drugset / Trial / NCT00939549

High Dose Cyclophosphamide Followed by Glatiramer Acetate in the Treatment of Relapsing Remitting Multiple Sclerosis

NCT00939549

Phase 2 Withdrawn Johns Hopkins University
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine if high-dose cyclophosphamide followed by a maintenance dose of glatiramer acetate is safe in patients with relapsing remitting multiple sclerosis (MS). The investigators hypothesize that institution of glatiramer acetate treatment following high-dose cyclophosphamide treatment will extend the period of disease free activity and further reduce the disability in patients with relapsing remitting multiple sclerosis. The investigators plan to investigate the properties of glatiramer acetate against the recurrence of MS disease activity following high dose cyclophosphamide induced cessation detectable autoimmunity. The investigators hypothesize that glatiramer acetate, given in the phase of immune reconstitution after high-dose cyclophosphamide, may bias the immune system to a more tolerated state, thus leading to more stable and potentially permanent remissions.

Timeline

Start
2010-11
Primary completion
2010-11
Completion
2010-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 50 mg/kg Intravenous
Subject Glatiramer Acetate Small molecule 20 mg Subcutaneous