drugset / Trial / NCT01757574

Alemtuzumab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIPD)

NCT01757574

NaSingle-groupOpen-labelTreatment

Summary

The objectives of this study are to determine the safety, tolerability and preliminary efficacy of alemtuzumab for infusion for the treatment of CIDP. Eligible subjects will be treated with alemtuzumab at the beginning of the study and then followed for three years. During the three year period, subjects will under go monthly safety evaluations consisting of blood and urine testing, symptom surveys and examination. Detailed neurological testing including nerve conduction testing, Rasch-built Overall Disability Scale (CIDP/RODS) and Overall Neuropathy Limitations Scale (ONLS) assessments will be performed every six months for three years. The study will also investigate and compare the responsiveness of the outcome measures being used.

Timeline

Start
2012-11
Primary completion
2016-08
Completion
2016-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Alemtuzumab Monoclonal antibody Other