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NCT01569451 · ClinicalTrials.gov registry record · Phase 2
Comparison of Rituximab Induction Therapy Followed by Glatiramer Acetate
A Phase 2 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
NCT01569451: Completed Phase 2 study, sponsored by University of Colorado, Denver.
NCT01569451 is a Phase 2 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01569451, a Phase 2 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
Study Summary
The purpose of this study is (1) to determine if rituximab induction therapy followed by glatiramer acetate (GA) is substantially superior to placebo rituximab induction followed by GA for the treatment of clinically isolated syndrome (CIS) or relapsing forms of multiple sclerosis (RMS).
Primary Outcome
Defined as patients without new lesions on brain MRI using the combined unique lesion approach (CUL), without sustained change in EDSS score over any 3-month period and without relapse. If a clear treatment effect is sustained in the R-GA arm, defined as a ≥ 70% decrease in brain lesions on MRI, using a CUL approach, attributable to MS and ≥ 70% reduction in annual relapse rates, compared to the GA arm, the study will continue under the extension protocol. If induction therapy fails to show supe
Interventions
- OTHER Placebo
- DRUG Rituximab
- DRUG Glatiramer Acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2012-02 |
| Est. Completion | 2015-05 |
| Phase | Phase 2 |
What the finished NCT01569451 record still lists
NCT01569451 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01569451 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01569451 about?
NCT01569451 is a clinical study titled "Comparison of Rituximab Induction Therapy Followed by Glatiramer Acetate". The purpose of this study is (1) to determine if rituximab induction therapy followed by glatiramer acetate (GA) is substantially superior to placebo rituximab induction followed by GA for the treatment of clinically isolated syndrome (CIS) or relapsing forms of multiple sclerosis (RMS).
What is the current status of trial NCT01569451?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2012-02. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01569451?
The interventions under investigation include: Placebo (OTHER), Rituximab (DRUG), Glatiramer Acetate (DRUG).
Who is sponsoring clinical trial NCT01569451?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01569451's enrollment target sits among peer trials
53 1171st of 2000 higher than 820 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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