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
2 other identifiers
interventional
86
13 countries
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 rheumatoid-arthritis
Started Oct 2009
Shorter than P25 for phase_2 rheumatoid-arthritis
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2009
CompletedFirst Posted
Study publicly available on registry
July 14, 2009
CompletedStudy Start
First participant enrolled
October 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2010
CompletedResults Posted
Study results publicly available
November 22, 2023
CompletedNovember 22, 2023
November 1, 2023
10 months
July 13, 2009
January 26, 2023
November 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 14
DAS28-4 (CRP) examines progression or improvement of RA. It was assessed from swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, CRP (normal range of CRP is less than (\<) 10 milligram per liter \[mg/L\], decrease in the level of CRP indicates reduction in inflammation) and participant global assessment (PGA) of disease activity (participant global assessment of diseases condition scores ranging from 0 \[very well condition\] to 100 \[very poor condition\], higher scores indicated greater affectation due to disease activity). Total DAS28-4 (CRP) transformed score range: 0 (least severe) to 10 (most severe), higher scores indicate more severe disease activity. DAS28-4 (CRP) scores: less than equal to (\<=) 3.2 implied low disease activity; greater than (\>) 3.2 to 5.1 implied moderate to high disease activity.
Baseline, Day 14
Secondary Outcomes (27)
Change From Baseline in Tender Joints Count at Day 7, 14, 42
Baseline, Day 7, 14, 42
Change From Baseline in Swollen Joints Count at Day 7, 14 and 42
Baseline, Day 7, 14, 42
Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42
Baseline, Day 7, 14, 42
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Day 7 and 14
Baseline, Day 7, 14
Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14
Baseline, Day 7, 14
- +22 more secondary outcomes
Study Arms (4)
PF-04171327 10 mg
EXPERIMENTALPF-04171327 25 mg
EXPERIMENTALPrednisone
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (41)
Anniston Medical Clinic, PC
Anniston, Alabama, 36207, United States
Pinnacle Research Group, LLC
Anniston, Alabama, 36207, United States
Allergy, Asthma, Arthritis and Lung
Daytona Beach, Florida, 32114, United States
Elite Research Institute
Miami, Florida, 33169, United States
Millennium Research
Ormond Beach, Florida, 32174, United States
Florida Medical Clinic, PA
Zephyrhills, Florida, 33542, United States
The Arthritis Center
Springfield, Illinois, 62704, United States
Premier Imaging Center
Bingham Farms, Michigan, 48025, United States
Quest Research Institute
Bingham Farms, Michigan, 48025, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
MEDIPONT Plus, s.r.o.
České Budějovice, 370 01, Czechia
ARTMEDI UPD s r.o.
Hostivice, 253 01, Czechia
Revmatologicka ambulance
Prague, 140 00, Czechia
Fakultni Thomayerova nemocnice s poliklinikou
Prague, 140 59, Czechia
DC Mediscan
Praha 11 - Chodov, 148 00, Czechia
Centre for Assessment and Treatment of Rheumatic Diseases, Department of Medicine and Geriatrics
New Territories, Hong Kong
Dr. Rethy Pal Korhaz es Rendelointezet\Reumatologia
Békéscsaba, 5600, Hungary
Synexus Magyarorszag Kft.
Budapest, H-1036, Hungary
Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum
Debrecen, 4032, Hungary
MAV Korhaz es Rendelointezet
Szolnok, H-5000, Hungary
Moscow SHI City Clinical Hospital #4, Department of Therapy of Moscow Faculty
Moscow, 115093, Russia
Institution of Russian Academy of Medical Sciences Research Institute of Rheumatology RAMS
Moscow, 115522, Russia
SI Saint-Petersburg SRI for Emergency Care named after I.I. Dzhanelidze
Saint Petersburg, 192242, Russia
Regional State Institution of Healthcare Smolensk Regional Clinical Hospital
Smolensk, 214018, Russia
Institute of Rheumatology
Belgrade, 11000, Serbia
Institute for Rheumatic and Cardiovascular Disease Niska Banja
Niška Banja, 18205, Serbia
Changi General Hospital
Singapore, 529889, Singapore
Narodny ustav reumatickych chorob, Klinicke oddelenie
Piešťany, 921 12, Slovakia
Nestatna reumatologicka ambulancia, MUDr. Pavol Polak, s.r.o.
Žilina, 010 01, Slovakia
Severance Hospital, Yonsei University College of Medicine, Rheumatology, Internal Medicine
Seoul, 120-752, South Korea
Hospital Nuestra Señora de La Esperanza
Santiago de Compostela, A Coruña, 15705, Spain
Hospital de Cruces
Barakaldo, Bilbao, 48903, Spain
Hospital de Basurto
Bilbao, Vizcaya, 48013, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Taichung Veterans General Hospital
Taichung, 407, Taiwan
Ankara University School fo Medicine
Ankara, 06100, Turkey (Türkiye)
Chair of Cardiology & Functional Diagnostic
Kharkiv, 61176, Ukraine
State Institution "Institute of Gerontology of AMS of Ukraine"
Kyiv, 04114, Ukraine
State Institution 'Institute of Gerontology of AMS of Ukraine'
Kyiv, 04114, Ukraine
Municipal City Clinical Hospital #4, Department of Rheumatology
Lviv, 79011, Ukraine
Vinnitsa Regional Clinical Hospital n.a. Pirogov
Vinnitsa, 21018, Ukraine
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2009
First Posted
July 14, 2009
Study Start
October 7, 2009
Primary Completion
July 29, 2010
Study Completion
July 29, 2010
Last Updated
November 22, 2023
Results First Posted
November 22, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.