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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00369928
• Other study ID #: 2006012
• Status: Completed
• Phase: Phase 2
• First received: August 29, 2006
• Last updated: August 4, 2011
• Start date: August 2006
• Est. completion date: January 2008

Study information

• Verified date: August 2011
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

The study will be conducted in North America and Europe at approximately 50 to 60 sites. Approximately 270 patients will be randomized, of which 189 are expected to complete the study.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Czech Republic	Research Facility	Ceska Lipa
Czech Republic	Research Facility	Hustopece
Czech Republic	Research Facility	Prague
Czech Republic	Research Facility	Uherske Hradiste
Czech Republic	Research Facility	Zlin
Hungary	Research Facility	Balatonfüred
Hungary	Research Facility	Budapest
Hungary	Research Facility	Eger
Hungary	Research Facility	Gyor
Hungary	Research Facility	Gyula
Hungary	Research Facility	Szolnok
Netherlands	Research Facility	Den Haag
Poland	Research Facility	Czestochowa
Poland	Research Facility	Dzialdowo
Poland	Research Facility	Elblag
Poland	Research Facility	Konskie
Poland	Research Facility	Krakow
Poland	Research Facility	Krakow
Poland	Research Facility	Lodz
Poland	Research Facility	Lublin
Poland	Research Facility	Poznan
Poland	Research Facility	Sopot
Poland	Research Facility	Szczecin
Poland	Research Facility	Torun
Poland	Research Facility	Warszawa
United Kingdom	Research Facility	Ashford
United Kingdom	Research Facility	Cambridge
United Kingdom	Research Facility	Glasgow
United Kingdom	Research Facility	Liverpool
United States	Research Facility	Austin	Texas
United States	Research Facility	Beverly Hills	California
United States	Research Facility	Charlotte	North Carolina
United States	Research Facility	Chiefland	Florida
United States	Research Facility	Dallas	Texas
United States	Research Facility	Dallas	Texas
United States	Research Facility	Decatur	Georgia
United States	Research Facility	Duncansville	Pennsylvania
United States	Research Facility	Dunedin	Florida
United States	Research Facility	Elizabeth	New Jersey
United States	Research Facility	Erie	Pennsylvania
United States	Research Facility	Ft. Lauderdale	Florida
United States	Research Facility	Hot Springs	Arkansas
United States	Research Facility	Marietta	Georgia
United States	Research Facility	Meridian	Idaho
United States	Research Facility	Minot	North Dakota
United States	Research Facility	Mission Viejo	California
United States	Research Facility	New Orleans	Louisiana
United States	Research Facility	Omaha	Nebraska
United States	Research Facility	Plainview	New York
United States	Research Facility	Rome	Georgia
United States	Research Facility	San Antonio	Texas
United States	Research Facility	Tavares	Florida
United States	Research Facility	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Countries where clinical trial is conducted

United States,  Czech Republic,  Hungary,  Netherlands,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No