Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grifols Therapeutics Inc.; Grifols Therapeutics LLC
• Treatments: Antibodies; gamma-Globulins; Immunoglobulin G; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

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