| Eligibility |
Inclusion Criteria:
- Adults (age = 18 years) with definite or probable CIDP according to the EFNS/PNS
criteria may enter the trial within 6 months of treatment onset or treatment naïve
patients. Written informed consent is obtained by the local investigator before entry
into the study.
2. IVIg treatment of 0.8 up to 1.2 g/kg per 30 days will be allowed up to 6 months. It
is expected some patients may be on variable treatment regimens, and as along as they
are not significantly declining, efforts will be made to continue treatment regimens
already instituted.
3. Prednisone in doses up to 20 mg /day will be allowed as long as dose has been
stable for 90 days and is not being escalated or tapered during study.
4. Previous plasma exchange will be allowed as long as it is not continued during the
study.
Exclusion Criteria:
- 1. Other causes of polyneuropathy, multifocal motor neuropathy, diabetes mellitus,
alcohol, family history of neuropathy, monoclonal gammopathy or malignancy, history of
drug or toxin exposure, which could reasonably cause neuropathy. Coexistent monoclonal
gammopathy will also be used as an exclusion as these patients may not have the same
response to IVIg.
2. Any other disease that may cause neurological symptoms and signs or that may
interfere with treatment or outcome assessments.
3. Severe conditions that may interfere with an evaluation of the study product or
satisfactory conduct of the study such as current malignancy or history of allogeneic
bone marrow/stem cell transplant, cardiac insufficiency (New York Heart Association
Classes III/IV), cardiomyopathy, cardiac arrhythmia requiring treatment, unstable or
advanced ischemic heart disease, congestive heart failure or severe hypertension,
chronic kidney disease deemed too severe to safely use IVIg, known hyperprolinemia,
known bleeding disorders, severe skin disease at the planned injection sites or biopsy
site, alcohol, drug or medication abuse.
4. History of keloids or other reactions to local anesthetic making skin biopsies
unsafe.
5. Patients with the following laboratory results:
1. Positive result at screening on any of the following viral markers: human
immunodeficiency virus-1 or 2, or hepatitis B or C virus.
2. Abnormal laboratory parameters: creatinine greater than 1.5 times the upper limit
of normal (ULN), blood urea nitrogen greater than three times the ULN if the
increase is related to potential kidney disease, or hemoglobin less than 10 g/dL
b. Abnormal laboratory parameters: creatinine greater than 1.5 times the upper limit
of normal (ULN), blood urea nitrogen greater than three times the ULN if the increase
is related to potential kidney disease, or hemoglobin less than 10 g/dL 6. Fulfilling
the following general criteria: inability to comply with study procedures and
treatment regimen; mental condition rendering the patient unable to understand the
nature, scope, and possible consequences of the study; pregnancy or nursing mother;
intention to become pregnant during the course of the study; female patients of
childbearing potential either not using or not willing to use a medically reliable
method of contraception for the entire duration of the study or not sexually abstinent
for the entire duration of the study or not surgically sterile; participation in
another clinical study or use of another investigational medicinal product within the
same time period of the study.
7. Additional medications and treatments other than prednisone and IVIg for treatment
of CIDP such as azathioprine, mycophenolate, rituximab and ongoing plasma exchange as
this will either confound or interfere with effects of IVIg.
|
