Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri®

PHASE3CompletedINTERVENTIONAL
Enrollment

265

Participants

Timeline

Start Date

October 1, 2019

Primary Completion Date

August 23, 2021

Study Completion Date

February 7, 2022

Conditions
Relapsing-Remitting Multiple Sclerosis (RRMS)
Interventions
BIOLOGICAL

Intravenous (IV) infusions

Intravenous (IV) infusions of a dose of 300mg, every 4 weeks with a total of 12 doses

Trial Locations (48)

2004

Institute for Emergency Medicine, Department of Neurology, Chisinau

2028

Institute for Emergency Medicine, Department of Neurology, Chisinau

National Institute of Neurology and Neurosurgery, Vascular Neurology Department, Chisinau

10000

University Hospital Centre Zagreb, Clinic of Neurology, Zagreb

10008

O.F. Herbachevskyi Regional Clinical Hospital, Zhytomyr

11000

Clinical Center of Serbia, Clinic of Neurology, Belgrade

11080

Clinical Hospital Center Zemun, Department of Neurology, Belgrade

21000

Clinical Hospital Center Split, Clinic of Neurology, Split

Clinical Center of Vojvodina, Clinic of Neurology, Novi Sad

31000

Clinical Hospital Center Osijek, Clinic of Neurology, Osijek

34000

Clinical Center Kragujevac, Clinic of Neurology, Kragujevac

210023

Vitebsk Regional Diagnostic Center, Vitebsk

210037

Vitebsk Regional Clinical Hospital, Vitebsk

220026

Minsk City Clinical Hospital #5, Minsk

220114

Republican Research and Development Center for Neurology and Neurosurgery, Minsk

220116

Minsk Scientific and Practical Center of Surgery, Transplantology and Hematology, Minsk

230017

Grodno Regional Clinical Hospital, Grodno

0112

P. Sarajishvili Institute of Neurology, LTD, Tbilisi

0159

LTD Saint Michael Archangel Multifunctional Clinical Hospital, Tbilisi

0172

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center, Tbilisi

0179

LTD S.Khechinashvili University Hospital, Tbilisi

Unknown

LTD Aversi Clinic, Tbilisi

Pineo Medical Ecosystem, Tbilisi

MED-Polonia, Sp. z o.o. (LLC), Poznan

Cherkasy Regional Hospital of Cherkasy Oblast Council, Cherkasy

Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital, Dnipro

Ivano-Frankivsk City Clinical Hospital #1, Ivano-Frankivsk

Regional Clinical Hospital, Ivano-Frankivsk

City Clinical Hospital #7, Kharkiv

Institute of Neurology, Psychiatry and Narcology, Kharkiv

Kharkiv Railway Clinical Hospital, Kharkiv

Kyiv City Clinical Hospital, Kyiv

Medical Center of First Private Clinic, Kyiv

National Research Center for Radiation Medicine, Kyiv

Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital, Lviv

Lviv City Clinical Hospital #5, Lviv

Center for Reconstructive and Restorative Medicine (University Clinic), Odesa

Sklifosovskyi Regional Clinical Hospital, Poltava

Ternopil Regional Clinical Psychonevrological Hospital, Ternopil

Vinnytsia O.I. Yushchenko Regional Psychoneurology Hospital, Vinnytsia

Clinical Hospital No. 9 under Zaporizhia City Council, Zaporizhia

City Clinical Hospital #2, Zaporizhzhya

Zaporizhia Regional Clinical Hospital, Zaporizhzhya

80-803

COPERNICUS Podmiot Leczniczy Sp. z o.o N. Copernicus Hospital, Department of Neurology, Gdansk

40-555

Neuro-Medic, Katowice

90-324

Neurology Center Krzysztof Selmaj, Lodz

10-561

Provincial Specialist Hospital in Olsztyn, Department of Neurology, Olsztyn

01-684

NeuroProtect Medical Center, Warsaw

Sponsors
All Listed Sponsors
lead

Polpharma Biologics S.A.

INDUSTRY