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Completed Phase 3 Interventional Results available

A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis

ClinicalTrials.gov ID: NCT00531817

Public ClinicalTrials.gov record NCT00531817. 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.

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ClinicalTrials.gov public records Last synced Oct 17, 2026, 3:54 AM EDT

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 to Evaluate the Safety and Efficacy of Tocilizumab (TCZ) Versus Placebo in Combination With Disease Modifying Antirheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This 2-arm study assessed the safety and efficacy of tocilizumab versus placebo, both in combination with disease modifying antirheumatic drugs (DMARDs), in regard to reduction in signs and symptoms, in patients with moderate to severe active rheumatoid arthritis with an inadequate response to DMARDs. Patients were randomized in a ratio of 2:1 to receive either tocilizumab 8 mg/kg intravenously (IV) or placebo IV every 4 weeks. All patients also received stable antirheumatic therapy, including permitted DMARDs. The anticipated time on study treatment was 3-12 months and the target sample size was 500+ individuals.

Study identification

NCT ID
NCT00531817
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
619 participants

Conditions and interventions

Interventions

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
Oct 2007 (Type not available)
Primary completion
Jun 2009 (Actual)
Completion
Mar 2011 (Actual)
Last update posted
Aug 20, 2012

2007 – 2011

United States locations

U.S. sites
156
U.S. states
42
U.S. cities
138
Facility City State ZIP Site status
Not listed Birmingham Alabama 35205 —
Not listed Birmingham Alabama 35215 —
Not listed Birmingham Alabama 35294-7201 —
Not listed Montgomery Alabama 36111 —
Not listed Lake Havasu City Arizona 86403 —
Not listed Paradise Valley Arizona 85253 —
Not listed Peoria Arizona 85381 —
Not listed Scottsdale Arizona 85251 —
Not listed Scottsdale Arizona 85258 —
Not listed Jonesboro Arkansas 72401 —
Not listed Beverly Hills California 90211 —
Not listed Escondido California 92025 —
Not listed La Jolla California 92037 —
Not listed Long Beach California 90815 —
Not listed Los Angeles California 90095 —
Not listed Pasadena California 91107 —
Not listed Santa Maria California 93454 —
Not listed Santa Monica California 90404 —
Not listed Upland California 91786 —
Not listed Van Nuys California 91405 —
Not listed Walnut Creek California 94598 —
Not listed Whittier California 90606 —
Not listed Colorado Springs Colorado 80910 —
Not listed Trumbull Connecticut 06611 —
Not listed Washington D.C. District of Columbia 20006 —
Not listed Dunedin Florida 34698 —
Not listed Fort Lauderdale Florida 33334 —
Not listed Lake Mary Florida 32746 —
Not listed Melbourne Florida 32901 —
Not listed Miami Florida 33133 —
Not listed Ocala Florida 34474 —
Not listed Orange Park Florida 32073 —
Not listed Orlando Florida 32804 —
Not listed Palm Harbor Florida 34684 —
Not listed Plantation Florida 33317 —
Not listed Sarasota Florida 34239 —
Not listed Tamarac Florida 33321 —
Not listed Tampa Florida 33609 —
Not listed Atlanta Georgia 30342 —
Not listed Blue Ridge Georgia 30513 —
Not listed Fort Valley Georgia 31030 —
Not listed Tifton Georgia 311794 —
Not listed Boise Idaho 83702 —
Not listed Idaho Falls Idaho 83404 —
Not listed Nampa Idaho 83687 —
Not listed Downers Grove Illinois 60515 —
Not listed Springfield Illinois 62704 —
Not listed Evansville Indiana 47714 —
Not listed Munster Indiana 46321 —
Not listed South Bend Indiana 46601 —
Not listed Leawood Kansas 66209 —
Not listed Bowling Green Kentucky 42102 —
Not listed Lexington Kentucky 40515 —
Not listed Baton Rouge Louisiana 70808 —
Not listed Baton Rouge Louisiana 70810 —
Not listed Monroe Louisiana 71203 —
Not listed New Orleans Louisiana 70112 —
Not listed Wheaton Maryland 20902 —
Not listed Mansfield Massachusetts 02048 —
Not listed Worcester Massachusetts 01605 —
Not listed Worcester Massachusetts 01610 —
Not listed Kalamazoo Michigan 49009 —
Not listed Saint Clair Shores Michigan 48080 —
Not listed Eagan Minnesota 55121 —
Not listed Flowood Mississippi 39232 —
Not listed Tupelo Mississippi 38802 —
Not listed Florissant Missouri 63031 —
Not listed St Louis Missouri 63141 —
Not listed Billings Montana 59101 —
Not listed Kalispell Montana 59907 —
Not listed Missoula Montana 59802 —
Not listed Grand Island Nebraska 68803 —
Not listed Las Vegas Nevada 89106 —
Not listed Las Vegas Nevada 89128 —
Not listed Reno Nevada 89502 —
Not listed Dover New Hampshire 03820 —
Not listed Freehold New Jersey 07728 —
Not listed New Brunswick New Jersey 08903 —
Not listed Passaic New Jersey 07055 —
Not listed Teaneck New Jersey 07666 —
Not listed Mineola New York 11501 —
Not listed New York New York 10003 —
Not listed New York New York 10029 —
Not listed Orchard Park New York 14127 —
Not listed Smithtown New York 11787 —
Not listed The Bronx New York 10451 —
Not listed Belmont North Carolina 28012 —
Not listed Charlotte North Carolina 28209 —
Not listed Charlotte North Carolina 28210 —
Not listed Durham North Carolina 27704 —
Not listed Greensboro North Carolina 27408 —
Not listed Greenville North Carolina 27834 —
Not listed Hickory North Carolina 28601 —
Not listed Rock Hill North Carolina 29732 —
Not listed Akron Ohio 44333 —
Not listed Beechwood Ohio 44122 —
Not listed Mayfield Ohio 44143 —
Not listed Middleburg Heights Ohio 44130 —
Not listed Perrysburg Ohio 43551 —
Not listed Zanesville Ohio 43701 —
Not listed Norman Oklahoma 73069 —
Not listed Oklahoma City Oklahoma 73103 —
Not listed Oklahoma City Oklahoma 73104 —
Not listed Lake Oswego Oregon 97035 —
Not listed Portland Oregon 97239 —
Not listed Salem Oregon 97302 —
Not listed Bethlehem Pennsylvania 10817 —
Not listed Philadelphia Pennsylvania 19102 —
Not listed Philadelphia Pennsylvania 19152 —
Not listed Pittsburgh Pennsylvania 15261 —
Not listed Wexford Pennsylvania 15090 —
Not listed Willow Grove Pennsylvania 80045 —
Not listed Charleston South Carolina 29407 —
Not listed Columbia South Carolina 29204 —
Not listed Florence South Carolina 29506 —
Not listed Greenville South Carolina 29601 —
Not listed Myrtle Beach South Carolina 29572 —
Not listed Rapid City South Dakota 57701 —
Not listed Rapid City South Dakota 57702 —
Not listed Sioux Falls South Dakota 57105 —
Not listed Watertown South Dakota 57201 —
Not listed Crossville Tennessee 38555 —
Not listed Hendersonville Tennessee 37073 —
Not listed Jackson Tennessee 38305 —
Not listed Knoxville Tennessee 37909 —
Not listed Memphis Tennessee 38119 —
Not listed Nashville Tennessee 37203 —
Not listed Amarillo Texas 79106 —
Not listed Amarillo Texas 79124 —
Not listed Bellaire Texas 77401 —
Not listed Carrollton Texas 75007 —
Not listed Dallas Texas 75231 —
Not listed Fort Worth Texas 76107 —
Not listed Houston Texas 77004 —
Not listed Houston Texas 77034 —
Not listed Houston Texas 77074 —
Not listed Houston Texas 77090 —
Not listed Mesquite Texas 75150 —
Not listed San Antonio Texas 78217 —
Not listed San Antonio Texas 78229 —
Not listed San Antonio Texas 78258 —
Not listed Temple Texas 76508 —
Not listed Waco Texas 76708 —
Not listed Salt Lake City Utah 84132 —
Not listed Burlington Vermont 05401 —
Not listed Burke Virginia 22015 —
Not listed Reston Virginia 22102 —
Not listed Salem Virginia 24153 —
Not listed Seattle Washington 98133 —
Not listed Seattle Washington 98195 —
Not listed Spokane Washington 99204-2336 —
Not listed Beckley West Virginia 25801 —
Not listed Clarksburg West Virginia 26301 —
Not listed Milwaukee Wisconsin 53209 —
Not listed Onalaska Wisconsin 54605 —
Not listed 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 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00531817, 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 Aug 20, 2012 · Synced Oct 17, 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 NCT00531817 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →