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

Completed · Phase 2

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

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.

Key facts

Study ID

NCT00220779

Run by

Grifols Therapeutics LLC

People needed

128

Starts

2002-12-01

Expected to finish

2005-02-01

Last updated by the study team

2016-04-27

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Barrow Neurological Institute at St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Northwest NeuroSpecialists, PLLC — Tucson, Arizona, United States
• The Mt. Sinai Medical Center, Department of Neurology — New York, New York, United States
• SUNY Health Science Center at Stony Brook, Department of Neurology — Stony Brook, New York, United States
• Wake Forest University - School of Medicine — Winston-Salem, North Carolina, United States
• Neurology Health Care Service, Fletcher Allen Health Care — Burlington, Vermont, United States
• Department of Neurology, Karl-Franzens University — Graz, Austria
• Foothills Hospital — Calgary, Alberta, Canada
• London Health Sciences Centre — London, Ontario, Canada
• The Ottawa Hospital, General Campus - Neurology Division — Ottawa, Ontario, Canada
• CHUM Hospital Notre Dame — Montreal, Quebec, Canada
• Fakultni nemocnice Brno-Bohunice — Brno, Czechia
• St. Anna's Teaching Hospital — Brno, Czechia
• Všeobecná fakultní nemocnice — Prague, Czechia
• Department of Neurology, Motol Teaching Hospital — Prague, Czechia
• Medizinische Einrichtungen der Heinrich Heine Universitat, Neurologische Klinik — Düsseldorf, Germany
• HELIOS Klinikum Erfurt GmbH, Klinik und Poliklinik fur Neurologie — Erfurt, Germany
• Klinikum der Justus-Liebig-Universitat, Zentrum fur Neurologie und Neurochirurgie — Giessen, Germany
• Universitatsklinikum Munster, Klinik und Poliklinik fur Neurologie — Münster, Germany
• Klinikum Osnabrück GmbH — Osnabrück, Germany
• Universitatsklinikum Ulm, Poliklinik fur Neurologie — Ulm, Germany
• Klinijum der Universitat Wurzburg, Neurologische Klinik und Poliklinik — Würzburg, Germany
• Henry Dunant Hospital — Athens, Greece
• Szent Imre Korhaz Neurologia — Budapest, Hungary
• Uzsoki Street Hospital — Budapest, Hungary

Full record on ClinicalTrials.gov

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