Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis (PRIVIG)
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis, Relapsing-Remitting |
Drug: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified Drug: Albumin (Human) 25%, United States Pharmacopeia (USP) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
- Percentage of Relapse Free Subjects (no Relapse) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]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.
- Effect on the Combined Unique Lesion Activity on Magnetic Resonance Imaging (MRI) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Enrollment: | 128 |
| Study Start Date: | December 2002 |
| Study Completion Date: | February 2005 |
| Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
IGIV-C 0.2 g/kg bw/infusion (2 ml/kg bw)
|
Drug: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified
Other Names:
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Experimental: Group 2
IGIV-C 0.4 g/kg bw/infusion (4 ml/kg bw)
|
Drug: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified
Other Names:
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Placebo Comparator: Group 3
placebo (0.1% albumin) 4 ml/kg bw/infusion
|
Drug: Albumin (Human) 25%, United States Pharmacopeia (USP)
Other Names:
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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 relapsing-remitting (RR) multiple sclerosis will be enrolled in this trial. Eligible patients must have a diagnosis of MS as per the McDonald Criteria. In addition, patients must have a diagnosis of relapsing-remitting course of 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. Patients must also have active disease with at least 1 defined documented relapse in the last year.
During a 2 month run-in period, 2 MRIs will be performed 6 weeks apart and patients will be stratified based on the presence or absence of 1 or more Gadolinium enhancing lesions on the first MRI (Gd-enhancing lesion yes-no) and will be randomized to one of two dose regimens of IGIV-C or matching placebo. Patients will receive study drug infusions every 4 weeks for 48 weeks for a total of 12 infusions. Patients will be evaluated by MRI every 6 weeks and by clinical assessments every 3 months. A follow-up visit will occur 4 weeks after the last infusion.
The treatment groups are as follows:
- IGIV-C - 0.2 g/kg body weight (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
For blinding purposes, at each infusion, all patients will receive a total volume of 4 ml/kg bw. For patients receiving 0.2 g/kg bw of IGIV-C, the final volume of 4 ml/kg bw will be adjusted by the addition of dextrose 5%. Placebo will be supplied as Albumin 5% or Albumin 25% and diluted with either dextrose 5% or saline to a final concentration of 0.1% albumin.
Dose adaptation will be performed for subsequent infusions in case the patient's body weight has changed > 10%. The maximum amount available per infusion will be 400 ml (8 vials) calculated for a patient with a body weight of 100 kg. The suggested initial infusion rate will be 0.02 ml/kg/min for the first 15 minutes. If there is no evidence of a hypersensitivity reaction, the infusion may be given at a slowly increasing rate over the next 30 minutes up to a maximum allowable rate of 0.08 ml/kg/min. As such, the infusion for a 70 kg patient will take approximately 1hour 15 min. The overall infusion time may have a range from 1 to 2 hours.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00220779
Show 37 Study Locations
| Principal Investigator: | Fred D Lublin, MD | Mt Sinai Medical Center, New York, NY |
More Information
Publications:
| Responsible Party: | Grifols Therapeutics Inc. |
| ClinicalTrials.gov Identifier: | NCT00220779 History of Changes |
| Other Study ID Numbers: | 100434 |
| Study First Received: | September 13, 2005 |
| Results First Received: | September 24, 2009 |
| Last Updated: | March 28, 2016 |
| Health Authority: | United States: Food and Drug Administration Greece: National Organization of Medicines Germany: Federal Institute for Drugs and Medical Devices Poland: Ministry of Health Hungary: National Institute of Pharmacy Czech Republic: State Institute for Drug Control Austria: Federal Ministry for Health and Women Canada: Health Canada Sweden: Medical Products Agency Israel: Israeli Health Ministry Pharmaceutical Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency Slovakia: State Institute for Drug Control |
Additional relevant MeSH terms:
|
Sclerosis Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases |
Immune System Diseases Immunoglobulins Antibodies Gamma-Globulins Immunoglobulins, Intravenous Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 23, 2016