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NCT02255656 · ClinicalTrials.gov registry record · Phase 4
Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409
A Phase 4 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,062
- Enrollment target
NCT02255656: Completed Phase 4 study, sponsored by Genzyme, a Sanofi Company.
NCT02255656 is a Phase 4 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 1,062 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (105% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02255656, a Phase 4 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,062 participants
- Enrollment target
Study Summary
Primary Objective: To evaluate long-term safety of alemtuzumab. Secondary Objectives: * To evaluate long term efficacy of alemtuzumab. * To evaluate the safety profile of participants who received other Disease Modifying Treatment (DMT) following alemtuzumab treatment. * To evaluate participant-reported Quality of Life (QoL) outcomes and health resource utilization of participant who received alemtuzumab. * To evaluate as needed re-treatment with alemtuzumab and other DMTs.
Primary Outcome
An Adverse Event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that developed/worsened during the 'treatment period (time from Baseline until the end of the study LPS13649 \[i.e. up to a maximum of 5.6 years\]). Serious adverse events (SAEs) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required
Interventions
- DRUG alemtuzumab GZ402673
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,062 participants |
| Start Date | 2015-01-07 |
| Est. Completion | 2020-07-15 |
| Phase | Phase 4 |
What the finished NCT02255656 record still lists
NCT02255656 is an interventional study that assigns participants to a tested intervention. Its 1,062 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (105% higher).
The record links to 0 conditions, and to 1 intervention - of which alemtuzumab GZ402673 is the first listed.
NCT02255656 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02255656 about?
NCT02255656 is a clinical study titled "Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409". Primary Objective: To evaluate long-term safety of alemtuzumab. Secondary Objectives: * To evaluate long term efficacy of alemtuzumab. * To evaluate the safety profile of participants who received other Disease Modifying Treatment (DMT) following alemtuzumab treatment. * To evaluate participant-r...
What is the current status of trial NCT02255656?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,062 participants. The study started on 2015-01-07. Estimated completion is 2020-07-15.
What interventions are being tested in trial NCT02255656?
The interventions under investigation include: alemtuzumab GZ402673 (DRUG).
Who is sponsoring clinical trial NCT02255656?
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 NCT02255656's enrollment target sits among peer trials
1,062 66th of 2000 higher than 1,935 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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