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NCT01034579 · ClinicalTrials.gov registry record · Phase 4
The REbif® vs Glatiramer Acetate in Relapsing Multiple Sclerosis Pharmacogenetics Trial
A Phase 4 study, sponsored by EMD Serono.
- Completed
- Registry status
- Phase 4
- Development phase
- 324
- Enrollment target
NCT01034579: Completed Phase 4 study, sponsored by EMD Serono.
NCT01034579 is a Phase 4 study that has completed, run by EMD Serono. The registered enrollment target is 324 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01034579, a Phase 4 study, has completed, sponsored by EMD Serono.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 324 participants
- Enrollment target
Study Summary
This study, REbif® vs Glatiramer acetate in relapsing multiple sclerosis (MS) disease - pharmacogenetic(s) (REGARD-PGx) is a single blood sampling exploratory pharmacogenetic study of the REGARD trial. The aim of this trial is to provide additional data on the factors influencing interferon (IFN) beta response. This is a Phase 4 trial involving subjects who previously participated in the REGARD trial. To address the trial objectives, a single visit follow-up trial will be performed during which a blood sample will be collected.
Primary Outcome
A responder was defined as a participant with no multiple sclerosis (MS) relapse and no Expanded Disability Status Scale (EDSS) progression during 96 weeks in 24735 (NCT00078338). All responders were categorized on the basis of following six SNP markers: SNP1, SNP2, SNP3, SNP4, SNP5, and SNP6. Two types of variables were possible for each SNP marker: two-level genotype-based or three-level allele-based association variables. For the two-level genotype-based SNP markers (SNP2, SNP4, and SNP6), th
Interventions
- OTHER Blood sampling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 324 participants |
| Start Date | 2010-02 |
| Est. Completion | 2010-11 |
| Phase | Phase 4 |
What the finished NCT01034579 record still lists
NCT01034579 is an interventional study that assigns participants to a tested intervention. The registered 324 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 1 intervention - of which Blood sampling is the first listed.
NCT01034579 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01034579 about?
NCT01034579 is a clinical study titled "The REbif® vs Glatiramer Acetate in Relapsing Multiple Sclerosis Pharmacogenetics Trial". This study, REbif® vs Glatiramer acetate in relapsing multiple sclerosis (MS) disease - pharmacogenetic(s) (REGARD-PGx) is a single blood sampling exploratory pharmacogenetic study of the REGARD trial. The aim of this trial is to provide additional data on the factors influencing interferon (IFN) b...
What is the current status of trial NCT01034579?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 324 participants. The study started on 2010-02. Estimated completion is 2010-11.
What interventions are being tested in trial NCT01034579?
The interventions under investigation include: Blood sampling (OTHER).
Who is sponsoring clinical trial NCT01034579?
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 NCT01034579's enrollment target sits among peer trials
324 254th of 2000 higher than 1,746 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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