A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy

ClinicalTrials.gov ID: NCT00468546

Public ClinicalTrials.gov record NCT00468546. 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 Sep 24, 2026, 3:51 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, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Alpha Therapies

Brief summary

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

This study will assess the safety and efficacy of rituximab combined with MTX in participants with active rheumatoid arthritis (RA) who have had an inadequate response to anti-Tumor Necrosis (TNF) alpha therapy. The anticipated time in the study is up to 2 years and the target sample size is 500 participants. Eligible participants may receive re-treatment with rituximab under a separate protocol WA17531.

Study identification

NCT ID: NCT00468546
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 520 participants

Conditions and interventions

Conditions

Rheumatoid Arthritis

Interventions

Drug · Other

Eligibility (public fields only)

Age range: 18 Years to 80 Years
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: Apr 30, 2003
Primary completion: Dec 31, 2004
Completion: Jun 30, 2012
Last update posted: Oct 24, 2016

2003 – 2012

United States locations

U.S. sites: 67
U.S. states: 25
U.S. cities: 57

Facility	City	State	ZIP	Site status
Not listed	Birmingham	Alabama	35294	—
Not listed	Mesa	Arizona	85208	—
Not listed	Paradise Valley	Arizona	85253	—
Not listed	Tucson	Arizona	85724	—
Not listed	Little Rock	Arkansas	72205	—
Not listed	Fullerton	California	92835	—
Not listed	La Jolla	California	92037	—
Not listed	Los Angeles	California	90045	—
Not listed	Los Angeles	California	90048	—
Not listed	Palo Alto	California	94304	—
Not listed	Pasadena	California	91105	—
Not listed	Rancho Mirage	California	92270	—
Not listed	Santa Maria	California	93454	—
Not listed	Upland	California	91786	—
Not listed	Danbury	Connecticut	06810	—
Not listed	Boca Raton	Florida	33486	—
Not listed	Delray Beach	Florida	33484	—
Not listed	Fort Lauderdale	Florida	33334	—
Not listed	Jupiter	Florida	33458	—
Not listed	Largo	Florida	33773	—
Not listed	Orlando	Florida	32806	—
Not listed	Boise	Idaho	83702	—
Not listed	Coeur d'Alene	Idaho	83814	—
Not listed	Meridian	Idaho	83642	—
Not listed	Chicago	Illinois	60612	—
Not listed	Chicago	Illinois	60637	—
Not listed	Indianapolis	Indiana	46202-5149	—
Not listed	Indianapolis	Indiana	46260	—
Not listed	Shreverport	Louisiana	71103	—
Not listed	Baltimore	Maryland	21224	—
Not listed	Boston	Massachusetts	02215	—
Not listed	Kalamazoo	Michigan	49048	—
Not listed	Lansing	Michigan	48910	—
Not listed	Rochester	Minnesota	55905	—
Not listed	St Louis	Missouri	63110	—
Not listed	St Louis	Missouri	63141	—
Not listed	Albany	New York	12206	—
Not listed	Manhasset	New York	11030	—
Not listed	New York	New York	10003	—
Not listed	Rochester	New York	14618	—
Not listed	Smithtown	New York	11787	—
Not listed	Chapel Hill	North Carolina	27599-7600	—
Not listed	Durham	North Carolina	27710	—
Not listed	Greenville	North Carolina	27834	—
Not listed	Cincinnati	Ohio	45267-0563	—
Not listed	Cleveland	Ohio	44195	—
Not listed	Dayton	Ohio	45402	—
Not listed	Mayfield	Ohio	44143	—
Not listed	Oklahoma City	Oklahoma	73103	—
Not listed	Oklahoma City	Oklahoma	73109	—
Not listed	Tulsa	Oklahoma	74135	—
Not listed	Duncansville	Pennsylvania	16635	—
Not listed	Philadelphia	Pennsylvania	19140	—
Not listed	Philadelphia	Pennsylvania	19141	—
Not listed	Philadelphia	Pennsylvania	19152	—
Not listed	Amarillo	Texas	79124	—
Not listed	Dallas	Texas	75231	—
Not listed	Dallas	Texas	75246	—
Not listed	Houston	Texas	77074	—
Not listed	Waco	Texas	76708	—
Not listed	Salt Lake City	Utah	84132	—
Not listed	Burlington	Vermont	05401	—
Not listed	Seattle	Washington	98101	—
Not listed	Seattle	Washington	98104	—
Not listed	Spokane	Washington	99204	—
Not listed	Madison	Wisconsin	53717	—
Not listed	Madison	Wisconsin	53792	—

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 48 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00468546, 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 Oct 24, 2016 · Synced Sep 24, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00468546 live on ClinicalTrials.gov.

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