A Study To Evaluate The Safety And Pharmacokinetic Profile Of A P38 Inhibitor (PH-797804) In Subjects With Rheumatoid Arthritis Who Are Also Taking Methotrexate
A 4-Week, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Safety And Pharmacokinetic Profile Of 1 And 5 Mg Ph-797804 Administered Once Daily In Subjects With Rheumatoid Arthritis Who Are Taking Oral Methotrexate
1 other identifier
interventional
27
1 country
7
Brief Summary
The hypothesis of this study is that the p38 inhibitor (PH-797804) will be safe and well tolerated in subjects with rheumatoid arthritis who are taking methotrexate and will not effect the blood levels of methotrexate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2008
Shorter than P25 for phase_2
7 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
First Submitted
Initial submission to the registry
January 10, 2008
CompletedFirst Posted
Study publicly available on registry
February 21, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedNovember 8, 2018
November 1, 2018
7 months
January 10, 2008
November 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events, laboratory data, vital signs, 12-lead ECGs and physical examination findings
6 weeks
Secondary Outcomes (1)
Estimate the effects of multiple doses of PH-797804 on the pharmacokinetic profile of methotrexate in subjects with RA taking a stable dose of MTX
6 weeks
Study Arms (3)
1
PLACEBO COMPARATOR2
EXPERIMENTAL3
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Adult with RA for at least 6 months
- Stable weekly dosage of oral methotrexate 12.5- 25 mg/week
You may not qualify if:
- Severe, progressive and/or uncontrolled other disease
- Chronic or recent serious infection; current infection
- Concomitant use of RA therapy other than methotrexate with some exceptions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (7)
Pfizer Investigational Site
Phoenix, Arizona, 85013, United States
Pfizer Investigational Site
Colorado Springs, Colorado, 80909, United States
Pfizer Investigational Site
Miami, Florida, 33169, United States
Pfizer Investigational Site
Frederick, Maryland, 21702, United States
Pfizer Investigational Site
Bingham Farms, Michigan, 48025, United States
Pfizer Investigational Site
Kalamazoo, Michigan, 49007, United States
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 10, 2008
First Posted
February 21, 2008
Study Start
March 1, 2008
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
November 8, 2018
Record last verified: 2018-11