Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00213135
Status:
COMPLETED
Last Update Posted:
2014-02-07
First Post:
2005-09-13
Brief Title:
A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis RRMS
Sponsor:
EMD Serono
Organization:
EMD Serono
Study Overview
Official Title:
A Phase III Randomized Double-blind Three-arm Placebo-controlled Multi-center Study to Evaluate the Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis RRMS
Status:
COMPLETED
Status Verified Date:
2014-01
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:
CLARITY
Brief Summary:
The purpose of the study is to determine if cladribine tablets are a safe and effective treatment for relapsing-remitting multiple sclerosis RRMS
Detailed Description:
This is a randomized double-blind three-arm placebo-controlled multi-center study The study includes a pre-study evaluation period up to 28 days prior to the start of treatment an initial treatment period from Week 1 to 48 and a re-treatment period during Week 49 to 96
During the initial treatment period Week 1 to 48 eligible subjects are equally randomized by a central randomization system to receive either a cladribine at a low dose 0875 milligram per kilogram per course mgkgcourse for two courses plus placebo for two courses b cladribine at a high dose 0875 mgkgcourse for four courses or c placebo four courses During the re-treatment period Weeks 49 to 96 subjects received either a cladribine at a low dose 0875 mgkgcourse for two courses or b placebo two courses
For all randomized subjects there is a rescue option of treatment with Rebif interferon beta-1a 44 microgram mcg given subcutaneously three times a week if the subject experienced more than one qualifying relapse andor experienced a sustained increase in their EDSS score of greater than or equal to 1 point or 15 points if baseline EDSS score is 0 over a period of three months or greater during a calendar year beginning at Week 24
To maintain the blind there is a treating physician who view clinical laboratory results and assess adverse events and safety information and an independent blinded evaluating physician who will perform neurological exams A central neuroradiology center also blinded to treatment will assess magnetic resonance imaging MRI evaluations
During the initial treatment period Week 1 to 48 eligible subjects are equally randomized by a central randomization system to receive either a cladribine at a low dose 0875 milligram per kilogram per course mgkgcourse for two courses plus placebo for two courses b cladribine at a high dose 0875 mgkgcourse for four courses or c placebo four courses During the re-treatment period Weeks 49 to 96 subjects received either a cladribine at a low dose 0875 mgkgcourse for two courses or b placebo two courses
For all randomized subjects there is a rescue option of treatment with Rebif interferon beta-1a 44 microgram mcg given subcutaneously three times a week if the subject experienced more than one qualifying relapse andor experienced a sustained increase in their EDSS score of greater than or equal to 1 point or 15 points if baseline EDSS score is 0 over a period of three months or greater during a calendar year beginning at Week 24
To maintain the blind there is a treating physician who view clinical laboratory results and assess adverse events and safety information and an independent blinded evaluating physician who will perform neurological exams A central neuroradiology center also blinded to treatment will assess magnetic resonance imaging MRI evaluations
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