Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis
A PHASE 2, RANDOMIZED, DOUBLE BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF 04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG.
2 other identifiers
interventional
323
18 countries
93
Brief Summary
The purpose of this study is to compare the safety and efficacy of multiple doses of PF-04171327, an experimental glucocorticoid drug, to prednisone at 5 mg or 10 mg and placebo in the treatment of rheumatoid arthritis. All subjects will also be receiving background treatment of methotrexate for their rheumatoid arthritis. Study medication will be given for eight weeks followed by a 4 week period during which the dose of study medication will be gradually reduced. The efficacy of the study medications will be determined by assessing severity of the rheumatoid arthritis during the study and safety will be determined by adverse event reporting, laboratory tests and biomarker analysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
Started Sep 2011
Longer than P75 for phase_2 rheumatoid-arthritis
93 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
June 13, 2011
CompletedFirst Posted
Study publicly available on registry
July 13, 2011
CompletedStudy Start
First participant enrolled
September 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2014
CompletedResults Posted
Study results publicly available
September 4, 2024
CompletedSeptember 4, 2024
August 1, 2024
2.7 years
June 13, 2011
January 12, 2023
August 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of Participants Achieving a 20% Improvement in American College of Rheumatology (ACR) Criteria at Week 8
ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Week 8
Mean Percent Change From Baseline in 0 Hour Procollagen Type 1 N Terminal Propeptide (P1NP) at Week 8 (Comparisons to Prednisone 5 mg)
Change from baseline in P1NP at week 8 is presented in this outcome measure.
Week 8
Mean Percent Change From Baseline in 0 Hour Urinary N Telopeptide/Urinary Creatinine (uNTx/uCr) at Week 8 (Comparisons to Prednisone 5 mg)
Change from baseline in uNTx/uCr at week 8 is presented in this outcome measure.
Week 8
Secondary Outcomes (25)
Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg)
Weeks 2, 4, and 12 (taper period)
Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg)
Weeks 2, 4, 6, 8, and 12 (taper period)
Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg)
Weeks 2, 4, 6, 8, and 12 (taper period)
Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg)
Weeks 2, 4, 6, and 8
Change From Baseline in Tender-Joint Counts at Week 12 (Descriptive Statistics)
Week 12
- +20 more secondary outcomes
Study Arms (7)
PF-04171327 1 mg QD
EXPERIMENTALPF-04171327 5 mg QD
EXPERIMENTALPF-04171327 10 mg QD
EXPERIMENTALPF-04171327 15 mg QD
EXPERIMENTALprednisone 5 mg QD
ACTIVE COMPARATORprednisone 10 mg QD
ACTIVE COMPARATORplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Subjects must have documented rheumatoid arthritis with a duration of at least 3 months as determined by the investigator using standardly accepted criteria, must have been receiving methotrexate for at least 3 months to treat their rheumatoid arthritis, and must be free of any signs or symptoms of infection.
You may not qualify if:
- Subjects cannot enter the study if they have recently received treatment with certain medications which might interfere with study medications;
- subjects cannot enter if they have abnormalities in certain blood tests, history of cancer, recent bone fracture or other significant conditions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (93)
Catalina Pointe Clinical Research, Inc.
Tucson, Arizona, 85704, United States
C. Michael Neuwelt, MD, Inc.
San Leandro, California, 94578, United States
Javed Rheumatology Associates, Inc.
Newark, Delaware, 19713, United States
Allergy, Asthma, Arthritis, and Lung Center
Daytona Beach, Florida, 32114, United States
Millennium Research
Ormond Beach, Florida, 32174, United States
Alastair C. Kennedy, MD
Vero Beach, Florida, 32960, United States
The Center for Arthritis and Rheumatism
Vero Beach, Florida, 32960, United States
Arthritis and Osteoporosis Medical Associates, PLLC
Brooklyn, New York, 11201, United States
Cincinnati Rheumatic Disease Study Group, Inc.
Cincinnati, Ohio, 45219, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Low Country Rheumatology, PA
Charleston, South Carolina, 29406, United States
Tricounty Radiology
Charleston, South Carolina, 29406, United States
Accurate Clinical Research, Inc.
Houston, Texas, 77034, United States
Arthritis Northwest, PLLC
Spokane, Washington, 99204, United States
Revmatologichen kabinet, DKTs Sv. Pantaleimon OOD
Pleven, 5800, Bulgaria
Revmatologichno Otdelenie, MBAL - Plovdiv
Plovdiv, 4000, Bulgaria
MBAL "Sveti Ivan Rilski" Sofia; Klinika po Revmatologia
Sofia, 1612, Bulgaria
MBAL Sveti Ivan Rilski Sofia; Klinika po Revmatologia
Sofia, 1612, Bulgaria
Hospital Pablo Tobon Uribe
Medellín, Antioquia, Colombia
Reumalab S.A.S
Medellín, Antioquia, Colombia
Centro Integral de Reumatologia e Inmunologia CIREI
Bogota, Cundinamarca, 110221, Colombia
Preventive Care SAS
Chía, Cundinamarca, 250001, Colombia
Revmatologie Bruntal, S.R.O.
Bruntál, 79201, Czechia
Revmatologicka ambulance
Ostrava - Poruba, 70800, Czechia
Revmatologicka ambulance
Prague, 140 00, Czechia
Thomayerova nemocnice
Prague, 140 59, Czechia
Charite Universitaetsmedizin Berlin, Klinik fuer Rheumatologie
Berlin, 10117, Germany
Klinische Forschung Berlin-Buch GmbH
Berlin, 13125, Germany
CIRI GmbH
Frankfurt am Main, 60528, Germany
Dr. Rethy Pal Korhaz es Rendelointezet, II. Reumatologia Szakrendeles
Békéscsaba, 5600, Hungary
Budai Irgalmasrendi Korhaz, Reumatologia I.
Budapest, 1027, Hungary
Revita Reumatologiai Rendelo
Budapest, 1027, Hungary
Qualiclinic Kft.
Budapest, 1036, Hungary
Fejer Megyei Szent Gyorgy Korhaz Reumatologia
Székesfehérvár, 8000, Hungary
MAV Korhaz es Rendelointezet, Reumatologiai szakrendeles
Szolnok, 5000, Hungary
Krishna Institute of Medical Sciences Ltd
Secunderabad, Andhra Pradesh, 500 003, India
Shirdi Sai Hospital
Bangalore, Karnataka, 560 054, India
Dapartment of Rheumatology
Lucknow, Uttar Pradesh, 226 018, India
Hospital Raja Permaisuri Bainun
Ipoh, Perak, 30990, Malaysia
Sunway Medical Centre
Petaling Jaya, Selangor, 46150, Malaysia
Centro de Estudios de Investigacion Basica y Clinica SC.
Guadalajara, Jalisco, 44690, Mexico
Unidad de Investigacion Biomedica del CEM
Mérida, Yucatán, 97000, Mexico
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.
San Luis Potosí City, 78200, Mexico
Centrum Kliniczno-Badawcze J. Brzezicki, B. Górniakiewicz-Brzezicka Lekarze Spółka Partnerska
Elblag, 82-300, Poland
Nzoz "Lecznica Mak-Med S.C."
Nadarzyn, 05-830, Poland
Wojewodzki Zespol Reumatologiczny im. dr J. Titz-Kosko
Sopot, 81-759, Poland
Spitalul Clinic "Sfanta Maria", Clinica de Medicina Interna si Reumatologie
Bucharest, 800578, Romania
Spitalul Clinic Judetean de Urgenta "Sfantul Apostol Andrei"
Galati, 800578, Romania
Spitalul Clinic de Recuperare
Iași, 700656, Romania
Spitalul Clinic Judetean de Urgenta Targu Mures, Reumatologic
Tg Mures, 540136, Romania
GBOU VPO "Orenburg State Medical Academy of Ministry of Healthcare of Russian Federation"
Orenburg, Russian Federation, 460000, Russia
Territorial Clinical Hospital
Barnaul, 656024, Russia
GBUZ of Kemerovo region Regional clinical hospital for was veterans
Kemerovo, 650000, Russia
Kemerovo Regional Clinical Hospital
Kemerovo, 650066, Russia
FSBI Scientific - Research Institute of Rheumatology RAMS n.a. V.A. Nasonova.
Moscow, 115522, Russia
LLC Consultative and Diagnostic Rheumatological Center Healthy Joints
Novosibirsk, 630091, Russia
Republican Hospital V.A.Baranov
Petrozavodsk, 185019, Russia
Ryazan Regional Clinical Cardiological Dispensary
Ryazan, 390026, Russia
Clinical Rheumatological Hospital #25
Saint Petersburg, 190068, Russia
Clinical Hospital #122 L.G. Sokolov
Saint Petersburg, 194291, Russia
MUZ City Clinical Hospital #12
Saratov, 410039, Russia
Smolensk Regional Clinical Hospital
Smolensk, 214018, Russia
Tomsk Regional Clinical Hospital
Tomsk, 634063, Russia
Vladimir Regional Clinical Hospital
Vladimir, 600023, Russia
Clinical Hospital of Emergency Care N.V. Soloviev
Yaroslavl, 150003, Russia
Yaroslavl Regional Clinical Hospital
Yaroslavl, 150062, Russia
Sverdlovsk Regional Clinical Hospital # 1
Yekaterinburg, 620102, Russia
Municilap Institution Central Clinical Hospital 6
Yekaterinburg, 620149, Russia
Institute of Rheumatology
Belgrade, 11000, Serbia
Institute for treatment and rehabilitation Niska Banja
Niška Banja, 18205, Serbia
AAGS, s.r.o. , nestatne zdravotnicke zariadenie
Dunajská Streda, 92901, Slovakia
Nestatna reumatologicka ambulancia
Považská Bystrica, 017 01, Slovakia
Reumatologicka ambulancia, REUMEX, s.r.o.
Rimavská Sobota, 979 01, Slovakia
Reumaglobal s.r.o.
Trnava, 917 01, Slovakia
Nestatna reumatologicka ambulancia
Žilina, 010 01, Slovakia
Panorama Medical Centre
Panorama, Cape Town, 7500, South Africa
Emmed Research
Pretoria, Gauteng, 0084, South Africa
KyungHee University Hospital
Seoul, Korea, 130-872, South Korea
Daegu Catholic University Medical Center, Department of Rheumatology
Daegu, 705-718, South Korea
Inha University Hospital, Medicine/Rheumatology
Incheon, 400-711, South Korea
Seoul National University Hospital, Rheumatology, Internal Medicine
Seoul, 110-744, South Korea
Konkuk University Medical Center, Department of Rheumatology
Seoul, 143-729, South Korea
Complejo Hospitalario Universitario A Coruña. Hospital Materno Infantil Teresa Herrera
A Coruña, 15006, Spain
Hospital SANITAS CIMA.
Barcelona, 08034, Spain
Municipal Medical Institution "City Clinical Hospital #3"
Chernivtsi, 58022, Ukraine
Municipal Medicoprophylactic Institution "Donetsk City Clinical Hospital #5".
Donetsk, 83001, Ukraine
National Scientific Centre "Institute of Cardiology n.a. M.D. Strazheska of NAMS of Ukraine".
Kiev, 03680, Ukraine
Komunalnyi zaklad Kyivskoi oblasnoi rady "Kyivska oblasna klinichna likarnia"
Kyiv, 04107, Ukraine
Komunalnyi zaklad Lvivskoi oblasnoi rady "Lvivskyi oblasnyi klinichnyi diahnostychnyi tsentr"
Lviv, 79010, Ukraine
Komunalna ustanova "Odeska oblasna klinichna likarnia"
Odesa, 65025, Ukraine
Municipal Establishment "City Clinical Hospital #9 n.a. O.I. Minakov", Department of Rheumatology
Odesa, 65026, Ukraine
Vinnytsya regional clinical hospital named after M.I. Pyrogova; Department of rheumatology
Vinnytsia, 21018, Ukraine
Municipal Institution:"Zaporizhzhya Regional Clinical Hospital",Rheumatology Dep.
Zaporizhzhya, 69600, Ukraine
Related Publications (1)
Buttgereit F, Strand V, Lee EB, Simon-Campos A, McCabe D, Genet A, Tammara B, Rojo R, Hey-Hadavi J. Fosdagrocorat (PF-04171327) versus prednisone or placebo in rheumatoid arthritis: a randomised, double-blind, multicentre, phase IIb study. RMD Open. 2019 Apr 16;5(1):e000889. doi: 10.1136/rmdopen-2018-000889. eCollection 2019.
PMID: 31168411DERIVED
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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2011
First Posted
July 13, 2011
Study Start
September 27, 2011
Primary Completion
June 3, 2014
Study Completion
June 9, 2014
Last Updated
September 4, 2024
Results First Posted
September 4, 2024
Record last verified: 2024-08
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.