A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
Public ClinicalTrials.gov record NCT01232569. 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 Randomized, Double-blind, Parallel Group Study of Safety and the Effect on Clinical Outcome of Tocilizumab Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with active, moderate to severe rheumatoid arthritis. In the double-blind part of the study, patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study, patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from Week 24 to Week 96 using a pre-filled syringe or an auto-injector.
Study identification
- NCT ID
- NCT01232569
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 656 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
- Mar 2011 (Type not available)
- Primary completion
- May 2012 (Actual)
- Completion
- Nov 2013 (Actual)
- Last update posted
- Jul 29, 2015
2011 – 2013
United States locations
- U.S. sites
- 44
- U.S. states
- 18
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Peoria | Arizona | 85381 | — |
| Not listed | Scottsdale | Arizona | 85258 | — |
| Not listed | Tucson | Arizona | 85723 | — |
| Not listed | Tucson | Arizona | 85724 | — |
| Not listed | Fullerton | California | 92835 | — |
| Not listed | San Diego | California | 92108 | — |
| Not listed | San Leandro | California | 94578 | — |
| Not listed | West Hills | California | 91307 | — |
| Not listed | Trumbull | Connecticut | 06611 | — |
| Not listed | Boca Raton | Florida | 33486 | — |
| Not listed | Jupiter | Florida | 33458 | — |
| Not listed | Ormond Beach | Florida | 32174 | — |
| Not listed | Sarasota | Florida | 34292 | — |
| Not listed | Gainesville | Georgia | 30501 | — |
| Not listed | Idaho Falls | Idaho | 83404 | — |
| Not listed | Meridan | Idaho | 83642 | — |
| Not listed | Springfield | Illinois | 62704 | — |
| Not listed | Vernon Hills | Illinois | 60061 | — |
| Not listed | Crofton | Maryland | 21114 | — |
| Not listed | Hagerstown | Maryland | 21740 | — |
| Not listed | Wheaton | Maryland | 20902 | — |
| Not listed | Flowood | Mississippi | 39232 | — |
| Not listed | Jackson | Mississippi | 39202 | — |
| Not listed | St Louis | Missouri | 63128 | — |
| Not listed | St Louis | Missouri | 63141 | — |
| Not listed | Lincoln | Nebraska | 68516 | — |
| Not listed | Brooklyn | New York | 11201 | — |
| Not listed | Belmont | North Carolina | 28012 | — |
| Not listed | Charlotte | North Carolina | 28204 | — |
| Not listed | Charlotte | North Carolina | 28207 | — |
| Not listed | Charlotte | North Carolina | 28211 | — |
| Not listed | Oklahoma City | Oklahoma | 73104 | — |
| Not listed | Allentown | Pennsylvania | 18103 | — |
| Not listed | Bethlehem | Pennsylvania | 18015 | — |
| Not listed | Duncansville | Pennsylvania | 16635 | — |
| Not listed | Wexford | Pennsylvania | 15090 | — |
| Not listed | Wyomissing | Pennsylvania | 19610 | — |
| Not listed | Memphis | Tennessee | 38104 | — |
| Not listed | Dallas | Texas | 75246 | — |
| Not listed | Fort Worth | Texas | 76107 | — |
| Not listed | Houston | Texas | 77034 | — |
| Not listed | Houston | Texas | 77459 | — |
| Not listed | San Antonio | Texas | 78232 | — |
| Not listed | Tacoma | Washington | 98405 | — |
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 97 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01232569, 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 Jul 29, 2015 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01232569 live on ClinicalTrials.gov.