Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
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 Oct 26, 2026, 6:21 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
Apr 2006 (Type not available)
Primary completion
Dec 2007 (Actual)
Completion
Dec 2007 (Actual)
Last update posted
Nov 2, 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 2, 2016 · Synced Oct 26, 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 NCT00303563 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →