drugset / Trial / NCT00282412

Rheumatoid Arthritis:Tolerance Induction by Mixed Chimerism

NCT00282412

Phase 1 Terminated 4 enrolled Northwestern University
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2002-09
Primary completion
2016-06
Completion
2016-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Alemtuzumab Monoclonal antibody 30 mg Intravenous
Subject Cyclophosphamide Other / unclassified 50 mg/kg Intravenous
Subject Fludarabine Small molecule 25 mg/m2 Intravenous
Background Cyclosporine Peptide 200 mg Oral
Background GCSF Unknown 5 ug/kg
Background GCSF Unknown 10 ug/kg
Background Mycophenolate Mofetil Small molecule 1 g Oral

Indications