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NCT01457924 · ClinicalTrials.gov registry record · Phase 2
Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple Sclerosis
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 232
- Enrollment target
NCT01457924: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT01457924 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 232 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01457924, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 232 participants
- Enrollment target
Study Summary
Ofatumumab is a novel Immunoglobulin 1ĸ ( IgG1ĸ) lytic monoclonal antibody (mAb) that specifically binds to the human Cluster of Differentiation 20 (CD20) antigen of which expression is restricted to B lymphocytes from the pre-B cell stage to the plasmacytoid immunoblast stage only. A recent trial with an anti-CD20 mAb (rituximab) demonstrated that targeting B-cells reduces the number of gadolinium-enhancing (GdE) T1 lesions and the relapse rate in relapsing-remitting multiple sclerosis (RRMS). Ofatumumab has been shown to be both well tolerated and efficacious in several indications, including a small, placebo-controlled trial in RRMS using an intravenous (IV) formulation. This double-blind, placebo-controlled, parallel-group study will investigate the safety and efficacy of a subcutaneous formulation of ofatumumab in the treatment of subjects with RRMS. The primary objective of the study is to investigate the efficacy as assessed by magnetic resonance imaging. Other objectives will include evaluation of tolerability/safety, dose-response relationship, pharmacokinetics, pharmacodynamics, exposure-response, as well as other clinical endpoints.
Primary Outcome
The cumulative number of new GdE T1 lesion at Week 12 were analyzed from screening based on magnetic resonance imaging (MRI) brain scans at Weeks 4, 8, and 12. The outcome measure was analyzed using an Emax model adjusting for the presence/absence of GdE lesions on the Screening MRI and assuming the number of new lesions followed a negative binomial distribution. Dose was fitted as a continuous variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset
Interventions
- DRUG Placebo
- DRUG Ofatumumab 3mg
- DRUG Ofatumumab 30mg
- DRUG Ofatumumab 60mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 232 participants |
| Start Date | 2011-11-01 |
| Est. Completion | 2015-06-10 |
| Phase | Phase 2 |
What the finished NCT01457924 record still lists
NCT01457924 is an interventional study that assigns participants to a tested intervention. The registered 232 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01457924 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01457924 about?
NCT01457924 is a clinical study titled "Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple Sclerosis". Ofatumumab is a novel Immunoglobulin 1ĸ ( IgG1ĸ) lytic monoclonal antibody (mAb) that specifically binds to the human Cluster of Differentiation 20 (CD20) antigen of which expression is restricted to B lymphocytes from the pre-B cell stage to the plasmacytoid immunoblast stage only. A recent trial w...
What is the current status of trial NCT01457924?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 232 participants. The study started on 2011-11-01. Estimated completion is 2015-06-10.
What interventions are being tested in trial NCT01457924?
The interventions under investigation include: Placebo (DRUG), Ofatumumab 3mg (DRUG), Ofatumumab 30mg (DRUG), Ofatumumab 60mg (DRUG).
Who is sponsoring clinical trial NCT01457924?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01457924's enrollment target sits among peer trials
232 256th of 2000 higher than 1,744 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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