Keratinocyte Growth Factor - Promoting Thymic Reconstitution and Preventing Autoimmunity After Alemtuzumab (Campath-1H) Treatment of Multiple Sclerosis
This is a single-centre, double-blinded, randomised controlled trial of palifermin
(Kepivance) vs. placebo in the prevention of autoimmunity following alemtuzumab treatment of
multiple sclerosis.
The dose of palifermin (kepivance)used in this trial will be informed by a dose-escalation
study.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
incidence of clinical autoimmunity
The primary endpoint is incidence of clinical autoimmunity within 30 months of starting treatment with alemtuzumab
within 30 months of starting treatment with alemtuzumab
Yes
Alasdair Coles, Phd FRCP
Principal Investigator
University of Cambridge
United Kingdom: Medicines and Healthcare Products Regulatory Agency
EudraCT 2011-005606-30
NCT01712945
June 2012
October 2017
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