Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With Rheumatoid Arthritis
NCT ID: NCT00550355
Last Updated: 2009-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
78 participants
INTERVENTIONAL
2007-08-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
PD 0360324
3 doses of PD 0360324 (Dose level 1) administered over 12 weeks
2
PD 0360324
3 doses of PD 0360324 (Dose level 2) administered over 12 weeks
3
PD 0360324
3 doses of PD 0360324 (Dose level 3) administered over 12 weeks
4
Placebo
3 doses of Placebo administered over 12 weeks
Interventions
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PD 0360324
3 doses of PD 0360324 (Dose level 1) administered over 12 weeks
PD 0360324
3 doses of PD 0360324 (Dose level 2) administered over 12 weeks
PD 0360324
3 doses of PD 0360324 (Dose level 3) administered over 12 weeks
Placebo
3 doses of Placebo administered over 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Must have been treated with methotrexate (≥7.5 mg/week to ≤25 mg/week) for at least 16 weeks immediately prior to enrollment. The dose of methotrexate must be stable for at least 6 weeks prior to enrollment.
* Females of childbearing potential are required to simultaneously use 2 effective contraceptive methods, 1 of which must be a barrier (condoms, diaphragm or cervical cap) with spermicide. Non-vasectomized men must be willing to abstain from sexual intercourse or willing to use a condom in addition to having their female partner use another form of contraception, if the woman could become pregnant from the time of the first dose of study medication until completion of follow up procedures
Exclusion Criteria
* Evidence of active or latent infection with Mycobacterium tuberculosis (TB).
* Use of etanercept, anakinra, or oral DMARDs with the exception of methotrexate, within the 4 weeks prior to enrollment. Use of biological DMARDs within the 8 (adalimumab or infliximab) or 12 (abatacept) or 56 (rituximab) weeks prior to enrollment. Use of oral corticosteroids, acetaminophen, NSAIDs, and opioids are permitted within the dose ranges defined in the protocol.
21 Years
70 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Peoria, Arizona, United States
Pfizer Investigational Site
Daytona Beach, Florida, United States
Pfizer Investigational Site
Port Orange, Florida, United States
Pfizer Investigational Site
Overland Park, Kansas, United States
Pfizer Investigational Site
Overland Park, Kansas, United States
Pfizer Investigational Site
Frederick, Maryland, United States
Pfizer Investigational Site
Lansing, Michigan, United States
Pfizer Investigational Site
Duncansville, Pennsylvania, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Buenos Aires, , Argentina
Pfizer Investigational Site
Pleven, , Bulgaria
Pfizer Investigational Site
Sofia, , Bulgaria
Pfizer Investigational Site
Sofia, , Bulgaria
Pfizer Investigational Site
Brno, , Czechia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
México, D.F., Mexico
Pfizer Investigational Site
Mexico City, Mexico City, Mexico
Pfizer Investigational Site
Bialystok, , Poland
Pfizer Investigational Site
Bialystok, , Poland
Pfizer Investigational Site
Krakow, , Poland
Pfizer Investigational Site
Krakow, , Poland
Pfizer Investigational Site
Warsaw, , Poland
Pfizer Investigational Site
Wroclaw, , Poland
Pfizer Investigational Site
Piešťany, , Slovakia
Pfizer Investigational Site
Santiago de Compostela, A CORUÑA, Spain
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6261002
Identifier Type: -
Identifier Source: org_study_id
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