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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-04171327 10 mg
Prednisone Placebo
PF-04171327 25 mg
Prednisone Placebo
Prednisone 5 mg
Placebo for PF-04171327
Placebo
Placebo for PF-04171327
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis Glucocorticoids Prednisone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

PF-04171327 10 mg

PF-04171327 25 mg

Prednisone

Placebo

Arm Description

Outcomes

Primary Outcome Measures

DAS28-4 (CRP)

Secondary Outcome Measures

Tender/painful and swollen joint count
CRP
Health Assessment Questionnaire-Disability Index
Patient Global Assessment of Arthritis and Arthritis Pain
Physician Global Assessment of Arthritis
SF-36 version 2 (acute)
DAS28-3
ACR 20/50/70 responder rate
Adverse events
Clinical laboratory abnormalities
Vital signs including weight
12-lead ECG
MTX clearance prior to dosing and in the presence of PF-00251802
Pharmacodynamic effects on biomarkers

Full Information

First Posted
July 13, 2009
Last Updated
November 30, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00938587
Brief Title
A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis Glucocorticoids Prednisone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-04171327 10 mg
Arm Type
Experimental
Arm Title
PF-04171327 25 mg
Arm Type
Experimental
Arm Title
Prednisone
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PF-04171327 10 mg
Intervention Description
PF-04171327 10 mg tablet every day for 14 days
Intervention Type
Other
Intervention Name(s)
Prednisone Placebo
Intervention Description
Placebo for Prednisone 5 mg tablet every day for 14 days
Intervention Type
Drug
Intervention Name(s)
PF-04171327 25 mg
Intervention Description
PF-04171327 25 mg tablet every day for 14 days
Intervention Type
Other
Intervention Name(s)
Prednisone Placebo
Intervention Description
Placebo for Prednisone 5 mg tablet every day for 14 days
Intervention Type
Drug
Intervention Name(s)
Prednisone 5 mg
Intervention Description
Prednisone 5 mg tablet every day for 14 days
Intervention Type
Other
Intervention Name(s)
Placebo for PF-04171327
Intervention Description
Placebo for PF-04171327 every day for 14 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet every day for 14 days
Intervention Type
Other
Intervention Name(s)
Placebo for PF-04171327
Intervention Description
Placebo tablet every day for 14 days
Primary Outcome Measure Information:
Title
DAS28-4 (CRP)
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Tender/painful and swollen joint count
Time Frame
14 days
Title
CRP
Time Frame
14 days
Title
Health Assessment Questionnaire-Disability Index
Time Frame
14 days
Title
Patient Global Assessment of Arthritis and Arthritis Pain
Time Frame
14 days
Title
Physician Global Assessment of Arthritis
Time Frame
14 days
Title
SF-36 version 2 (acute)
Time Frame
14 days
Title
DAS28-3
Time Frame
14 days
Title
ACR 20/50/70 responder rate
Time Frame
14 days
Title
Adverse events
Time Frame
42 days
Title
Clinical laboratory abnormalities
Time Frame
42 days
Title
Vital signs including weight
Time Frame
42 days
Title
12-lead ECG
Time Frame
14 days
Title
MTX clearance prior to dosing and in the presence of PF-00251802
Time Frame
14 days
Title
Pharmacodynamic effects on biomarkers
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Pfizer Investigational Site
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Pfizer Investigational Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Pfizer Investigational Site
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Pfizer Investigational Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Pfizer Investigational Site
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
Pfizer Investigational Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Pfizer Investigational Site
City
Ceske Budejovice
ZIP/Postal Code
370 01
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Hostivice
ZIP/Postal Code
253 01
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Praha 11 - Chodov
ZIP/Postal Code
148 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Pfizer Investigational Site
City
New Territories
ZIP/Postal Code
0
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
H-1036
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Szolnok
ZIP/Postal Code
H-5000
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
115093
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Pfizer Investigational Site
City
Niska Banja
ZIP/Postal Code
18205
Country
Serbia
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Facility Name
Pfizer Investigational Site
City
Piestany
ZIP/Postal Code
921 12
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Zilina
ZIP/Postal Code
010 01
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15705
Country
Spain
Facility Name
Pfizer Investigational Site
City
Baracaldo
State/Province
Bilbao
ZIP/Postal Code
48903
Country
Spain
Facility Name
Pfizer Investigational Site
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Pfizer Investigational Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Pfizer Investigational Site
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Kharkiv
ZIP/Postal Code
61176
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kyiv
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Lviv
ZIP/Postal Code
79011
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Vinnitsa
ZIP/Postal Code
21018
Country
Ukraine

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9391005&StudyName=A%20Study%20Of%20PF-04171327%20In%20The%20Treatment%20Of%20The%20Signs%20And%20Symptoms%20Of%20Rheumatoid%20Arthritis
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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