A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

284

Participants

Timeline

Start Date

September 11, 2018

Primary Completion Date

August 26, 2019

Study Completion Date

May 5, 2020

Conditions
Multiple Sclerosis
Interventions
COMBINATION_PRODUCT

ofatumumab with PRF

ofatumumab 20 mg subcutanious injection administered with pre-filled syringe (PRF)

COMBINATION_PRODUCT

ofatumumab with AI

ofatumumab 20 mg subcutaneous injection administered with autoinjector (AI)

Trial Locations (41)

1010

Novartis Investigative Site, Vienna

1090

Novartis Investigative Site, Vienna

1113

Novartis Investigative Site, Sofia

1309

Novartis Investigative Site, Sofia

1413

Novartis Investigative Site, Sofia

1431

Novartis Investigative Site, Sofia

10617

Novartis Investigative Site, Tallinn

28223

Novartis Investigative Site, Pozuelo de Alarcón

30120

Novartis Investigative Site, El Palmar

33136

Novartis Investigative Site, Miami

33407

Novartis Investigative Site, West Palm Beach

33609

Novartis Investigative Site, Tampa

33612

Novartis Investigative Site, Tampa

37922

Novartis Investigative Site, Knoxville

41950

Novartis Investigative Site, Castilleja de la Cuesta

46256

Novartis Investigative Site, Indianapolis

51014

Novartis Investigative Site, Tartu

65721

Novartis Investigative Site, Ozark

75092

Novartis Investigative Site, Sherman

78681

Novartis Investigative Site, Round Rock

80045

Novartis Investigative Site, Aurora

80301

Novartis Investigative Site, Boulder

81621

Novartis Investigative Site, Basalt

92835

Novartis Investigative Site, Fullerton

127015

Novartis Investigative Site, Moscow

190000

Novartis Investigative Site, Saint Petersburg

197022

Novartis Investigative Site, Saint Petersburg

420021

Novartis Investigative Site, Kazan'

630007

Novartis Investigative Site, Novosibirsk

660049

Novartis Investigative Site, Krasnoyarsk

656 91

Novartis Investigative Site, Brno

736 01

Novartis Investigative Site, Havířov

415 01

Novartis Investigative Site, Teplice

500 05

Novartis Investigative Site, Hradec Králové

532 03

Novartis Investigative Site, Pardubice

LV-1005

Novartis Investigative Site, Riga

LV 1002

Novartis Investigative Site, Riga

LV-1038

Novartis Investigative Site, Riga

LT 50161

Novartis Investigative Site, Kaunas

LT-08661

Novartis Investigative Site, Vilnius

08035

Novartis Investigative Site, Barcelona

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY