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| Name | Class |
|---|---|
| Elan Pharmaceuticals | INDUSTRY |
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The primary objective of the study is to evaluate the evolution of walking capacity as measured by the timed 100-meter walk test (T100T), timed 25-foot walk test (T25FW), maximum walking distance (MWD), and Expanded Disability Status Scale (EDSS) during the first year of therapy with natalizumab. The secondary objectives of this study are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Natalizumab | Experimental | natalizumab 300 mg IV every 4 weeks for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BG00002 (natalizumab) | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Timed 100-meter Walk Test (T100T) | In the T100T, the participant is instructed to walk as fast as possible for a distance of 100 meters. | Baseline, Week 24, Week 48 |
| Change From Baseline in the Timed 25-foot Walk Test (T25FW) | In the T25FW, the participant is instructed to walk as fast as possible for a distance of 25 feet. | Baseline, Week 24, Week 48 |
| Change From Baseline in Maximum Walking Distance (MWD) | Baseline, Week 24, Week 48 | |
| Change From Baseline in Expanded Disability Status Scale (EDSS) | EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. | Baseline, Week 24, Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between the EDSS and MWD (Pearson Correlation Coefficient) | Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. | Baseline, Week 24, Week 48 |
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Key Inclusion Criteria:
Must give written informed consent and provide all authorizations required by local law (for example, Protected Health Information [PHI])
Men or women between 18 and 60 years of age, inclusive
Must have Expanded Disability Status Scale (EDSS) less than or equal to 5.5 at baseline
Must be able to walk at least 100 m without assistive devices
Must be natalizumab-naïve
Must have a documented diagnosis of a relapsing remitting form of multiple sclerosis (MS0 as defined by the revised McDonald Committee criteria (Polman et al., 2005)
Must have had a recent (within 3 months from baseline) magnetic resonance imaging (MRI)
Must have had at least 1 relapse in the previous year and must satisfy the locally approved therapeutic indications for Tysabri. If Tysabri is not yet approved in a specific country, patients must fulfill the following criteria:
Must be stable in disability for at least 30 days prior to enrollment to the study
Must be stable in symptomatic management of the disease, specifically spasticity, depression and fatigue for at least 30 days prior to enrollment to the study
Must be considered by the Investigator to be free of signs and symptoms suggestive of progressive multifocal leukoencephalopathy (PML) based on medical history, physical examination, or laboratory testing
Must be willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including interferon [IFN] and glatiramer acetate [GA]) while being treated with natalizumab during the study.
Key Exclusion Criteria:
Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of the Screening Visit:
NOTE: Other eligibility criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biogen Idec Investigative Site | Liège | Belgium | ||||
| Biogen Idec Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25511792 | Background | Voloshyna N, Havrdova E, Hutchinson M, Nehrych T, You X, Belachew S, Hotermans C, Paes D. Natalizumab improves ambulation in relapsing-remitting multiple sclerosis: results from the prospective TIMER study and a retrospective analysis of AFFIRM. Eur J Neurol. 2015 Mar;22(3):570-7. doi: 10.1111/ene.12618. Epub 2014 Dec 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Natalizumab | natalizumab 300 mg IV every 4 weeks for 48 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Correlation Between the EDSS and MWD (Spearman Correlation Coefficient) | Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. | Baseline, Week 24, Week 48 |
| Correlation Between the T100T and T25FW (Pearson Correlation Coefficient) | Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. | Baseline, Week 24, Week 48 |
| Correlation Between the T100T and T25FW (Spearman Correlation Coefficient) | Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. | Baseline, Week 24, Week 48 |
| Correlation Between the EDSS and T25FW (Pearson Correlation Coefficient) | Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. | Baseline, Week 24, Week 48 |
| Correlation Between the EDSS and T25FW (Spearman Correlation Coefficient) | Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. | Baseline, Week 24, Week 48 |
| Correlation Between the EDSS and T100T (Pearson Correlation Coefficient) | Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. | Baseline, Week 24, Week 48 |
| Correlation Between the EDSS and T100T (Spearman Correlation Coefficient) | Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. | Baseline, Week 24, Week 48 |
| Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | To determine how well each of the walking tests, T100T or T25FW, predicts walking limitations, participants were stratified by baseline EDSS scores, and walking tests at Weeks 24 and 48 were analyzed. A 15% or 20% improvement indicates that, when compared with baseline walking speed (meters per second), there is at least 15% or 20% improvement at the corresponding timepoint, e.g. (speed at Week 24 - speed at baseline)/speed at baseline*100% ≥ 15% or 20%. Confirmed (conf) improvement at Week 48 indicates that the participant has at least 15% (or 20%) improvement in walking speed at both Week 24 and Week 48. | Baseline, Week 24, Week 48 |
| Puebla City |
| Mexico |
| Biogen Idec Investigative Site | Bialystok | Poland |
| Biogen Idec Investigative Site | Bydgoszcz | Poland |
| Biogen Idec Investigative Site | Lodz | Poland |
| Biogen Idec Investigative Site | Poznan | Poland |
| Biogen Idec Investigative Site | Warsaw | Poland |
| Biogen Idec Investigative Site | Bucharest | Romania |
| Biogen Idec Investigative Site | Mures | Romania |
| Biogen Idec Investigative Site | Riyadh | Saudi Arabia |
| Biogen Idec Investigative Site | Dnipropetrovsk | Ukraine |
| Biogen Idec Investigative Site | Kharkiv | Ukraine |
| Biogen Idec Investigative Site | Kyiv | Ukraine |
| Biogen Idec Investigative Site | Lviv | Ukraine |
| Biogen Idec Investigative Site | Simferopol | Ukraine |
| Safety Analysis Population |
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| Efficacy Analysis Population |
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| COMPLETED |
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| NOT COMPLETED |
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Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation)
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| ID | Title | Description |
|---|---|---|
| BG000 | Natalizumab | natalizumab 300 mg IV every 4 weeks for 48 weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Timed 100-meter Walk Test (T100T) | In the T100T, the participant is instructed to walk as fast as possible for a distance of 100 meters. | Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data at given time point. | Posted | Median | Inter-Quartile Range | seconds | Baseline, Week 24, Week 48 |
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| Primary | Change From Baseline in the Timed 25-foot Walk Test (T25FW) | In the T25FW, the participant is instructed to walk as fast as possible for a distance of 25 feet. | Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data at given time point. | Posted | Median | Inter-Quartile Range | seconds | Baseline, Week 24, Week 48 |
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| Primary | Change From Baseline in Maximum Walking Distance (MWD) | Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=those participants with observed data at given time point. | Posted | Median | Inter-Quartile Range | meters | Baseline, Week 24, Week 48 |
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| Primary | Change From Baseline in Expanded Disability Status Scale (EDSS) | EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. | Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data at given time point. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, Week 24, Week 48 |
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| Secondary | Correlation Between the EDSS and MWD (Pearson Correlation Coefficient) | Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. | Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point. | Posted | Number | Correlation coefficient | Baseline, Week 24, Week 48 |
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| Secondary | Correlation Between the EDSS and MWD (Spearman Correlation Coefficient) | Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. | Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point. | Posted | Number | Correlation coefficient | Baseline, Week 24, Week 48 |
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| Secondary | Correlation Between the T100T and T25FW (Pearson Correlation Coefficient) | Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. | Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point. | Posted | Number | Correlation coefficient | Baseline, Week 24, Week 48 |
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| Secondary | Correlation Between the T100T and T25FW (Spearman Correlation Coefficient) | Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. | Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point. | Posted | Number | Correlation coefficient | Baseline, Week 24, Week 48 |
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| Secondary | Correlation Between the EDSS and T25FW (Pearson Correlation Coefficient) | Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. | Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point. | Posted | Number | Correlation coefficient | Baseline, Week 24, Week 48 |
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| Secondary | Correlation Between the EDSS and T25FW (Spearman Correlation Coefficient) | Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. | Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point. | Posted | Number | Correlation coefficient | Baseline, Week 24, Week 48 |
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| Secondary | Correlation Between the EDSS and T100T (Pearson Correlation Coefficient) | Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. | Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point. | Posted | Number | Correlation coefficient | Baseline, Week 24, Week 48 |
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| Secondary | Correlation Between the EDSS and T100T (Spearman Correlation Coefficient) | Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and -1 inclusive, where 1 is total positive correlation, 0 is no correlation, and -1 is total negative correlation. | Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point. | Posted | Number | Correlation coefficient | Baseline, Week 24, Week 48 |
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| Secondary | Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48 | To determine how well each of the walking tests, T100T or T25FW, predicts walking limitations, participants were stratified by baseline EDSS scores, and walking tests at Weeks 24 and 48 were analyzed. A 15% or 20% improvement indicates that, when compared with baseline walking speed (meters per second), there is at least 15% or 20% improvement at the corresponding timepoint, e.g. (speed at Week 24 - speed at baseline)/speed at baseline*100% ≥ 15% or 20%. Confirmed (conf) improvement at Week 48 indicates that the participant has at least 15% (or 20%) improvement in walking speed at both Week 24 and Week 48. | Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n= number of participants with evaluable data at time point. | Posted | Number | participants | Baseline, Week 24, Week 48 |
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Day 1 (Baseline) through Week 48 (± 7 days) plus 4 weeks (± 7 days) follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Natalizumab | natalizumab 300 mg IV every 4 weeks for 48 weeks | 7 | 218 | 28 | 218 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
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| Aortic valve stenosis | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
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| Sudden death | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA 17.0 | Systematic Assessment |
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| Multiple sclerosis relapse | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Calculus ureteric | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Biogen Idec Study Medical Director | Biogen Idec | clinicaltrials@biogenidec.com |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069442 | Natalizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| 0.0002 |
| Superiority or Other |
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| Title | Denominators | Categories |
|---|
| Baseline; n=143 |
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| Change from Baseline at Week 24; n=136 |
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| Change from Baseline at Week 48; n=129 |
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natalizumab 300 mg IV every 4 weeks for 48 weeks in participants with a Baseline EDSS >= 4.5 |
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