Chronic Inflammatory Demyelinating Neuropathy Clinical Trial
Official title:
An Open-Label Trial of Alemtuzumab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIPD)
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.
This is an open-label multi-center trial of alemtuzumab in the treatment of Chronic
Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). The study will have 4 phases.
Approximately 16 eligible participants will receive at least one cycle of alemtuzumab (5
days of drug infusion). Additional cycles of alemtuzumab (3 days of drug infusion) may be
provided at the discretion of the participants' treating physician such as if clinical
worsening occurs.
Phase 1: Screening Participants meeting the inclusion and exclusion criteria and having
signed the informed consent document will enter the screening phase and undergo baseline
evaluations.
Phase 2: Drug Infusion Participants will receive alemtuzumab by infusion using a
standardized protocol. Participants will be maintained on their prior CIDP therapy during
the drug infusions and then followed at regular intervals.
Phase 3. Alteration of CIDP therapy CIDP therapy may be altered at the discretion of the
treating physician - either taper, discontinuation, or increase of current or additional
medications. For those participants on chronic corticosteroid therapy, following pulse IV
methylprednisolone and alemtuzumab cycle, corticosteroids will be tapered as rapidly and as
far as possible according to according to the investigator's discretion. While the aim will
be to discontinue corticosteroids, it is recognized that some participants will have a
suppressed pituitary-adrenal axis and complete discontinuation may not be possible.
Phase 4: Extended Follow-up Each participant will be followed per protocol for a minimum of
36 months. All participants will undergo safety assessments and monitoring for at least 36
months after the last cycle of alemtuzumab. Additional cycles of alemtuzumab may be provided
at the discretion of the participants' treating physician with at least a 12 month interval
between cycles.
NUMBER OF PARTICIPANTS: Approximately 16 participants will join this study.
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