A Study to Assess the Effect of Tocilizumab + Methotrexate on Prevention of Structural Joint Damage in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)

ClinicalTrials.gov ID: NCT00106535

Public ClinicalTrials.gov record NCT00106535. 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 23, 2026, 10:16 PM 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 Study of Safety and Prevention of Structural Joint Damage During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis

Brief summary

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

This 3 arm study will compare the safety and efficacy, with respect to a reduction in signs and symptoms and prevention of joint damage, of tocilizumab versus placebo, both in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients will be randomized to receive tocilizumab 4 mg/kg IV, tocilizumab 8 mg/kg IV or placebo IV, every 4 weeks. All patients will also receive methotrexate, 10-25 mg/week. The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals. After completion of the 2 year study participants could participate in the optional 3 year open label extension phase (year 3 to 5).

Study identification

NCT ID: NCT00106535
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 1,196 participants

Conditions and interventions

Conditions

Rheumatoid Arthritis

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: Jan 2005 (Type not available)
Primary completion: May 2007 (Actual)
Completion: Jul 2012 (Actual)
Last update posted: Feb 6, 2014

2005 – 2012

United States locations

U.S. sites: 61
U.S. states: 26
U.S. cities: 60

Facility	City	State	ZIP	Site status
Not listed	Birmingham	Alabama	35233-7333	—
Not listed	Huntsville	Alabama	35801	—
Not listed	Scottsdale	Arizona	85251	—
Not listed	Tucson	Arizona	85724	—
Not listed	Anaheim	California	92801	—
Not listed	Long Beach	California	90806	—
Not listed	Los Angeles	California	90095	—
Not listed	San Diego	California	92108	—
Not listed	San Francisco	California	94118	—
Not listed	Santa Maria	California	93454	—
Not listed	Torrance	California	90505	—
Not listed	Boulder	Colorado	80304	—
Not listed	Colorado Springs	Colorado	80910	—
Not listed	Denver	Colorado	80230	—
Not listed	Aventura	Florida	33180	—
Not listed	Fort Lauderdale	Florida	33334	—
Not listed	Tampa	Florida	33614	—
Not listed	West Palm Beach	Florida	33407	—
Not listed	Boise	Idaho	83702	—
Not listed	Coeur d'Alene	Idaho	83814	—
Not listed	Idaho Falls	Idaho	83404	—
Not listed	Meridan	Idaho	83642	—
Not listed	Chicago	Illinois	60612-3824	—
Not listed	Rockford	Illinois	61103	—
Not listed	Indianapolis	Indiana	46202-5100	—
Not listed	Lexington	Kentucky	40515	—
Not listed	Frederick	Maryland	21702	—
Not listed	Hagerstown	Maryland	21740	—
Not listed	Wheaton	Maryland	20902	—
Not listed	St Louis	Missouri	63131	—
Not listed	St Louis	Missouri	63141	—
Not listed	Billings	Montana	59101	—
Not listed	Missoula	Montana	59802	—
Not listed	Reno	Nevada	89502	—
Not listed	Dover	New Hampshire	03820	—
Not listed	Medford	New Jersey	08055	—
Not listed	Voorhees Township	New Jersey	08043	—
Not listed	Albany	New York	12206	—
Not listed	Brooklyn	New York	11201	—
Not listed	Lake Success	New York	11042	—
Not listed	New York	New York	10016	—
Not listed	Stony Brook	New York	11794-8161	—
Not listed	Asheville	North Carolina	28801	—
Not listed	Charlotte	North Carolina	28211	—
Not listed	Raleigh	North Carolina	27609	—
Not listed	Wilmington	North Carolina	28401	—
Not listed	Canton	Ohio	44718	—
Not listed	Oklahoma City	Oklahoma	73109	—
Not listed	Tulsa	Oklahoma	74135	—
Not listed	Eugene	Oregon	97401	—
Not listed	Bethlehem	Pennsylvania	18015	—
Not listed	Duncansville	Pennsylvania	16635	—
Not listed	Philadelphia	Pennsylvania	19140	—
Not listed	Wyomissing	Pennsylvania	19610	—
Not listed	Columbia	South Carolina	29204	—
Not listed	Nashville	Tennessee	37203	—
Not listed	Dallas	Texas	75231	—
Not listed	San Antonio	Texas	78217	—
Not listed	Olympia	Washington	98502	—
Not listed	Seattle	Washington	98104	—
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 91 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00106535, 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 Feb 6, 2014 · Synced Oct 23, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00106535 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →