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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: Clinical Trial Phase 1 study, sponsored by Northwestern University.

NCT00282412 is a Phase 1 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The number of participants who survived treatment

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG GCSF
  • BIOLOGICAL Hematopoietic Stem Cell Transplantation
  • DRUG Campath 1H

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2002-09
Est. Completion 2016-06
Phase Phase 1
Northwestern University

1,209 total trials

Why NCT00282412 stopped before completion

NCT00282412 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT00282412 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00282412's enrollment target sits among peer trials

4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT00282412, the US trial registry maintained by the National Library of Medicine. NCT00282412 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.