Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate
NCT ID: NCT00369928
Last Updated: 2011-09-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
254 participants
INTERVENTIONAL
2006-08-31
2008-01-31
Brief Summary
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Detailed Description
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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. The washout period will be 4 weeks for sulfasalazine, hydroxychloroquine, azathioprine, D-penicillamine, etanercept, and anakinra, 8 weeks for gold, infliximab, and adalimumab, and 12 weeks for abatacept.
After the washout period, the 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 (Weeks 1, 2, 4, 6, 8, and 12) and a follow-up visit 4 weeks after the last treatment visit (Week 16). Patients will not initiate new therapies until after the 4-week follow-up is completed. Liver function tests will be evaluated at every visit.
The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response criteria after 12 weeks of treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo, oral dose, BID
Placebo dose
placebo, BID, oral for 12 weeks
25 mg PG-760564
25 mg BID, of oral PG-760564
PG-760564
25 mg BID, of oral PG-760564
100 mg PG-760564
100 mg BID, of oral PG-760564
PG-760564
100 mg BID, of oral PG-760564
Interventions
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PG-760564
100 mg BID, of oral PG-760564
Placebo dose
placebo, BID, oral for 12 weeks
PG-760564
25 mg BID, of oral PG-760564
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Procter and Gamble
INDUSTRY
Responsible Party
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Procter and Gamble Pharmaceuticals
Principal Investigators
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Muhammad Rehman, MD
Role: STUDY_DIRECTOR
Procter and Gamble
Locations
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Research Facility
Hot Springs, Arkansas, United States
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
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, Netherlands
Research Facility
Częstochowa, Częstochowa, Poland
Research Facility
Działdowo, Działdowo, Poland
Research Facility
Elblag, Elbląg, Poland
Research Facility
Gmina Końskie, Konskie, Poland
Research Facility
Krakow, Krakow, Poland
Research Facility
Krakow, Krakow, Poland
Research Facility
Lublin, Lublin Voivodeship, Poland
Research Facility
Poznan, Poznań, Poland
Research Facility
Sopot, Sopot, Poland
Research Facility
Szczecin, Szczecin, Poland
Research Facility
Torun, Torun, Poland
Research Facility
Warsaw, Warszawa, Poland
Research Facility
Lodz, Łódź Voivodeship, Poland
Research Facility
Ashford, Ashford, United Kingdom
Research Facility
Cambridge, Cambridge, United Kingdom
Research Facility
Glasgow, Glasgow, United Kingdom
Research Facility
Liverpool, Liverpool, United Kingdom
Countries
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Other Identifiers
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2006012
Identifier Type: -
Identifier Source: org_study_id
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