Trial Outcomes & Findings for Natalizumab De-escalation With Interferon Beta-1b (NCT NCT01144052)
NCT ID: NCT01144052
Last Updated: 2014-04-17
Results Overview
Patients were followed-up during 12 months and time to first on-study relapse from randomization was recorded.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
19 participants
Primary outcome timeframe
12 months
Results posted on
2014-04-17
Participant Flow
Recruitment period: 2010 to 2011 Out-patients of Neurology ambulatory
Participant milestones
| Measure |
Natalizumab
Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
|
Interferon-beta-1b
250 mcg (8 MIU) subcutaneous injections every other day
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
COMPLETED
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Natalizumab
Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
|
Interferon-beta-1b
250 mcg (8 MIU) subcutaneous injections every other day
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Natalizumab De-escalation With Interferon Beta-1b
Baseline characteristics by cohort
| Measure |
Natalizumab
n=10 Participants
Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
|
Interferon-beta-1b
n=9 Participants
250 mcg (8 MIU) subcutaneous injections every other day
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 10.83 • n=99 Participants
|
39 years
STANDARD_DEVIATION 13.26 • n=107 Participants
|
41 years
STANDARD_DEVIATION 12.05 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
Switzerland
|
10 participants
n=99 Participants
|
9 participants
n=107 Participants
|
19 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: All enrolled and randomized patients fulfilled the criteria for analysis.
Patients were followed-up during 12 months and time to first on-study relapse from randomization was recorded.
Outcome measures
| Measure |
Natalizumab
n=10 Participants
Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
|
Interferon-beta-1b
n=9 Participants
250 mcg (8 MIU) subcutaneous injections every other day
|
|---|---|---|
|
Number of Days Until First On-study Relapse
|
NA days
This value is not available, because zero patients experienced a relapse.
|
103 days
Interval 103.0 to 103.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All enrolled and randomized patients were analyzed.
Outcome measures
| Measure |
Natalizumab
n=10 Participants
Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
|
Interferon-beta-1b
n=9 Participants
250 mcg (8 MIU) subcutaneous injections every other day
|
|---|---|---|
|
Number of Participants With Relapses
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Natalizumab
n=10 Participants
Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
|
Interferon-beta-1b
n=9 Participants
250 mcg (8 MIU) subcutaneous injections every other day
|
|---|---|---|
|
Number of Relapses
|
0 number of events
|
3 number of events
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Natalizumab
n=10 Participants
Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
|
Interferon-beta-1b
n=9 Participants
250 mcg (8 MIU) subcutaneous injections every other day
|
|---|---|---|
|
Proportion of Relapse Free Patients
|
10 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 12 months vs baselineChange of Expanded Disability Status Scale (EDSS 1-10). Higher values represent a worser outcome.
Outcome measures
| Measure |
Natalizumab
n=10 Participants
Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
|
Interferon-beta-1b
n=9 Participants
250 mcg (8 MIU) subcutaneous injections every other day
|
|---|---|---|
|
Severity of Relapses
|
0 units on a scale
Interval 0.0 to 0.0
|
0.5 units on a scale
Interval 0.5 to 1.5
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All enrolled and randomized patients were analyzed.
Number of new T2-hyperintense lesions, Number of Gd-enhancing lesions on T1-weighted images. Assessments at month 3, 6, 9, 12, 18, 24.
Outcome measures
| Measure |
Natalizumab
n=10 Participants
Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
|
Interferon-beta-1b
n=9 Participants
250 mcg (8 MIU) subcutaneous injections every other day
|
|---|---|---|
|
MRI Parameters
nT2L month 3
|
0 Lesions
Interval 0.0 to 1.0
|
0.5 Lesions
Interval 0.0 to 2.0
|
|
MRI Parameters
nT2L month 6
|
0 Lesions
Interval 0.0 to 2.0
|
1.5 Lesions
Interval 0.0 to 9.0
|
|
MRI Parameters
nT2L month 9
|
0 Lesions
Interval 0.0 to 0.0
|
0.5 Lesions
Interval 0.0 to 6.0
|
|
MRI Parameters
nT2L month 12
|
0 Lesions
Interval 0.0 to 0.0
|
0 Lesions
Interval 0.0 to 12.0
|
|
MRI Parameters
GD+L month 3
|
0 Lesions
Interval 0.0 to 0.0
|
0 Lesions
Interval 0.0 to 1.0
|
|
MRI Parameters
GD+L month 6
|
0 Lesions
Interval 0.0 to 0.0
|
0 Lesions
Interval 0.0 to 5.0
|
|
MRI Parameters
GD+L month 9
|
0 Lesions
Interval 0.0 to 0.0
|
0 Lesions
Interval 0.0 to 1.0
|
|
MRI Parameters
GD+L month 12
|
0 Lesions
Interval 0.0 to 1.0
|
0 Lesions
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All patients enrolled and randomized were analyzed.
Recording and reporting according to regulations. Monthly assessments or if necessary.
Outcome measures
| Measure |
Natalizumab
n=10 Participants
Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
|
Interferon-beta-1b
n=9 Participants
250 mcg (8 MIU) subcutaneous injections every other day
|
|---|---|---|
|
Number of Patients With Adverse Events
Number of patients with infections
|
7 participants
|
4 participants
|
|
Number of Patients With Adverse Events
Number of patients with injections site reactions
|
0 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Natalizumab
n=10 Participants
Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
|
Interferon-beta-1b
n=9 Participants
250 mcg (8 MIU) subcutaneous injections every other day
|
|---|---|---|
|
Number of Infections
|
25 events
|
8 events
|
Adverse Events
Natalizumab
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Interferon-beta-1b
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Natalizumab
n=10 participants at risk
Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
|
Interferon-beta-1b
n=9 participants at risk
250 mcg (8 MIU) subcutaneous injections every other day
|
|---|---|---|
|
Gastrointestinal disorders
gastroenteritis
|
10.0%
1/10 • Number of events 1 • Adverse events were collected during the 12 months of the trial
|
0.00%
0/9 • Adverse events were collected during the 12 months of the trial
|
Other adverse events
| Measure |
Natalizumab
n=10 participants at risk
Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
|
Interferon-beta-1b
n=9 participants at risk
250 mcg (8 MIU) subcutaneous injections every other day
|
|---|---|---|
|
Infections and infestations
Infection
|
70.0%
7/10 • Number of events 7 • Adverse events were collected during the 12 months of the trial
|
33.3%
3/9 • Number of events 3 • Adverse events were collected during the 12 months of the trial
|
|
Investigations
Injection site reaction
|
0.00%
0/10 • Adverse events were collected during the 12 months of the trial
|
44.4%
4/9 • Number of events 4 • Adverse events were collected during the 12 months of the trial
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place