A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)
Public ClinicalTrials.gov record NCT02453256. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients With Systemic Sclerosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02453256
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 212 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 20, 2015 (Actual)
- Primary completion
- Jan 15, 2018 (Actual)
- Completion
- Feb 4, 2019 (Actual)
- Last update posted
- Mar 9, 2020
2015 – 2019
United States locations
- U.S. sites
- 16
- U.S. states
- 10
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| TriWest Research Associates, LLC | El Cajon | California | 92020 | — |
| St. Joseph's Heritage Healthcare | Fullerton | California | 92835 | — |
| Univ of Calif., Los Angeles; Rheumatology | Los Angeles | California | 90025 | — |
| Arthritis Associates of Southern California | Los Angeles | California | 90045 | — |
| Georgetown Uni. Hosp.; Rheumatology, Immunology and Allergy Dept. | Washington D.C. | District of Columbia | 20007 | — |
| Rheumatology Assoc. of S. Florida - Clinical Research Center | Boca Raton | Florida | 33486 | — |
| Millenium Research | Ormond Beach | Florida | 32174 | — |
| Boston Univ Med Center - AC | Boston | Massachusetts | 02118 | — |
| University of Michigan | Ann Arbor | Michigan | 48109-0934 | — |
| West Michigan Rheumatology, PLLC | Grand Rapids | Michigan | 49546 | — |
| Joint & Muscle Research Institute | Charlotte | North Carolina | 28204 | — |
| Arthritis and Rheumatology; Center of Oklahoma PLLC | Oklahoma City | Oklahoma | 73103 | — |
| Thomas Jefferson Uni ; Division of Rheumatology | Philadelphia | Pennsylvania | 19131 | — |
| Clinical Research Center of Reading | Wyomissing | Pennsylvania | 19610 | — |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | — |
| Metroplex Clinical Research | Dallas | Texas | 75231 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 67 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02453256, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 9, 2020 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02453256 live on ClinicalTrials.gov.