Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate

ClinicalTrials.gov ID: NCT00369928

Public ClinicalTrials.gov record NCT00369928. 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 12, 2026, 2:07 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 Multicenter, Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG-760564 in Adult Patients With RA Receiving Methotrexate

Brief summary

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

This will be a 12-week, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the safety, efficacy, and PK of oral administration of PG-760564 in adult patients with active RA receiving treatment with MTX. Two oral doses of PG-760564 will be evaluated: 25 mg BID and 100 mg BID. The study will consist of a screening visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and anti-cytokine therapies except MTX. After the washout period, patients determined to be eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or placebo for 12 weeks. There will be 6 treatment visits and a follow-up visit 4 weeks after the last treatment visit. The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response criteria after 12 weeks of treatment.

Study identification

NCT ID: NCT00369928
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Procter and Gamble; Industry
Enrollment: 254 participants

Conditions and interventions

Conditions

Rheumatoid Arthritis

Interventions

PG-760564 Drug
Placebo dose Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 70 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: Jul 31, 2006
Primary completion: Dec 31, 2007
Completion: Dec 31, 2007
Last update posted: Sep 7, 2011

2006 – 2008

United States locations

U.S. sites: 24
U.S. states: 13
U.S. cities: 23

Facility	City	State	ZIP	Site status
Research Facility	Hot Springs	Arkansas	71913	—
Research Facility	Beverly Hills	California	90211	—
Research Facility	Mission Viejo	California	92691	—
Research Facility	Chiefland	Florida	32626	—
Research Facility	Dunedin	Florida	34698	—
Research Facility	Fort Lauderdale	Florida	33334	—
Research Facility	Tavares	Florida	32778	—
Research Facility	Decatur	Georgia	30033	—
Research Facility	Marietta	Georgia	30060	—
Research Facility	Rome	Georgia	30165	—
Research Facility	Meridian	Idaho	83642	—
Research Facility	New Orleans	Louisiana	70121	—
Research Facility	Omaha	Nebraska	68134	—
Research Facility	Elizabeth	New Jersey	07202	—
Research Facility	Plainview	New York	11803	—
Research Facility	Charlotte	North Carolina	28209	—
Research Facility	Wilmington	North Carolina	28401	—
Research Facility	Minot	North Dakota	58701	—
Research Facility	Duncansville	Pennsylvania	16635	—
Research Facility	Erie	Pennsylvania	16508	—
Research Facility	Austin	Texas	78705	—
Research Facility	Dallas	Texas	75231	—
Research Facility	Dallas	Texas	75235	—
Research Facility	San Antonio	Texas	78217	—

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 29 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00369928, 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 Sep 7, 2011 · Synced Sep 12, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00369928 live on ClinicalTrials.gov.

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