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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02576717
Other study ID # RPC01-3001
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 16, 2015
Est. completion date January 5, 2023

Study information

Verified date January 2024
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with relapsing multiple sclerosis.


Description:

The trial is an open label extension study. Eligible patients from the RPC01-201, RPC01-301, and RPC01-1001 trials diagnosed with relapsing Multiple Sclerosis (RMS) will be enrolled to receive study drug until the end of the trial or until the Sponsor discontinues the development program.


Recruitment information / eligibility

Status Completed
Enrollment 2494
Est. completion date January 5, 2023
Est. primary completion date January 5, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Eligibility Criteria: To be eligible to participate in this trial, patients must meet all of the following criteria: 1. Completed one of the parent trials 2. Does not have a condition that would require withdrawal from one of the parent trials 3. Has no conditions requiring treatment with a prohibited concomitant medication 4. Is not receiving treatment with any of the following drugs or interventions within the corresponding timeframe: At Baseline (Day 1) - CYP2C8 inhibitors (eg, gemfibrozil or clopidogrel) or inducers (eg, rifampicin) Two weeks prior to Baseline (Day 1) - Monoamine oxidase inhibitors (eg, selegiline, phenelzine) 5. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments 6. Female patients of childbearing potential: Must agree to practice a highly effective method of contraception throughout the study until completion of the 90-day Safety Follow-up Visit. Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly. Acceptable methods of birth control in this study are the following: - Combined hormonal (estrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal - Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable - Placement of an intrauterine device (IUD) - Placement of an intrauterine hormone-releasing system (IUS) - Bilateral tubal occlusion - Vasectomised partner - Sexual abstinence. Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
RPC1063


Locations

Country Name City State
Belarus Local Institution - 904 Gomel
Belarus Local Institution - 907 Grodno
Belarus Local Institution - 901 Minsk
Belarus Local Institution - 902 Minsk
Belarus Local Institution - 903 Minsk
Belarus Local Institution - 905 Vitebsk
Belarus Local Institution - 906 Vitebsk
Belgium Local Institution - 256 Brugge
Belgium Local Institution - 255 Bruxelles
Belgium Local Institution - 252 Montegnee
Bosnia and Herzegovina Local Institution - 913 Banja Luka
Bosnia and Herzegovina Local Institution - 911 Sarajevo
Bulgaria Local Institution - 452 Sofia
Bulgaria Local Institution - 453 Sofia
Bulgaria Local Institution - 454 Sofia
Bulgaria Local Institution - 455 Sofia
Bulgaria Local Institution - 456 Sofia
Bulgaria Local Institution - 457 Sofia
Bulgaria Local Institution - 460 Sofia
Croatia Local Institution - 923 Osijek
Croatia Local Institution - 921 Zagreb
Croatia Local Institution - 922 Zagreb
Croatia Local Institution - 924 Zagreb
Estonia Local Institution - 471 Tallinn
Estonia Local Institution - 473 Tallinn
Estonia Local Institution - 472 Tartu
Georgia Local Institution - 301 Tbilisi
Georgia Local Institution - 302 Tbilisi
Georgia Local Institution - 303 Tbilisi
Georgia Local Institution - 304 Tbilisi
Georgia Local Institution - 306 Tbilisi
Germany Local Institution - 487 Leipzig
Germany Local Institution - 496 Potsdam
Germany Local Institution - 488 Ulm
Greece Local Institution - 551 Athens
Greece Local Institution - 552 Athens
Greece Local Institution - 553 Athens
Greece Local Institution - 555 Thessaloniki
Hungary Local Institution - 352 Budapest
Hungary Local Institution - 356 Budapest
Hungary Local Institution - 354 Esztergom
Hungary Local Institution - 358 Kistarcsa
Hungary Local Institution - 351 Nyiregyhaza
Italy Local Institution - 654 Catania
Italy Local Institution - 653 Cefalu
Italy Local Institution - 655 Milan
Italy Local Institution - 659 Montichiari
Italy Local Institution - 651 Roma
Latvia Local Institution - 561 Riga
Latvia Local Institution - 562 Riga
Lithuania Local Institution - 622 Kaunas Kauno Apskritis
Lithuania Local Institution - 621 Klaipeda
Moldova, Republic of Local Institution - 931 Chisinau
Moldova, Republic of Local Institution - 932 Chisinau
Moldova, Republic of Local Institution - 933 Chisinau
New Zealand Local Institution - 511 Christchurch
New Zealand Local Institution - 510 Hamilton
Poland Local Institution - 401 Bialystok
Poland Local Institution - 423 Bydgoszcz
Poland Local Institution - 406 Czeladz
Poland Local Institution - 405 Gdansk
Poland Local Institution - 432 Jaroslaw
Poland Local Institution - 407 Katowice
Poland Local Institution - 417 Katowice
Poland Local Institution - 426 Katowice
Poland Local Institution - 427 Katowice
Poland Local Institution - 424 Kielce
Poland Local Institution - 404 Konstancin Jeziorna
Poland Local Institution - 414 Krakow
Poland Local Institution - 411 Lódzkie
Poland Local Institution - 412 Lublin
Poland Local Institution - 420 Lublin
Poland Local Institution - 429 Lublin
Poland Local Institution - 431 Mazowieckie
Poland Local Institution - 415 Olsztyn
Poland Local Institution - 421 Plewiska
Poland Local Institution - 425 Pomorskie
Poland Local Institution - 408 Poznan
Poland Local Institution - 418 Poznan
Poland Local Institution - 433 Rybnik
Poland Local Institution - 435 Rzeszow
Poland Local Institution - 419 Szczecin
Poland Local Institution - 402 Warminsko-mazurskie
Poland Local Institution - 410 Warsaw
Poland Local Institution - 403 Warszawa
Poland Local Institution - 413 Warszawa
Poland Local Institution - 422 Warszawa
Poland Local Institution - 428 Warszawa
Poland Local Institution - 434 Warszawa Mazowieckie
Portugal Local Institution - 772 Braga
Portugal Local Institution - 775 Coimbra
Portugal Local Institution - 773 Torres Vedras
Romania Local Institution - 503 Brasov
Romania Local Institution - 504 Bucharest
Romania Local Institution - 509 Bucharest
Romania Local Institution - 520 Bucharest
Romania Local Institution - 502 Campulung
Romania Local Institution - 508 Cluj Napoca
Romania Local Institution - 501 Cluj-Napoca
Romania Local Institution - 507 Constanta
Romania Local Institution - 506 Timisoara
Serbia Local Institution - 601 Belgrade
Serbia Local Institution - 602 Belgrade
Serbia Local Institution - 603 Belgrade
Serbia Local Institution - 604 Belgrade
Serbia Local Institution - 605 Kragujevac
Serbia Local Institution - 606 Nis
Slovakia Local Institution - 946 Bratislava
Slovakia Local Institution - 942 Lucenec
Slovakia Local Institution - 945 Trnava
South Africa Local Institution - 953 Pretoria
Spain Local Institution - 756 Barcelona
Spain Local Institution - 758 Barcelona
Spain Local Institution - 761 Bilbao
Spain Local Institution - 760 Girona
Spain Local Institution - 757 Madrid
Spain Local Institution - 754 Majadahonda
Spain Local Institution - 764 Pamplona/ Navarra
Spain Local Institution - 759 San Sebastian
Spain Local Institution - 766 Sant Joan Despí
Spain Local Institution - 755 Sevillla
Spain Local Institution - 752 Valencia
Spain Local Institution - 767 Valencia
Sweden Local Institution - 780 Goteborg
Ukraine Local Institution - 823 Cherkasy
Ukraine Local Institution - 805 Chernihiv
Ukraine Local Institution - 830 Chernihiv
Ukraine Local Institution - 813 Chernivtsi
Ukraine Local Institution - 802 Dnipropetrovsk
Ukraine Local Institution - 815 Dnipropetrovsk
Ukraine Local Institution - 801 Ivano Frankivsk
Ukraine Local Institution - 829 Ivano-Frankivsk
Ukraine Local Institution - 814 Kharkiv
Ukraine Local Institution - 827 Kharkiv
Ukraine Local Institution - 832 Kharkiv
Ukraine Local Institution - 811 Kherson
Ukraine Local Institution - 803 Kyiv
Ukraine Local Institution - 818 Kyiv
Ukraine Local Institution - 822 Kyiv
Ukraine Local Institution - 824 Kyiv
Ukraine Local Institution - 817 Lutsk
Ukraine Local Institution - 812 Lviv
Ukraine Local Institution - 821 Lviv
Ukraine Local Institution - 804 Odesa
Ukraine Local Institution - 810 Odesa
Ukraine Local Institution - 831 Odesa
Ukraine Local Institution - 826 Poltava
Ukraine Local Institution - 820 Uzhhorod
Ukraine Local Institution - 809 Vinnytsia
Ukraine Local Institution - 825 Zaporizhia
Ukraine Local Institution - 828 Zaporizhzhia
Ukraine Local Institution - 806 Zaporizhzhya
Ukraine Local Institution - 819 Zhytomyr
United Kingdom Local Institution - 965 East Sussex
United Kingdom Local Institution - 963 Inverness
United Kingdom Local Institution - 964 Sheffield
United States Local Institution - 110 Berkeley California
United States Local Institution - 103 Fresno California
United States Local Institution - 137 Golden Valley Minnesota
United States Local Institution - 141 Kirkland Washington
United States Local Institution - 144 Knoxville Tennessee
United States Local Institution - 170 Las Vegas Nevada
United States Local Institution - 122 Long Beach California
United States Local Institution - 138 Lubbock Texas
United States Local Institution - 114 Maitland Florida
United States Local Institution - 115 Phoenix Arizona
United States Local Institution - 118 Phoenix Arizona
United States Local Institution - 123 Port Charlotte Florida
United States Local Institution - 143 Raleigh North Carolina
United States Local Institution - 179 Round Rock Texas
United States Local Institution - 112 Sacramento California
United States Local Institution - 120 San Francisco California
United States Local Institution - 124 Sunrise Florida
United States Local Institution - 147 Tampa Florida
United States Local Institution - 107 Westerville Ohio

Sponsors (1)

Lead Sponsor Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Belarus,  Belgium,  Bosnia and Herzegovina,  Bulgaria,  Croatia,  Estonia,  Georgia,  Germany,  Greece,  Hungary,  Italy,  Latvia,  Lithuania,  Moldova, Republic of,  New Zealand,  Poland,  Portugal,  Romania,  Serbia,  Slovakia,  South Africa,  Spain,  Sweden,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Experiencing Adverse Events (AEs) An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product. From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
Primary Number of Participants Experiencing Serious Adverse Events (SAEs) A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization. From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
Primary Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product. From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
Primary Number of Participants Experiencing Adverse Events (AEs) Leading to Withdrawal An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product. From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
Primary Number of Participants Experiencing Adverse Events (AEs) of Special Interest An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product. From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
Primary Number of Participants With Abnormalities in Blood Absolute Lymphocyte Count (ALC) An absolute lymphocyte count (ALC) is a part of a blood test that measures the number of lymphocytes, a type of white blood cell, in the blood. Lymphocytes help fight infections and diseases. Reductions in ALC levels for participants in this study is expected and is a primary pharmacodynamic effect of RPC1063.
LLN = Lower limit of normal
From first dose up until last dose of study treatment (up to approximately 82 months)
Primary Number of Participants With Abnormalities in White Blood Cell Count (WBC) A white blood cell count is a part of a blood test that measures the number of white blood cells in the blood. White blood cells help fight infections and diseases.
LLN = Lower limit of normal
From first dose up until last dose of study treatment (up to approximately 82 months)
Primary Number of Participants With Abnormalities in Blood Absolute Neutrophil Count (ANC) An absolute neutrophil count is a part of a blood test that measures the number of neutrophils, a type of white blood cell, in the blood. Neutrophils help fight infections and diseases. From first dose up until last dose of study treatment (up to approximately 82 months)
Primary Number of Participants With Abnormalities in Specific Liver Function Tests The number of participants with laboratory abnormalities in specific liver tests above ULN by category. ULN = Upper Limit of Normal From first dose up until last dose of study treatment (up to approximately 82 months)
Primary Number of Participants With Electrocardiogram (ECG) Result Abnormalities An electrocardiogram (ECG) measures electrical activity of the heart to detect cardiac problems. From first dose to 28-days post last dose (an average of 63 months up to a max of 83 months)
Primary Number of Participants With Clinically Relevant Abnormalities in Vital Signs Vital signs included body temperature, sitting heart rate/pulse (HR), sitting systolic blood pressure (SBP), sitting diastolic blood pressure (DBP).
Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and 60 months after first dose of study therapy
Primary Number of Participants With Physical Examination Abnormalities The number of participants with abnormal physical examination results. The assessments included abdominal, extremity, head, heart, lungs, neck, neurological non-MS, other and skin assessments.
Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and every 12 months thereafter up until 84 months post first dose.
Primary Number of Participants Self-Identifying Suicidality by Columbia-Suicide Severity Rating Scale (C-SSRS) The Columbia-Suicide Severity Rating Scale (C-SSRS) is a unique suicide risk assessment tool that supports suicide risk assessment through a series of simple, plain-language questions. The answers help users identify whether someone is at risk for suicide, assess the severity and immediacy of that risk, and gauge the level of support that the person needs.
Results are displayed as the number of participants who answered "Yes" to at least one of the 10 questions in the suicidal ideation or suicidal behavior section.
Ideation from 1 (wishing to be dead) - 5 (Active suicidal ideation with specific plan and intent) Behavior from 6 (Preparatory acts or behavior) - 10 (Completed suicide). Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and every 3 months thereafter up until 78 months post first dose.
Primary Number of Participants With Changes in Suicidality From Last Day on Treatment Per the Columbia-Suicide Severity Rating Scale (C-SSRS) The Columbia-Suicide Severity Rating Scale (C-SSRS) is a unique suicide risk assessment tool that supports suicide risk assessment through a series of simple, plain-language questions. The answers help users identify whether someone is at risk for suicide, assess the severity and immediacy of that risk, and gauge the level of support that the person needs.
Results are displayed as the number of participants who answered "Yes" to at least one of the 10 questions in the suicidal ideation or suicidal behavior section.
Ideation from 1 (wishing to be dead) - 5 (Active suicidal ideation with specific plan and intent) Behavior from 6 (Preparatory acts or behavior) - 10 (Completed suicide).
1, 4, 7, 14, 21, 28, and 90 days post last dose.
Primary Change in Physician's Withdrawal Checklist (PWC-20) Total Score From Last Day on Treatment The PWC-20 is a rater-administered 20-item scale to assess signs and symptoms of withdrawal. Twenty items are rated on a 4-point scale as not present (0 points), mild (1 point), moderate (2 points), or severe (3 points). The points from all items are calculated as a total score. Higher scores indicate more severe withdrawal symptoms. 1, 4, 7, 14, 21, and 90 days post last dose.
Primary Change in Hospital Anxiety and Depression Scale (HADS) Score From Last Day on Treatment The HADS is a validated patient reported outcome for assessing anxiety and depression. It consists of 14 items in total, 7 items related to anxiety and 7 items related to depression. For each item patients select a statement (valued at 0 to 3 points) that closest matches their own feeling over the past week. Separate total scores for anxiety and depression are derived by adding up points. Total scores can range from 0 to 21 points. Higher scores indicate more severe anxiety and depression and scores of 8 to 10 are generally considered indicative of borderline anxiety/depression disorders and scores of 11 and higher are generally considered indicative of anxiety/depression disorders. 1, 4, 7, 14, 21, and 90 days post last dose.
Primary Changes in Epworth Sleepiness Scale (ESS) Score From Last Day on Treatment The ESS is a validated self administered questionnaire with 8 questions. Respondents rate on a 4-point scale (0 to 3) their chances of dozing off or falling asleep while engaged in 8 different activities. The ESS score is the sum of 8 item scores and can range from 0 to 24 points. Higher scores indicate more daytime sleepiness. 1, 4, 7, 14, 21, and 90 days post last dose.
Primary Changes in Vital Sign Values From Last Day on Treatment Vital signs included sitting systolic blood pressure (SBP), sitting diastolic blood pressure (DBP). 1, 4, 7, 14, 21, 28, and 90 days post last dose.
Secondary Annualized Relapse Rate (ARR) The Annualized Relapse Rate (ARR) is the average number of relapses per study arm in one year. A relapse is defined as the occurrence of new or worsening neurological symptoms attributable to multiple sclerosis (MS) and immediately preceded by a relatively stable or improving neurological state of at least 30 days. The adjusted ARR was based on the negative binomial regression model with parent treatment group, adjusted for region (Eastern Europe vs Rest of World), age at parent baseline, and the parent baseline number of gadolinium-enhanced (GdE) lesions. The natural log transformation of time on treatment was used as an offset term to adjust for participants having different exposure times. From first dose up until last dose of study treatment or data-cutoff date, whichever occurred first (up to approximately 87 months)
Secondary Time to First Relapse (TFR) The time between first dose of study treatment and first relapse if experienced by a participant. A participant was censored if follow-up ended before a relapse occurred, whether due to the participant completing study, withdrawing from the study, or due to the cutoff of data collection for the analysis. The censor date was the date of the end of study or the date of the data cutoff for participant who were ongoing. Participants who withdrew from the study after the baseline visit were censored at the last known date while on study. Based on Kaplan-Meier product limit estimates. Overall: From first dose to first relapse, last dose, or data-cutoff date, whichever occurred first (up to approx 87 months); Visits: 2 weeks post first dose, 3 months post first dose, and every 3 months thereafter up until 81 months post first dose.
Secondary Number of Participants Who Were Relapse Free The number of participants who did not experience relapse. A relapse is defined as the occurrence of new or worsening neurological symptoms attributable to multiple sclerosis (MS) and immediately preceded by a relatively stable or improving neurological state of at least 30 days. From first dose to last dose of study treatment or data-cutoff date, whichever occurred first (up to approximately 87 months)
Secondary Average Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions Per Scan at Each Visit Adjusted Mean of new enlarging T2 lesions per scan at each visit. Based on a negative binomial regression model, adjusted for parent study, region (Eastern Europe vs. Rest of the World), age at Baseline, and baseline number of GdE lesions.
T2 Magnetic Resonance Imaging (MRI) sequences are used to highlight areas of demyelination in brain neurons, which happens when the outer layer of the neurons is damaged due to multiple sclerosis (MS) activity. T2 sequences can be used to count the total number of MS lesions, which look like bright white spots on T2 sequences, and can be called "hyperintense".
At 12 months post first dose and every 12 months thereafter up until 72 months post first dose.
Secondary Average Number of Gadolinium-Enhanced (GdE) Brain MRI Lesions Per Scan at Each Visit Number of gadolinium-enhanced (GdE) (also called GdE enhanced T1) brain MRI lesions per scan at each visit.
Increased numbers of GdE lesions indicates an increase in the in the amount of active inflammation at the site and may be indicative of progressive disease.
Based on a negative binomial regression model, adjusted for parent study, region (Eastern Europe vs. Rest of the World), age at Baseline, and Baseline number of GdE lesions.
Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and every 12 months thereafter up until 72 months post first dose.
Secondary Time to Onset of Disability Progression as Defined by a Sustained Worsening in Expanded Disability Status Scale (EDSS) Multiple sclerosis (MS) disability progression is defined as a sustained worsening in EDSS of 1.0 points or more from baseline, confirmed after a 3-month and 6-month period. The EDSS is a standardized method, widely accepted, numerical scale used to evaluate disability in people with multiple sclerosis (MS). The EDSS is evaluated according to signs and symptoms observed during a standard neurological examination. These clinical observations are classified in 7 FS scales, each of them grading signs and symptoms for different neurological functions: pyramidal, cerebellar, brainstem, sensory, bowel or bladder, visual, and cerebral.
Derived using Kaplan-Meier estimates.
At 3 and 6 months post first dose.
Secondary Number of Participants Free of Gadolinium-Enhanced (GdE) Brain Lesions at Each Visit Number of participants without gadolinium enhanced (GdE) brain MRI lesions at each visit. Increased numbers of GdE lesions indicates an increase in the in the amount of active inflammation at the site and may be indicative of progressive disease.
Based on cumulative number of GdE lesions at a participant level.
At baseline and every 12 months thereafter up until 72 months post first dose.
Secondary Number of Participants Free of New or Enlarging T2 Lesions at Each Visit Number of participants without new or enlarging T2 brain MRI lesions at each visit. Some multiple Sclerosis (MS) lesions appear as bright spots in a T2-weighted MRI scan - these are called T2 lesions. The presence of new or larger T2 lesions may mean the participant is at higher risk of disability and may have a less favorable long-term outcome.
Based on cumulative number of new or enlarging T2 lesions at a participant level.
Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and every 12 months thereafter up until 72 months post first dose.
Secondary Percent Change in Normalized Brain Volume (Atrophy) on Brain MRI Scans From Baseline at Each Visit Percent change in normalized brain volume (Atrophy) on brain MRI scans from baseline at each visit. Brain atrophy can be seen in the earliest stages of multiple sclerosis (MS) and is a reliable predictor of future physical and cognitive disability.
Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and every 12 months thereafter up until approximately 87 months post first dose.
Secondary Change in Multiple Sclerosis Functional Composite (MSFC) Score From Baseline at Each Applicable Visit The Multiple Sclerosis Functional Composite (MSFC) is a 3-part tool to measure disability progression in those with multiple sclerosis (MS). It assesses leg, arm, hand, and cognitive function using 3 individual scales: - The Timed 25-Foot Walk: To measure leg function - The 9-Hole Peg Test: To measure arm and hand function - The Symbol Digit Modalities Test (SDMT): To measure cognitive processing speed, flexibility, and calculation ability. Scores from each of the three are converted into Z-scores and averaged to create an overall composite score. The Low-Contrast Letter Acuity Test (LCLA) is performed with the MSFC using a set of charts to assess low contrast visual acuity. Each chart corresponds to a different contrast level, and charts are scored based on the number of letters identified correctly. A Z-score of 0 represents the population mean. Standard deviations above the mean represent a better outcome. Baseline refers to assessments on or before receiving study treatment. At baseline and every 12 months thereafter up until 84 months post first dose.
Secondary Change in Multiple Sclerosis Quality of Life 54 Score From Baseline at Each Applicable Visit The Multiple Sclerosis Quality of Life 54 (MSQOL-54) questionnaire is a health-related quality of life (HRQOL) instrument specific for multiple sclerosis (MS). This 54-item instrument generates 12 subscales along with two summary scores (physical health and mental health - derived from a weighted combination of scale scores), and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The MSQOL-54 items are transformed to 0-100 scores, and final scores are obtained by averaging items within the scales. The overall quality of life is assessed in question 54, which is scored on a scale of 0-100. Higher scores indicate better health-related quality of life. Baseline refers to assessments made on or before the first day participants received study treatment. At baseline and every 12 months thereafter up until 84 months post first dose.
Secondary Change From Baseline in Volume of Gadolinium Enhanced T1 Lesions Change from baseline in volume of gadolinium enhanced T1 lesions. T1-lesions are permanently damaged areas of the brain that appear as dark spots or "black holes" on a type of MRI scan. The growth of T1 lesions may mean the participant's Multiple Sclerosis (MS) is progressing.
Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and every 12 months thereafter up until 72 months post first dose.
Secondary Change From Baseline in Volume of T2 Lesions Some multiple Sclerosis (MS) lesions appear as bright spots in a T2-weighted MRI scan - these are called T2 lesions. Larger T2 lesions may mean the participant is at higher risk of disability and may have a less favorable long-term outcome.
Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and every 12 months thereafter up until 72 months post first dose.
Secondary Change From Baseline in Volume of Unenhancing T1 Lesions Change from baseline in volume of unenhancing T1 lesions. T1-lesions are permanently damaged areas of the brain that appear as dark spots or "black holes" on a type of MRI scan. The growth of T1 lesions may mean the participant's Multiple Sclerosis (MS) is progressing.
Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and every 12 months thereafter up until 72 months post first dose.
Secondary Cumulative Number of New Unenhancing T1 Lesions Number of new unenhancing T1 lesions. T1-lesions are permanently damaged areas of the brain that appear as dark spots or "black holes" on a type of MRI scan. The appearance of new T1 lesions may mean the participant's MS is progressing.
Derived as the cumulative number of new or enlarging T1 lesions relative to baseline at a participant level.
Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and every 12 months thereafter up until 72 months post first dose.
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