4 participants.
The verdict
NCT00282412, a Phase 1 study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
Rheumatoid arthritis disease is believed to be due to immune cells, cells that normally protect the body and are now causing damage to the body. Risk of death is highest in people with twenty or more joints actively involved with disease, positive rheumatoid factor, an elevated sedimentation rate (laboratory measures of active inflammation), and patients with limitation of daily activities (trouble doing simple things like opening a carton of milk). In these high risk patients, life is significantly shortened. Death is usually from heart disease, kidney failure, neck dislocation, broken hip bones, or blood clots to the lung. In this study we use moderate dose chemotherapy (cyclophosphamide and fludarabine) and CAMPATH-1H (a protein that kills the immune cells that are thought to be causing the disease), followed by infusion of blood stem cells that have been collected from the patient's brother or sister (allogeneic stem cell transplant). The purpose of the moderate dose chemotherapy and CAMPATH-1H is to destroy the cells in the immune system and to allow the cells from the patient's brother or sister to grow. The purpose of the stem cell infusion is to restore blood cell production, which will be severely impaired by the moderate dose chemotherapy and CAMPATH-1H, and to produce a normal immune system that will no longer attack the body.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG GCSF
- BIOLOGICAL Hematopoietic Stem Cell Transplantation
- DRUG Campath 1H
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2002-09 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00282412
The ClinicalTrials.gov registry entry for NCT00282412 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00282412 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00282412 about?
NCT00282412 is a clinical study titled "Rheumatoid Arthritis:Tolerance Induction by Mixed Chimerism". Rheumatoid arthritis disease is believed to be due to immune cells, cells that normally protect the body and are now causing damage to the body. Risk of death is highest in people with twenty or more joints actively involved with disease, positive rheumatoid factor, an elevated sedimentation rate (l...
What is the current status of trial NCT00282412?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2002-09. Estimated completion is 2016-06.
What interventions are being tested in trial NCT00282412?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), GCSF (DRUG), Hematopoietic Stem Cell Transplantation (BIOLOGICAL), Campath 1H (DRUG).
Who is sponsoring clinical trial NCT00282412?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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