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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003618-26 | EudraCT Number |
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The primary objective of the study is to assess full-field visual evoked potential (FF-VEP) latency in subjects who were enrolled in Study NCT01721161 2 years (+ up to 12 months) after the last study visit. The secondary objective is to assess clinical progression and severity of central nervous system (CNS) demyelinating disease in subjects who were enrolled in Study NCT01721161 2 years (+ up to 12 months) after the last study visit. Intervention was administered in the previous study. The participants, investigator and outcome assessors remain blinded in this follow-up study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | This was a follow-up study, investigational product was administered in the previous study. Participants in the placebo arm have received at least 1 dose of placebo. |
|
| BIIB033 100mg/Kg | Experimental | This was a follow-up study, investigational product was administered in the previous study. Participants in the BIIB033 arm have received at least 1 dose of 100 mg/kg BIIB033. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| FF-VEP Latency of the Affected Eye as Compared to the Baseline of the Fellow Eye at 2 Years (+ up to 12 Months) After the Last Study Visit Assessment (Week 32) in RENEW Study (NCT01721161) | A full field visual evoked potential (FF-VEP) is an evoked potential caused by a visual stimulus, such as an alternating checkerboard pattern on a computer screen. Responses are recorded from electrodes that are placed on the back of the head and are observed as a reading on an electroencephalogram (EEG). These responses usually originate from the occipital cortex, the area of the brain involved in receiving and interpreting visual signals. | Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Developed Clinically Definite Multiple Sclerosis (CDMS) After Enrollment in RENEW Study (NCT01721161) | The diagnosis of clinically definite multiple sclerosis (CDMS) was made on the basis of clinical criteria and requires that a patient experience at least 2 neurologic events consistent with demyelination, separated both in time and in location in the central nervous system. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Sydney | New South Wales | Australia | |||
| Research Site |
The number of participants eligible for this study was determined by the number of participants who participated in RENEW Study (NCT01721161). A total of 82 participants were enrolled in RENEW Study (NCT01721161) and received at least 1 dose of study treatment. A total of 52 participants participated in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | This was a follow-up study with no investigational product administered. Participants in the placebo arm had received at least 1 dose of placebo in RENEW Study (NCT01721161). |
| FG001 | BIIB033 (Opicinumab) 100 mg/kg | This was a follow-up study with no investigational product administered. Participants in the BIIB033 (Opicinumab) arm had received at least 1 dose of 100 milligram per kilogram (mg/kg) BIIB033 in RENEW Study (NCT01721161). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The intent-to-treat (ITT) population was defined as all randomized participants who received at least 1 dose of study treatment in RENEW Study (NCT01721161) and completed at least 1 of the Day 1 assessments in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | This was a follow-up study with no investigational product administered. Participants in the placebo arm had received at least 1 dose of placebo in RENEW Study (NCT01721161). |
| BG001 | BIIB033 (Opicinumab) 100 mg/kg |
| 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 | FF-VEP Latency of the Affected Eye as Compared to the Baseline of the Fellow Eye at 2 Years (+ up to 12 Months) After the Last Study Visit Assessment (Week 32) in RENEW Study (NCT01721161) | A full field visual evoked potential (FF-VEP) is an evoked potential caused by a visual stimulus, such as an alternating checkerboard pattern on a computer screen. Responses are recorded from electrodes that are placed on the back of the head and are observed as a reading on an electroencephalogram (EEG). These responses usually originate from the occipital cortex, the area of the brain involved in receiving and interpreting visual signals. | Per protocol (PP) population: defined as participants from ITT population who completed the study, did not miss more than 1 dose of BIIB033 (Opicinumab) or placebo, and did not receive MS modifying therapies in RENEW Study (NCT01721161). The statistical analysis plan specified that efficacy analyses performed in PP were considered primary analyses. | Posted | Mean | Standard Deviation | milliseconds (msec) | Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915) |
|
Day 1 (NCT02657915)
The safety population was defined as all participants who received at least 1 dose of study treatment in RENEW Study (NCT01721161) and completed at least 1 of the 1-day assessments in this study.
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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 | Placebo | This was a follow-up study with no investigational product administered. Participants in the placebo arm had received at least 1 dose of placebo in RENEW Study (NCT01721161). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Biogen Study Medical Director | Biogen | 866-633-4636 | clinicaltrials@biogen.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 2, 2017 | May 7, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 8, 2016 | May 7, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D009934 | Organization and Administration |
| C000625770 | opicinumab |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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This was a follow-up study with no investigational product; however, the allocation method in RENEW Study (NCT01721161) was randomised-controlled and to maintain the blind from RENEW, the treatment disclosure for RENEW was not shared with study sites or participants until the end of this study.
| BIIB033 100mg/Kg | Drug | Administered as specified in the treatment arm. |
|
| RENEW Study (NCT01721161) to Day 1 (NCT02657915) |
| Time to Diagnosis of CDMS | The diagnosis of CDMS was made on the basis of clinical criteria and requires that a patient experience at least 2 neurologic events consistent with demyelination, separated both in time and in location in the central nervous system. Time to diagnosis of CDMS in Study NCT02657915 was the time from the diagnosis of acute optic neuritis (AON) to the date of confirmed MS. Measured in Days using the Median (50th percentile) for each arm. | RENEW Study (NCT01721161) to Day 1 (NCT02657915) |
| Severity of Central Nervous System (CNS) Demyelinating Disease as Assessed Using the Expanded Disability Status Scale (EDSS) | The EDSS score is based on neurological testing and an examination of functional systems (FS), which are areas of the central nervous system which control bodily functions. These functional systems are: pyramidal (ability to walk), Cerebellar (coordination), brain stem (speech and swallowing), sensory (touch and pain), bowel and bladder functions, visual, mental and Other (includes any other neurological findings due to MS). An overall score ranging from 0 (normal) to 10 (disability) was calculated. Higher scores indicate greater disability. | Day 1 (NCT02657915) |
| Severity of CNS Demyelinating Disease as Assessed Using the Symbol- Digit Modalities Test (SDMT) | SDMT is a screening test for cognitive impairment. Participants were given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best). Originate from the occipital cortex, the area of the brain involved in receiving and interpreting visual signals. | Day 1 (NCT02657915) |
| Severity of CNS Demyelinating Disease as Assessed Using the Multiple Sclerosis Functional Composite (MSFC) Assessment | MSFC has 3 component- timed 25-foot walk (T25FW), 9-hole peg test (9HPT) [dominant and nondominant hands] and (3-second) paced auditory serial addition Test (PASAT). The MSFC Z-score is calculated by creating Z-scores for each component of the MSFC and averaging them to create an overall composite score. MSFC Z-score = (Z25-foot-walk + Z9HPT + ZPASAT-3)/3, where Zj refers to Z-scores of component j. A Z-score represented the number of standard deviations participant's test result was higher (Z >0) or lower (Z <0) than the average test result (Z = 0) from the reference population. Higher scores indicate better outcomes. | Day 1 (NCT02657915) |
| Change in Number of Gadolinium (Gd)-Enhanced Lesions From Baseline in RENEW Study (NCT01721161) to Day 1 (NCT02657915) | Change in disease activity from baseline with brain magnetic resonance imaging (MRI) was calculated and reported. MRI analysis included number of consensus GD-enhanced lesions as a measure of disease activity. | Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915) |
| Change in Volume of T2 Lesions From Baseline in RENEW Study (NCT01721161) to Day 1 (NCT02657915) | Change in disease activity from baseline with brain magnetic MRI was calculated and reported. MRI analysis included volume of T2 lesions as disease activity. | Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915) |
| Parkville |
| Victoria |
| Australia |
| Research Site | Bruges | Belgium |
| Research Site | Ottawa | Ontario | Canada |
| Research Site | Olomouc | Czechia |
| Research Site | Prague | Czechia |
| Research Site | Glostrup Municipality | Denmark |
| Research Site | Bamberg | Germany |
| Research Site | Berlin | Germany |
| Research Site | Dresden | Germany |
| Research Site | Düsseldorf | Germany |
| Research Site | Tübingen | Germany |
| Research Site | Budapest | Hungary |
| Research Site | Milan | Italy |
| Research Site | Barcelona | Spain |
| Research Site | Córdoba | Spain |
| Research Site | Murcia | Spain |
| Research Site | Seville | Spain |
| Research Site | Valencia | Spain |
| Research Site | Solna | Sweden |
| Research Site | Birmingham | United Kingdom |
| Research Site | Glasgow | United Kingdom |
| Research Site | London | United Kingdom |
This was a follow-up study with no investigational product administered. Participants in the BIIB033 (Opicinumab) arm had received at least 1 dose of 100 milligram per kilogram (mg/kg) BIIB033 in RENEW Study (NCT01721161).
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Reason for Not Reporting category of Race/Ethnicity is confidentiality regulations. | Count of Participants | Participants |
|
| OG000 | Placebo | This was a follow-up study with no investigational product administered. Participants in the placebo arm had received at least 1 dose of placebo in RENEW Study (NCT01721161). |
| OG001 | BIIB033 (Opicinumab) 100 mg/kg | This was a follow-up study with no investigational product administered. Participants in the BIIB033 (Opicinumab) arm had received at least 1 dose of 100 milligram per kilogram (mg/kg) BIIB033 in RENEW Study (NCT01721161). |
|
|
|
| Secondary | Number of Participants That Developed Clinically Definite Multiple Sclerosis (CDMS) After Enrollment in RENEW Study (NCT01721161) | The diagnosis of clinically definite multiple sclerosis (CDMS) was made on the basis of clinical criteria and requires that a patient experience at least 2 neurologic events consistent with demyelination, separated both in time and in location in the central nervous system. | The PP population was defined as participants from the ITT population who completed the study, did not miss more than one dose of BIIB033 (Opicinumab) or placebo, and did not receive MS modifying therapies in RENEW Study (NCT01721161). | Posted | Number | participants | RENEW Study (NCT01721161) to Day 1 (NCT02657915) |
|
|
|
| Secondary | Time to Diagnosis of CDMS | The diagnosis of CDMS was made on the basis of clinical criteria and requires that a patient experience at least 2 neurologic events consistent with demyelination, separated both in time and in location in the central nervous system. Time to diagnosis of CDMS in Study NCT02657915 was the time from the diagnosis of acute optic neuritis (AON) to the date of confirmed MS. Measured in Days using the Median (50th percentile) for each arm. | The PP population was defined as participants from the ITT population who completed the study, did not miss more than one dose of BIIB033 (Opicinumab) or placebo, and did not receive MS modifying therapies in RENEW Study (NCT01721161). | Posted | Median | Inter-Quartile Range | days | RENEW Study (NCT01721161) to Day 1 (NCT02657915) |
|
|
|
| Secondary | Severity of Central Nervous System (CNS) Demyelinating Disease as Assessed Using the Expanded Disability Status Scale (EDSS) | The EDSS score is based on neurological testing and an examination of functional systems (FS), which are areas of the central nervous system which control bodily functions. These functional systems are: pyramidal (ability to walk), Cerebellar (coordination), brain stem (speech and swallowing), sensory (touch and pain), bowel and bladder functions, visual, mental and Other (includes any other neurological findings due to MS). An overall score ranging from 0 (normal) to 10 (disability) was calculated. Higher scores indicate greater disability. | The PP population was defined as participants from the ITT population who completed the study, did not miss more than one dose of BIIB033 (Opicinumab) or placebo, and did not receive MS modifying therapies in RENEW Study (NCT01721161). | Posted | Mean | Standard Deviation | score on a scale | Day 1 (NCT02657915) |
|
|
|
| Secondary | Severity of CNS Demyelinating Disease as Assessed Using the Symbol- Digit Modalities Test (SDMT) | SDMT is a screening test for cognitive impairment. Participants were given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best). Originate from the occipital cortex, the area of the brain involved in receiving and interpreting visual signals. | The PP population was defined as participants from the ITT population who completed the study, did not miss more than one dose of BIIB033 (Opicinumab) or placebo, and did not receive MS modifying therapies in RENEW Study (NCT01721161). | Posted | Mean | Standard Deviation | score on a scale | Day 1 (NCT02657915) |
|
|
|
| Secondary | Severity of CNS Demyelinating Disease as Assessed Using the Multiple Sclerosis Functional Composite (MSFC) Assessment | MSFC has 3 component- timed 25-foot walk (T25FW), 9-hole peg test (9HPT) [dominant and nondominant hands] and (3-second) paced auditory serial addition Test (PASAT). The MSFC Z-score is calculated by creating Z-scores for each component of the MSFC and averaging them to create an overall composite score. MSFC Z-score = (Z25-foot-walk + Z9HPT + ZPASAT-3)/3, where Zj refers to Z-scores of component j. A Z-score represented the number of standard deviations participant's test result was higher (Z >0) or lower (Z <0) than the average test result (Z = 0) from the reference population. Higher scores indicate better outcomes. | The PP population was defined as participants from the ITT population who completed the study, did not miss more than one dose of BIIB033 (Opicinumab) or placebo, and did not receive MS modifying therapies in RENEW Study (NCT01721161). | Posted | Mean | Standard Deviation | Z-score | Day 1 (NCT02657915) |
|
|
|
| Secondary | Change in Number of Gadolinium (Gd)-Enhanced Lesions From Baseline in RENEW Study (NCT01721161) to Day 1 (NCT02657915) | Change in disease activity from baseline with brain magnetic resonance imaging (MRI) was calculated and reported. MRI analysis included number of consensus GD-enhanced lesions as a measure of disease activity. | The PP population was defined as participants from the ITT population who completed the study, did not miss more than one dose of BIIB033 (Opicinumab) or placebo, and did not receive MS modifying therapies in RENEW Study (NCT01721161). | Posted | Mean | Standard Deviation | lesions | Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915) |
|
|
|
| Secondary | Change in Volume of T2 Lesions From Baseline in RENEW Study (NCT01721161) to Day 1 (NCT02657915) | Change in disease activity from baseline with brain magnetic MRI was calculated and reported. MRI analysis included volume of T2 lesions as disease activity. | The PP population was defined as participants from the ITT population who completed the study, did not miss more than one dose of BIIB033 (Opicinumab) or placebo, and did not receive MS modifying therapies in RENEW Study (NCT01721161). | Posted | Mean | Standard Deviation | millilitres (mL) | Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915) |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | BIIB033 (Opicinumab) 100 mg/kg | This was a follow-up study with no investigational product administered. Participants in the BIIB033 (Opicinumab) arm had received at least 1 dose of 100 milligram per kilogram (mg/kg) BIIB033 in RENEW Study (NCT01721161). | 0 | 28 | 0 | 28 | 0 | 28 |
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.
| D017670 |
| Sodium Compounds |
| D006298 | Health Services Administration |
| Change at Day 1 |
|
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| Change at Day 1 |
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