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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04353492
Ethics application status
Date submitted
16/04/2020
Date registered
20/04/2020

Titles & IDs
Public title
An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab
Scientific title
A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient-reported Outcomes (PRO) in Patients With Relapsing Multiple Sclerosis (RMS) Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod
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
Treatment: Other - Ofatumumab

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


Treatment: Other: Ofatumumab
Subjects will receive ofatumumab injections in an autoinjector (AI) for subcutaneous administration containing 20 mg ofatumumab (50 mg/ml, 0.4 ml content)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annual Relapse Rate (ARR)
Timepoint [1] 0 0
Up to 96 weeks from baseline
Secondary outcome [1] 0 0
Safety evaluation
Timepoint [1] 0 0
96 weeks

Eligibility
Key inclusion criteria
* Diagnosis of MS according to the 2017 Revised McDonald criteria
* Relapsing MS: relapsing forms of MS (RMS) including RMS and secondary progressive MS (SPMS)
* Disability status at screening defined by Expanded Disability Status Scale (EDSS) score of 0 to 4 (inclusive)
* MS treatment history with a maximum of 3 Disease Modifying Therapies (DMTs), where all fumarates are considered as one DMT
* Subject transitioning from either any fumarate-based RMS approved therapies, such as dimethyl fumarate (DMF) or diroximel fumarate (DRF), or fingolimod which was administered for a period of at least 6 months, as their last DMT before first study drug administration
* Breakthrough disease activity while the participant was adequately using fumarates or fingolimod prior to transitioning for a minimum of 6 months as evidenced by one or more clinically reported relapses or one or more signs of Magnetic Resonance Imaging (MRI) activity (e.g. Gd+ enhancement, new or enlarging T2 lesions)
* Neurologically stable within one month prior to first study drug administration
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects with primary progressive MS or SPMS without disease activity
* Subjects meeting criteria for neuromyelitis optica
* Disease duration of more than 10 years since diagnosis
* Pregnant or nursing (lactating) women
* Women of child-bearing potential unless they are using highly effective forms of contraception during dosing and for at least 6 months after stopping study medication
* Subjects with active chronic disease of the immune system other than MS or with immunodeficiency syndrome
* Subjects with active systemic bacterial, fungal or viral infections (such as hepatitis, HIV, COVID-19), or known to have Acquired Immunodeficiency Syndrome (AIDS)
* Subjects with neurological symptoms consistent with Progressive Multifocal Leukoencephalopathy (PML) or with confirmed PML
* Subjects at risk of developing or having reactivation of syphilis or tuberculosis (e.g. subjects with known exposure to, or history of syphilis, or active or latent tuberculosis, even if previously treated), as confirmed by medical history or per local practice
* Subjects with active hepatitis B and C disease, assessed locally
* Have received any live or live-attenuated vaccines within 4 weeks prior to first study drug administration
* Have been treated with medications as specified or within timeframes specified (e.g. corticosteroids, ofatumumab, rituximab, ocrelizumab, alemtuzumab, natalizumab, daclizumab, cyclophosphamide, teriflunomide etc.)
* Subjects suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the investigator

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/04/2025
Actual
Sample size
Target
Accrual to date
Final
564
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - New Lambton Heights
Recruitment hospital [2] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment hospital [3] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
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United States of America
State/province [3] 0 0
Delaware
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Maryland
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United States of America
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Nevada
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Wisconsin
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Argentina
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Santa Fe
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Argentina
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Buenos Aires
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Argentina
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Tucuman
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Austria
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Oberoesterreich
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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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Brugge
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Belgium
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Bruxelles
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Bulgaria
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Pleven
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Bulgaria
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Sofia
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Canada
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Ontario
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Czechia
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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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Havirov
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Czechia
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Praha
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Czechia
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Teplice
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Estonia
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Tallinn
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Estonia
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Tartu
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Germany
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Bielefeld
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Germany
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Cottbus
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Germany
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Heidelberg
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Germany
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Koln
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Germany
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Leipzig
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Germany
State/province [41] 0 0
Muenchen
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Germany
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Osnabrück
Country [43] 0 0
Germany
State/province [43] 0 0
Potsdam
Country [44] 0 0
Germany
State/province [44] 0 0
Siegen
Country [45] 0 0
Germany
State/province [45] 0 0
Ulm
Country [46] 0 0
Germany
State/province [46] 0 0
Westerstede Oldenburg
Country [47] 0 0
Greece
State/province [47] 0 0
GR
Country [48] 0 0
Greece
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Greece
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Greece
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Thessaloniki
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Hungary
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HUN
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Hungary
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Budapest
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Hungary
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Pecs
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Italy
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FI
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Italy
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PV
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Italy
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RM
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Italy
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VR
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Latvia
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LV
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Latvia
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Riga
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Lebanon
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Ashrafieh
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Lebanon
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Beirut
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Mexico
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Distrito Federal
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Mexico
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Michoacan
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Norway
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Oslo
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Poland
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Woj Kujawsko-pomorskie
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Poland
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Katowice
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Poland
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Kielce
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Poland
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Lodz
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Poland
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Wroclaw
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Portugal
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Braga
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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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Porto
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Russian Federation
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Moscow
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Russian Federation
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St Petersburg
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Saudi Arabia
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SAU
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Saudi Arabia
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Jeddah
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Slovakia
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Slovak Republic
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Slovakia
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Banska Bystrica
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Slovakia
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Bratislava
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Slovakia
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Nitra
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Slovakia
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Trnava
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Slovenia
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Ljubljana
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Slovenia
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Maribor
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Spain
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Andalucia
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Spain
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Comunidad Valenciana
Country [86] 0 0
Spain
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Murcia
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Spain
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Vizcaya
Country [88] 0 0
Spain
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Barcelona
Country [89] 0 0
Spain
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Madrid
Country [90] 0 0
Spain
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Santa Cruz de Tenerife
Country [91] 0 0
Spain
State/province [91] 0 0
Valencia
Country [92] 0 0
Switzerland
State/province [92] 0 0
Basel
Country [93] 0 0
Turkey
State/province [93] 0 0
Istanbul
Country [94] 0 0
Turkey
State/province [94] 0 0
TUR
Country [95] 0 0
Turkey
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Izmir
Country [96] 0 0
Turkey
State/province [96] 0 0
Samsun
Country [97] 0 0
Turkey
State/province [97] 0 0
Trabzon
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Cardiff
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Swansea

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT04353492