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NCT02453256 · ClinicalTrials.gov registry record · Phase 3
A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 212
- Enrollment target
NCT02453256 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 212 participants.
The verdict
NCT02453256, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 212 participants
- Enrollment target
Study Summary
This study will assess the efficacy and safety of tocilizumab compared with placebo in participants with SSc across approximately 120 planned global study sites. The study will consist of a 48-week, double-blind, placebo-controlled period followed by a 48-week open-label treatment period. Participants will be assigned, in a 1:1 ratio, to double-blind treatment with active tocilizumab or matching placebo. In the open-label period, eligible participants from either arm may receive active tocilizumab.
Interventions
- DRUG Placebo
- DRUG Tocilizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 212 participants |
| Start Date | 2015-11-20 |
| Est. Completion | 2019-02-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02453256
The ClinicalTrials.gov registry entry for NCT02453256 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 212 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02453256 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02453256 about?
NCT02453256 is a clinical study titled "A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)". This study will assess the efficacy and safety of tocilizumab compared with placebo in participants with SSc across approximately 120 planned global study sites. The study will consist of a 48-week, double-blind, placebo-controlled period followed by a 48-week open-label treatment period. Participan...
What is the current status of trial NCT02453256?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 212 participants. The study started on 2015-11-20. Estimated completion is 2019-02-04.
What interventions are being tested in trial NCT02453256?
The interventions under investigation include: Placebo (DRUG), Tocilizumab (DRUG).
Who is sponsoring clinical trial NCT02453256?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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