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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02657915
Registration number
NCT02657915
Ethics application status
Date submitted
23/12/2015
Date registered
18/01/2016
Date last updated
23/09/2019
Titles & IDs
Public title
Long-Term Assessment of Remyelinating Therapy
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Scientific title
A Multicenter, Follow-Up Study to Assess Long-Term Electrophysiologic and Clinical Outcomes in Subjects Previously Enrolled in Study 215ON201
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Secondary ID [1]
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2015-003618-26
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Secondary ID [2]
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215ON203
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Universal Trial Number (UTN)
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Trial acronym
RENEWED
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Optic Neuritis
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Condition category
Condition code
Neurological
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Other neurological disorders
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Eye
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - BIIB033 100mg/Kg
Placebo Comparator: Placebo - 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.
Experimental: BIIB033 100mg/Kg - 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.
Treatment: Drugs: Placebo
Administered as specified in the treatment arm.
Treatment: Drugs: BIIB033 100mg/Kg
Administered as specified in the treatment arm.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915)
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Secondary outcome [1]
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Number of Participants That Developed Clinically Definite Multiple Sclerosis (CDMS) After Enrollment in RENEW Study (NCT01721161)
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Assessment method [1]
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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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Timepoint [1]
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RENEW Study (NCT01721161) to Day 1 (NCT02657915)
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Secondary outcome [2]
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Time to Diagnosis of CDMS
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Assessment method [2]
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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.
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Timepoint [2]
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RENEW Study (NCT01721161) to Day 1 (NCT02657915)
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Secondary outcome [3]
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Severity of Central Nervous System (CNS) Demyelinating Disease as Assessed Using the Expanded Disability Status Scale (EDSS)
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Assessment method [3]
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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.
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Timepoint [3]
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Day 1 (NCT02657915)
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Secondary outcome [4]
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Severity of CNS Demyelinating Disease as Assessed Using the Symbol- Digit Modalities Test (SDMT)
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Assessment method [4]
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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.
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Timepoint [4]
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Day 1 (NCT02657915)
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Secondary outcome [5]
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Severity of CNS Demyelinating Disease as Assessed Using the Multiple Sclerosis Functional Composite (MSFC) Assessment
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Assessment method [5]
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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.
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Timepoint [5]
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Day 1 (NCT02657915)
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Secondary outcome [6]
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Change in Number of Gadolinium (Gd)-Enhanced Lesions From Baseline in RENEW Study (NCT01721161) to Day 1 (NCT02657915)
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915)
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Secondary outcome [7]
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Change in Volume of T2 Lesions From Baseline in RENEW Study (NCT01721161) to Day 1 (NCT02657915)
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Assessment method [7]
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Change in disease activity from baseline with brain magnetic MRI was calculated and reported. MRI analysis included volume of T2 lesions as disease activity.
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Timepoint [7]
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Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915)
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Eligibility
Key inclusion criteria
Key
- 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).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/03/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/01/2017
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Sample size
Target
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Accrual to date
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Final
52
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Research Site - Sydney
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Recruitment hospital [2]
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Research Site - Parkville
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment postcode(s) [2]
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- Parkville
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Brugge
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Canada
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State/province [2]
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Ontario
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Czechia
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State/province [3]
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Olomouc
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Czechia
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State/province [4]
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Praha
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Country [5]
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Denmark
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State/province [5]
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Glostrup
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Country [6]
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Germany
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State/province [6]
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Bamberg
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Country [7]
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Germany
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State/province [7]
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Berlin
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Country [8]
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Germany
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State/province [8]
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Dresden
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Country [9]
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Germany
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State/province [9]
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Düsseldorf
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Country [10]
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Germany
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State/province [10]
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Tübingen
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Country [11]
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Hungary
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State/province [11]
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Budapest
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Country [12]
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Italy
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State/province [12]
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Milan
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Country [13]
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Spain
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State/province [13]
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Barcelona
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Spain
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State/province [14]
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Córdoba
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Spain
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State/province [15]
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Murcia
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Country [16]
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Spain
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State/province [16]
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Sevilla
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Country [17]
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Spain
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State/province [17]
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Valencia
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Sweden
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Solna
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United Kingdom
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Birmingham
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United Kingdom
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Glasgow
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Country [21]
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United Kingdom
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State/province [21]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Biogen
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02657915
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Biogen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02657915
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