Status:
COMPLETED
Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis
Lead Sponsor:
Grifols Therapeutics LLC
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief 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.
Detailed Description
This trial is designed as a multi-national, randomized, double-blind, placebo-controlled prospective trial with three parallel groups. One hundred twenty (120) patients, 40 per treatment arm, with re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00220779
Start Date
December 1 2002
End Date
February 1 2005
Last Update
April 27 2016
Active Locations (37)
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1
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
2
Northwest NeuroSpecialists, PLLC
Tucson, Arizona, United States, 85741-3537
3
The Mt. Sinai Medical Center, Department of Neurology
New York, New York, United States, 10029
4
SUNY Health Science Center at Stony Brook, Department of Neurology
Stony Brook, New York, United States, 11794-8121