Back to resultsLong-Term Assessment of Remyelinating Therapy (RENEWED)
Primary Purpose
Acute Optic Neuritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
BIIB033 100mg/Kg
Sponsored by
About this trial
This is an interventional other trial for Acute Optic Neuritis focused on measuring FF-VEP, mfVEP, Human anti-LINGO-1, BIIB033, AON
Eligibility Criteria
Key Inclusion Criteria:
- Must have participated in Study NCT01721161 and received at least 1 dose of BIIB033 or placebo, as per protocol, within 2 years (+ 4 months) from Day 1 of this study (2 years from Week 32 or projected Week 32 visit, if the subject did not complete all visits in Study NCT01721161).
Key Exclusion Criteria:
- Not previously enrolled in Study NCT01721161
- Subjects with recent kidney function, such as serum creatinine above upper limit of normal range, will not be allowed to receive administration of Gd but will otherwise be allowed to participate in the study, including magnetic resonance imaging (MRI) assessments not requiring the use of Gd.
- Female subjects must have had a recent pregnancy test and must not be breastfeeding prior to MRI assessments with Gd.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
BIIB033 100mg/Kg
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02657915
Brief Title
Long-Term Assessment of Remyelinating Therapy
Acronym
RENEWED
Official Title
A Multicenter, Follow-Up Study to Assess Long-Term Electrophysiologic and Clinical Outcomes in Subjects Previously Enrolled in Study 215ON201
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 10, 2016 (Actual)
Primary Completion Date
January 23, 2017 (Actual)
Study Completion Date
January 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Optic Neuritis
Keywords
FF-VEP, mfVEP, Human anti-LINGO-1, BIIB033, AON
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
BIIB033 100mg/Kg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sterile normal saline (0.9% sodium chloride for IV administration)
Intervention Description
Administered as specified in the treatment arm.
Intervention Type
Drug
Intervention Name(s)
BIIB033 100mg/Kg
Intervention Description
Administered as specified in the treatment arm.
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915)
Secondary Outcome Measure Information:
Title
Number of Participants That Developed Clinically Definite Multiple Sclerosis (CDMS) After Enrollment in RENEW Study (NCT01721161)
Description
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.
Time Frame
RENEW Study (NCT01721161) to Day 1 (NCT02657915)
Title
Time to Diagnosis of CDMS
Description
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.
Time Frame
RENEW Study (NCT01721161) to Day 1 (NCT02657915)
Title
Severity of Central Nervous System (CNS) Demyelinating Disease as Assessed Using the Expanded Disability Status Scale (EDSS)
Description
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.
Time Frame
Day 1 (NCT02657915)
Title
Severity of CNS Demyelinating Disease as Assessed Using the Symbol- Digit Modalities Test (SDMT)
Description
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.
Time Frame
Day 1 (NCT02657915)
Title
Severity of CNS Demyelinating Disease as Assessed Using the Multiple Sclerosis Functional Composite (MSFC) Assessment
Description
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.
Time Frame
Day 1 (NCT02657915)
Title
Change in Number of Gadolinium (Gd)-Enhanced Lesions From Baseline in RENEW Study (NCT01721161) to Day 1 (NCT02657915)
Description
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.
Time Frame
Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915)
Title
Change in Volume of T2 Lesions From Baseline in RENEW Study (NCT01721161) to Day 1 (NCT02657915)
Description
Change in disease activity from baseline with brain magnetic MRI was calculated and reported. MRI analysis included volume of T2 lesions as disease activity.
Time Frame
Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Must have participated in Study NCT01721161 and received at least 1 dose of BIIB033 or placebo, as per protocol, within 2 years (+ 4 months) from Day 1 of this study (2 years from Week 32 or projected Week 32 visit, if the subject did not complete all visits in Study NCT01721161).
Key Exclusion Criteria:
Not previously enrolled in Study NCT01721161
Subjects with recent kidney function, such as serum creatinine above upper limit of normal range, will not be allowed to receive administration of Gd but will otherwise be allowed to participate in the study, including magnetic resonance imaging (MRI) assessments not requiring the use of Gd.
Female subjects must have had a recent pregnancy test and must not be breastfeeding prior to MRI assessments with Gd.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Parkville
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Brugge
Country
Belgium
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Olomouc
Country
Czechia
Facility Name
Research Site
City
Praha
Country
Czechia
Facility Name
Research Site
City
Glostrup
Country
Denmark
Facility Name
Research Site
City
Bamberg
Country
Germany
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Dresden
Country
Germany
Facility Name
Research Site
City
Düsseldorf
Country
Germany
Facility Name
Research Site
City
Tübingen
Country
Germany
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Milan
Country
Italy
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Córdoba
Country
Spain
Facility Name
Research Site
City
Murcia
Country
Spain
Facility Name
Research Site
City
Sevilla
Country
Spain
Facility Name
Research Site
City
Valencia
Country
Spain
Facility Name
Research Site
City
Solna
Country
Sweden
Facility Name
Research Site
City
Birmingham
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Long-Term Assessment of Remyelinating Therapy
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