## Protocol Section
### Identification Module
**NCT ID:** NCT00220779

**Acronym:** PRIVIG

**Brief Title:** Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis

**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

#### Organization Study ID Info
**ID:** 100434
#### Organization
**Class:** INDUSTRY
**Full Name:** Grifols Therapeutics LLC
### Status Module
#### Completion Date
**Date:** 2005-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-04-27

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-03-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2005-02

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2014-04-11

**Type:** ESTIMATED

**Results First Submit Date:** 2009-09-24

**Results First Submit QC Date:** 2014-03-06

#### Start Date
**Date:** 2002-12

**Status Verified Date:** 2016-03

#### Study First Post Date
**Date:** 2005-09-22
**Type:** ESTIMATED
**Study First Submit Date:** 2005-09-13
**Study First Submit QC Date:** 2005-09-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Grifols Therapeutics LLC

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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 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.

### Conditions Module

**Conditions:**

- Multiple Sclerosis, Relapsing-Remitting

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 128

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** IGIV-C 0.2 g/kg bw/infusion (2 ml/kg bw)

**Intervention Names:**

- Drug: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified

**Label:** Group 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** IGIV-C 0.4 g/kg bw/infusion (4 ml/kg bw)

**Intervention Names:**

- Drug: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified

**Label:** Group 2

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** placebo (0.1% albumin) 4 ml/kg bw/infusion

**Intervention Names:**

- Drug: Albumin (Human) 25%, United States Pharmacopeia (USP)

**Label:** Group 3

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group 1

- Group 2

**Name:** Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified

**Other Names:**

- Gamunex®

- IGIVnex®

- Gaminex

- IGIV-C

- Immune Globulin Intravenous (Human) , 10%

- IGIV

- BAY 41-1000

- TAL-05-00004

- IGIV-C, 10%

- IVIG

- Immune Globulin (Human), 10% (IGIV)

- Immune Globulin Intravenous, 10% by Chromatography Process

- NDC 13533-645-12

- NDC 13533-645-15

- NDC 13533-645-20

- NDC 13533-645-24

- NDC 13533-645-71

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Group 3

**Name:** Albumin (Human) 25%, United States Pharmacopeia (USP)

**Other Names:**

- Plasbumin®-5

- Plasbumin®-25

- Plasbumin®-5 (Low Aluminum)

- Plasbumin®-25 (Low Aluminum)

- Albumin (Human) 5%, USP

- Albumin (Human) 25%, USP

- TAL-05-00009

- TAL-05-00023

- TAL-05-00025

- TAL-05-00026

- BAY 34-9255

- NDC 13533-684-16

- NDC 13533-684-25

- NDC 13533-684-71

- NDC 13533-685-20

- NDC 13533-685-25

- NDC 13533-685-27

- NDC 13533-690-20

- NDC 13533-690-25

- NDC 13533-690-27

- NDC 13533-692-16

- NDC 13533-692-20

- NDC 13533-692-71

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Percentage of Relapse Free Subjects (no Relapse)

**Time Frame:** 12 months

#### Secondary Outcomes

**Measure:** Effect on the Combined Unique Lesion Activity on Magnetic Resonance Imaging (MRI)

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Phoenix

**Country:** United States

**Facility:** Barrow Neurological Institute at St. Joseph's Hospital and Medical Center

**State:** Arizona

**Zip:** 85013

**Location 2:**

**City:** Tucson

**Country:** United States

**Facility:** Northwest NeuroSpecialists, PLLC

**State:** Arizona

**Zip:** 85741-3537

**Location 3:**

**City:** New York

**Country:** United States

**Facility:** The Mt. Sinai Medical Center, Department of Neurology

**State:** New York

**Zip:** 10029

**Location 4:**

**City:** Stony Brook

**Country:** United States

**Facility:** SUNY Health Science Center at Stony Brook, Department of Neurology

**State:** New York

**Zip:** 11794-8121

**Location 5:**

**City:** Winston-Salem

**Country:** United States

**Facility:** Wake Forest University - School of Medicine

**State:** North Carolina

**Zip:** 27157

**Location 6:**

**City:** Burlington

**Country:** United States

**Facility:** Neurology Health Care Service, Fletcher Allen Health Care

**State:** Vermont

**Zip:** 05401

**Location 7:**

**City:** Graz

**Country:** Austria

**Facility:** Department of Neurology, Karl-Franzens University

**Zip:** 8010

**Location 8:**

**City:** Calgary

**Country:** Canada

**Facility:** Foothills Hospital

**State:** Alberta

**Zip:** T2N 2T9

**Location 9:**

**City:** London

**Country:** Canada

**Facility:** London Health Sciences Centre

**State:** Ontario

**Zip:** N6A 5A5

**Location 10:**

**City:** Ottawa

**Country:** Canada

**Facility:** The Ottawa Hospital, General Campus - Neurology Division

**State:** Ontario

**Zip:** K1H 8L6

**Location 11:**

**City:** Montreal

**Country:** Canada

**Facility:** CHUM Hospital Notre Dame

**State:** Quebec

**Zip:** H2L4M1

**Location 12:**

**City:** Brno

**Country:** Czech Republic

**Facility:** Fakultni nemocnice Brno-Bohunice

**Zip:** 63900

**Location 13:**

**City:** Brno

**Country:** Czech Republic

**Facility:** St. Anna's Teaching Hospital

**Zip:** 65691

**Location 14:**

**City:** Prague 2

**Country:** Czech Republic

**Facility:** Všeobecná fakultní nemocnice

**Zip:** 12808

**Location 15:**

**City:** Prague

**Country:** Czech Republic

**Facility:** Department of Neurology, Motol Teaching Hospital

**Zip:** 15600

**Location 16:**

**City:** Dusseldorf

**Country:** Germany

**Facility:** Medizinische Einrichtungen der Heinrich Heine Universitat, Neurologische Klinik

**Zip:** 40225

**Location 17:**

**City:** Erfurt

**Country:** Germany

**Facility:** HELIOS Klinikum Erfurt GmbH, Klinik und Poliklinik fur Neurologie

**Zip:** 99089

**Location 18:**

**City:** Giessen

**Country:** Germany

**Facility:** Klinikum der Justus-Liebig-Universitat, Zentrum fur Neurologie und Neurochirurgie

**Location 19:**

**City:** Munster

**Country:** Germany

**Facility:** Universitatsklinikum Munster, Klinik und Poliklinik fur Neurologie

**Zip:** 48149

**Location 20:**

**City:** Osnabrück

**Country:** Germany

**Facility:** Klinikum Osnabrück GmbH

**Zip:** 49076

**Location 21:**

**City:** Ulm

**Country:** Germany

**Facility:** Universitatsklinikum Ulm, Poliklinik fur Neurologie

**Zip:** 89075

**Location 22:**

**City:** Wurzburg

**Country:** Germany

**Facility:** Klinijum der Universitat Wurzburg, Neurologische Klinik und Poliklinik

**Location 23:**

**City:** Athens

**Country:** Greece

**Facility:** Henry Dunant Hospital

**Zip:** 11526

**Location 24:**

**City:** Budapest

**Country:** Hungary

**Facility:** Szent Imre Korhaz Neurologia

**Zip:** 115

**Location 25:**

**City:** Budapest

**Country:** Hungary

**Facility:** Uzsoki Street Hospital

**Zip:** H-1145

**Location 26:**

**City:** Budapest

**Country:** Hungary

**Facility:** Jahn Ferenc Delpesti Teaching Hospital

**Zip:** H-1204

**Location 27:**

**City:** Szeged

**Country:** Hungary

**Facility:** Szeged University of Science

**Zip:** H-5720

**Location 28:**

**City:** Haifa

**Country:** Israel

**Facility:** Lady Davis Carmel Medical Center

**Zip:** 34362

**Location 29:**

**City:** Katowice-Ligota

**Country:** Poland

**Facility:** Katedra I Klinika Neurologii; Slaskiej Akademii Medycznej, Samodzielny Publiczny Centralny Szpital Kliniczny

**Zip:** 40-752

**Location 30:**

**City:** Lodz

**Country:** Poland

**Facility:** Katedra I Klinika Neurologii, Univerytetu Medycznego w Lodzi

**Zip:** 90-153

**Location 31:**

**City:** Lublin

**Country:** Poland

**Facility:** Katedra I Klinika Neurologii

**Zip:** 20-954

**Location 32:**

**City:** Warsaw

**Country:** Poland

**Facility:** Klinika Neurologiczna, Wojskowy Instut Medyczny

**Zip:** 00-909

**Location 33:**

**City:** Bratislava 2

**Country:** Slovakia

**Facility:** Fakultna menocnica Bratislava

**Zip:** 83-305

**Location 34:**

**City:** Bratislava 2

**Country:** Slovakia

**Facility:** Dererova nemocnica s Poliklinikou Nerologicka Klinika

**Zip:** 833 05

**Location 35:**

**City:** Lund

**Country:** Sweden

**Facility:** Lasarette Neurologiavdeling

**Location 36:**

**City:** Stockholm

**Country:** Sweden

**Facility:** Karilinska Sjukhuset

**Location 37:**

**City:** Nottingham

**Country:** United Kingdom

**Facility:** University Hospital, Queens Medical Centre

**Zip:** NG7 2UH

#### Overall Officials

**Official 1:**

**Affiliation:** Mt Sinai Medical Center, New York, NY

**Name:** Fred D Lublin, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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:** 18645164

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000020278

- Term: Demyelinating Autoimmune Diseases, CNS

- ID: D000020274

- Term: Autoimmune Diseases of the Nervous System

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000003711

- Term: Demyelinating Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M12060

- Name: Multiple Sclerosis

- Relevance: HIGH

- As Found: Multiple Sclerosis

- ID: M15415

- Name: Sclerosis

- Relevance: HIGH

- As Found: Sclerosis

- ID: M22314

- Name: Multiple Sclerosis, Relapsing-Remitting

- Relevance: HIGH

- As Found: Multiple Sclerosis, Relapsing-Remitting

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22098

- Name: Demyelinating Autoimmune Diseases, CNS

- Relevance: LOW

- As Found: Unknown

- ID: M22094

- Name: Autoimmune Diseases of the Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M6909

- Name: Demyelinating Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009103

- Term: Multiple Sclerosis

- ID: D000020529

- Term: Multiple Sclerosis, Relapsing-Remitting

- ID: D000012598

- Term: Sclerosis

### Intervention Browse Module - Ancestors

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: HIGH

- As Found: Cap

- ID: M10184

- Name: Immunoglobulins

- Relevance: HIGH

- As Found: Cap

- ID: M19117

- Name: Immunoglobulins, Intravenous

- Relevance: HIGH

- As Found: Dronabinol

- ID: M8836

- Name: gamma-Globulins

- Relevance: HIGH

- As Found: Dronabinol

- ID: M20191

- Name: Rho(D) Immune Globulin

- Relevance: HIGH

- As Found: Dronabinol

- ID: M10122

- Name: Immunoglobulin G

- Relevance: HIGH

- As Found: Cap

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000007136

- Term: Immunoglobulins

- ID: D000000906

- Term: Antibodies

- ID: D000005719

- Term: gamma-Globulins

- ID: D000016756

- Term: Immunoglobulins, Intravenous

- ID: D000018029

- Term: Rho(D) Immune Globulin

- ID: D000007074

- Term: Immunoglobulin G

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)

**ID:** EG000

**Other Num Affected:** 32

**Other Num at Risk:** 45

**Serious Number Affected:** 2

**Serious Number At Risk:** 45

**Title:** IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)

**Group ID:** EG001

**Title:** IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)

**ID:** EG001

**Other Num Affected:** 26

**Other Num at Risk:** 42

**Serious Number Affected:** 2

**Serious Number At Risk:** 42

**Title:** IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)

**Group ID:** EG002

**Title:** Placebo (0.1% Albumin) 4 mL/kg bw/Infusion

**ID:** EG002

**Other Num Affected:** 29

**Other Num at Risk:** 41

**Serious Number Affected:** 1

**Serious Number At Risk:** 41

**Title:** Placebo (0.1% Albumin) 4 mL/kg bw/Infusion

**Frequency Threshold:** 5

#### Other Events

**Term:** Vertigo

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** 

**Term:** Nausea

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Vomiting

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Asthenia

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Fatigue

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Feeling cold

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Pyrexia

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Bronchitis

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Influenza

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Nasopharyngitis

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Rhinitis

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Upper respiratory tract infection

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Urinary tract infection

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Arthralgia

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Back pain

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Dizziness

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Headache

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Hypoaesthesia

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Paraesthesia

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Depression

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Cough

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Pharyngolaryngeal pain

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Erythema

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

#### Serious Events

**Term:** Headache

**Notes:** Subject #2005

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 45

**Group ID:** EG001

**Num At Risk:** 42

**Group ID:** EG002

**Num At Risk:** 41

**Term:** Herpes Zoster ophthalmic

**Notes:** Subject #506004

**Organ System:** Eye disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 45

**Group ID:** EG001

**Num At Risk:** 42

**Group ID:** EG002

**Num At Risk:** 41

**Term:** Vasculitis, peripheral

**Notes:** Subject #502004

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 45

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 42

**Group ID:** EG002

**Num At Risk:** 41

**Term:** Panic attacks

**Notes:** Subject #506003

**Organ System:** Psychiatric disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 45

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 42

**Group ID:** EG002

**Num At Risk:** 41

**Term:** Toothache

**Notes:** Subject #507003

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 45

**Group ID:** EG001

**Num At Risk:** 42

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 41

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 45

**Group ID:** BG001

**Value:** 42

**Group ID:** BG002

**Value:** 41

**Group ID:** BG003

**Value:** 128

**Units:** Participants

### Group

**ID:** BG000

**Title:** IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)

### Group

**ID:** BG001

**Title:** IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)

### Group

**ID:** BG002

**Title:** Placebo (0.1% Albumin) 4 mL/kg bw/Infusion

### Group

**ID:** BG003

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 1

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 45

#### Measurement

**Group ID:** BG001

**Value:** 41

#### Measurement

**Group ID:** BG002

**Value:** 41

#### Measurement

**Group ID:** BG003

**Value:** 127

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 7.5

**Value:** 31.9

#### Measurement

**Group ID:** BG001

**Spread:** 7.9

**Value:** 34.4

#### Measurement

**Group ID:** BG002

**Spread:** 8.7

**Value:** 33.0

#### Measurement

**Group ID:** BG003

**Spread:** 8.0

**Value:** 33.1

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 38

#### Measurement

**Group ID:** BG001

**Value:** 27

#### Measurement

**Group ID:** BG002

**Value:** 31

#### Measurement

**Group ID:** BG003

**Value:** 96

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 15

#### Measurement

**Group ID:** BG002

**Value:** 10

#### Measurement

**Group ID:** BG003

**Value:** 32

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 3

#### Measurement

**Group ID:** BG003

**Value:** 11

**Class Title:** United States

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 10

#### Measurement

**Group ID:** BG002

**Value:** 6

#### Measurement

**Group ID:** BG003

**Value:** 22

**Class Title:** Czech Republic

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 8

**Class Title:** Hungary

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 3

**Class Title:** Greece

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 5

#### Measurement

**Group ID:** BG003

**Value:** 11

**Class Title:** Canada

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 8

#### Measurement

**Group ID:** BG003

**Value:** 24

**Class Title:** Poland

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 6

**Class Title:** Austria

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 3

**Class Title:** Israel

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 15

#### Measurement

**Group ID:** BG002

**Value:** 11

#### Measurement

**Group ID:** BG003

**Value:** 35

**Class Title:** Germany

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 5

**Class Title:** United Kingdom

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** The investigator must send a draft manuscript of the publication or abstract to the sponsor thirty days in advance of submission in order to obtain approval prior to submission of the final version for publication. This will be reviewed promptly and approval will not be withheld unreasonably. In case of a difference of opinion between the sponsor and the investigator(s), the contents of the publication will be discussed in order to find a solution which satisfies both parties.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** ralph.kantor@talecris.com
**Organization:** Talecris Biotherapeutics
**Phone:** 1-800-520-2807
**Title:** Ralph Kantor, PhD
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** The primary efficacy comparison was the comparison of the proportions of relapse free subjects (relapse defined as reported, not necessarily confirmed relapse). The multiple test procedure (hierarchical procedure) was to be stopped as soon as one of the statistical tests resulted in a non-significant P value \> 0.05.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.221
**P-Value Comment:** 0.2g/kg IGIV Group versus Placebo
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** The primary efficacy comparison was the comparison of the proportions of relapse free subjects (relapse defined as reported, not necessarily confirmed relapse). The multiple test procedure (hierarchical procedure) was to be stopped as soon as one of the statistical tests resulted in a non-significant P value \> 0.05.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.471
**P-Value Comment:** 0.4 g/kg IGIV Group versus Placebo
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** False
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
#### Outcome Measure 2
**Anticipated Posting Date:** 2009-09
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 56.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 59.5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 68.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 43.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 40.5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 31.7
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Reporting Status:** NOT_POSTED
**Time Frame:** 1 year
**Title:** Effect on the Combined Unique Lesion Activity on Magnetic Resonance Imaging (MRI)
**Type:** SECONDARY
#### Outcome Measure 2
**Description:** 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.
**Parameter Type:** NUMBER
**Population Description:** Intent-to-Treat (ITT) Population was all randomized subjects. This was the primary analysis population.
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Percentage of Relapse Free Subjects (no Relapse)
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**ID:** OG000
**Title:** IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)
##### Group
**ID:** OG001
**Title:** IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)
##### Group
**ID:** OG002
**Title:** Placebo (0.1% Albumin) 4 mL/kg bw/Infusion
### Participant Flow Module
#### Group
**Description:** Immune globulin (intravenous) (IGIV)
**ID:** FG000
**Title:** IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg Body Weight)
#### Group
**Description:** Immune globulin (intravenous) (IGIV)
**ID:** FG001
**Title:** IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg Body Weight)
#### Group
**Description:** Immune globulin (intravenous) (IGIV)
**ID:** FG002
**Title:** Placebo (0.1% Albumin) 4 mL/kg Body Weight/Infusion
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
##### Withdraw
**Type:** Non-compliance
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Too time consuming
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Pregnancy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 45
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 42
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 41
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 38
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 38
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 37
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 4
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 4
**Recruitment Details:** The study was conducted in 31 study centers in Austria, Canada, Czech Republic, Germany, United Kingdom, Greece, Hungary, Israel, Poland, and the United States.
**Has Results:** True