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NCT00930553 · ClinicalTrials.gov registry record · Phase 3
An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab
A Phase 3 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,314
- Enrollment target
NCT00930553: Completed Phase 3 study, sponsored by Genzyme, a Sanofi Company.
NCT00930553 is a Phase 3 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 1,314 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00930553, a Phase 3 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,314 participants
- Enrollment target
Study Summary
This open-label, rater-blinded extension study enrolled participants who had relapsing-remitting multiple sclerosis (RRMS) and who participated in one of three prior Genzyme-sponsored studies of alemtuzumab (CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\] also known as CARE-MS I, or CAMMS324 \[NCT00548405\] also known as CARE-MS II). The purposes of this study were: 1. To examine the long term safety and efficacy of alemtuzumab treatment in participants who received alemtuzumab as their study treatment in one of the prior studies. 2. To examine the safety and efficacy of initial alemtuzumab treatment in this study for participants who received Rebif® (interferon beta-1a) as their study treatment in one of the prior studies. 3. To determine the safety and efficacy of additional "as needed" alemtuzumab treatment courses. This applied both to participants who received alemtuzumab for the first time in one of the prior studies or for the first time in this extension study.
Primary Outcome
Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis (MS) that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of follow-up time of all
Interventions
- BIOLOGICAL alemtuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,314 participants |
| Start Date | 2009-08 |
| Est. Completion | 2016-02 |
| Phase | Phase 3 |
What the finished NCT00930553 record still lists
NCT00930553 is an interventional study that assigns participants to a tested intervention. Its 1,314 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% higher).
The record links to 0 conditions, and to 1 intervention - of which alemtuzumab is the first listed.
NCT00930553 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00930553 about?
NCT00930553 is a clinical study titled "An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab". This open-label, rater-blinded extension study enrolled participants who had relapsing-remitting multiple sclerosis (RRMS) and who participated in one of three prior Genzyme-sponsored studies of alemtuzumab (CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\] also known as CARE-MS I, or CAMMS324 \[NC...
What is the current status of trial NCT00930553?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,314 participants. The study started on 2009-08. Estimated completion is 2016-02.
What interventions are being tested in trial NCT00930553?
The interventions under investigation include: alemtuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00930553?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00930553's enrollment target sits among peer trials
1,314 185th of 2000 higher than 1,814 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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