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

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00369928

Run by

Procter and Gamble

People needed

254

Starts

2006-08-01

Expected to finish

2008-01-01

Last updated by the study team

2011-09-08

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meet American College of Rheumatology (ACR) criteria for Rheumatoid Arthritis
• Disease duration of at least 6 months
• Must be treated with Methotrexate for at least 24 weeks
• At least 6 swollen joints and 6 tender joints
• Washout required for other Disease Modifying Anti-rheumatic Drugs (DMARDs)
• Women of childbearing age and all males must use acceptable method of birth control

You may not qualify if…

• Tuberculosis
• Malignancies
• Abnormal electrocardiograms as described in the protocol
• Current infection or recurrent infections or immunodeficiency
• Liver diseases and abnormalities in liver function tests as described in the protocol
• Autoimmune diseases other than RA except Sjogren's syndrome secondary to RA;
• History of demyelization diseases
• Any condition that in the opinion of the investigator could be detrimental to patients enrolling in the study including clinically important changes in laboratory values and other diseases described in the protocol

Where it is running

• Research Facility — Beverly Hills, California, United States
• Research Facility — Mission Viejo, California, United States
• Research Facility — Chiefland, Florida, United States
• Research Facility — Dunedin, Florida, United States
• Research Facility — Fort Lauderdale, Florida, United States
• Research Facility — Tavares, Florida, United States
• Research Facility — Decatur, Georgia, United States
• Research Facility — Marietta, Georgia, United States
• Research Facility — Rome, Georgia, United States
• Research Facility — Meridian, Idaho, United States
• Research Facility — New Orleans, Louisiana, United States
• Research Facility — Omaha, Nebraska, United States
• Research Facility — Elizabeth, New Jersey, United States
• Research Facility — Plainview, New York, United States
• Research Facility — Charlotte, North Carolina, United States
• Research Facility — Wilmington, North Carolina, United States
• Research Facility — Minot, North Dakota, United States
• Research Facility — Duncansville, Pennsylvania, United States
• Research Facility — Erie, Pennsylvania, United States
• Research Facility — Austin, Texas, United States
• Research Facility — Dallas, Texas, United States
• Research Facility — Dallas, Texas, United States
• Research Facility — San Antonio, Texas, United States
• Research Facility — Česká Lípa, Czechia
• Research Facility — Hot Springs, Arkansas, United States

Full record on ClinicalTrials.gov

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