Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate
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
1 other identifier
interventional
254
6 countries
53
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
Started Aug 2006
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 29, 2006
CompletedFirst Posted
Study publicly available on registry
August 30, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedResults Posted
Study results publicly available
September 8, 2011
CompletedSeptember 8, 2011
August 1, 2011
1.4 years
August 29, 2006
August 4, 2011
August 4, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Patients Meeting American College of Rheumatology 20 Response Criteria (ACR20) at 12weeks
percent, relative to baseline, of patients meeting the American College of Rheumatology 20 response criteria (ACR20) at 12weeks
12 weeks
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo, oral dose, BID
25 mg PG-760564
EXPERIMENTAL25 mg BID, of oral PG-760564
100 mg PG-760564
EXPERIMENTAL100 mg BID, of oral PG-760564
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
Research Facility
Hot Springs, Arkansas, 71913, United States
Research Facility
Beverly Hills, California, 90211, United States
Research Facility
Mission Viejo, California, 92691, United States
Research Facility
Chiefland, Florida, 32626, United States
Research Facility
Dunedin, Florida, 34698, United States
Research Facility
Fort Lauderdale, Florida, 33334, United States
Research Facility
Tavares, Florida, 32778, United States
Research Facility
Decatur, Georgia, 30033, United States
Research Facility
Marietta, Georgia, 30060, United States
Research Facility
Rome, Georgia, 30165, United States
Research Facility
Meridian, Idaho, 83642, United States
Research Facility
New Orleans, Louisiana, 70121, United States
Research Facility
Omaha, Nebraska, 68134, United States
Research Facility
Elizabeth, New Jersey, 07202, United States
Research Facility
Plainview, New York, 11803, United States
Research Facility
Charlotte, North Carolina, 28209, United States
Research Facility
Wilmington, North Carolina, 28401, United States
Research Facility
Minot, North Dakota, 58701, United States
Research Facility
Duncansville, Pennsylvania, 16635, United States
Research Facility
Erie, Pennsylvania, 16508, United States
Research Facility
Austin, Texas, 78705, United States
Research Facility
Dallas, Texas, 75231, United States
Research Facility
Dallas, Texas, 75235, United States
Research Facility
San Antonio, Texas, 78217, United States
Research Facility
Česká Lípa, Czechia
Research Facility
Hustopeče, Czechia
Research Facility
Prague, Czechia
Research Facility
Uherské Hradiště, Czechia
Research Facility
Zlín, Czechia
Research Facility
Balatonfüred, Hungary
Research Facility
Budapest, Hungary
Research Facility
Eger, Hungary
Research Facility
Győr, Hungary
Research Facility
Gyula, Hungary
Research Facility
Szolnok, Hungary
Research Facility
The Hague, Den Haag, 2545 CH, Netherlands
Research Facility
Częstochowa, Częstochowa, 42-200, Poland
Research Facility
Działdowo, Działdowo, 13-200, Poland
Research Facility
Elblag, Elbląg, 83-300, Poland
Research Facility
Gmina Końskie, Konskie, 26-200, Poland
Research Facility
Krakow, Krakow, 30-510, Poland
Research Facility
Krakow, Krakow, 31-121, Poland
Research Facility
Lublin, Lublin Voivodeship, 20-954, Poland
Research Facility
Poznan, Poznań, 60-733, Poland
Research Facility
Sopot, Sopot, 81-759, Poland
Research Facility
Szczecin, Szczecin, 71-252, Poland
Research Facility
Torun, Torun, 85-168, Poland
Research Facility
Warsaw, Warszawa, 00-909, Poland
Research Facility
Lodz, Łódź Voivodeship, 33-513, Poland
Research Facility
Ashford, Ashford, TW15 3AA, United Kingdom
Research Facility
Cambridge, Cambridge, United Kingdom
Research Facility
Glasgow, Glasgow, G20 0XA, United Kingdom
Research Facility
Liverpool, Liverpool, L9 7AL, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Thomas
- Organization
- Procter & Gamble
Study Officials
- STUDY DIRECTOR
Muhammad Rehman, MD
Procter and Gamble
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 29, 2006
First Posted
August 30, 2006
Study Start
August 1, 2006
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
September 8, 2011
Results First Posted
September 8, 2011
Record last verified: 2011-08