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NCT02028884 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 85
- Enrollment target
NCT02028884: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT02028884 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 85 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02028884, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 85 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic, and immunogenic profiles of satralizumab, compared with placebo, in addition to baseline immunosuppressive treatment in participants with NMO and NMOSD.
Primary Outcome
TFR was defined as time from randomization to first occurrence of relapse in the DB period. Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neurological neuromyelitis optica (NMO) or neuromyelitis optica spectrum disorder (NMOSD) as adjudicated by an independent clinical endpoint committee (CEC). Symptoms had to persist for \>24 hours and not be attributable to confounding clinical factors (e.g., fever, infection, injury, change in mood, adverse
Interventions
- DRUG Placebo
- DRUG Satralizumab
- DRUG Baseline Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2014-02-20 |
| Est. Completion | 2021-12-23 |
| Phase | Phase 3 |
What the finished NCT02028884 record still lists
NCT02028884 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02028884 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02028884 about?
NCT02028884 is a clinical study titled "Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)". The objective of this study is to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic, and immunogenic profiles of satralizumab, compared with placebo, in addition to baseline immunosuppressive treatment in participants with NMO and NMOSD.
What is the current status of trial NCT02028884?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 85 participants. The study started on 2014-02-20. Estimated completion is 2021-12-23.
What interventions are being tested in trial NCT02028884?
The interventions under investigation include: Placebo (DRUG), Satralizumab (DRUG), Baseline Treatment (DRUG).
Who is sponsoring clinical trial NCT02028884?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02028884's enrollment target sits among peer trials
85 1747th of 2000 higher than 252 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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