A Phase 2 Study of Cladribine Add-on to Interferon-beta (IFN-beta) Therapy in Multiple Sclerosis (MS) Subjects With Active Disease (ONWARD)

PHASE2CompletedINTERVENTIONAL
Enrollment

172

Participants

Timeline

Start Date

November 30, 2006

Primary Completion Date

September 30, 2011

Study Completion Date

March 31, 2012

Conditions
Multiple Sclerosis
Interventions
DRUG

Cladribine

Participants were administered with cladribine tablets orally as cumulative dose.

DRUG

Placebo

Participants were administered with placebo orally.

DRUG

Interferon-beta (IFN-beta)

Participants received IFN-beta therapy (Rebif® new formulation \[RNF\] 44 microgram \[mcg\] three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during both DB period of 96 weeks and OL extension period of 48 weeks.

Trial Locations (39)

Unknown

Research Site, Cullman

Research Site, Phoenix

Research Site, Scottsdale

Research Site, Los Angeles

Research Site, Boulder

Research Site, Fort Collins

Research Site, Tampa

Research Site, Atlanta

Research Site, Peoria

Research Site, Boston

Research Site, St Louis

Research Site, Newark

Research Site, Albuquerque

Research Site, Charlotte

Research Site, Winston-Salem

Research Site, Bethlehem

Research Site, Philadelphia

Research Site, Nashville

Research Site, Houston

Research Site, Round Rock

Research Site, Burlington

Research Site, Fidenza

Research Site, Milan

Research Site, Napoli

Research Site, Rome

Research Site, Arkhangelsk

Research Site, Kazan'

Research Site, Moscow

Research Site, Novosibirsk

Research Site, Saint Petersburg

Research Site, Samara

Research Site, Smolensk

Research Site, Alicante

Research site, Barcelona

Research Site, Bilbao

Research Site, Madrid

Research Site, Málaga

Research Site, Santiago

Research Site, Seville

All Listed Sponsors
lead

EMD Serono Research & Development Institute, Inc.

INDUSTRY

NCT00436826 - A Phase 2 Study of Cladribine Add-on to Interferon-beta (IFN-beta) Therapy in Multiple Sclerosis (MS) Subjects With Active Disease (ONWARD) | Biotech Hunter | Biotech Hunter