Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050778
Status:
COMPLETED
Last Update Posted:
2015-01-08
First Post:
2002-12-19
Brief Title:
A Phase II Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Rebif in Patients With Early Active Relapsing-Remitting Multiple Sclerosis
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase II Randomized Open-Label Three-Arm Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Subcutaneous Interferon Beta-1a Rebif in Patients With Early Active Relapsing-Remitting Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2015-01
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:
None
Brief Summary:
This was a Phase II randomized open-label rater-blinded three-arm study comparing two different doses of alemtuzumab Lemtrada and one dose of subcutaneous SC interferon beta-1a Rebif in participants with early active relapsing-remitting multiple sclerosis MS who had not been previously treated with MS therapies other than steroids The study was conducted for an initial period of 3 years and a follow-up to 5 years or more
Detailed Description:
The aims of MS therapy are to prevent the progression of disease and accumulation of long-term disability The hypothesis underlying this study was that aggressive treatment of inflammation in the brain early in the course of MS would protect the participant from disease progression and accumulating disability
This protocol compared two different doses of alemtuzumab and high-dose high frequency of SC interferon beta-1a to evaluate the safety profiles of the respective treatments and to evaluate efficacy in terms of
Slowing the sustained accumulation of disability in participant with MS
Reducing the frequency of relapses experienced by participant with MS and
Reducing the harmful effects of MS on the brain as assessed by magnetic resonance imaging MRI
Participants who received alemtuzumab during the initial 36-month treatment period may have been eligible for re-treatment with alemtuzumab in the extension study CAMMS03409 NCT00930553 to evaluate
How long the effects of prior alemtuzumab treatment lasted
If additional treatments with alemtuzumab continued to reduce the effects of MS and
What kind of side effects participants experienced upon retreatment with alemtuzumab
This protocol compared two different doses of alemtuzumab and high-dose high frequency of SC interferon beta-1a to evaluate the safety profiles of the respective treatments and to evaluate efficacy in terms of
Slowing the sustained accumulation of disability in participant with MS
Reducing the frequency of relapses experienced by participant with MS and
Reducing the harmful effects of MS on the brain as assessed by magnetic resonance imaging MRI
Participants who received alemtuzumab during the initial 36-month treatment period may have been eligible for re-treatment with alemtuzumab in the extension study CAMMS03409 NCT00930553 to evaluate
How long the effects of prior alemtuzumab treatment lasted
If additional treatments with alemtuzumab continued to reduce the effects of MS and
What kind of side effects participants experienced upon retreatment with alemtuzumab
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