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| Name | Class |
|---|---|
| Elan Pharmaceuticals | INDUSTRY |
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The primary objective of the study was to evaluate the immunogenicity of natalizumab (Tysabri®) produced by a modified manufacturing process (natalizumab high titer; BG00002-E) administered intravenously (IV) to participants with relapsing forms of multiple sclerosis (MS). The secondary objective of this study was to evaluate the safety of natalizumab high titer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Natalizumab High Titer | Experimental | natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BG00002-E (natalizumab high titer) | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Anti-Natalizumab Antibody Negative, Transient Positive, and Persistent Positive Status | Negative: no detectable antibody at all post-baseline visits. Persistent positive: antibody positive at 2 or more post-baseline visits at least 42 days apart, or positive at the last post-baseline visit. Transient positive: antibody positive at only 1 post-baseline visit prior to the last visit. | Assessed every 12 weeks from Week 0 (Baseline) to Week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs | AE: any sign, symptom, or diagnosis/disease that was unfavorable or unintended, new, or if pre-existing, worsened in a participant administered a study treatment and that did not necessarily have a causal relationship with this treatment. SAE: an event that resulted in death; an event that, in the view of the investigator, placed the participant at immediate risk of death (life-threatening event); an outcome that resulted in a congenital anomaly/birth defect diagnosed in a child of a participant in this study; an event that required or prolonged inpatient hospitalization; an event that resulted in persistent or significant disability/incapacity; any other medically important event that, in the opinion of the investigator, may have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed above. Events were classified as 'related' or 'not related' to study drug, and categorized as 'mild' moderate' or 'severe' per protocol. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Washington D.C. | District of Columbia | 20007 | United States | ||
| Research Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Natalizumab High Titer | natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Natalizumab High Titer | natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Anti-Natalizumab Antibody Negative, Transient Positive, and Persistent Positive Status | Negative: no detectable antibody at all post-baseline visits. Persistent positive: antibody positive at 2 or more post-baseline visits at least 42 days apart, or positive at the last post-baseline visit. Transient positive: antibody positive at only 1 post-baseline visit prior to the last visit. | Participants who received at least 1 dose of natalizumab, had a negative baseline antibody result, and had at least 1 antibody assessment after the first dose. | Posted | Number | participants | Assessed every 12 weeks from Week 0 (Baseline) to Week 36 |
|
AEs: collected from Baseline (Week 0) until Week 36 or premature withdrawal. SAEs: collected from informed consent until Week 36 or premature withdrawal.
Includes all participants who received at least 1 dose of study drug.
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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 High Titer | natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Biogen Idec Medical Director | Biogen Idec Inc. | clinicaltrials@biogenidec.com |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000069442 | Natalizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| AEs: collected from Baseline (Week 0) until Week 36 or premature withdrawal. SAEs: collected from informed consent until Week 36 or premature withdrawal. |
| Mean Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 36 | EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. The change in EDSS at Month 36 was calculated as EDSS at Month 36 minus EDSS at baseline. | Baseline, Week 36 |
| Annualized Relapse Rate | Annualized relapse rate was calculated as the total number of relapses that occurred during the study divided by the total number of years the participant was followed in the study. The annualized relapse rate was based only on those relapses that were determined to meet the definition of relapse per the investigator's clinical judgment. New or recurrent symptoms that occurred less than 30 days following the onset of a protocol-defined relapse were considered part of the same relapse. | Through Week 36 |
| Maitland |
| Florida |
| 32751 |
| United States |
| Research Site | Miami | Florida | 33136 | United States |
| Research Site | Atlanta | Georgia | 30327 | United States |
| Research Site | Farmington Hills | Michigan | 48334 | United States |
| Research Site | Buffalo | New York | 14203 | United States |
| Research Site | New York | New York | 10003 | United States |
| Research Site | Charlotte | North Carolina | 28207 | United States |
| Research Site | Philadelphia | Pennsylvania | 19104 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15212 | United States |
| Research Site | Dallas | Texas | 75214 | United States |
| Research site | Round Rock | Texas | 78681 | United States |
| Research Site | Milwaukee | Wisconsin | 53215 | United States |
| Noncompliance |
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| Death |
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| Persistent Antibodies per Protocol |
|
| Relocated |
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| Pregnancy |
|
| Received Medication From Another Study |
|
| years |
|
| Age, Customized | Protocol deviations were filed for the 2 participants >=56 years. | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Expanded Disability Status Score (EDSS) Score | EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. All participants who were dosed (n=112) had an EDSS baseline score recorded. | Mean | Standard Deviation | scores on a scale |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs | AE: any sign, symptom, or diagnosis/disease that was unfavorable or unintended, new, or if pre-existing, worsened in a participant administered a study treatment and that did not necessarily have a causal relationship with this treatment. SAE: an event that resulted in death; an event that, in the view of the investigator, placed the participant at immediate risk of death (life-threatening event); an outcome that resulted in a congenital anomaly/birth defect diagnosed in a child of a participant in this study; an event that required or prolonged inpatient hospitalization; an event that resulted in persistent or significant disability/incapacity; any other medically important event that, in the opinion of the investigator, may have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed above. Events were classified as 'related' or 'not related' to study drug, and categorized as 'mild' moderate' or 'severe' per protocol. | Participants who received at least 1 dose of study drug. | Posted | Number | participants | AEs: collected from Baseline (Week 0) until Week 36 or premature withdrawal. SAEs: collected from informed consent until Week 36 or premature withdrawal. |
|
|
|
| Secondary | Mean Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 36 | EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. The change in EDSS at Month 36 was calculated as EDSS at Month 36 minus EDSS at baseline. | Participants with EDSS scores at Baseline and Week 36 (includes participants who withdrew from the study). | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 36 |
|
|
|
| Secondary | Annualized Relapse Rate | Annualized relapse rate was calculated as the total number of relapses that occurred during the study divided by the total number of years the participant was followed in the study. The annualized relapse rate was based only on those relapses that were determined to meet the definition of relapse per the investigator's clinical judgment. New or recurrent symptoms that occurred less than 30 days following the onset of a protocol-defined relapse were considered part of the same relapse. | Participants who received at least 1 dose of study drug. | Posted | Number | relapses/participant-years | Through Week 36 |
|
|
|
| 7 |
| 112 |
| 79 |
| 112 |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chest pain | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Demyelination | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 10.0 | Systematic Assessment |
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| Gait disturbance | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
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.
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| AE related to study drug |
|
| Serious adverse event (SAE) |
|
| SAE related to study drug |
|
| Treatment discontinuation due to AE |
|
| Withdrawal from study due to AE |
|