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Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Tucson, Arizona, 85704 United States
Contact
1-800-718-1021
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
19+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects must have documented rheumatoid arthritis with a duration of at least 3
months as determined by the investigator using standardly accepted criteria, must have
been receiving methotrexate for at least 3 months to treat their rheumatoid arthritis,
and must be free of any signs or symptoms of infection.

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

- Subjects cannot enter the study if they have recently received treatment with certain
medications which might interfere with study medications;

- subjects cannot enter if they have abnormalities in certain blood tests, history of
cancer, recent bone fracture or other significant conditions.

NCT01393639
Pfizer
Completed
Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis

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Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis
A Phase 2, Randomized, Double Blind Assessment Of Efficacy And Safety Of PF-04171327 (1, 5, 10, 15 Mg Dose, Daily) Compared To 5 Mg And 10 Mg Prednisone Daily And Placebo Daily In Subjects With Rheumatoid Arthritis Over An 8 Week Period Followed By A 4 Week Period Of Tapering Of Study Drug
The purpose of this study is to compare the safety and efficacy of multiple doses of PF-04171327, an experimental glucocorticoid drug, to prednisone at 5 mg or 10 mg and placebo in the treatment of rheumatoid arthritis. All subjects will also be receiving background treatment of methotrexate for their rheumatoid arthritis. Study medication will be given for eight weeks followed by a 4 week period during which the dose of study medication will be gradually reduced. The efficacy of the study medications will be determined by assessing severity of the rheumatoid arthritis during the study and safety will be determined by adverse event reporting, laboratory tests and biomarker analysis.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: PF-04171327
    1 mg tablet once daily (QD) for 8 weeks
  • Drug: PF-04171327
    5 mg tablet once daily (QD) for 8 weeks
  • Drug: PF-04171327
    10 mg tablet once daily (QD) for 8 weeks
  • Drug: PF-04171327
    15 mg tablet once daily (QD) for 8 weeks
  • Drug: prednisone
    5 mg capsule once daily for 8 weeks
  • Other: prednisone
    10 mg capsule once daily for 8 weeks
  • Other: placebo
    placebo (tablet or capsule) once daily (QD) for 8 weeks
  • Experimental: PF-04171327 1 mg QD
    Intervention: Drug: PF-04171327
  • Experimental: PF-04171327 5 mg QD
    Intervention: Drug: PF-04171327
  • Experimental: PF-04171327 10 mg QD
    Intervention: Drug: PF-04171327
  • Experimental: PF-04171327 15 mg QD
    Intervention: Drug: PF-04171327
  • Active Comparator: prednisone 5 mg QD
    Intervention: Drug: prednisone
  • Active Comparator: prednisone 10 mg QD
    Intervention: Other: prednisone
  • Placebo Comparator: placebo
    Intervention: Other: placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
323
June 2014
June 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must have documented rheumatoid arthritis with a duration of at least 3 months as determined by the investigator using standardly accepted criteria, must have been receiving methotrexate for at least 3 months to treat their rheumatoid arthritis, and must be free of any signs or symptoms of infection.

Exclusion Criteria:

  • Subjects cannot enter the study if they have recently received treatment with certain medications which might interfere with study medications;
  • subjects cannot enter if they have abnormalities in certain blood tests, history of cancer, recent bone fracture or other significant conditions.
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Colombia,   Czech Republic,   Germany,   Hungary,   India,   Korea, Republic of,   Malaysia,   Mexico,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Ukraine,   United States
Canada
 
NCT01393639
A9391010
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2014

ICMJE     Data element required by the

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

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