A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid Arthritis
Public ClinicalTrials.gov record NCT01194414. 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 the Safety and Effect on Clinical Outcome of Tocilizumab SC Versus Tocilizumab IV, 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, double-blind, parallel group study compares the efficacy and safety of subcutaneous (sc) versus intravenous (iv) administration of tocilizumab in participants with moderate to severe active rheumatoid arthritis. Participants were randomized to receive either tocilizumab 162 mg sc weekly plus iv placebo every 4 weeks, or tocilizumab 8 mg/kg iv every 4 weeks plus sc placebo weekly during the double-blind period from baseline to Week 24. The double-blind period was followed by a 72-week open-label treatment with some switching of sc and iv administration. No placebo was administered in the open-label phase. Participants continued on their stable dose of disease-modifying antirheumatic drugs (DMARDs) throughout the study. Anticipated time on study treatment was 2 years.
Study identification
- NCT ID
- NCT01194414
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,262 participants
Conditions and interventions
Conditions
Interventions
- tocilizumab SC Drug
- tocilizumab IV Drug
- placebo to tocilizumab SC Drug
- placebo to tocilizumab IV Drug
- Disease-modifying antirheumatic drugs (DMARDs) Drug
Drug
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
- Sep 2010 (Type not available)
- Primary completion
- Jan 2012 (Actual)
- Completion
- Aug 2013 (Actual)
- Last update posted
- Jun 20, 2016
2010 – 2013
United States locations
- U.S. sites
- 54
- U.S. states
- 25
- U.S. cities
- 51
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Huntsville | Alabama | 35801 | — |
| Not listed | Tuscaloosa | Alabama | 35406 | — |
| Not listed | Tucson | Arizona | 85704 | — |
| Not listed | Tucson | Arizona | 85712 | — |
| Not listed | Long Beach | California | 90806 | — |
| Not listed | Los Angeles | California | 90048 | — |
| Not listed | Upland | California | 91786 | — |
| Not listed | Van Nuys | California | 91405 | — |
| Not listed | Denver | Colorado | 80230-7127 | — |
| Not listed | Bridgeport | Connecticut | 06606 | — |
| Not listed | Delray Beach | Florida | 33484 | — |
| Not listed | Miami | Florida | 33133 | — |
| Not listed | Ocala | Florida | 34474 | — |
| Not listed | Orlando | Florida | 32806 | — |
| Not listed | Palm Harbor | Florida | 34684 | — |
| Not listed | Pinellas Park | Florida | 33782 | — |
| Not listed | South Miami | Florida | 33143 | — |
| Not listed | Tampa | Florida | 33614 | — |
| Not listed | Coeur d'Alene | Idaho | 83814 | — |
| Not listed | Morton Grove | Illinois | 60053 | — |
| Not listed | Wichita | Kansas | 67208 | — |
| Not listed | Monroe | Louisiana | 71203 | — |
| Not listed | Petoskey | Michigan | 49770 | — |
| Not listed | Saint Claire Shores | Michigan | 48081 | — |
| Not listed | Eagan | Minnesota | 55121 | — |
| Not listed | Florissant | Missouri | 63031 | — |
| Not listed | St Louis | Missouri | 63117 | — |
| Not listed | St Louis | Missouri | 63131 | — |
| Not listed | Lebanon | New Hampshire | 03756 | — |
| Not listed | Clifton | New Jersey | 07012 | — |
| Not listed | Manalapan | New Jersey | 07726 | — |
| Not listed | Voorhees Township | New Jersey | 08043 | — |
| Not listed | Albuquerque | New Mexico | 87102 | — |
| Not listed | Albany | New York | 12206 | — |
| Not listed | Binghamton | New York | 13905 | — |
| Not listed | Orchard Park | New York | 14127 | — |
| Not listed | Asheville | North Carolina | 28803 | — |
| Not listed | Raleigh | North Carolina | 27609 | — |
| Not listed | Wilmington | North Carolina | 28401 | — |
| Not listed | Cincinnati | Ohio | 45219 | — |
| Not listed | Toledo | Ohio | 43623 | — |
| Not listed | Oklahoma City | Oklahoma | 73103 | — |
| Not listed | Tulsa | Oklahoma | 74135 | — |
| Not listed | Bethlehem | Pennsylvania | 18015 | — |
| Not listed | Charleston | South Carolina | 29406 | — |
| Not listed | Charleston | South Carolina | 29407 | — |
| Not listed | Knoxville | Tennessee | 37909 | — |
| Not listed | Memphis | Tennessee | 38119 | — |
| Not listed | Houston | Texas | 77004 | — |
| Not listed | San Antonio | Texas | 78217 | — |
| Not listed | Olympia | Washington | 98502 | — |
| Not listed | Seattle | Washington | 98122 | — |
| Not listed | Spokane | Washington | 99204 | — |
| Not listed | Wenatchee | Washington | 98801 | — |
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 162 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01194414, 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 Jun 20, 2016 · Synced Nov 1, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01194414 live on ClinicalTrials.gov.