Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436826
Status:
COMPLETED
Last Update Posted:
2020-10-12
First Post:
2007-02-15
Brief Title:
A Phase 2 Study of Cladribine Add-on to Interferon-beta IFN-beta Therapy in Multiple Sclerosis MS Subjects With Active Disease ONWARD
Sponsor:
EMD Serono Research Development Institute Inc
Organization:
EMD Serono
Study Overview
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-β Treatment in Multiple Sclerosis Subjects With Active Disease
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ONWARD
Brief Summary:
The goal of this study was to evaluate the safety tolerability and effectiveness of oral cladribine when taken in combination with Interferon-beta IFN-beta therapy for the treatment of multiple sclerosis MS
This study randomized around 200 participants from approximately 50 sites located world-wide who have experienced at least one relapse while taking IFN-beta therapy within 48 weeks prior to Screening irrespective of disability progression Secondary progressive multiple sclerosis SPMS participants who were still experiencing relapses and participants who have received disease modifying drugs DMDs other than IFN-beta therapy during their MS treatment history but were currently on IFN-beta therapy and have experienced active MS symptoms at least 1 relapse during the 48 weeks prior to Screening were enrolled
Participants were randomized in a 21 fashion to receive up to 4 cycles of oral cladribine or matching placebo in combination with IFN-beta therapy Participants who completed the double-blind portion of the study were invited to participate in an open-label extension phase of matching study design
This study randomized around 200 participants from approximately 50 sites located world-wide who have experienced at least one relapse while taking IFN-beta therapy within 48 weeks prior to Screening irrespective of disability progression Secondary progressive multiple sclerosis SPMS participants who were still experiencing relapses and participants who have received disease modifying drugs DMDs other than IFN-beta therapy during their MS treatment history but were currently on IFN-beta therapy and have experienced active MS symptoms at least 1 relapse during the 48 weeks prior to Screening were enrolled
Participants were randomized in a 21 fashion to receive up to 4 cycles of oral cladribine or matching placebo in combination with IFN-beta therapy Participants who completed the double-blind portion of the study were invited to participate in an open-label extension phase of matching study design
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-003366-33 | EUDRACT_NUMBER | None | None |