Clinical trial NCT03650114: Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Relapsing Multiple Sclerosis
Keywords: ofatumumab
relapsing multiple sclerosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2018-08-28
Enrollment: 1882
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

COVID-19 sub-study:

The purpose of this research sub-study is to explore the immune response following Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination in a subset of subjects on long-term ofatumumab 20 mg sc. Note: Novartis is not supplying the SARS-CoV-2 vaccine.


Eligibility criteria: Inclusion Criteria:

1. Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks
2. Written informed consent

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

Primary outcomes:
measure: Number of patients that experience an adverse event or abnormal laboratory, vital and/or ECG results and positive suicidiality outcomes
timeFrame: Up to 8 years
Secondary outcomes:
measure: Number of relapse rates per year
timeFrame: Data from the core studies through the first 5 years in this study.
measure: Patients with confirmed 3 and 6 month disability worsening
timeFrame: During the first 5 years of treatment in the study.
measure: Patients with confirmed 6, 12, and 24 month disability improvement and improvement during the first 5 years of the study.
timeFrame: During the first 5 years of treatment in the study.
measure: Patients with changes in Expanded Disability Status Scale (EDSS) scores
timeFrame: Data from the core studies through the first 5 years in this study, (depending on if first dose was in the core or in this extension study or comparator randomization)
measure: Changes in and time to 6 month confirmed worsening of Symbol Digit Modalities Test Scores
timeFrame: During the first 5 years of the study.
measure: Changes in the Magnetic Resonance Image (MRI) related to brain volume loss
timeFrame: Data from the core studies through the first 5 years in this study.
measure: Changes in the Magnetic Resonance Image (MRI) related to T2 lesions
timeFrame: Data from the core studies through the first 5 years in this study.
measure: Changes in the Magnetic Resonance Image (MRI) related to Gd-enhancing lesions
timeFrame: Data from the core studies through the first 5 years in this study.
measure: Changes in neurofilament light change serum concentration
timeFrame: Data from the core studies through the first 5 years in this study.
Other outcomes:
measure: Hummoral immune response to TT vaccine
timeFrame: Pre-vaccination, 4 and 8 weeks post-vaccination
measure: Hummoral immune response to 13-valent pneumococcal conjugate vaccine (13-PCV)
timeFrame: 4 and 8 weeks
measure: Hummoral immune response to 13-PCV boosted eight weeks later by 23-valent pneumococcal polysaccharide vaccine (23-PPV)
timeFrame: Pre-vaccination, 4 and 8 weeks post-vaccination
measure: Humoral immune response to KLH neo-antigen
timeFrame: Pre-administration, 4, 8, 12 weeks after initial administration and 4 weeks after last administration
measure: Hummoral immune response to 2020-2021 seasonal quadrivalent influenza vaccine
timeFrame: Pre-vaccination and 4 weeks post-vaccination
measure: Antibody response rate to TT and influenza vaccination as a function of exposure to ofatumumab
timeFrame: 8 weeks
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Cullman
country: United States
facility: North Central Neurology Associates PC
state: Alabama
city: Phoenix
country: United States
facility: Barrow Neurological Clinics at St Josephs Hospital and MC
state: Arizona
city: Fullerton
country: United States
facility: Fullerton Neuro and Headache Ctr
state: California
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: Aurora
country: United States
facility: CU Anschutz Med Campus
state: Colorado
city: Basalt
country: United States
facility: Mountain Neuro Research Center PC
state: Colorado
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Springs Neurological Associates
state: Colorado
city: Denver
country: United States
facility: Colorado Neurological Research PC
state: Colorado
city: Fort Collins
country: United States
facility: University of Colorado Health Neurology
state: Colorado
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Atlantis
country: United States
facility: Jem Research Institute
state: Florida
city: Delray Beach
country: United States
facility: Neurology Offices of South Florida PLLC
state: Florida
city: Hollywood
country: United States
facility: Infinity Clinical Research LLC
state: Florida
city: Homestead
country: United States
facility: Homestead Assoc In Research Inc
state: Florida
city: Maitland
country: United States
facility: Neurology Associates PA
state: Florida
city: Miami
country: United States
facility: UM Department Of Neurology
state: Florida
city: Naples
country: United States
facility: Aqualane Clinical Research
state: Florida
city: Oldsmar
country: United States
facility: MS and Neuromuscular Center of Excellence
state: Florida
city: Ormond Beach
country: United States
facility: Neurology Associates of Ormond Beach
state: Florida
city: Pensacola
country: United States
facility: Emerald Coast Neurology
state: Florida
city: Port Charlotte
country: United States
facility: Neurostudies Inc
state: Florida
city: Sarasota
country: United States
facility: Negroski Neurology
state: Florida
city: Sarasota
country: United States
facility: Roskamp Institute Inc
state: Florida
city: Tallahassee
country: United States
facility: AMO Corporation
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida Inc
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research of Florida
state: Florida
city: Tampa
country: United States
facility: University Of South Florida
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute
state: Florida
city: Savannah
country: United States
facility: Velocity Clinical Research
state: Georgia
city: Suwanee
country: United States
facility: Georgia Neurology and Sleep Medicine Assoc
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Pacific Neuroscience LLC
state: Hawaii
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Northbrook
country: United States
facility: Consultants in Neurology
state: Illinois
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology P.C
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Overland Park
country: United States
facility: College Park Family Care Center
state: Kansas
city: Alexandria
country: United States
facility: Neuro Medical Clinic of Cenla LLC
state: Louisiana
city: Baton Rouge
country: United States
facility: The Neuromedical Center
state: Louisiana
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Wellesley
country: United States
facility: Dragonfly Research LLC
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University Multiple Sclerosis Clinic
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Ozark
country: United States
facility: Sharlin Health and Neurology
state: Missouri
city: Saint Louis
country: United States
facility: WA Uni School Of Med
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Research
state: Missouri
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Great Falls
country: United States
facility: Advanced Neurology Specialists
state: Montana
city: Las Vegas
country: United States
facility: Cleveland Clinic Foundation
state: Nevada
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Latham
country: United States
facility: Ms Ctr Of Northeastern Ny
state: New York
city: Asheville
country: United States
facility: Asheville Neurology Specialists PA
state: North Carolina
city: Charlotte
country: United States
facility: The Neurological Institute PA
state: North Carolina
city: Greensboro
country: United States
facility: Guilford Neurologic Associate Research
state: North Carolina
city: Raleigh
country: United States
facility: Velocity Clinical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston Salem
state: North Carolina
city: Akron
country: United States
facility: Neurology and Neuroscience Assos
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Westerville
country: United States
facility: Columbus Neuroscience
state: Ohio
city: Oklahoma City
country: United States
facility: Multiple Sclerosis Center of Excellence of OMRF
state: Oklahoma
city: Portland
country: United States
facility: Providence Neurological Services West
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Willow Grove
country: United States
facility: Abington Neurological Associates Ltd
state: Pennsylvania
city: Greenville
country: United States
facility: Premier Neurology
state: South Carolina
city: Spartanburg
country: United States
facility: BG Neurology
state: South Carolina
city: Spartanburg
country: United States
facility: Upstate Clinical Trials LLC
state: South Carolina
city: Cordova
country: United States
facility: Wesley Neurology Clinic
state: Tennessee
city: Johnson
country: United States
facility: Tri State Mountain Neurology
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Ctr
state: Tennessee
city: Knoxville
country: United States
facility: Sibyl Wray MD Neurology PC
state: Tennessee
city: El Paso
country: United States
facility: Med Research Inc
state: Texas
city: Lubbock
country: United States
facility: Neurology and Sleep Center
state: Texas
city: Round Rock
country: United States
facility: Central TX Neuro Consultants P A
state: Texas
city: San Antonio
country: United States
facility: Lonestar Neurology of San Antonio
state: Texas
city: Sherman
country: United States
facility: Texas Institute for Neurological Disorders
state: Texas
city: Salt Lake City
country: United States
facility: Rocky Mountain MS Clinic
state: Utah
city: Salt Lake City
country: United States
facility: The University of Utah
state: Utah
city: Virginia Beach
country: United States
facility: Sentara Neuroscience Institute
state: Virginia
city: Kirkland
country: United States
facility: Evergreen Health Multiple Sclerosis Center
state: Washington
city: Tacoma
country: United States
facility: MultiCare Research Institute for Research and Innovation
state: Washington
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Madison
state: Wisconsin
city: Milwaukee
country: United States
facility: Ascension St Francis Center
state: Wisconsin
city: Milwaukee
country: United States
facility: St Luke s Medical Center Aurora
state: Wisconsin
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Tucuman
country: Argentina
facility: Novartis Investigative Site
city: New Lambton Heights
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Liverpool
country: Australia
facility: Novartis Investigative Site
city: St Leonards
country: Australia
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Brasschaat
country: Belgium
facility: Novartis Investigative Site
city: Brugge
country: Belgium
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Edegem
country: Belgium
facility: Novartis Investigative Site
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Pleven
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Gatineau
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Greenfield Park
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Rijeka
country: Croatia
facility: Novartis Investigative Site
state: HRV
city: Osijek
country: Croatia
facility: Novartis Investigative Site
city: Zagreb
country: Croatia
facility: Novartis Investigative Site
city: Hradec Kralove
country: Czechia
facility: Novartis Investigative Site
state: CZE
city: Brno
country: Czechia
facility: Novartis Investigative Site
city: Havirov
country: Czechia
facility: Novartis Investigative Site
city: JIhlava
country: Czechia
facility: Novartis Investigative Site
city: Olomouc
country: Czechia
facility: Novartis Investigative Site
city: Ostrava Poruba
country: Czechia
facility: Novartis Investigative Site
city: Pardubice
country: Czechia
facility: Novartis Investigative Site
city: Praha 10
country: Czechia
facility: Novartis Investigative Site
city: Praha 4
country: Czechia
facility: Novartis Investigative Site
city: Praha 5
country: Czechia
facility: Novartis Investigative Site
city: Teplice
country: Czechia
facility: Novartis Investigative Site
city: Copenhagen
country: Denmark
facility: Novartis Investigative Site
city: Odense C
country: Denmark
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tartu
country: Estonia
facility: Novartis Investigative Site
city: Tampere
country: Finland
facility: Novartis Investigative Site
city: Turku
country: Finland
facility: Novartis Investigative Site
city: Lille
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Nantes Cedex 1
country: France
facility: Novartis Investigative Site
city: Nice
country: France
facility: Novartis Investigative Site
city: Nimes
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Strasbourg
country: France
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Barsinghausen
country: Germany
facility: Novartis Investigative Site
city: Bayreuth
country: Germany
facility: Novartis Investigative Site
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Minden
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Neuburg an der Donau
country: Germany
facility: Novartis Investigative Site
city: Potsdam
country: Germany
facility: Novartis Investigative Site
city: Siegen
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Unterhaching
country: Germany
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
state: GR
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
state: HUN
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Kistarcsa
country: Hungary
facility: Novartis Investigative Site
city: Pecs
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: New Delhi
country: India
facility: Novartis Investigative Site
state: Delhi
city: New Delhi
country: India
facility: Novartis Investigative Site
state: Delhi
city: Kochi
country: India
facility: Novartis Investigative Site
state: Kerala
city: Mumbai
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Pune
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Chandigarh
country: India
facility: Novartis Investigative Site
state: Punjab
city: Hyderabad
country: India
facility: Novartis Investigative Site
state: Telangana
city: Howrah
country: India
facility: Novartis Investigative Site
state: West Bengal
city: Mangalore
country: India
facility: Novartis Investigative Site
city: Ashkelon
country: Israel
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Sefad
country: Israel
facility: Novartis Investigative Site
city: Tel Aviv
country: Israel
facility: Novartis Investigative Site
city: Toon city
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Sapporo city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Morioka
country: Japan
facility: Novartis Investigative Site
state: Iwate
city: Sendai city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Sendai city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Kawagoe
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Kodaira
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chiba
country: Japan
facility: Novartis Investigative Site
city: Niigata
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
state: LV
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
state: LTU
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Ciudad de Mexico
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Mexico
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Chihuahua
country: Mexico
facility: Novartis Investigative Site
city: Sittard-Geleen
country: Netherlands
facility: Novartis Investigative Site
state: BG
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
state: Zuid Holland
city: Amsterdam
country: Netherlands
facility: Novartis Investigative Site
city: Drammen
country: Norway
facility: Novartis Investigative Site
city: Cercado De Lima
country: Peru
facility: Novartis Investigative Site
state: Lima
city: San Isidro
country: Peru
facility: Novartis Investigative Site
state: Lima
city: Lima
country: Peru
facility: Novartis Investigative Site
city: Bydgoszcz
country: Poland
facility: Novartis Investigative Site
state: Woj Kujawsko-pomorskie
city: Gdansk
country: Poland
facility: Novartis Investigative Site
city: Gdansk
country: Poland
facility: Novartis Investigative Site
city: Gdansk
country: Poland
facility: Novartis Investigative Site
city: Glogow
country: Poland
facility: Novartis Investigative Site
city: Katowice
country: Poland
facility: Novartis Investigative Site
city: Kielce
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Rzeszow
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Zabrze
country: Poland
facility: Novartis Investigative Site
city: Braga
country: Portugal
facility: Novartis Investigative Site
city: Coimbra
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Loures
country: Portugal
facility: Novartis Investigative Site
city: Matosinhos
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Santa Maria da Feira
country: Portugal
facility: Novartis Investigative Site
city: Ekaterinburg
country: Russian Federation
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Kemerovo
country: Russian Federation
facility: Novartis Investigative Site
city: Krasnoyarsk
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Nizhny Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Novosibirsk
country: Russian Federation
facility: Novartis Investigative Site
city: Novosibirsk
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saransk
country: Russian Federation
facility: Novartis Investigative Site
city: Sestroretsk
country: Russian Federation
facility: Novartis Investigative Site
city: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Tyumen
country: Russian Federation
facility: Novartis Investigative Site
city: Banska Bystrica
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Martin
country: Slovakia
facility: Novartis Investigative Site
city: Trnava
country: Slovakia
facility: Novartis Investigative Site
city: Pretoria
country: South Africa
facility: Novartis Investigative Site
city: Rosebank
country: South Africa
facility: Novartis Investigative Site
city: Cadiz
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Hospitalet de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Salt
country: Spain
facility: Novartis Investigative Site
state: Cataluna
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Pozuelo de Alarcon
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: El Palmar
country: Spain
facility: Novartis Investigative Site
state: Murcia
city: San Sebastian
country: Spain
facility: Novartis Investigative Site
state: Pais Vasco
city: Castilleja De La Cuesta
country: Spain
facility: Novartis Investigative Site
state: Sevilla
city: Baracaldo
country: Spain
facility: Novartis Investigative Site
state: Vizcaya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Goeteborg
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Lugano
country: Switzerland
facility: Novartis Investigative Site
city: Tainan
country: Taiwan
facility: Novartis Investigative Site
city: Khon Kaen
country: Thailand
facility: Novartis Investigative Site
state: THA
city: Sancaktepe
country: Turkey
facility: Novartis Investigative Site
state: Istanbul
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
state: TUR
city: Haseki Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Kocaeli
country: Turkey
facility: Novartis Investigative Site
city: Mersin
country: Turkey
facility: Novartis Investigative Site
city: Samsun
country: Turkey
facility: Novartis Investigative Site
city: Trabzon
country: Turkey
facility: Novartis Investigative Site
city: Luton
country: United Kingdom
facility: Novartis Investigative Site
state: Beds
city: Sheffield
country: United Kingdom
facility: Novartis Investigative Site
state: South Yorkshire
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Oxford
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
References: