Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Condition: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
MeSH terms: Polyneuropathies; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Polyradiculoneuropathy
Intervention: Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified; Albumin (Human) 25%, United States Pharmacopeia (USP)
Intervention description: 2 g/kg body weight ideally over 2-4 days . Thereafter, study drug infusion (IGIV-C) will be administered every 3 weeks at a dose of 1 g/kg bw, given over 1-2 days for a total of 7 additional infusions; Albumin 25%, USP diluted with dextrose 5% to a final concentration of 0.1% as an intravenous infusion. Alternatively, it may be a bottled placebo of 0.1% Albumin (Human) in 0.2 M Glycine, 1.1 mm sodium caprylate, 0.25% sodium chloride. 2 g/kg body weight ideally over 2-4 days . Thereafter, infusion (placebo) will be administered every 3 weeks at a dose of 1 g/kg bw, given over 1-2 days for a total of 7 additional infusions
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin; Immunoglobulin G
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Immunoglobulin G

Summary:

      The intent of this study is to demonstrate the efficacy and safety of Immune Globulin
      Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in newly or previously
      diagnosed CIDP subjects. Eight courses of treatment with either placebo or IGIV-C will occur
      every 3 weeks. Neurological function will be measured by Inflammatory Neuropathy Cause and
      Treatment (INCAT) scores. Patients who deteriorate or show no improvement between day 16 and
      month 6 will receive the alternate study drug for an additional 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of CIDP must be made by a neurologist specializing/experienced in
             neuromuscular diseases based on: a) Progressive or relapsing motor and sensory
             dysfunction of more than one limb resulting from neuropathy over the 2 months prior to
             the date informed consent is obtained, and b) Cerebrospinal fluid (CSF) less than 50
             white cells/µl since CIDP diagnosis (CSF testing studies are NOT mandatory)

          -  Fulfillment of INCAT neurophysiological criteria for focal demyelinating
             polyradiculoneuropathy

          -  Overall INCAT score between 2-9 and significant disability in upper or lower limb
             function in at least 2 limbs. (An INCAT score of 2 must be exclusively from leg
             disability to qualify.)

        Exclusion Criteria:

          -  Treatment with IGIV or plasma within 3 months prior to entry

          -  Steroids (Prednisolone or equivalent) > 10 mg/day or equivalent (i.e., > 20 mg every 2
             days) during the last 3 months prior to entry

          -  Treatment with immunomodulatory/immunosuppressive agents (azathioprin,
             tacrolimus,cyclosporin, Muromonab-CD3 (OKT3), any interferon), previous lymphoid
             irradiation or prior treatment with cyclophosphamide, methotrexate, mitoxantrone or
             any other immunosuppressant drug within the past 6 months prior to entry

          -  Concomitant use of supplements containing any amount of fish oil within 30 days prior
             to entry

          -  Respiratory impairment requiring mechanical ventilation

          -  Myelopathy or evidence of central demyelination or persisting neurological deficits
             from stroke, central nervous system (CNS) trauma or peripheral neuropathies of other
             cause which include diabetes mellitus (defined as a history of type 1 or type 2
             diabetes with fasting plasma glucose ≥ 7.0 mmol/L), uremic, toxic and familial
             neuropathies

          -  Pure motor syndrome fulfilling criteria for multifocal motor neuropathy with
             conduction block. Lower motor neuron disorder with motor weakness in an upper limb,
             without sensory deficit and with proximal conduction block (50% decrease in
             amplitude/area with proximal distal stimulation ) in motor nerves and normal sensory
             nerve conduction studies.

          -  Clinical or known evidence of associated systemic diseases that might cause
             neuropathy, including but not limited to connective tissue disease, HIV infection,
             hepatitis, Lyme disease, cancer (with the exception of benign skin cancer),
             Castleman's disease and systemic lupus erythematosus, diabetes mellitus (defined as a
             history of type 1 or type 2 diabetes with fasting plasma glucose ≥ 7.0 mmol/L), a
             malignant plasma cell dysplasia, immunoglobulin M (IgM) paraproteinemia, and
             amiodarone therapy.

          -  History of anaphylaxis or severe systemic response to immunoglobulin or with a blood
             product.

          -  Cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia
             requiring treatment, unstable or advanced ischemic heart disease, or history of
             congestive heart failure, severe hypertension (diastolic pressure >120 mmHg or
             systolic >170 mmHg).

          -  Females who are pregnant, breast feeding, or if of childbearing potential, unwilling
             to practice adequate contraception throughout the study.

          -  Known hyperviscosity.

          -  History of renal insufficiency or serum creatinine levels > 221 µmol/L (2.5 mg/dL).

          -  Known selective immunoglobulin A (IgA) deficiency.

          -  Other investigational drugs received within the 30 days prior to entry

          -  Conditions whose symptoms and effects could alter protein catabolism and/or
             immunoglobulin G (IgG) utilization (e.g. protein-losing enteropathies, nephrotic
             syndrome).

          -  Known hypercoagulable state.

          -  Mentally challenged adult subjects who cannot give independent informed consent.

          -  Subjects with uncompensated hypothyroidism (abnormally high thyroid-stimulating
             hormone (TSH) and abnormally low T4) or vitamin B12 deficiency (abnormally low) within
             the last 3 months prior to entry.