A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis
Public ClinicalTrials.gov record NCT00109408. 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 Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.
Study identification
- NCT ID
- NCT00109408
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 673 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
- Jul 2005 (Type not available)
- Primary completion
- Dec 2007 (Actual)
- Completion
- Dec 2007 (Actual)
- Last update posted
- Nov 2, 2016
2005 – 2007
United States locations
- U.S. sites
- 70
- U.S. states
- 29
- U.S. cities
- 66
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Montgomery | Alabama | 36111 | — |
| Not listed | Mesa | Arizona | 85208 | — |
| Not listed | Paradise Valley | Arizona | 85253 | — |
| Not listed | Phoenix | Arizona | 85013 | — |
| Not listed | Little Rock | Arkansas | 72205 | — |
| Not listed | Huntington Beach | California | 92646 | — |
| Not listed | Long Beach | California | 90806 | — |
| Not listed | Los Angeles | California | 90045 | — |
| Not listed | Palm Springs | California | 92262 | — |
| Not listed | Sacramento | California | 95825 | — |
| Not listed | San Leandro | California | 94578 | — |
| Not listed | Santa Maria | California | 93454 | — |
| Not listed | Jupiter | Florida | 33458 | — |
| Not listed | Palm Habor | Florida | 34684 | — |
| Not listed | Palm Harbor | Florida | 34684 | — |
| Not listed | Port Orange | Florida | 32127 | — |
| Not listed | Tampa | Florida | 33609 | — |
| Not listed | Tampa | Florida | 33614 | — |
| Not listed | Idaho Falls | Idaho | 83404 | — |
| Not listed | Meridian | Idaho | 83642 | — |
| Not listed | Morton Grove | Illinois | 60053 | — |
| Not listed | Springfield | Illinois | 62704 | — |
| Not listed | Indianapolis | Indiana | 46202 | — |
| Not listed | Cedar Rapids | Iowa | 52401 | — |
| Not listed | Des Moines | Iowa | 50322 | — |
| Not listed | Bowling Green | Kentucky | 42102 | — |
| Not listed | Baton Rouge | Louisiana | 70808 | — |
| Not listed | Slidell | Louisiana | 70458 | — |
| Not listed | Greenbelt | Maryland | 20770 | — |
| Not listed | Pittsfield | Massachusetts | 01201 | — |
| Not listed | Grand Rapids | Michigan | 49546 | — |
| Not listed | Kalamazoo | Michigan | 49048 | — |
| Not listed | Lansing | Michigan | 48910 | — |
| Not listed | Eagan | Minnesota | 55121 | — |
| Not listed | Saint Cloud | Minnesota | 56303 | — |
| Not listed | Flowood | Mississippi | 39232 | — |
| Not listed | Tupelo | Mississippi | 38802 | — |
| Not listed | St Louis | Missouri | 63117 | — |
| Not listed | St Louis | Missouri | 63131 | — |
| Not listed | Dover | New Hampshire | 03820 | — |
| Not listed | Nashua | New Hampshire | 03060 | — |
| Not listed | Haddon Heights | New Jersey | 08035 | — |
| Not listed | New Brunswick | New Jersey | 08903 | — |
| Not listed | Albany | New York | 12206 | — |
| Not listed | Syracuse | New York | 13210 | — |
| Not listed | Fayetteville | North Carolina | 28304 | — |
| Not listed | Canton | Ohio | 44718 | — |
| Not listed | Mayfield | Ohio | 44143 | — |
| Not listed | Oklahoma City | Oklahoma | 73103 | — |
| Not listed | Oklahoma City | Oklahoma | 73109 | — |
| Not listed | Tulsa | Oklahoma | 74104 | — |
| Not listed | Tulsa | Oklahoma | 74135 | — |
| Not listed | Duncansville | Pennsylvania | 16635 | — |
| Not listed | Philadelphia | Pennsylvania | 19152 | — |
| Not listed | Willow Grove | Pennsylvania | 19090 | — |
| Not listed | Wyomissing | Pennsylvania | 19610 | — |
| Not listed | Charleston | South Carolina | 29406 | — |
| Not listed | Columbia | South Carolina | 29204 | — |
| Not listed | Greenville | South Carolina | 29601 | — |
| Not listed | Hickory Grove | South Carolina | 28602 | — |
| Not listed | Hixson | Tennessee | 37343 | — |
| Not listed | Nashville | Tennessee | 37203 | — |
| Not listed | Amarillo | Texas | 79124 | — |
| Not listed | Austin | Texas | 78705 | — |
| Not listed | Mesquite | Texas | 75150 | — |
| Not listed | Chesapeake | Virginia | 23320 | — |
| Not listed | Mountlake Terrace | Washington | 98043 | — |
| Not listed | Olympia | Washington | 98502 | — |
| Not listed | Spokane | Washington | 99204 | — |
| Not listed | Yakima | Washington | 98902 | — |
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 77 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00109408, 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 Nov 2, 2016 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00109408 live on ClinicalTrials.gov.