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A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Anniston, Alabama, 36207 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
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients ≥ 18 years of age, diagnosed with rheumatoid arthritis for a minimum duration
of 3 months

- On stable dose of methotrexate for at least 6 weeks prior to screening

- Patient must have minimum disease activity level of ≥ 6 tender/painful joints, ≥ 6
swollen joints and CRP ≥ 0.7 mg/dL

- Not currently receiving steroid medication

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

- Pregnant or nursing women

- Patients that have active infections, TB, HIV and/or Hepatitis B or C

- Patients that have a history of intolerance or significant adverse effects with the
use of glucocorticoids

NCT00938587
Pfizer
Completed
A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis

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A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis
A Phase 2a, Randomized, Double-Blind, Active And Placebo-Controlled Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis
This study will investigate the safety and efficacy of an investigational drug, PF-04171327 on the signs and symptoms of rheumatoid arthritis in patients that require glucocorticoids while on background methotrexate. This study will also look at the response of chemical and biological markers in rheumatoid arthritis patients. Lastly, this study will measure the PK (amount of drug in the blood) of methotrexate while patients may be taking PF-04171327.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: PF-04171327 10 mg
    PF-04171327 10 mg tablet every day for 14 days
  • Other: Prednisone Placebo
    Placebo for Prednisone 5 mg tablet every day for 14 days
  • Drug: PF-04171327 25 mg
    PF-04171327 25 mg tablet every day for 14 days
  • Drug: Prednisone 5 mg
    Prednisone 5 mg tablet every day for 14 days
  • Other: Placebo for PF-04171327
    Placebo for PF-04171327 every day for 14 days
  • Other: Placebo
    Placebo tablet every day for 14 days
  • Other: Placebo for PF-04171327
    Placebo tablet every day for 14 days
  • Experimental: PF-04171327 10 mg
    Interventions:
    • Drug: PF-04171327 10 mg
    • Other: Prednisone Placebo
  • Experimental: PF-04171327 25 mg
    Interventions:
    • Drug: PF-04171327 25 mg
    • Other: Prednisone Placebo
  • Active Comparator: Prednisone
    Interventions:
    • Drug: Prednisone 5 mg
    • Other: Placebo for PF-04171327
  • Placebo Comparator: Placebo
    Interventions:
    • Other: Placebo
    • Other: Placebo for PF-04171327
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
July 2010
July 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients ? 18 years of age, diagnosed with rheumatoid arthritis for a minimum duration of 3 months
  • On stable dose of methotrexate for at least 6 weeks prior to screening
  • Patient must have minimum disease activity level of ? 6 tender/painful joints, ? 6 swollen joints and CRP ? 0.7 mg/dL
  • Not currently receiving steroid medication

Exclusion Criteria:

  • Pregnant or nursing women
  • Patients that have active infections, TB, HIV and/or Hepatitis B or C
  • Patients that have a history of intolerance or significant adverse effects with the use of glucocorticoids
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Hong Kong,   Hungary,   Korea, Republic of,   Russian Federation,   Serbia,   Singapore,   Slovakia,   Spain,   Taiwan,   Turkey,   Ukraine,   United States
 
 
NCT00938587
A9391005
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2011

ICMJE     Data element required by the

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

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