Trial Outcomes & Findings for Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis (NCT NCT00220779)
NCT ID: NCT00220779
Last Updated: 2016-04-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
128 participants
Primary outcome timeframe
12 months
Results posted on
2016-04-27
Participant Flow
The study was conducted in 31 study centers in Austria, Canada, Czech Republic, Germany, United Kingdom, Greece, Hungary, Israel, Poland, and the United States.
Participant milestones
| Measure |
IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg Body Weight)
Immune globulin (intravenous) (IGIV)
|
IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg Body Weight)
Immune globulin (intravenous) (IGIV)
|
Placebo (0.1% Albumin) 4 mL/kg Body Weight/Infusion
Immune globulin (intravenous) (IGIV)
|
|---|---|---|---|
|
Overall Study
STARTED
|
45
|
42
|
41
|
|
Overall Study
COMPLETED
|
38
|
38
|
37
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
4
|
Reasons for withdrawal
| Measure |
IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg Body Weight)
Immune globulin (intravenous) (IGIV)
|
IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg Body Weight)
Immune globulin (intravenous) (IGIV)
|
Placebo (0.1% Albumin) 4 mL/kg Body Weight/Infusion
Immune globulin (intravenous) (IGIV)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
1
|
|
Overall Study
Non-compliance
|
1
|
0
|
0
|
|
Overall Study
Too time consuming
|
1
|
0
|
0
|
|
Overall Study
Pregnancy
|
0
|
0
|
2
|
|
Overall Study
Lack of Efficacy
|
3
|
0
|
1
|
Baseline Characteristics
Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Placebo (0.1% Albumin) 4 mL/kg bw/Infusion
n=41 Participants
|
Total
n=128 Participants
Total of all reporting groups
|
IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)
n=45 Participants
|
IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)
n=42 Participants
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=206 Participants
|
127 Participants
n=7 Participants
|
45 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
|
Age, Continuous
|
33.0 years
STANDARD_DEVIATION 8.7 • n=206 Participants
|
33.1 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
31.9 years
STANDARD_DEVIATION 7.5 • n=99 Participants
|
34.4 years
STANDARD_DEVIATION 7.9 • n=107 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=206 Participants
|
96 Participants
n=7 Participants
|
38 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
7 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=206 Participants
|
11 participants
n=7 Participants
|
5 participants
n=99 Participants
|
3 participants
n=107 Participants
|
|
Region of Enrollment
Czech Republic
|
6 participants
n=206 Participants
|
22 participants
n=7 Participants
|
6 participants
n=99 Participants
|
10 participants
n=107 Participants
|
|
Region of Enrollment
Hungary
|
2 participants
n=206 Participants
|
8 participants
n=7 Participants
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
|
Region of Enrollment
Greece
|
0 participants
n=206 Participants
|
3 participants
n=7 Participants
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=206 Participants
|
11 participants
n=7 Participants
|
5 participants
n=99 Participants
|
1 participants
n=107 Participants
|
|
Region of Enrollment
Poland
|
8 participants
n=206 Participants
|
24 participants
n=7 Participants
|
10 participants
n=99 Participants
|
6 participants
n=107 Participants
|
|
Region of Enrollment
Austria
|
2 participants
n=206 Participants
|
6 participants
n=7 Participants
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
|
Region of Enrollment
Israel
|
2 participants
n=206 Participants
|
3 participants
n=7 Participants
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
|
Region of Enrollment
Germany
|
11 participants
n=206 Participants
|
35 participants
n=7 Participants
|
9 participants
n=99 Participants
|
15 participants
n=107 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=206 Participants
|
5 participants
n=7 Participants
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Intent-to-Treat (ITT) Population was all randomized subjects. This was the primary analysis population.
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.
Outcome measures
| Measure |
IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)
n=44 Participants
|
IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)
n=42 Participants
|
Placebo (0.1% Albumin) 4 mL/kg bw/Infusion
n=41 Participants
|
|---|---|---|---|
|
Percentage of Relapse Free Subjects (no Relapse)
No Relapse
|
56.8 percentage of participants
|
59.5 percentage of participants
|
68.3 percentage of participants
|
|
Percentage of Relapse Free Subjects (no Relapse)
At Least One Relapse
|
43.2 percentage of participants
|
40.5 percentage of participants
|
31.7 percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
Adverse Events
IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo (0.1% Albumin) 4 mL/kg bw/Infusion
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)
n=45 participants at risk
|
IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)
n=42 participants at risk
|
Placebo (0.1% Albumin) 4 mL/kg bw/Infusion
n=41 participants at risk
|
|---|---|---|---|
|
General disorders
Headache
|
2.2%
1/45
|
0.00%
0/42
|
0.00%
0/41
|
|
Eye disorders
Herpes Zoster ophthalmic
|
2.2%
1/45
|
0.00%
0/42
|
0.00%
0/41
|
|
Vascular disorders
Vasculitis, peripheral
|
0.00%
0/45
|
2.4%
1/42
|
0.00%
0/41
|
|
Psychiatric disorders
Panic attacks
|
0.00%
0/45
|
2.4%
1/42
|
0.00%
0/41
|
|
General disorders
Toothache
|
0.00%
0/45
|
0.00%
0/42
|
2.4%
1/41
|
Other adverse events
| Measure |
IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)
n=45 participants at risk
|
IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)
n=42 participants at risk
|
Placebo (0.1% Albumin) 4 mL/kg bw/Infusion
n=41 participants at risk
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
8.9%
4/45
|
4.8%
2/42
|
4.9%
2/41
|
|
Gastrointestinal disorders
Nausea
|
4.4%
2/45
|
11.9%
5/42
|
0.00%
0/41
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/45
|
9.5%
4/42
|
0.00%
0/41
|
|
General disorders
Asthenia
|
4.4%
2/45
|
2.4%
1/42
|
7.3%
3/41
|
|
General disorders
Fatigue
|
11.1%
5/45
|
4.8%
2/42
|
12.2%
5/41
|
|
General disorders
Feeling cold
|
8.9%
4/45
|
2.4%
1/42
|
0.00%
0/41
|
|
General disorders
Pyrexia
|
6.7%
3/45
|
7.1%
3/42
|
0.00%
0/41
|
|
Infections and infestations
Bronchitis
|
4.4%
2/45
|
0.00%
0/42
|
7.3%
3/41
|
|
Infections and infestations
Influenza
|
4.4%
2/45
|
2.4%
1/42
|
12.2%
5/41
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
9/45
|
16.7%
7/42
|
26.8%
11/41
|
|
Infections and infestations
Rhinitis
|
6.7%
3/45
|
16.7%
7/42
|
9.8%
4/41
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
3/45
|
0.00%
0/42
|
12.2%
5/41
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/45
|
14.3%
6/42
|
4.9%
2/41
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
1/45
|
7.1%
3/42
|
7.3%
3/41
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.9%
4/45
|
11.9%
5/42
|
4.9%
2/41
|
|
Nervous system disorders
Dizziness
|
6.7%
3/45
|
2.4%
1/42
|
2.4%
1/41
|
|
Nervous system disorders
Headache
|
15.6%
7/45
|
11.9%
5/42
|
14.6%
6/41
|
|
Nervous system disorders
Hypoaesthesia
|
6.7%
3/45
|
9.5%
4/42
|
4.9%
2/41
|
|
Nervous system disorders
Paraesthesia
|
8.9%
4/45
|
2.4%
1/42
|
9.8%
4/41
|
|
Psychiatric disorders
Depression
|
2.2%
1/45
|
2.4%
1/42
|
7.3%
3/41
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
1/45
|
2.4%
1/42
|
9.8%
4/41
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.4%
2/45
|
11.9%
5/42
|
9.8%
4/41
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/45
|
7.1%
3/42
|
2.4%
1/41
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER