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NCT00853762 · ClinicalTrials.gov registry record · Phase 2
Atacicept in Multiple Sclerosis Extension Study, Phase II
A Phase 2 study, sponsored by EMD Serono.
- Terminated
- Registry status
- Phase 2
- Development phase
- 74
- Enrollment target
NCT00853762: Clinical Trial Phase 2 study, sponsored by EMD Serono.
NCT00853762 is a Phase 2 study that was terminated before completion, run by EMD Serono. The registered enrollment target is 74 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00853762, a Phase 2 study, was terminated before completion, sponsored by EMD Serono.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 74 participants
- Enrollment target
Study Summary
This study (28851) is a long-term follow-up study of subjects enrolled in ATAMS study 28063 (NCT00642902). The aim of this study is to monitor the safety and tolerability of atacicept administered for up to 5 years to subjects with relapsing multiple sclerosis (RMS). This extension study consists of two parts. Part A will be double blind and Part B will be open label. During Part A, subjects initially randomized to atacicept will continue to receive the atacicept dose to which they have been randomized in study 28063 (ATAMS) once a week subcutaneously (under the skin). Subjects randomized to placebo in ATAMS will receive atacicept at 150 mg once a week subcutaneously during Part A. Once the results of ATAMS are available and the atacicept dose with the best benefit / risk ratio has been identified, all subjects will be switched to this dose and will continue the extension study open-label (Part B). Throughout the study, subjects and investigators will remain blinded with respect to initial and part A treatment allocation/dose.
Primary Outcome
TEAEs were defined as AEs with a start date after or on the date of the first DB treatment injection in ATAMS Extension and that occurred anytime after treatment discontinuation, or up to the day before first Rebif® rescue medication injection in ATAMS Extension. A serious TEAE was an AE that resulted in any of the following: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE severity was gr
Interventions
- DRUG Atacicept 75 mg
- DRUG Atacicept 150 mg
- DRUG Atacicept 25 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2009-03 |
| Est. Completion | 2011-02 |
| Phase | Phase 2 |
Why NCT00853762 stopped before completion
NCT00853762 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 3 interventions - of which Atacicept 75 mg is the first listed.
NCT00853762 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00853762 about?
NCT00853762 is a clinical study titled "Atacicept in Multiple Sclerosis Extension Study, Phase II". This study (28851) is a long-term follow-up study of subjects enrolled in ATAMS study 28063 (NCT00642902). The aim of this study is to monitor the safety and tolerability of atacicept administered for up to 5 years to subjects with relapsing multiple sclerosis (RMS). This extension study consists o...
What is the current status of trial NCT00853762?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2009-03. Estimated completion is 2011-02.
What interventions are being tested in trial NCT00853762?
The interventions under investigation include: Atacicept 75 mg (DRUG), Atacicept 150 mg (DRUG), Atacicept 25 mg (DRUG).
Who is sponsoring clinical trial NCT00853762?
This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00853762's enrollment target sits among peer trials
74 920th of 2000 higher than 1,077 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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