A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis Currently on Methotrexate Therapy
Public ClinicalTrials.gov record NCT00106522. 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 Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Study identification
- NCT ID
- NCT00106522
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 499 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
- May 2005 (Type not available)
- Primary completion
- Nov 2007 (Actual)
- Completion
- Nov 2007 (Actual)
- Last update posted
- Nov 2, 2016
2005 – 2007
United States locations
- U.S. sites
- 97
- U.S. states
- 36
- U.S. cities
- 84
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 35294 | — |
| Not listed | Huntsville | Alabama | 35801 | — |
| Not listed | Scottsdale | Arizona | 85251 | — |
| Not listed | Scottsdale | Arizona | 85258 | — |
| Not listed | Tucson | Arizona | 85724 | — |
| Not listed | Hot Springs | Arkansas | 71913 | — |
| Not listed | Little Rock | Arkansas | 72205 | — |
| Not listed | Anaheim | California | 92801 | — |
| Not listed | Fullerton | California | 92835 | — |
| Not listed | Long Beach | California | 90806 | — |
| Not listed | Long Beach | California | 90808 | — |
| Not listed | Los Angeles | California | 90095 | — |
| Not listed | Palm Desert | California | 92260 | — |
| Not listed | San Diego | California | 92101 | — |
| Not listed | San Diego | California | 92108 | — |
| Not listed | Santa Maria | California | 93454 | — |
| Not listed | Torrance | California | 90505 | — |
| Not listed | Colorado Springs | Colorado | 80910 | — |
| Not listed | Aventura | Florida | 33180 | — |
| Not listed | Boca Raton | Florida | 33486 | — |
| Not listed | Fort Lauderdale | Florida | 33334 | — |
| Not listed | Palm Habor | Florida | 34684 | — |
| Not listed | Sarasota | Florida | 34239 | — |
| Not listed | Tampa | Florida | 33614 | — |
| Not listed | Tavares | Florida | 32778 | — |
| Not listed | West Palm Beach | Florida | 33407 | — |
| Not listed | Zephyrhills | Florida | 33540 | — |
| Not listed | Atlanta | Georgia | 30342 | — |
| Not listed | Boise | Idaho | 83702 | — |
| Not listed | Meridian | Idaho | 83642 | — |
| Not listed | Chicago | Illinois | 60611 | — |
| Not listed | Springfield | Illinois | 62703 | — |
| Not listed | Springfield | Illinois | 62704 | — |
| Not listed | Indianapolis | Indiana | 46202-5100 | — |
| Not listed | Bowling Green | Kentucky | 42102 | — |
| Not listed | Elizabethtown | Kentucky | 42701 | — |
| Not listed | Lexington | Kentucky | 40515 | — |
| Not listed | Louisville | Kentucky | 40202 | — |
| Not listed | New Orleans | Louisiana | 70121 | — |
| Not listed | Portland | Maine | 04102 | — |
| Not listed | Baltimore | Maryland | 21201 | — |
| Not listed | Baltimore | Maryland | 21205 | — |
| Not listed | Wheaton | Maryland | 20902 | — |
| Not listed | Springfield | Massachusetts | 01107 | — |
| Not listed | Worcester | Massachusetts | 01605 | — |
| Not listed | Lansing | Michigan | 48910 | — |
| Not listed | Duluth | Minnesota | 55805 | — |
| Not listed | Rochester | Minnesota | 55905 | — |
| Not listed | Tupelo | Mississippi | 38802 | — |
| Not listed | St Louis | Missouri | 63110 | — |
| Not listed | St Louis | Missouri | 63128 | — |
| Not listed | St Louis | Missouri | 63131 | — |
| Not listed | St Louis | Missouri | 63141 | — |
| Not listed | Billings | Montana | 59107-5100 | — |
| Not listed | Missoula | Montana | 59802 | — |
| Not listed | Las Vegas | Nevada | 89119 | — |
| Not listed | Medford | New Jersey | 08055 | — |
| Not listed | Mercerville | New Jersey | 08619 | — |
| Not listed | Teaneck | New Jersey | 07666 | — |
| Not listed | Albany | New York | 12206 | — |
| Not listed | Binghamton | New York | 13905 | — |
| Not listed | Great Neck | New York | 11020 | — |
| Not listed | Johnson City | New York | 13790 | — |
| Not listed | New York | New York | 10003 | — |
| Not listed | New York | New York | 10021 | — |
| Not listed | Orchard Park | New York | 14127 | — |
| Not listed | Rochester | New York | 14618 | — |
| Not listed | Asheville | North Carolina | 28801 | — |
| Not listed | Chapel Hill | North Carolina | 27599-7280 | — |
| Not listed | Charlotte | North Carolina | 28210 | — |
| Not listed | Wilmington | North Carolina | 28401 | — |
| Not listed | Bismarck | North Dakota | 58501 | — |
| Not listed | Canton | Ohio | 44718 | — |
| Not listed | Cincinnati | Ohio | 45219 | — |
| Not listed | Oklahoma City | Oklahoma | 73103 | — |
| Not listed | Tulsa | Oklahoma | 74104 | — |
| Not listed | Tulsa | Oklahoma | 74135 | — |
| Not listed | Eugene | Oregon | 97401 | — |
| Not listed | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Not listed | Danville | Pennsylvania | 17822 | — |
| Not listed | Duncansville | Pennsylvania | 16635 | — |
| Not listed | Philadelphia | Pennsylvania | 19140 | — |
| Not listed | Philadelphia | Pennsylvania | 19152 | — |
| Not listed | Willow Grove | Pennsylvania | 80045 | — |
| Not listed | Hickory Grove | South Carolina | 28602 | — |
| Not listed | Jackson | Tennessee | 38305 | — |
| Not listed | Austin | Texas | 78705 | — |
| Not listed | Dallas | Texas | 75231-4406 | — |
| Not listed | Dallas | Texas | 75231 | — |
| Not listed | Houston | Texas | 77074 | — |
| Not listed | Ogden | Utah | 84403 | — |
| Not listed | Norfolk | Virginia | 23502 | — |
| Not listed | Richmond | Virginia | 23298 | — |
| Not listed | Salem | Virginia | 24153 | — |
| Not listed | Seattle | Washington | 98104 | — |
| Not listed | Seattle | Washington | 98195 | — |
| Not listed | Glendale | Wisconsin | 53217 | — |
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 71 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00106522, 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 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00106522 live on ClinicalTrials.gov.