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NCT00655824 · ClinicalTrials.gov registry record · Phase 2
Long-term Efficacy and Safety of Repeated Ofatumumab Treatment Courses in RA Patients Who Previously Received Ofatumumab or Placebo in Trial Hx-CD20-403
A Phase 2 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 2
- Development phase
- 124
- Enrollment target
NCT00655824: Clinical Trial Phase 2 study, sponsored by GlaxoSmithKline.
NCT00655824 is a Phase 2 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 124 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00655824, a Phase 2 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 124 participants
- Enrollment target
Study Summary
A 3-year open-label trial for patients who previously participated in Trial Hx-CD20-403 and who fulfill the eligibility criteria for this trial (GEN413) . Th e primary purpose of the trial is to evaluate the long-term effectiveness of repeated courses ( a maximum of 9 treatment courses) of ofatumumab in RA patients who previously received ofatumumab or placebo in Trial Hx-CD20-403.
Primary Outcome
Time to treatment withdrawal was defined as the time from the first infusion of ofatumumab until the date of treatment withdrawal. The sponsor discontinued the intravenous route of administration development program for rheumatoid arthritis (RA), and this study was terminated early; hence, this primary endpoint was not evaluated.
Interventions
- DRUG ofatumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2008-01-01 |
| Est. Completion | 2013-03-19 |
| Phase | Phase 2 |
Why NCT00655824 stopped before completion
NCT00655824 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which ofatumumab is the first listed.
NCT00655824 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00655824 about?
NCT00655824 is a clinical study titled "Long-term Efficacy and Safety of Repeated Ofatumumab Treatment Courses in RA Patients Who Previously Received Ofatumumab or Placebo in Trial Hx-CD20-403". A 3-year open-label trial for patients who previously participated in Trial Hx-CD20-403 and who fulfill the eligibility criteria for this trial (GEN413) . Th e primary purpose of the trial is to evaluate the long-term effectiveness of repeated courses ( a maximum of 9 treatment courses) of ofatumuma...
What is the current status of trial NCT00655824?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2008-01-01. Estimated completion is 2013-03-19.
What interventions are being tested in trial NCT00655824?
The interventions under investigation include: ofatumumab (DRUG).
Who is sponsoring clinical trial NCT00655824?
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 NCT00655824's enrollment target sits among peer trials
124 564th of 2000 higher than 1,437 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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