Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA

PHASE4CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

Conditions
Relapsing-remitting Multiple Sclerosis
Interventions
DRUG

Alemtuzumab GZ402673

Pharmaceutical form:concentration for solution Route of administration: intravenous infusion

DRUG

cetirizine

Pharmaceutical form:tablet Route of administration: oral

DRUG

ranitidine

Pharmaceutical form:tablet Route of administration: oral

DRUG

methylprednisolone

Pharmaceutical form:tablet Route of administration: oral

DRUG

methylprednisolone

Pharmaceutical form:solution Route of administration: intravenous

DRUG

aciclovir

Pharmaceutical form:tablet Route of administration: oral

DRUG

esomeprazole

Pharmaceutical form:tablet Route of administration: oral

DRUG

ibuprofen

Pharmaceutical form:tablet Route of administration: oral

DRUG

paracetamol

Pharmaceutical form:tablet Route of administration: oral

Trial Locations (20)

1070

Investigational Site Number 056001, Brussels

8000

Investigational Site Number 056002, Bruges

21000

Investigational Site Number 250009, Dijon

28040

Investigational Site Number 724002, Madrid

29010

Investigational Site Number 724006, Málaga

30029

Investigational Site Number 250007, Nîmes

31200

Investigational Site Number 250002, Toulouse

35033

Investigational Site Number 250004, Rennes

41071

Investigational Site Number 724003, Seville

44093

Investigational Site Number 250010, Nantes

46009

Investigational Site Number 724004, Valencia

48013

Investigational Site Number 724005, Bilbao

59037

Investigational Site Number 250005, Lille

67098

Investigational Site Number 250003, Strasbourg

69677

Investigational Site Number 250001, Lyon Bron

75970

Investigational Site Number 250008, Paris

Unknown

Investigational Site Number 250006, Nancy

4818CK

Investigational Site Number 528001, Breda

3079DZ

Investigational Site Number 528002, Rotterdam

08035

Investigational Site Number 724001, Barcelona

All Listed Sponsors
lead

Genzyme, a Sanofi Company

INDUSTRY

NCT02205489 - Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA | Biotech Hunter | Biotech Hunter