Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified; Albumin (Human) 25%, United States Pharmacopeia (USP)
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Immunoglobulin G
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The trial will study 2 doses of Immune Globulin Intravenous (Human), 10%
      Caprylate/Chromatography Purified (IGIV-C) for the number of relapses that occur in a 1 year
      treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptoms consistent with Multiple Sclerosis up to 5 years

          -  Diagnosis of multiple sclerosis according to McDonald criteria.

          -  Diagnosis of relapsing-remitting (RR) multiple sclerosis (MS) (Defined as periods of
             worsening of neurological function with full recovery or with sequelae and residual
             deficit upon recovery; periods between disease relapses characterized by lack of
             disease progression

          -  Kurtzke Extended Disability Status Scale (EDSS) < 5.0

          -  At least 1 defined and documented relapse during the last year. Prior relapses where
             symptoms were due solely to a change in Bowel/Bladder Function or Cognitive Function
             will not be considered relapses as defined by this protocol and therefore not counted
             for inclusion into the study.

          -  Females or males; females of childbearing potential must use adequate contraception

          -  Clinically stable for at least 30 days prior to entry

          -  At least 9 hyperintense T2 lesions on MRI or 1 Gd-enhancing lesion according to
             McDonald/Barkhof dissemination-in-space criteria at entry

          -  Patients who have been informed about available treatments and decided, not to go on
             these treatments

          -  Written informed consent obtained prior to the initiation of any study related
             procedures

        Exclusion Criteria:

          -  Females who are pregnant, breast feeding, or if, of childbearing potential, unwilling
             to practice adequate contraception throughout the study

          -  Prior therapy with azathioprine or any immunosuppressant agents within 6 months prior
             to study entry

          -  Prior steroid, methylprednisolone or adrenocorticotropic hormone (ACTH) therapy within
             30 days prior to study entry

          -  Therapy with interferons (Betaseron®, Avonex®, Rebif®), glatiramer acetate (Copaxone®)
             or IGIV within 3 months prior to study entry or during the study

          -  Use of an investigational compound within 6 months prior to study entry

          -  Previous lymphoid irradiation or prior to treatment with cyclophosphamide,
             methotrexate or mitoxantrone

          -  Cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia
             requiring treatment, unstable or advanced ischemic heart disease (CCS III or IV), or
             malignant hypertension

          -  History of renal insufficiency or serum creatinine levels greater than 2.5 mg/dL (221
             µmol/L)

          -  Known selective immunoglobulin A (IgA) deficiency or known antibodies to IgA

          -  Conditions whose symptoms and effects could alter protein catabolism and/or
             immunoglobulin G (IgG) utilization (e.g., protein-losing enteropathies, nephrotic
             syndrome)

          -  Any medical, psychiatric or other circumstances which impede or restrict the patient's
             participation in the study or any contraindication to contrast enhanced MRI
             (e.g.,pacemaker, aortic clip or any metal implant)

          -  Patients with clinically significant medical conditions including, but not limited to
             cardiac, pulmonary, hepatic, hematological (e.g. known coagulation disorder, history
             of deep venous thrombosis and/or pulmonary embolism), endocrine,or renal dysfunction,
             autoimmune disorders, severe environmental allergies or chronic infections