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Completed Phase 2 Interventional

A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis

ClinicalTrials.gov ID: NCT00303563

Public ClinicalTrials.gov record NCT00303563. 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.

ClinicalTrials.gov public records Last synced Sep 9, 2026, 6:14 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 to Compare the Effect of RO4402257 Monotherapy and Methotrexate Monotherapy on Disease Response in Patients With Active Rheumatoid Arthritis.

Brief summary

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

This 4 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of P38 Inhibitor (4) (50, 150 or 300mg po qd) monotherapy versus methotrexate monotherapy in adult patients with active rheumatoid arthritis. Patients will be randomized to receive one of 3 doses of P38 Inhibitor (4) or methotrexate. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.

Study identification

NCT ID
NCT00303563
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
204 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
Mar 31, 2006
Primary completion
Nov 30, 2007
Completion
Nov 30, 2007
Last update posted
Nov 1, 2016

2006 – 2007

United States locations

U.S. sites
22
U.S. states
15
U.S. cities
21
Facility City State ZIP Site status
Not listed Anniston Alabama 36207
Not listed Scottsdale Arizona 85251
Not listed Tucson Arizona 85704
Not listed Tucson Arizona 85712
Not listed Escondido California 92025
Not listed Loma Linda California 92357
Not listed Stamford Connecticut 06905
Not listed Morton Grove Illinois 60053
Not listed South Bend Indiana 46601
Not listed Wichita Kansas 67207
Not listed Louisville Kentucky 40292
Not listed New Orleans Louisiana 70115
Not listed Belmont North Carolina 28012
Not listed Bend Oregon 97701
Not listed Danville Pennsylvania 17822
Not listed Lancaster Pennsylvania 17604
Not listed Charleston South Carolina 29407
Not listed Knoxville Tennessee 37909
Not listed Memphis Tennessee 38104
Not listed Nashville Tennessee 37203
Not listed Amarillo Texas 79106
Not listed Dallas Texas 75231

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 39 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00303563, 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 1, 2016 · Synced Sep 9, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00303563 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →