Phase II Cladribine Add-on to Interferon-beta (IFN-b) Therapy in MS Subjects With Active Disease (ONWARD)
The goal of this study is to evaluate the safety, tolerability and effectiveness of oral cladribine when taken in combination with Interferon-beta therapy for the treatment of MS.
This study will randomize 200 subjects from approximately 50 sites located world-wide, who have experienced at least one relapse while taking Interferon-beta therapy within 48 weeks prior to Screening, irrespective of disability progression. Secondary progressive multiple sclerosis (SPMS) patients, who are still experiencing relapses, and patients who have received disease modifying drugs (DMDs), other than Interferon-beta therapy, during their MS treatment history, but are currently on Interferon-beta therapy and have experienced active MS symptoms (at least 1 relapse) during the 48 weeks prior to Screening, may also be enrolled.
Subjects will be randomised in a 2:1 fashion to receive up to 4 cycles of oral cladribine or matching placebo in combination with Interferon-beta therapy. Subjects who complete the double-blind portion of the study are invited to participate in an open-label extension phase of matching study design. Total participation is 208 weeks.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase II, Multicenter, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability and Efficacy Study of Add-on Cladribine Tablet Therapy With Interferon-beta (IFN-b) Treatment in Multiple Sclerosis Subjects With Active Disease|
- To evaluate the safety and tolerability of oral cladribine compared to placebo as an add-on therapy to injectable IFN-b treatments in MS subjects with active disease. [ Time Frame: Quarterly safety review. Efficacy measure at 96 weeks ] [ Designated as safety issue: Yes ]
- To explore the efficacy of oral cladribine as an add-on to IFN-b treatments compared to placebo as an add-on to IFN-b treatments in MS subjects with active disease on: Lesion activity [MRI]; Qualifying relapse rate; Progression of disability [ Time Frame: At 96 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 2006|
|Study Completion Date:||June 2012|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Cladribine will be administered in the form of a pill. Subjects will receive up to 4 cycles of cladribine in combination with their interferon therapy over a period of 2 years. A cycle is defined as daily administration given consecutively over 4 to 5 days. Subjects will receive 0.875 mg/kg/cycle. Cycles will be administered on Study Day 1, Weeks 5, 48 and 52 of the study.
|Placebo Comparator: 2||
This treatment arm is identical to treatment arm #1 with the exception that subjects will receive placebo instead of cladribine.
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