Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate
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.
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
- Enrollment
- 254 participants
Conditions and interventions
Conditions
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
- Aug 2006 (Type not available)
- Primary completion
- Jan 2008 (Actual)
- Completion
- Jan 2008 (Actual)
- Last update posted
- Sep 8, 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 8, 2011 · Synced Oct 31, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00369928 live on ClinicalTrials.gov.