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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03650114
Registration number
NCT03650114
Ethics application status
Date submitted
17/08/2018
Date registered
28/08/2018
Titles & IDs
Public title
Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS
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Scientific title
An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis
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Secondary ID [1]
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0
COMB157G2399
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Universal Trial Number (UTN)
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Trial acronym
ALITHIOS
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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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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Ofatumumab
Treatment: Other - Tetanus toxoid (TT) containing vaccine (Td, Tdap)
Treatment: Other - 13-valent pneumococcal conjugate vaccine (13-PCV)
Treatment: Other - 23-valent pneumococcal polysaccharide vaccine (23-PPV)
Treatment: Other - Seasonal Quadrivalent influenza vaccine
Treatment: Other - Keyhole limpet hemocyanin (KLH) neo-antigen
Experimental: Ofatumumab - Subcutaneous injection
Treatment: Other: Ofatumumab
subcutaneous injection of 20 mg ofatumumab every 4 weeks
Treatment: Other: Tetanus toxoid (TT) containing vaccine (Td, Tdap)
0.5mL Vial/Syringe Containing 5 limit of flocculation (LF) tetanus toxoid
Treatment: Other: 13-valent pneumococcal conjugate vaccine (13-PCV)
0.5mL Vial/Syringe
Treatment: Other: 23-valent pneumococcal polysaccharide vaccine (23-PPV)
0.5mL Vial/Syringe
Treatment: Other: Seasonal Quadrivalent influenza vaccine
Seasonal 2020-2021 0.5mL Vial/Syringe (trivalent may be used where quadrivalent is not available)
Treatment: Other: Keyhole limpet hemocyanin (KLH) neo-antigen
1mg Vial
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Intervention code [1]
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Treatment: Other
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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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Number of patients that experience an adverse event or abnormal laboratory, vital and/or ECG results and positive suicidiality outcomes
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Assessment method [1]
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Timepoint [1]
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Up to 5 years
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Secondary outcome [1]
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Number of relapse rates per year
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Assessment method [1]
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Annual Relapse Rate (ARR) time calculated as number of confirmed relapses divided by time in study per year and will also be presented for the entire duration
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Timepoint [1]
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Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)
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Secondary outcome [2]
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Patients with confirmed 3 and 6 month disability worsening
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Assessment method [2]
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A confirmed disability worsening is an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at last 3, or 6 months EDSS consists of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral functions (Fatigue contributes).
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Timepoint [2]
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Duration of the study, approximately 5 years
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Secondary outcome [3]
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Patients with confirmed 6, 12 and 24 month disability improvement and improvement until end of study
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Assessment method [3]
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Confirmed disability improvement is a decrease from baseline in Expanded Disability Status Scale (EDSS) score sustained for at least 6, 12 or 24 months EDSS consists of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral functions (Fatigue contributes).
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Timepoint [3]
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Duration of the study, approximately 5 years
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Secondary outcome [4]
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Patients with changes in Expanded Disability Status Scale (EDSS) scores
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Assessment method [4]
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Score changes in Expanded Disability Status Scale (EDSS) over time EDSS consists of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral functions (Fatigue contributes).
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Timepoint [4]
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Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)
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Secondary outcome [5]
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Changes in and time to 6 month confirmed worsening of Symbol Digit Modalities Test Scores
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Assessment method [5]
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Score changes and confirmed 4-point worsening sustained for 6 months in Symbol Digit Modalities Test (SDMT) scores The Symbol Digit Modalities Test is a neuropsychological, timed test for sustained attention and concentration. 3 versions will be used, alternating at each visit where done. The number of correct responses will be counted for the score.
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Timepoint [5]
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Duration of the study, approximately 5 years
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Secondary outcome [6]
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Changes in the Magnetic Resonance Image (MRI) related to brain volume loss
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Assessment method [6]
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Percent change from baseline in brain volume loss (BVL)
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Timepoint [6]
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Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)
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Secondary outcome [7]
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Changes in the Magnetic Resonance Image (MRI) related to T2 lesions
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Assessment method [7]
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Number of new or enlarging T2 lesions
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Timepoint [7]
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Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)
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Secondary outcome [8]
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Changes in the Magnetic Resonance Image (MRI) related to Gd-enhancing lesions
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Assessment method [8]
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Total number of Gd-enhancing lesions on all MRI scans adjusted for different time of scan versus follow up time in study
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Timepoint [8]
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Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)
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Secondary outcome [9]
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Changes in neurofilament light change serum concentration
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Assessment method [9]
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Extent of neurofilament light change concentration in blood NfL is a component of the neuronal cytoskeleton and is released into the cerebrospinal fluid and into subsequently blood following neuro-axonal damage
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Timepoint [9]
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Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)
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Eligibility
Key inclusion criteria
1. Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks
2. Written informed consent
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Minimum age
18
Years
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Maximum age
100
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
* Emergence of any clinically significant condition/disease during the previous ofatumumab study in which study participation might result in safety risk for the subject
* Subjects with active systemic bacterial, viral or fingal infections, or chronic infection (e.g. AIDS)
* Subjects taking medications prohibited by the protocol
* Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply
Vaccination sub-study:
Inclusion criteria
1. Informed consent
2. Actively enrolled in the COMB157G2399 Study
3. 12 weeks of continuous treatment within the COMB157G2399 Study
4. prior vaccination history as per protocol-defined
Exclusion criteria
* known hypersensitivity or history of systemic allergic, neurologic or other reactions to vaccines
* allergies to egg or shellfish
* any safety findings including low IgG/IgM requiring ofatumumab interruption within 12 weeks prior to vaccination sub-study start
* any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks of the first vaccination sub-study visit
Other protocol-defined inclusion/exclusion criteria may apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
Recruiting
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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
28/12/2018
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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
7/09/2028
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Actual
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Sample size
Target
2060
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Novartis Investigative Site - Liverpool
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Recruitment hospital [2]
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Novartis Investigative Site - New Lambton Heights
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Novartis Investigative Site - St Leonards
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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2305 - New Lambton Heights
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Recruitment postcode(s) [3]
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2065 - St Leonards
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Recruitment outside Australia
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Ehime
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Japan
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Hokkaido
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Japan
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Iwate
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Japan
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Miyagi
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Japan
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Saitama
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Japan
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Tokyo
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Japan
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Chiba
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Japan
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Niigata
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Japan
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Osaka
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Latvia
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LV
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Latvia
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Riga
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LTU
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Lithuania
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Vilnius
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Mexico
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Distrito Federal
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Mexico
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Mexico
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Netherlands
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BG
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Netherlands
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Zuid Holland
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Netherlands
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Amsterdam
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Norway
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Drammen
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Peru
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Lima
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Poland
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Woj Kujawsko-pomorskie
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Poland
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Gdansk
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Glogow
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Kielce
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Lodz
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Rzeszow
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Warszawa
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Wroclaw
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Poland
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Zabrze
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Portugal
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Porto
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Portugal
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Braga
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Loures
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Portugal
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Santa Maria da Feira
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Russian Federation
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Ekaterinburg
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Russian Federation
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Kazan
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Russian Federation
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Kemerovo
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Russian Federation
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Nizhny Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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Saint Petersburg
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Russian Federation
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Russian Federation
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Sestroretsk
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Russian Federation
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St Petersburg
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Russian Federation
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St. Petersburg
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Russian Federation
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Tyumen
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Slovakia
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Banska Bystrica
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Bratislava
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Martin
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Slovakia
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Nitra
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Slovakia
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Trnava
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South Africa
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Pretoria
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South Africa
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Rosebank
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Spain
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Andalucia
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Spain
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Barcelona
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Spain
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Cataluna
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Catalunya
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Spain
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Madrid
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Murcia
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Pais Vasco
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Spain
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Sevilla
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Spain
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Vizcaya
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Spain
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Valencia
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Sweden
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Goeteborg
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Sweden
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Stockholm
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Basel
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Lugano
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Tainan
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THA
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Turkey
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Istanbul
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TUR
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Turkey
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Haseki Istanbul
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Turkey
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Izmir
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Kocaeli
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Mersin
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Turkey
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Samsun
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Turkey
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Trabzon
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United Kingdom
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Beds
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United Kingdom
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Oxfordshire
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United Kingdom
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South Yorkshire
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United Kingdom
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Glasgow
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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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Name
Novartis Pharmaceuticals
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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 purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study. Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS).
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Trial website
https://clinicaltrials.gov/study/NCT03650114
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
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Contact person for public queries
Name
0
0
Novartis Pharmaceuticals
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Address
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0
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Country
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0
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Phone
0
0
1-888-669-6682
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Fax
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0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03650114