Long-Term Assessment of Remyelinating Therapy (RENEWED)
|ClinicalTrials.gov Identifier: NCT02657915|
Recruitment Status : Completed
First Posted : January 18, 2016
Results First Posted : September 23, 2019
Last Update Posted : September 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Optic Neuritis||Drug: Placebo Drug: BIIB033 100mg/Kg||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes 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.|
|Official Title:||A Multicenter, Follow-Up Study to Assess Long-Term Electrophysiologic and Clinical Outcomes in Subjects Previously Enrolled in Study 215ON201|
|Actual Study Start Date :||March 10, 2016|
|Actual Primary Completion Date :||January 23, 2017|
|Actual Study Completion Date :||January 23, 2017|
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.
Administered as specified in the treatment arm.
Other Name: Sterile normal saline (0.9% sodium chloride for IV administration)
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.
Drug: BIIB033 100mg/Kg
Administered as specified in the treatment arm.
- 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) [ Time Frame: Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915) ]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.
- Number of Participants That Developed Clinically Definite Multiple Sclerosis (CDMS) After Enrollment in RENEW Study (NCT01721161) [ Time Frame: RENEW Study (NCT01721161) to Day 1 (NCT02657915) ]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 [ Time Frame: RENEW Study (NCT01721161) to Day 1 (NCT02657915) ]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) [ Time Frame: Day 1 (NCT02657915) ]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) [ Time Frame: Day 1 (NCT02657915) ]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 [ Time Frame: Day 1 (NCT02657915) ]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) [ Time Frame: Baseline (RENEW Study [NCT01721161]), 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) [ Time Frame: Baseline (RENEW Study [NCT01721161]), 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657915
|Australia, New South Wales|
|Sydney, New South Wales, Australia|
|Parkville, Victoria, Australia|
|Ottawa, Ontario, Canada|
|Birmingham, United Kingdom|
|Glasgow, United Kingdom|
|London, United Kingdom|
|Study Director:||Medical Director||Biogen|