Clinical trial NCT00369928: Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2006-08-30
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Patients Meeting American College of Rheumatology 20 Response Criteria (ACR20) at 12weeks
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Research Facility
state: Arkansas
city: Beverly Hills
country: United States
facility: Research Facility
state: California
city: Mission Viejo
country: United States
facility: Research Facility
state: California
city: Chiefland
country: United States
facility: Research Facility
state: Florida
city: Dunedin
country: United States
facility: Research Facility
state: Florida
city: Ft. Lauderdale
country: United States
facility: Research Facility
state: Florida
city: Tavares
country: United States
facility: Research Facility
state: Florida
city: Decatur
country: United States
facility: Research Facility
state: Georgia
city: Marietta
country: United States
facility: Research Facility
state: Georgia
city: Rome
country: United States
facility: Research Facility
state: Georgia
city: Meridian
country: United States
facility: Research Facility
state: Idaho
city: New Orleans
country: United States
facility: Research Facility
state: Louisiana
city: Omaha
country: United States
facility: Research Facility
state: Nebraska
city: Elizabeth
country: United States
facility: Research Facility
state: New Jersey
city: Plainview
country: United States
facility: Research Facility
state: New York
city: Charlotte
country: United States
facility: Research Facility
state: North Carolina
city: Wilmington
country: United States
facility: Research Facility
state: North Carolina
city: Minot
country: United States
facility: Research Facility
state: North Dakota
city: Duncansville
country: United States
facility: Research Facility
state: Pennsylvania
city: Erie
country: United States
facility: Research Facility
state: Pennsylvania
city: Austin
country: United States
facility: Research Facility
state: Texas
city: Dallas
country: United States
facility: Research Facility
state: Texas
city: Dallas
country: United States
facility: Research Facility
state: Texas
city: San Antonio
country: United States
facility: Research Facility
state: Texas
city: Ceska Lipa
country: Czech Republic
facility: Research Facility
city: Hustopece
country: Czech Republic
facility: Research Facility
city: Prague
country: Czech Republic
facility: Research Facility
city: Uherske Hradiste
country: Czech Republic
facility: Research Facility
city: Zlin
country: Czech Republic
facility: Research Facility
city: Balatonfüred
country: Hungary
facility: Research Facility
city: Budapest
country: Hungary
facility: Research Facility
city: Eger
country: Hungary
facility: Research Facility
city: Gyor
country: Hungary
facility: Research Facility
city: Gyula
country: Hungary
facility: Research Facility
city: Szolnok
country: Hungary
facility: Research Facility
city: Den Haag
country: Netherlands
facility: Research Facility
city: Częstochowa
country: Poland
facility: Research Facility
city: Działdowo
country: Poland
facility: Research Facility
city: Elbląg
country: Poland
facility: Research Facility
city: Konskie
country: Poland
facility: Research Facility
city: Krakow
country: Poland
facility: Research Facility
city: Krakow
country: Poland
facility: Research Facility
city: Lodz
country: Poland
facility: Research Facility
city: Lublin
country: Poland
facility: Research Facility
city: Poznań
country: Poland
facility: Research Facility
city: Sopot
country: Poland
facility: Research Facility
city: Szczecin
country: Poland
facility: Research Facility
city: Torun
country: Poland
facility: Research Facility
city: Warszawa
country: Poland
facility: Research Facility
city: Ashford
country: United Kingdom
facility: Research Facility
city: Cambridge
country: United Kingdom
facility: Research Facility
city: Glasgow
country: United Kingdom
facility: Research Facility
city: Liverpool
country: United Kingdom
facility: Research Facility
Study officials:
affiliation: Procter and Gamble
name: Muhammad Rehman, MD
role: STUDY_DIRECTOR
References: