A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis
NCT ID: NCT00938587
Last Updated: 2023-11-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
86 participants
INTERVENTIONAL
2009-10-07
2010-07-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PF-04171327 10 mg
PF-04171327 10 mg
PF-04171327 10 mg tablet every day for 14 days
Prednisone Placebo
Placebo for Prednisone 5 mg tablet every day for 14 days
PF-04171327 25 mg
PF-04171327 25 mg
PF-04171327 25 mg tablet every day for 14 days
Prednisone Placebo
Placebo for Prednisone 5 mg tablet every day for 14 days
Prednisone
Prednisone 5 mg
Prednisone 5 mg tablet every day for 14 days
Placebo for PF-04171327
Placebo for PF-04171327 every day for 14 days
Placebo
Placebo
Placebo tablet every day for 14 days
Placebo for PF-04171327
Placebo tablet every day for 14 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PF-04171327 10 mg
PF-04171327 10 mg tablet every day for 14 days
Prednisone Placebo
Placebo for Prednisone 5 mg tablet every day for 14 days
PF-04171327 25 mg
PF-04171327 25 mg tablet every day for 14 days
Prednisone Placebo
Placebo for Prednisone 5 mg tablet every day for 14 days
Prednisone 5 mg
Prednisone 5 mg tablet every day for 14 days
Placebo for PF-04171327
Placebo for PF-04171327 every day for 14 days
Placebo
Placebo tablet every day for 14 days
Placebo for PF-04171327
Placebo tablet every day for 14 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Anniston Medical Clinic, PC
Anniston, Alabama, United States
Pinnacle Research Group, LLC
Anniston, Alabama, United States
Allergy, Asthma, Arthritis and Lung
Daytona Beach, Florida, United States
Elite Research Institute
Miami, Florida, United States
Millennium Research
Ormond Beach, Florida, United States
Florida Medical Clinic, PA
Zephyrhills, Florida, United States
The Arthritis Center
Springfield, Illinois, United States
Premier Imaging Center
Bingham Farms, Michigan, United States
Quest Research Institute
Bingham Farms, Michigan, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
MEDIPONT Plus, s.r.o.
České Budějovice, , Czechia
ARTMEDI UPD s r.o.
Hostivice, , Czechia
Revmatologicka ambulance
Prague, , Czechia
Fakultni Thomayerova nemocnice s poliklinikou
Prague, , Czechia
DC Mediscan
Praha 11 - Chodov, , 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, , Hungary
Synexus Magyarorszag Kft.
Budapest, , Hungary
Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum
Debrecen, , Hungary
MAV Korhaz es Rendelointezet
Szolnok, , Hungary
Moscow SHI City Clinical Hospital #4, Department of Therapy of Moscow Faculty
Moscow, , Russia
Institution of Russian Academy of Medical Sciences Research Institute of Rheumatology RAMS
Moscow, , Russia
SI Saint-Petersburg SRI for Emergency Care named after I.I. Dzhanelidze
Saint Petersburg, , Russia
Regional State Institution of Healthcare Smolensk Regional Clinical Hospital
Smolensk, , Russia
Institute of Rheumatology
Belgrade, , Serbia
Institute for Rheumatic and Cardiovascular Disease Niska Banja
Niška Banja, , Serbia
Changi General Hospital
Singapore, , Singapore
Narodny ustav reumatickych chorob, Klinicke oddelenie
Piešťany, , Slovakia
Nestatna reumatologicka ambulancia, MUDr. Pavol Polak, s.r.o.
Žilina, , Slovakia
Severance Hospital, Yonsei University College of Medicine, Rheumatology, Internal Medicine
Seoul, , South Korea
Hospital Nuestra Señora de La Esperanza
Santiago de Compostela, A Coruña, Spain
Hospital de Cruces
Barakaldo, Bilbao, Spain
Hospital de Basurto
Bilbao, Vizcaya, Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Taichung Veterans General Hospital
Taichung, , Taiwan
Ankara University School fo Medicine
Ankara, , Turkey (Türkiye)
Chair of Cardiology & Functional Diagnostic
Kharkiv, , Ukraine
State Institution "Institute of Gerontology of AMS of Ukraine"
Kyiv, , Ukraine
State Institution 'Institute of Gerontology of AMS of Ukraine'
Kyiv, , Ukraine
Municipal City Clinical Hospital #4, Department of Rheumatology
Lviv, , Ukraine
Vinnitsa Regional Clinical Hospital n.a. Pirogov
Vinnitsa, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-013223-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A9391005
Identifier Type: -
Identifier Source: org_study_id