An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA)
Public ClinicalTrials.gov record NCT01791153. 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 Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of tocilizumab in participants with GCA. The study will consist of 2 parts: a 52-week double-blind treatment period (Part 1) followed by a 104-week open label long-term follow-up period (Part 2). In Part 1 of the study eligible participants will be randomized to receive either tocilizumab every week (qw) or every 2 weeks (q2w) or placebo for 52 weeks, with tapering oral daily doses of prednisone. After Week 52, participants in remission will stop study treatment and enter long-term follow-up, whereas participants with disease activity or flares will receive open-label tocilizumab or other treatment at the discretion of the investigator for a maximum period of 104 weeks.
Study identification
- NCT ID
- NCT01791153
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 251 participants
Conditions and interventions
Conditions
Interventions
- Tocilizumab Drug
- Prednisone Drug
- Tocilizumab Placebo Drug
- Prednisone Placebo Drug
- Corticosteroids Drug
- Methotrexate Drug
Drug
Eligibility (public fields only)
- Age range
- 50 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
- Jul 22, 2013 (Actual)
- Primary completion
- Apr 11, 2016 (Actual)
- Completion
- Jun 4, 2018 (Actual)
- Last update posted
- Feb 6, 2020
2013 – 2018
United States locations
- U.S. sites
- 14
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ of Calif., Los Angeles; Rheumatology | Los Angeles | California | 90025 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Rheumatology Assoc. of S. Florida - Clinical Research Center | Boca Raton | Florida | 33486 | — |
| Sarasota Arthritis Res Center | Sarasota | Florida | 34239 | — |
| Four Rivers Clinical Research Inc. | Paducah | Kentucky | 42003 | — |
| Rheumatology Associates | Portland | Maine | 04102 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Shores Rheumatology | Saint Clair Shores | Michigan | 48081 | — |
| Mayo Clinic Rochester | Rochester | Minnesota | 55902 | — |
| Hospital For Special Surgery; Dept of Medicine - Rheumatology | New York | New York | 10021 | — |
| Asheville Arthritis & Osteoporosis Center, PA | Asheville | North Carolina | 28803 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| University of Utah; Division of Rheumatology | Salt Lake City | Utah | 84132 | — |
| Marshfield Clinic Wausau Ctr | Wausau | Wisconsin | 54401 | — |
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 64 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01791153, 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 Feb 6, 2020 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01791153 live on ClinicalTrials.gov.