Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis
PRIVIG
Randomized, Double-Blind, Placebo-Controlled Study to Compare the Effects of Different Dose Regimens of IGIV Chromatography (IGIV-C), 10% Treatment on Relapses in Patients With Relapsing Remitting Multiple Sclerosis
1 other identifier
interventional
128
12 countries
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2002
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedResults Posted
Study results publicly available
April 11, 2014
CompletedApril 27, 2016
March 1, 2016
2.2 years
September 13, 2005
September 24, 2009
March 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Relapse Free Subjects (no Relapse)
A relapse was defined for the purposes of this study as the appearance or reappearance of one or more neurological symptoms or worsening of an old symptom attributed to multiple sclerosis (MS) persisting for at least 48 hours and immediately preceded by a relatively stable or improving neurological state of at least 30 days.
12 months
Secondary Outcomes (1)
Effect on the Combined Unique Lesion Activity on Magnetic Resonance Imaging (MRI)
1 year
Study Arms (3)
Group 1
EXPERIMENTALIGIV-C 0.2 g/kg bw/infusion (2 ml/kg bw)
Group 2
EXPERIMENTALIGIV-C 0.4 g/kg bw/infusion (4 ml/kg bw)
Group 3
PLACEBO COMPARATORplacebo (0.1% albumin) 4 ml/kg bw/infusion
Interventions
Eligibility Criteria
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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Northwest NeuroSpecialists, PLLC
Tucson, Arizona, 85741-3537, United States
The Mt. Sinai Medical Center, Department of Neurology
New York, New York, 10029, United States
SUNY Health Science Center at Stony Brook, Department of Neurology
Stony Brook, New York, 11794-8121, United States
Wake Forest University - School of Medicine
Winston-Salem, North Carolina, 27157, United States
Neurology Health Care Service, Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
Department of Neurology, Karl-Franzens University
Graz, 8010, Austria
Foothills Hospital
Calgary, Alberta, T2N 2T9, Canada
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
The Ottawa Hospital, General Campus - Neurology Division
Ottawa, Ontario, K1H 8L6, Canada
CHUM Hospital Notre Dame
Montreal, Quebec, H2L4M1, Canada
Fakultni nemocnice Brno-Bohunice
Brno, 63900, Czechia
St. Anna's Teaching Hospital
Brno, 65691, Czechia
Všeobecná fakultní nemocnice
Prague, 12808, Czechia
Department of Neurology, Motol Teaching Hospital
Prague, 15600, Czechia
Medizinische Einrichtungen der Heinrich Heine Universitat, Neurologische Klinik
Düsseldorf, 40225, Germany
HELIOS Klinikum Erfurt GmbH, Klinik und Poliklinik fur Neurologie
Erfurt, 99089, Germany
Klinikum der Justus-Liebig-Universitat, Zentrum fur Neurologie und Neurochirurgie
Giessen, Germany
Universitatsklinikum Munster, Klinik und Poliklinik fur Neurologie
Münster, 48149, Germany
Klinikum Osnabrück GmbH
Osnabrück, 49076, Germany
Universitatsklinikum Ulm, Poliklinik fur Neurologie
Ulm, 89075, Germany
Klinijum der Universitat Wurzburg, Neurologische Klinik und Poliklinik
Würzburg, Germany
Henry Dunant Hospital
Athens, 11526, Greece
Szent Imre Korhaz Neurologia
Budapest, 115, Hungary
Uzsoki Street Hospital
Budapest, H-1145, Hungary
Jahn Ferenc Delpesti Teaching Hospital
Budapest, H-1204, Hungary
Szeged University of Science
Szeged, H-5720, Hungary
Lady Davis Carmel Medical Center
Haifa, 34362, Israel
Katedra I Klinika Neurologii; Slaskiej Akademii Medycznej, Samodzielny Publiczny Centralny Szpital Kliniczny
Katowice-Ligota, 40-752, Poland
Katedra I Klinika Neurologii, Univerytetu Medycznego w Lodzi
Lodz, 90-153, Poland
Katedra I Klinika Neurologii
Lublin, 20-954, Poland
Klinika Neurologiczna, Wojskowy Instut Medyczny
Warsaw, 00-909, Poland
Fakultna menocnica Bratislava
Bratislava, 83-305, Slovakia
Dererova nemocnica s Poliklinikou Nerologicka Klinika
Bratislava, 833 05, Slovakia
Lasarette Neurologiavdeling
Lund, Sweden
Karilinska Sjukhuset
Stockholm, Sweden
University Hospital, Queens Medical Centre
Nottingham, NG7 2UH, United Kingdom
Related Publications (1)
Fazekas F, Lublin FD, Li D, Freedman MS, Hartung HP, Rieckmann P, Sorensen PS, Maas-Enriquez M, Sommerauer B, Hanna K; PRIVIG Study Group; UBC MS/MRI Research Group. Intravenous immunoglobulin in relapsing-remitting multiple sclerosis: a dose-finding trial. Neurology. 2008 Jul 22;71(4):265-71. doi: 10.1212/01.wnl.0000318281.98220.6f.
PMID: 18645164RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ralph Kantor, PhD
- Organization
- Talecris Biotherapeutics
Study Officials
- PRINCIPAL INVESTIGATOR
Fred D Lublin, MD
Mt Sinai Medical Center, New York, NY
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 22, 2005
Study Start
December 1, 2002
Primary Completion
February 1, 2005
Study Completion
February 1, 2005
Last Updated
April 27, 2016
Results First Posted
April 11, 2014
Record last verified: 2016-03