Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis (PRIVIG)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis, Relapsing-Remitting |
Drug: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified Drug: Albumin (Human) 25%, 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 |
- MS relapse free [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- 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%, 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/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 |
| 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 IgA deficiency or known antibodies to IgA
- Conditions whose symptoms and effects could alter protein catabolism and/or 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 Locations
Show 37 Study Locations| Principal Investigator: | Fred D Lublin, MD | Mt Sinai Medical Center, New York, NY |
More Information
Additional Information:
Publications:
| Responsible Party: | Gerald Klein, MD, Chief Medical Officer, Vice President of Medical and Clinical Affairs, Talecris Biotherapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00220779 History of Changes |
| Other Study ID Numbers: | 100434 |
| Study First Received: | September 13, 2005 |
| Last Updated: | August 21, 2009 |
| 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:
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
Pathologic Processes Antibodies Immunoglobulins Immunoglobulins, Intravenous Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013