Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis (PRIVIG)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Grifols Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00220779
First received: September 13, 2005
Last updated: March 6, 2014
Last verified: March 2014
Results First Received: September 24, 2009  
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
Condition: Multiple Sclerosis, Relapsing-Remitting
Interventions: Drug: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified
Drug: Albumin (Human) 25%, United States Pharmacopeia (USP)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted in 31 study centers in Austria, Canada, Czech Republic, Germany, United Kingdom, Greece, Hungary, Israel, Poland, and the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw) Immune globulin (intravenous) (IGIV)
IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw) Immune globulin (intravenous) (IGIV)
Placebo (0.1% Albumin) 4 mL/kg bw/Infusion Immune globulin (intravenous) (IGIV)

Participant Flow:   Overall Study
    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  
STARTED     45     42     41  
COMPLETED     38     38     37  
NOT COMPLETED     7     4     4  
Adverse Event                 1                 0                 0  
Withdrawal by Subject                 1                 4                 1  
Non-compliance                 1                 0                 0  
Too time consuming                 1                 0                 0  
Pregnancy                 0                 0                 2  
Lack of Efficacy                 3                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw) No text entered.
IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw) No text entered.
Placebo (0.1% Albumin) 4 mL/kg bw/Infusion No text entered.
Total Total of all reporting groups

Baseline Measures
    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     Total  
Number of Participants  
[units: participants]
  45     42     41     128  
Age  
[units: participants]
       
<=18 years     0     1     0     1  
Between 18 and 65 years     45     41     41     127  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  31.9  ± 7.5     34.4  ± 7.9     33.0  ± 8.7     33.1  ± 8.0  
Gender  
[units: participants]
       
Female     38     27     31     96  
Male     7     15     10     32  
Region of Enrollment  
[units: participants]
       
United States     5     3     3     11  
Czech Republic     6     10     6     22  
Hungary     4     2     2     8  
Greece     1     2     0     3  
Canada     5     1     5     11  
Poland     10     6     8     24  
Austria     3     1     2     6  
Israel     1     0     2     3  
Germany     9     15     11     35  
United Kingdom     1     2     2     5  



  Outcome Measures

1.  Primary:   Percentage of Relapse Free Subjects (no Relapse)   [ Time Frame: 12 months ]

2.  Secondary:   Effect on the Combined Unique Lesion Activity on Magnetic Resonance Imaging (MRI)   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Ralph Kantor, PhD
Organization: Talecris Biotherapeutics
phone: 1-800-520-2807
e-mail: ralph.kantor@talecris.com


Publications of Results:

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 6, 2014
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