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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/NCT01247324
Registration number
NCT01247324
Ethics application status
Date submitted
23/11/2010
Date registered
24/11/2010
Date last updated
4/03/2024
Titles & IDs
Public title
A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
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Scientific title
A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif®) in Patients With Relapsing Multiple Sclerosis
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Secondary ID [1]
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2010-020337-99
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Secondary ID [2]
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WA21092
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsing Multiple Sclerosis
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Interferon beta-1a
Treatment: Drugs - Ocrelizumab-matching placebo
Treatment: Drugs - Ocrelizumab
Treatment: Drugs - Interferon beta-1a-matching placebo
Active Comparator: Interferon beta-1a 44 mcg SC - Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
Experimental: Ocrelizumab - Ocrelizumab 600 mg intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.
Treatment: Drugs: Interferon beta-1a
Treatment: Drugs: Ocrelizumab-matching placebo
Treatment: Drugs: Ocrelizumab
Treatment: Drugs: Interferon beta-1a-matching placebo
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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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Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks
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Assessment method [1]
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ARR was protocol-defined and calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of exposure to that treatment.
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Timepoint [1]
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Week 96
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Secondary outcome [1]
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Time to Onset of Confirmed Disability Progression (CDP) for at Least 12 Weeks During the Double-Blind Treatment Period
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Assessment method [1]
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Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) >=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (<=) 5.5 B) >=0.5 point from the baseline EDSS score when the baseline score was >5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening. EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.
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Timepoint [1]
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Week 108
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Secondary outcome [2]
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Number of T1 Gadolinium (Gd)-Enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-Blind Treatment
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Assessment method [2]
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The total number of T1 gadolinium-enhancing lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.
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Timepoint [2]
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Baseline up to Week 96
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Secondary outcome [3]
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Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double Blind Treatment
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Assessment method [3]
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The total number of new and/or enlarging T2 lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.
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Timepoint [3]
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Baseline up to Week 96
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Secondary outcome [4]
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Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 12 Weeks
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Assessment method [4]
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Disability improvement was assessed only for the subgroup of participants with a baseline EDSS score of >= 2.0. It was defined as a reduction in EDSS score of: A) >=1.0 from the baseline EDSS score when the baseline score was >=2 and <=5.5 B) >= 0.5 when the baseline EDSS score > 5.5. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined.
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Timepoint [4]
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Week 96
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Secondary outcome [5]
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Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks During the Double-Blind Treatment Period
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Assessment method [5]
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Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) >=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (<=) 5.5 B) >=0.5 point from the baseline EDSS score when the baseline score was >5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 24 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.
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Timepoint [5]
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Week 108
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Secondary outcome [6]
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Number of T1 Hypointense Lesions During the Double-Blind Treatment
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Assessment method [6]
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The total number of new T1-Hypo-Intense Lesions (Chronic Black Holes) for all participants in the treatment group was calculated as the sum of the individual number of new lesions at Weeks 24, 48, and 96.
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Timepoint [6]
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Baseline up to Week 96
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Secondary outcome [7]
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Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score to Week 96
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Assessment method [7]
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MSFC score consists of: A) Timed 25-Foot walk; B) 9-Hole Peg Test (9-HPT); and C) Paced Auditory Serial Addition Test (PASAT-3 version). The MSFCS is based on the concept that scores for these three dimensions (arm, leg, and cognitive function) are combined to create a single score (the MSFC) that can be used to detect change over time in a group of participants with MS. Since the three primary measures differ in what they actually measure, a common composite score for the three different measures i.e., Z- score was selected for the purpose. MSFC Score = {Z arm, average + Z leg, average + Z cognitive} / 3.0. The results from each of these three tests are transformed into Z-scores and averaged to yield a composite score for each participant at each time point. A score of +1 indicates that, on average, an individual scored 1 standard deviation (SD) better than the reference population and a score of -1 indicates that an individual scored 1 SD worse than the reference population.
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Timepoint [7]
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Baseline, Week 96
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Secondary outcome [8]
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Percent Change in Brain Volume as Detected by Brain Magnetic Resonance Imaging (MRI) From Week 24 to Week 96
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Assessment method [8]
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Brain volume was recorded as an absolute "normalized" value at the baseline visit then recorded at subsequent visits as a percentage change relative to the absolute value at the baseline visit. Therefore, brain volume at Week 24 was calculated as the brain volume at the baseline visit multiplied by 1 + ([percentage change in brain volume from baseline visit to Week 24]/100). Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: Percentage Change = Brain Volume at Week 24 + Geographical Region (US vs. ROW) + Baseline EDSS (< 4.0 vs. >= 4.0) + Week + Treatment + Treatment*Week (repeated values over Week) + Brain Volume at Week 24*Week.
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Timepoint [8]
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From Week 24 up to Week 96
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Secondary outcome [9]
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Change From Baseline in Short Form Health Survey-36 (SF-36) Physical Component Summary (PCS) Score at Week 96
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Assessment method [9]
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The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t- scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.
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Timepoint [9]
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Baseline, Week 96
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Secondary outcome [10]
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Percentage of Participants Who Have No Evidence of Disease Activity (NEDA) up to Week 96
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Assessment method [10]
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NEDA was defined only for participants with a baseline EDSS score >=2.0. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Participants who completed the 96- week treatment period were considered as having evidence of disease activity if at least one protocol- defined relapse (PDR), a confirmed disability progression (CDP) event or at least one MRI scan showing MRI activity (defined as Gd-enhancing T1 lesions, or new or enlarging T2 lesions) was reported during the 96-week treatment period, otherwise the participant was considered as having NEDA.
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Timepoint [10]
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Week 96
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Secondary outcome [11]
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Number of Participants With Adverse Events (AEs)
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Assessment method [11]
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AEs included infusion related reactions (IRRs) and serious MS relapses, but excluded non-serious MS relapses. Serious Adverse Events (SAEs) included serious MS relapses and serious IRRs.
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Timepoint [11]
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Baseline up to 588 weeks
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Secondary outcome [12]
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Exposure to Ocrelizumab (Area Under the Concentration - Time Curve, AUC)
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Assessment method [12]
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AUC represents total drug exposure for one dosing interval after the 4th dose.
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Timepoint [12]
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Pre-infusion at Weeks 1, 24, 48, 72; and 30 minutes post-infusion at Week 72; at any time during Weeks 84 and 96
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Secondary outcome [13]
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Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab
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Assessment method [13]
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Number of participants positive for anti-drug antibodies (ADAs) to ocrelizumab is the number of post- baseline evaluable participants determined to have treatment-induced ADA or treatment-enhanced ADA during the study period.
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Timepoint [13]
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Baseline up to week 96
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Eligibility
Key inclusion criteria
- Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria
(2010)
- At least 2 documented clinical attacks within the last 2 years prior to screening or
one clinical attack in the years prior to screening (but not within 30 days prior to
screening)
- Neurologic stability for greater than or equal to (>=) 30 days prior to both screening
and baseline
- Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive
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Minimum age
18
Years
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Maximum age
55
Years
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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
- Primary progressive multiple sclerosis
- Disease duration of more than 10 years in participants with EDSS less than or equal to
(<=) 2.0 at screening
- Contraindications for MRI
- Known presence of other neurological disorders which may mimic multiple sclerosis
- Pregnancy or lactation
- Requirement for chronic treatment with systemic corticosteroids or immunosuppressants
during the course of the study
- History of or currently active primary or secondary immunodeficiency
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies
- Active infection, or history of or known presence of recurrent or chronic infection
(e.g., hepatitis B or C, human immunodeficiency virus [HIV], syphilis, tuberculosis)
- History of progressive multifocal leukoencephalopathy
- Contraindications to or intolerance of oral or iv corticosteroids
- Contraindications to Rebif or incompatibility with Rebif use
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Study design
Purpose of the study
Treatment
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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 3
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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
31/08/2011
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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
31/12/2022
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Sample size
Target
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Accrual to date
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Final
821
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Royal North Shore Hospital; Department of Neurology - St Leonards
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Florida
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Georgia
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Illinois
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Indiana
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Nebraska
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North Carolina
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Vermont
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Washington
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Argentina
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Buenos Aires
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Argentina
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Rosario
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Linz
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Bruxelles
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Roeselare
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GO
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Brazil
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RS
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Brazil
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SC
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Tampere
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Oldenburg
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Prien
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Rostock
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Germany
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Tübingen
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Budapest
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Tatabánya
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Israel
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Italy
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Italy
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Lithuania
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Mexico
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Mexico CITY (federal District)
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Mexico
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Lima
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Plewiska
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Portugal
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Braga
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Russian Federation
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Moskovskaja Oblast
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Russian Federation
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Sankt Petersburg
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Russian Federation
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Sverdlovsk
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Russian Federation
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Tjumen
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Russian Federation
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Kemerovo
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Russian Federation
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Novosibirsk
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Samara
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Russian Federation
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Smolensk
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Russian Federation
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Tyumen
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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NIS
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Bratislava
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Zilina
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Madrid
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Sevilla
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Basel
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Lugano
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Mannouba
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Tunis
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Ukraine
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Donetsk
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Ukraine
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Kharkov
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Vinnytsya
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United Kingdom
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Liverpool
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Hoffmann-La Roche
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Summary
Brief summary
This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy
and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with
relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab
600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the
first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks,
with placebo injections matching interferon beta-1a SC three times per week; or interferon
beta-1a 44 mcg SC injections three times per week (with placebo infusions matching
ocrelizumab infusions every 24 weeks). Planned duration of double-blind treatment is 96
weeks. Participants who complete the 96-week double-blind treatment will have an option to
enter a single-group, active-treatment, open-label extension period, providing they fulfill
the eligibility criteria.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01247324
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Clinical Trials
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Hoffmann-La Roche
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01247324
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