Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Clinical Trial
Official title:
Randomised, Double-blinded, Placebo-controlled Trial of Subcutaneous Immunoglobulin Treatment in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
The purpose of this study is to determine whether subcutaneous immunoglobulin given in small doses, is effective in maintaining the force, in patients with chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo (saline infusions), and intravenous immunoglobulin.
CIDP is an autoimmune disease of the peripheral nervous system, responding well to treatment
with intravenous immunoglobulin (IVIg), steroids and plasmapheresis. IVIg is effective in
treating patients with CIDP, but most of the patients need long time maintenance treatment,
which is associated with decreased autonomy and regular hospital admissions. Furthermore
many of the patients complain of infusion related side effects such as headache, chills and
fatigue, and over time there is problems obtaining intravenous entry because of occlusion of
the veins.
There is therefore a critical need for alternative methods to IVIg treatment. The aim of
this study is to evaluate the efficacy, tolerability and safety of small doses of
immunoglobulin administered subcutaneously (SCIg), compared with placebo. At the same time
we compare the efficacy of SCIg with the regular IVIg treatment.
We therefore hypothesize, 1: SCIg is better than subcutaneous placebo infusions, and is as
good as IVIg in maintaining muscle function in patients with CIDP. 2: SCIg home treatment is
safe and tolerable. 3: SCIg home treatment is preferred to IVIg under hospital admission, by
the patients.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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