A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy

ClinicalTrials.gov ID: NCT00361335

Public ClinicalTrials.gov record NCT00361335. 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 2, 2026, 5:50 AM EDT

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Official title

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Brief summary

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

The purpose of this study is to assess the clinical effectiveness and safety of golimumab intravenous (IV) infusions every 12 weeks with or without Methotrexate (MTX), compared with MTX alone, in patients with active rheumatoid arthritis (RA) despite concurrent MTX treatment. In addition, the safety of subcutaneous (SC) golimumab injections following transition from IV golimumab infusions will also be evaluated.

Study identification

NCT ID: NCT00361335
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Centocor, Inc.; Industry
Enrollment: 643 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: Aug 31, 2006
Primary completion: Nov 30, 2007
Completion: Aug 31, 2009
Last update posted: Jul 28, 2014

2006 – 2009

United States locations

U.S. sites: 20
U.S. states: 11
U.S. cities: 20

Facility	City	State	ZIP	Site status
Not listed	Peoria	Arizona	—	—
Not listed	Aventura	Florida	—	—
Not listed	Orlando	Florida	—	—
Not listed	Tampa	Florida	—	—
Not listed	Atlanta	Georgia	—	—
Not listed	Lincoln	Nebraska	—	—
Not listed	Omaha	Nebraska	—	—
Not listed	Voorhees Township	New Jersey	—	—
Not listed	Albany	New York	—	—
Not listed	Roslyn	New York	—	—
Not listed	Charlotte	North Carolina	—	—
Not listed	Oklahoma City	Oklahoma	—	—
Not listed	Duncansville	Pennsylvania	—	—
Not listed	Norristown	Pennsylvania	—	—
Not listed	West Reading	Pennsylvania	—	—
Not listed	Willow Grove	Pennsylvania	—	—
Not listed	Amarillo	Texas	—	—
Not listed	Fort Worth	Texas	—	—
Not listed	Lubbock	Texas	—	—
Not listed	Spokane	Washington	—	—

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 52 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00361335, 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 Jul 28, 2014 · Synced Sep 2, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00361335 live on ClinicalTrials.gov.

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