Clinical Trial Results:
A Prospective, Non-interventional, Multicenter, Open-label Safety and Efficacy Study of Intravenous Natalizumab Administered to Patients With Relapsing Forms of Multiple Sclerosis who Participated in STRATA
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Summary
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EudraCT number |
2014-003669-97 |
Trial protocol |
BE |
Global end of trial date |
12 Jan 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
22 Aug 2019
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First version publication date |
22 Aug 2019
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
BEL-TYS-14-10675
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Biogen
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Sponsor organisation address |
250 Binney Street, Cambridge, United States, 02142
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Public contact |
Biogen Study Medical Director, Biogen, clinicaltrials@biogen.com
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Scientific contact |
Biogen Study Medical Director, Biogen, clinicaltrials@biogen.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
12 Jan 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Jan 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective for this study was long-term safety (incidence and pattern of serious adverse events) in subjects receiving natalizumab.
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Protection of trial subjects |
Written informed consent was obtained from each subject prior to evaluations performed for eligibility. Subjects were given adequate time to review the information in the informed consent and were allowed to ask, and have answered, questions concerning all portions of the conduct of the study
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
10 Dec 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 7
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Worldwide total number of subjects |
7
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EEA total number of subjects |
7
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
7
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were recruited from 4 sites in Belgium. | ||||||||||||||||
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Pre-assignment
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Screening details |
A total of 7 subjects with relapsing forms of multiple sclerosis were enrolled in the study. | ||||||||||||||||
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Period 1
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Period 1 title |
Overall Period
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||
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Arms
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Arm title
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Natalizumab 300 milligram (mg) | ||||||||||||||||
Arm description |
Subjects received single dose of natalizumab 300 mg infusion, intravenously, once every 4 weeks for 96 weeks. | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Natalizumab
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Single dose of natalizumab 300 mg infusion, intravenously, once every 4 weeks for 96 weeks
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Baseline characteristics reporting groups
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Reporting group title |
Overall Period
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Reporting group description |
Subjects received single dose of natalizumab 300 mg infusion, intravenously, once every 4 weeks for 96 weeks. | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Natalizumab 300 milligram (mg)
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Reporting group description |
Subjects received single dose of natalizumab 300 mg infusion, intravenously, once every 4 weeks for 96 weeks. | ||
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End point title |
Number of Subjects with Adverse Events (AEs) and Serious Adverse Events (SAEs) [1] | ||||||||||
End point description |
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, places the subject at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event. Safety analysis set included all subjects enrolled in the study.
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End point type |
Primary
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End point timeframe |
up to 96 weeks
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis was planned to be reported for this endpoint. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Expanded Disability Status Scale (EDSS) Score to Measure Disability Progression at Week 0, 24, 48, 72 and 96 | ||||||||||||||||||
End point description |
EDSS is used to measure disability progression. EDSS score ranges from 0.0 (normal neurological exam) to 10.0 (death due to multiple sclerosis {MS}). Disability progression is defined as 1.5-point increase from baseline in subjects with baseline EDSS score = 0.0; OR 1-point increase in EDSS from baseline in subjects with baseline EDSS score of 1.0 to 5.0 inclusive; OR 0.5-point increase in EDSS from baseline in subjects with baseline EDSS score >5.0. Higher scores indicates worsening of disability progression. Full analysis set (FAS) included all subjects enrolled in the study.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24, 48, 72 and 96
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Number of Subjects with Clinical Relapses | ||||||
End point description |
Multiple Sclerosis (MS) disease activity was assessed by the occurrence of clinical relapses over the study period. FAS included all subjects enrolled in the study.
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End point type |
Secondary
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End point timeframe |
up to week 96
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| No statistical analyses for this end point | |||||||
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End point title |
Percentage of Subjects with Positive Anti-JC Virus (JCV) Antibodies | ||||||||||||||||
End point description |
FAS included all subjects enrolled in the study. Here, '99999' signifies data was not collected at Week 96 for subjects with positive anti-JC virus.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24, 48, 72 and 96
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Percentage of Subjects With Frequent Magnetic Resonance Imaging (MRI) Monitoring at Week 24, 48, 72 and 96 | ||||||||||||||||
End point description |
MRI monitoring in MS subjects performed as per Belgian Study Group of MS (BSGMS) guidelines. FAS included all subjects enrolled in the study.
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End point type |
Secondary
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End point timeframe |
Week 24, 48, 72 and 96
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
EuroQol-5D (EQ-5D) Score to Assess Quality of life (QoL) at Week 0, 24, 48, 72 and 96 | ||||||||||||||||||
End point description |
The health-related quality of life (HRQoL) was measured using the global evaluation scale of the EuroQol-5 Dimensions (EQ-5D) questionnaire every 6 months. Subjects were asked to evaluate their health status on a scale from 0 (worst possible health status) to 10 (best possible health status). Highest scores indicates healthy quality of life. A average score for all the subjects were reported. FAS included all subjects enrolled in the study.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24, 48, 72 and 96
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Cognitive Evaluation by Symbol Digit Modalities Test (SDMT) at Week 0, 24, 48, 72 and 96 | ||||||||
End point description |
Data for this endpoint was not collected.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24, 48, 72 and 96
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| Notes [2] - Data was not collected. |
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Up to 96 weeks
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
PI observed events | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
0.0
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Reporting groups
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Reporting group title |
Natalizumab 300 mg
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Reporting group description |
Subjects received single dose of natalizumab 300 mg infusion, intravenously, once every 4 weeks for 96 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
