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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/NCT03650114
Registration number
NCT03650114
Ethics application status
Date submitted
17/08/2018
Date registered
28/08/2018
Date last updated
22/05/2024
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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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
Other interventions - Ofatumumab
Other interventions - Tetanus toxoid (TT) containing vaccine (Td, Tdap)
Other interventions - 13-valent pneumococcal conjugate vaccine (13-PCV)
Other interventions - 23-valent pneumococcal polysaccharide vaccine (23-PPV)
Other interventions - Seasonal Quadrivalent influenza vaccine
Other interventions - Keyhole limpet hemocyanin (KLH) neo-antigen
Experimental: Ofatumumab - Subcutaneous injection
Other interventions: Ofatumumab
subcutaneous injection of 20 mg ofatumumab every 4 weeks
Other interventions: Tetanus toxoid (TT) containing vaccine (Td, Tdap)
0.5mL Vial/Syringe Containing 5 limit of flocculation (LF) tetanus toxoid
Other interventions: 13-valent pneumococcal conjugate vaccine (13-PCV)
0.5mL Vial/Syringe
Other interventions: 23-valent pneumococcal polysaccharide vaccine (23-PPV)
0.5mL Vial/Syringe
Other interventions: Seasonal Quadrivalent influenza vaccine
Seasonal 2020-2021 0.5mL Vial/Syringe (trivalent may be used where quadrivalent is not available)
Other interventions: Keyhole limpet hemocyanin (KLH) neo-antigen
1mg Vial
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Intervention code [1]
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Other interventions
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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
N/A
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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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Recruitment hospital [3]
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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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Japan
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State/province [113]
0
0
Iwate
Query!
Country [114]
0
0
Japan
Query!
State/province [114]
0
0
Miyagi
Query!
Country [115]
0
0
Japan
Query!
State/province [115]
0
0
Saitama
Query!
Country [116]
0
0
Japan
Query!
State/province [116]
0
0
Tokyo
Query!
Country [117]
0
0
Japan
Query!
State/province [117]
0
0
Chiba
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Country [118]
0
0
Japan
Query!
State/province [118]
0
0
Niigata
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Country [119]
0
0
Japan
Query!
State/province [119]
0
0
Osaka
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Country [120]
0
0
Latvia
Query!
State/province [120]
0
0
LV
Query!
Country [121]
0
0
Latvia
Query!
State/province [121]
0
0
Riga
Query!
Country [122]
0
0
Lithuania
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State/province [122]
0
0
LTU
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Country [123]
0
0
Lithuania
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State/province [123]
0
0
Vilnius
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Country [124]
0
0
Mexico
Query!
State/province [124]
0
0
Distrito Federal
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Country [125]
0
0
Mexico
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State/province [125]
0
0
Michoacan
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Country [126]
0
0
Mexico
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State/province [126]
0
0
Chihuahua
Query!
Country [127]
0
0
Netherlands
Query!
State/province [127]
0
0
Amsterdam
Query!
Country [128]
0
0
Netherlands
Query!
State/province [128]
0
0
Rotterdam
Query!
Country [129]
0
0
Netherlands
Query!
State/province [129]
0
0
Sittard-Geleen
Query!
Country [130]
0
0
Norway
Query!
State/province [130]
0
0
Drammen
Query!
Country [131]
0
0
Peru
Query!
State/province [131]
0
0
Lima
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Country [132]
0
0
Poland
Query!
State/province [132]
0
0
Woj Kujawsko-pomorskie
Query!
Country [133]
0
0
Poland
Query!
State/province [133]
0
0
Gdansk
Query!
Country [134]
0
0
Poland
Query!
State/province [134]
0
0
Glogow
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Country [135]
0
0
Poland
Query!
State/province [135]
0
0
Katowice
Query!
Country [136]
0
0
Poland
Query!
State/province [136]
0
0
Kielce
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Country [137]
0
0
Poland
Query!
State/province [137]
0
0
Lodz
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Country [138]
0
0
Poland
Query!
State/province [138]
0
0
Rzeszow
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Country [139]
0
0
Poland
Query!
State/province [139]
0
0
Warszawa
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Country [140]
0
0
Poland
Query!
State/province [140]
0
0
Wroclaw
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Country [141]
0
0
Poland
Query!
State/province [141]
0
0
Zabrze
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Country [142]
0
0
Portugal
Query!
State/province [142]
0
0
Porto
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Country [143]
0
0
Portugal
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State/province [143]
0
0
Braga
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Country [144]
0
0
Portugal
Query!
State/province [144]
0
0
Coimbra
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Country [145]
0
0
Portugal
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State/province [145]
0
0
Lisboa
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Country [146]
0
0
Portugal
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State/province [146]
0
0
Loures
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Country [147]
0
0
Portugal
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State/province [147]
0
0
Santa Maria da Feira
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Country [148]
0
0
Russian Federation
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State/province [148]
0
0
Ekaterinburg
Query!
Country [149]
0
0
Russian Federation
Query!
State/province [149]
0
0
Kazan
Query!
Country [150]
0
0
Russian Federation
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State/province [150]
0
0
Kemerovo
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Country [151]
0
0
Russian Federation
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State/province [151]
0
0
Krasnoyarsk
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Country [152]
0
0
Russian Federation
Query!
State/province [152]
0
0
Moscow
Query!
Country [153]
0
0
Russian Federation
Query!
State/province [153]
0
0
Nizhny Novgorod
Query!
Country [154]
0
0
Russian Federation
Query!
State/province [154]
0
0
Novosibirsk
Query!
Country [155]
0
0
Russian Federation
Query!
State/province [155]
0
0
Saint Petersburg
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Country [156]
0
0
Russian Federation
Query!
State/province [156]
0
0
Saransk
Query!
Country [157]
0
0
Russian Federation
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State/province [157]
0
0
Sestroretsk
Query!
Country [158]
0
0
Russian Federation
Query!
State/province [158]
0
0
St Petersburg
Query!
Country [159]
0
0
Russian Federation
Query!
State/province [159]
0
0
St. Petersburg
Query!
Country [160]
0
0
Russian Federation
Query!
State/province [160]
0
0
Tyumen
Query!
Country [161]
0
0
Slovakia
Query!
State/province [161]
0
0
Banska Bystrica
Query!
Country [162]
0
0
Slovakia
Query!
State/province [162]
0
0
Bratislava
Query!
Country [163]
0
0
Slovakia
Query!
State/province [163]
0
0
Martin
Query!
Country [164]
0
0
Slovakia
Query!
State/province [164]
0
0
Nitra
Query!
Country [165]
0
0
Slovakia
Query!
State/province [165]
0
0
Trnava
Query!
Country [166]
0
0
South Africa
Query!
State/province [166]
0
0
Pretoria
Query!
Country [167]
0
0
South Africa
Query!
State/province [167]
0
0
Rosebank
Query!
Country [168]
0
0
Spain
Query!
State/province [168]
0
0
Andalucia
Query!
Country [169]
0
0
Spain
Query!
State/province [169]
0
0
Barcelona
Query!
Country [170]
0
0
Spain
Query!
State/province [170]
0
0
Cataluna
Query!
Country [171]
0
0
Spain
Query!
State/province [171]
0
0
Catalunya
Query!
Country [172]
0
0
Spain
Query!
State/province [172]
0
0
Madrid
Query!
Country [173]
0
0
Spain
Query!
State/province [173]
0
0
Murcia
Query!
Country [174]
0
0
Spain
Query!
State/province [174]
0
0
Pais Vasco
Query!
Country [175]
0
0
Spain
Query!
State/province [175]
0
0
Sevilla
Query!
Country [176]
0
0
Spain
Query!
State/province [176]
0
0
Vizcaya
Query!
Country [177]
0
0
Spain
Query!
State/province [177]
0
0
Valencia
Query!
Country [178]
0
0
Sweden
Query!
State/province [178]
0
0
Goeteborg
Query!
Country [179]
0
0
Sweden
Query!
State/province [179]
0
0
Stockholm
Query!
Country [180]
0
0
Switzerland
Query!
State/province [180]
0
0
Basel
Query!
Country [181]
0
0
Switzerland
Query!
State/province [181]
0
0
Lugano
Query!
Country [182]
0
0
Taiwan
Query!
State/province [182]
0
0
Tainan
Query!
Country [183]
0
0
Thailand
Query!
State/province [183]
0
0
THA
Query!
Country [184]
0
0
Turkey
Query!
State/province [184]
0
0
Istanbul
Query!
Country [185]
0
0
Turkey
Query!
State/province [185]
0
0
TUR
Query!
Country [186]
0
0
Turkey
Query!
State/province [186]
0
0
Haseki Istanbul
Query!
Country [187]
0
0
Turkey
Query!
State/province [187]
0
0
Izmir
Query!
Country [188]
0
0
Turkey
Query!
State/province [188]
0
0
Kocaeli
Query!
Country [189]
0
0
Turkey
Query!
State/province [189]
0
0
Mersin
Query!
Country [190]
0
0
Turkey
Query!
State/province [190]
0
0
Samsun
Query!
Country [191]
0
0
Turkey
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State/province [191]
0
0
Trabzon
Query!
Country [192]
0
0
United Kingdom
Query!
State/province [192]
0
0
Beds
Query!
Country [193]
0
0
United Kingdom
Query!
State/province [193]
0
0
Oxfordshire
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Country [194]
0
0
United Kingdom
Query!
State/province [194]
0
0
South Yorkshire
Query!
Country [195]
0
0
United Kingdom
Query!
State/province [195]
0
0
Glasgow
Query!
Country [196]
0
0
United Kingdom
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State/province [196]
0
0
London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
Query!
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).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03650114
Query!
Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
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Country
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0
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Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Novartis Pharmaceuticals
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-888-669-6682
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03650114
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