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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04353492




Registration number
NCT04353492
Ethics application status
Date submitted
16/04/2020
Date registered
20/04/2020
Date last updated
1/04/2021

Titles & IDs
Public title
An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Dimethyl Fumarate or Fingolimod to Ofatumumab
Scientific title
A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient Reported Outcomes in Patients With Relapsing Multiple Sclerosis Transitioning From Dimethyl Fumarate or Fingolimod Therapy
Secondary ID [1] 0 0
2019-001341-40
Secondary ID [2] 0 0
COMB157G23101
Universal Trial Number (UTN)
Trial acronym
ARTIOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Ofatumumab

Experimental: Ofatumumab - Ofatumumab 20 mg subcutaneous injections every 4 weeks, following loading of 3 doses in the first 14 days


Other interventions: Ofatumumab
Patients in the ofatumumab will receive injections of ofatumumab provided in an autoinjector (AI) for subcutaneous administration containing 20 mg ofatumumab (50 mg/ml, 0.4 ml content)

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annual Relapse Rate (AAR) - ARR is the number of confirmed relapses in a year calculated based on cumulative number of relapses by patient adjusted for time-in-study by patient
Timepoint [1] 0 0
up to 96 weeks from baseline
Secondary outcome [1] 0 0
Safety evaluation - Proportion of patients with adverse events, including injection related reactions, abnormal laboratory results or vital signs as well as proportion of patients discontinuing treatment due to insufficient effectiveness or safety
Timepoint [1] 0 0
96 weeks

Eligibility
Key inclusion criteria
- Diagnosis of multiple sclerosis (MS)

- Relapsing MS (RRMS or SPMS) course

- Subject transitioning from either fingolimod or dimethyl fumarate, following min 6
months treatment with either drug

- Breakthrough disease as evidence by clinical relapses or MRI

- EDSS score of 0 to 4
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Primary progressive MS or SPMS without disease activity

- Disease duration of more than 10 years since diagnosis

- Patients with an active chronic disease of the immune system other than MS

- Patients at risk of developing or having reactivation of hepatitis

- Patients with active systemic infections or with neurological findings consistent with
PML Other protocol-defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Liverpool
Recruitment hospital [2] 0 0
Novartis Investigative Site - New Lambton Heights
Recruitment hospital [3] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment hospital [4] 0 0
Novartis Investigative Site - Heidelberg
Recruitment hospital [5] 0 0
Novartis Investigative Site - Parkville
Recruitment hospital [6] 0 0
Novartis Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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California
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Colorado
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Florida
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Georgia
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Hawaii
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Indiana
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Michigan
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Minnesota
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Nebraska
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Nevada
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New York
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Ohio
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Oklahoma
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Pennsylvania
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Texas
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Austria
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Linz
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Austria
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Vienna
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Austria
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Wien
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Belgium
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Antwerpen
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Belgium
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Bonheiden
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Belgium
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Brugge
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Belgium
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Bruxelles
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Pleven
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Sofia
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Czech Republic
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Czechia
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CZE
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Czechia
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Praha
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Bavaria
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Alzenau
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Germany
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Bielefeld
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Germany
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Cottbus
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Heidelberg
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Koln
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Leipzig
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Germany
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Minden
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Muenchen
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Potsdam
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Siegen
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Ulm
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Unterhaching
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Westerstede/Oldenburg
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Greece
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Thessaloniki
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Hungary
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Komarom Esztergom
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VR
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Drammen
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Woj Kujawsko-pomorskie
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Katowice
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Kielce
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Wroclaw
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Braga
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Lisboa
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Porto
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St Petersburg
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Nitra
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Switzerland
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St Gallen
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Izmir
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Samsun
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Trabzon

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The open label study to evaluate effectiveness of treatment with ofatumumab in patients
transitioning from commonly used oral MS therapies - fingolimod or dimethyl fumarate, due to
breakthrough disease.
Trial website
https://clinicaltrials.gov/show/NCT04353492
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
novartis.email@novartis.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04353492