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.

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: PF-04171327; Drug: PF-04171327; Drug: PF-04171327; Drug: PF-04171327; Drug: prednisone; Other: prednisone; Other: placebo

• Study Type: Interventional
• Enrollment (Actual): 323
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Pleven, Bulgaria, 5800
    • Revmatologichen kabinet, DKTs Sv. Pantaleimon OOD
  • Plovdiv, Bulgaria, 4000
    • Revmatologichno Otdelenie, MBAL - Plovdiv
  • Sofia, Bulgaria, 1612
    • MBAL "Sveti Ivan Rilski" Sofia; Klinika po Revmatologia
  • Sofia, Bulgaria, 1612
    • MBAL Sveti Ivan Rilski Sofia; Klinika po Revmatologia
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia
      • Hospital Pablo Tobon Uribe
    • Medellin, Antioquia, Colombia
      • Reumalab S.A.S
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 110221
      • Centro Integral de Reumatologia e Inmunologia CIREI
    • Chía, Cundinamarca, Colombia, 250001
      • Preventive Care SAS
• Czechia
  • Bruntal, Czechia, 79201
    • Revmatologie Bruntal, s.r.o.
  • Ostrava - Poruba, Czechia, 70800
    • Revmatologicka ambulance
  • Praha 4, Czechia, 140 59
    • Thomayerova nemocnice
  • Praha 4, Czechia, 140 00
    • Revmatologicka ambulance
• Germany
  • Berlin, Germany, 10117
    • Charite Universitaetsmedizin Berlin, Klinik fuer Rheumatologie
  • Berlin, Germany, 13125
    • Klinische Forschung Berlin-Buch GmbH
  • Frankfurt am Main, Germany, 60528
    • CIRI GmbH
• Hungary
  • Bekescsaba, Hungary, 5600
    • Dr. Rethy Pal Korhaz es Rendelointezet, II. Reumatologia Szakrendeles
  • Budapest, Hungary, 1027
    • Budai Irgalmasrendi Korhaz, Reumatologia I.
  • Budapest, Hungary, 1027
    • Revita Reumatologiai Rendelo
  • Budapest, Hungary, 1036
    • Qualiclinic Kft.
  • Szekesfehervar, Hungary, 8000
    • Fejer Megyei Szent Gyorgy Korhaz Reumatologia
  • Szolnok, Hungary, 5000
    • MAV Korhaz es Rendelointezet, Reumatologiai szakrendeles
• India
  • Andra Pradesh
    • Secunderabad, Andra Pradesh, India, 500 003
      • Krishna Institute of Medical Sciences Ltd
  • Karnataka
    • Bangalore, Karnataka, India, 560 054
      • Shirdi Sai Hospital
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226 018
      • Dapartment of Rheumatology
• Korea, Republic of
  • Daegu, Korea, Republic of, 705-718
    • Daegu Catholic University Medical Center, Department of Rheumatology
  • Incheon, Korea, Republic of, 400-711
    • Inha University Hospital, Medicine/Rheumatology
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital, Rheumatology, Internal Medicine
  • Seoul, Korea, Republic of, 143-729
    • Konkuk University Medical Center, Department of Rheumatology
  • Korea
    • Seoul, Korea, Korea, Republic of, 130-872
      • KyungHee University Hospital
• Malaysia
  • Perak
    • Ipoh, Perak, Malaysia, 30990
      • Hospital Raja Permaisuri Bainun
  • Selangor Darul Ehsan
    • Petaling Jaya, Selangor Darul Ehsan, Malaysia, 46150
      • Sunway Medical Centre
• Mexico
  • San Luis Potosi, Mexico, 78200
    • Centro de Alta Especialidad en Reumatología e Investigación del Potosí S.C.
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44690
      • Centro de Estudios de Investigacion Basica y Clinica SC.
  • Yucatan
    • Merida, Yucatan, Mexico, 97000
      • Unidad de Investigacion Biomedica del CEM
• Poland
  • Elbląg, Poland, 82-300
    • Centrum Kliniczno-Badawcze J. Brzezicki, B. Górniakiewicz-Brzezicka Lekarze Spółka Partnerska
  • Nadarzyn, Poland, 05-830
    • Nzoz "Lecznica Mak-Med S.C."
  • Sopot, Poland, 81-759
    • Wojewodzki Zespol Reumatologiczny im. dr J. Titz-Kosko
• Romania
  • Bucuresti, Romania, 800578
    • Spitalul Clinic "Sfanta Maria", Clinica de Medicina Interna si Reumatologie
  • Galati, Romania, 800578
    • Spitalul Clinic Judetean de Urgenta "Sfantul Apostol Andrei"
  • Iasi, Romania, 700656
    • Spitalul Clinic de Recuperare
  • Tg Mures, Romania, 540136
    • Spitalul Clinic Judetean de Urgenta Targu Mures, Reumatologic
• Russian Federation
  • Barnaul, Russian Federation, 656024
    • Territorial Clinical Hospital
  • Ekaterinburg, Russian Federation, 620102
    • Sverdlovsk Regional Clinical Hospital # 1
  • Ekaterinburg, Russian Federation, 620149
    • Municilap Institution Central Clinical Hospital 6
  • Kemerovo, Russian Federation, 650066
    • Kemerovo Regional Clinical Hospital
  • Kemerovo, Russian Federation, 650000
    • GBUZ of Kemerovo region Regional clinical hospital for was veterans
  • Moscow, Russian Federation, 115522
    • FSBI Scientific - Research Institute of Rheumatology RAMS n.a. V.A. Nasonova.
  • Novosibirsk, Russian Federation, 630091
    • LLC Consultative and Diagnostic Rheumatological Center Healthy Joints
  • Orenburg, Russian Federation, 460000
    • GBOU VPO "Orenburg State Medical Academy of Ministry of Healthcare of Russian Federation"
  • Petrozavodsk, Russian Federation, 185019
    • Republican Hospital V.A.Baranov
  • Ryazan, Russian Federation, 390026
    • Ryazan Regional Clinical Cardiological Dispensary
  • Saint-Petersburg, Russian Federation, 190068
    • Clinical Rheumatological Hospital #25
  • Saint-Petersburg, Russian Federation, 194291
    • Clinical Hospital #122 L.G. Sokolov
  • Saratov, Russian Federation, 410039
    • MUZ City Clinical Hospital #12
  • Smolensk, Russian Federation, 214018
    • Smolensk Regional Clinical Hospital
  • Tomsk, Russian Federation, 634063
    • Tomsk Regional Clinical Hospital
  • Vladimir, Russian Federation, 600023
    • Vladimir Regional clinical hospital
  • Yaroslavl, Russian Federation, 150003
    • Clinical hospital of emergency care N.V. Soloviev
  • Yaroslavl, Russian Federation, 150062
    • Yaroslavl Regional Clinical Hospital
• Serbia
  • Belgrade, Serbia, 11000
    • Institute of Rheumatology
  • Niska Banja, Serbia, 18205
    • Institute for Treatment and Rehabilitation Niska Banja
• Slovakia
  • Dunajska Streda, Slovakia, 92901
    • AAGS, s.r.o. , nestatne zdravotnicke zariadenie
  • Povazska Bystrica, Slovakia, 017 01
    • Neštátna Reumatologická Ambulancia
  • Rimavska Sobota, Slovakia, 979 01
    • Reumatologicka ambulancia, REUMEX, s.r.o.
  • Trnava, Slovakia, 917 01
    • Reumaglobal s.r.o.
  • Zilina, Slovakia, 010 01
    • Neštátna Reumatologická Ambulancia
• South Africa
  • Cape Town
    • Panorama, Cape Town, South Africa, 7500
      • Panorama Medical Centre
  • Gauteng
    • Pretoria, Gauteng, South Africa, 0084
      • Emmed Research
• Spain
  • Barcelona, Spain, 08034
    • Hospital SANITAS CIMA.
  • La Coruna, Spain, 15006
    • Complejo Hospitalario Universitario A Coruña. Hospital Materno Infantil Teresa Herrera
• Ukraine
  • Chernivtsi, Ukraine, 58022
    • Municipal Medical Institution "City Clinical Hospital #3"
  • Donetsk, Ukraine, 83001
    • Municipal Medicoprophylactic Institution "Donetsk City Clinical Hospital #5".
  • Kiev, Ukraine, 03680
    • National Scientific Centre "Institute of Cardiology n.a. M.D. Strazheska of NAMS of Ukraine".
  • Kyiv, Ukraine, 04107
    • Komunalnyi zaklad Kyivskoi oblasnoi rady "Kyivska oblasna klinichna likarnia"
  • Lviv, Ukraine, 79010
    • Komunalnyi zaklad Lvivskoi oblasnoi rady "Lvivskyi oblasnyi klinichnyi diahnostychnyi tsentr"
  • Odesa, Ukraine, 65025
    • Komunalna ustanova "Odeska oblasna klinichna likarnia"
  • Odesa, Ukraine, 65026
    • Municipal Establishment "City Clinical Hospital #9 n.a. O.I. Minakov", Department of Rheumatology
  • Vinnytsya, Ukraine, 21018
    • Vinnytsya regional clinical hospital named after M.I. Pyrogova; Department of rheumatology
  • Zaporizhzhya, Ukraine, 69600
    • Municipal Institution:"Zaporizhzhya Regional Clinical Hospital",Rheumatology Dep.
• United States
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Catalina Pointe Clinical Research, Inc.
  • California
    • San Leandro, California, United States, 94578
      • C. Michael Neuwelt, MD, Inc.
  • Delaware
    • Newark, Delaware, United States, 19713
      • Javed Rheumatology Associates, Inc.
  • Florida
    • Daytona Beach, Florida, United States, 32114
      • Allergy, Asthma, Arthritis, and Lung Center
    • Ormond Beach, Florida, United States, 32174
      • Millennium Research
    • Vero Beach, Florida, United States, 32960
      • Alastair C. Kennedy, MD
    • Vero Beach, Florida, United States, 32960
      • The Center for Arthritis and Rheumatism
  • New York
    • Brooklyn, New York, United States, 11201
      • Arthritis and Osteoporosis Medical Associates, PLLC
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Cincinnati Rheumatic Disease Study Group, Inc.
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Low Country Rheumatology, PA
    • Charleston, South Carolina, United States, 29406
      • Tricounty Radiology
  • Texas
    • Houston, Texas, United States, 77034
      • Accurate Clinical Research, Inc.
  • Washington
    • Spokane, Washington, United States, 99204
      • Arthritis Northwest, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Other: placebo; placebo (tablet or capsule) once daily (QD) for 8 weeks
Experimental: PF-04171327 1 mg QD	Drug: PF-04171327; 1 mg tablet once daily (QD) for 8 weeks; Drug: PF-04171327; 5 mg tablet once daily (QD) for 8 weeks; Drug: PF-04171327; 10 mg tablet once daily (QD) for 8 weeks; Drug: PF-04171327; 15 mg tablet once daily (QD) for 8 weeks
Experimental: PF-04171327 5 mg QD	Drug: PF-04171327; 1 mg tablet once daily (QD) for 8 weeks; Drug: PF-04171327; 5 mg tablet once daily (QD) for 8 weeks; Drug: PF-04171327; 10 mg tablet once daily (QD) for 8 weeks; Drug: PF-04171327; 15 mg tablet once daily (QD) for 8 weeks
Experimental: PF-04171327 10 mg QD	Drug: PF-04171327; 1 mg tablet once daily (QD) for 8 weeks; Drug: PF-04171327; 5 mg tablet once daily (QD) for 8 weeks; Drug: PF-04171327; 10 mg tablet once daily (QD) for 8 weeks; Drug: PF-04171327; 15 mg tablet once daily (QD) for 8 weeks
Experimental: PF-04171327 15 mg QD	Drug: PF-04171327; 1 mg tablet once daily (QD) for 8 weeks; Drug: PF-04171327; 5 mg tablet once daily (QD) for 8 weeks; Drug: PF-04171327; 10 mg tablet once daily (QD) for 8 weeks; Drug: PF-04171327; 15 mg tablet once daily (QD) for 8 weeks
Active Comparator: prednisone 5 mg QD	Drug: prednisone; 5 mg capsule once daily for 8 weeks
Active Comparator: prednisone 10 mg QD	Other: prednisone; 10 mg capsule once daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants achieving a 20% improvement in American College of Rheumatology (ACR) criteria	baseline and week 8
Change in levels of dissociation biomarker P1NP measured in blood	baseline and week 8
Change in levels of dissociation biomarker urinary N-telopeptide/urinary creatinine ration (UNTx/Ucr) measure in blood	baseline and week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants achieving a 20% improvement according to ACR criteria from baseline to multiple timepoints listed in timeframe	baseline and Week 2, 4, 12
Number of participants achieving a 50% improvement according to ACR criteria from baseline to multiple timepoints listed in timeframe	baseline and Week 2,4,6,8,12
Change in Disease Activity Score (DAS) 28-3 using C-reactive protein (CRP) from baseline to multiple timepoints listed in timeframe	baseline and Week 2,4,6,8,12
Change in SF-36 (Quality of Life) score from baseline to multiple timepoints listed in timeframe	baseline and Week 4,8,12
Number of participants achieving a 70% improvement according to ACR criteria from baseline to multiple timepoints listed in timeframe	baseline and Week 2,4,6,8,12
Change in Disease Activity Score (DAS)-4 using C-reactive protein(CRP) from baseline to multiple timepoints listed in timeframe	baseline and Week 2,4,6,8,12
Number of participants achieving improvement according to ACR hybrid criteria from baseline to multiple timepoints listed in timeframe	baseline and Week 2,4,6,8,12
Number of participants achieving improvement in individual components of the ACR criteria from baseline to multiple timepoints listed in timeframe	baseline and Week 2,4,6,8,12

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2011
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: June 13, 2011
• First Submitted That Met QC Criteria: July 11, 2011
• First Posted (Estimate): July 13, 2011

Study Record Updates

• Last Update Posted (Actual): December 14, 2018
• Last Update Submitted That Met QC Criteria: December 12, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: treatment of rheumatoid arthritis; treatment of RA; patients on methotrexate for rheumatoid arthritis; prednisone for rheumatoid arthritis
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone
• Other Study ID Numbers: A9391010; 2010-023782-22 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No