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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: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT02453256 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 212 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The efficacy of TCZ vs placebo is evaluated in terms of in mean change in mRSS. Skin thickness will be assessed by palpation and rated using an mRSS that ranges from 0 (normal) to 3 (severe skin thickening) across 17 different body sites. The total score is the sum of the individual skin scores from all of these sites and ranges from 0 to 51 units.
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 |
What the finished NCT02453256 record still lists
NCT02453256 is an interventional study that assigns participants to a tested intervention. The registered 212 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02453256 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02453256's enrollment target sits among peer trials
212 1335th of 2000 higher than 664 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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