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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

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NCT00620685

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85013 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Adult with RA for at least 6 months

- Stable weekly dosage of oral methotrexate 12.5- 25 mg/week

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00620685
Pfizer
Completed
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

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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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • Drug: Placebo
    Tablet, once daily for 4 weeks
  • Drug: PH-797804
    Tablet, 1 mg PH-797804, once daily for 4 weeks
  • Drug: PH-797804
    Tablet, 5 mg PH-797804, once daily for 4 weeks
  • Placebo Comparator: 1
    Intervention: Drug: Placebo
  • Experimental: 2
    Intervention: Drug: PH-797804
  • Experimental: 3
    Intervention: Drug: PH-797804
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
October 2008
October 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult with RA for at least 6 months
  • Stable weekly dosage of oral methotrexate 12.5- 25 mg/week

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00620685
A6631005
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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