Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis (PRIVIG)
Multiple Sclerosis, Relapsing-Remitting
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting
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
Sites / Locations
- Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
- Northwest NeuroSpecialists, PLLC
- The Mt. Sinai Medical Center, Department of Neurology
- SUNY Health Science Center at Stony Brook, Department of Neurology
- Wake Forest University - School of Medicine
- Neurology Health Care Service, Fletcher Allen Health Care
- Department of Neurology, Karl-Franzens University
- Foothills Hospital
- London Health Sciences Centre
- The Ottawa Hospital, General Campus - Neurology Division
- CHUM Hospital Notre Dame
- Fakultni nemocnice Brno-Bohunice
- St. Anna's Teaching Hospital
- Všeobecná fakultní nemocnice
- Department of Neurology, Motol Teaching Hospital
- Medizinische Einrichtungen der Heinrich Heine Universitat, Neurologische Klinik
- HELIOS Klinikum Erfurt GmbH, Klinik und Poliklinik fur Neurologie
- Klinikum der Justus-Liebig-Universitat, Zentrum fur Neurologie und Neurochirurgie
- Universitatsklinikum Munster, Klinik und Poliklinik fur Neurologie
- Klinikum Osnabrück GmbH
- Universitatsklinikum Ulm, Poliklinik fur Neurologie
- Klinijum der Universitat Wurzburg, Neurologische Klinik und Poliklinik
- Henry Dunant Hospital
- Szent Imre Korhaz Neurologia
- Uzsoki Street Hospital
- Jahn Ferenc Delpesti Teaching Hospital
- Szeged University of Science
- Lady Davis Carmel Medical Center
- Katedra I Klinika Neurologii; Slaskiej Akademii Medycznej, Samodzielny Publiczny Centralny Szpital Kliniczny
- Katedra I Klinika Neurologii, Univerytetu Medycznego w Lodzi
- Katedra I Klinika Neurologii
- Klinika Neurologiczna, Wojskowy Instut Medyczny
- Fakultna menocnica Bratislava
- Dererova nemocnica s Poliklinikou Nerologicka Klinika
- Lasarette Neurologiavdeling
- Karilinska Sjukhuset
- University Hospital, Queens Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Group 1
Group 2
Group 3
IGIV-C 0.2 g/kg bw/infusion (2 ml/kg bw)
IGIV-C 0.4 g/kg bw/infusion (4 ml/kg bw)
placebo (0.1% albumin) 4 ml/kg bw/infusion