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

NCT00938587

Last updated date
Study Location
Pfizer Investigational Site
Anniston, Alabama, 36207, United States
Contact
1-800-718-1021

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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 30, 2010)
86
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2009)
80
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Hong Kong,   Hungary,   Korea, Republic of,   Russian Federation,   Serbia,   Singapore,   Slovakia,   Spain,   Taiwan,   Turkey,   Ukraine,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00938587
Other Study ID Numbers  ICMJE A9391005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP