Clinical trial NCT01393639: Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: treatment of rheumatoid arthritis
treatment of RA
patients on methotrexate for rheumatoid arthritis
prednisone for rheumatoid arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-07-13
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Achieving a 20% Improvement in American College of Rheumatology (ACR) Criteria at Week 8
timeFrame: Week 8
measure: Mean Percent Change From Baseline in 0 Hour Procollagen Type 1 N Terminal Propeptide (P1NP) at Week 8 (Comparisons to Prednisone 5 mg)
timeFrame: Week 8
measure: Mean Percent Change From Baseline in 0 Hour Urinary N Telopeptide/Urinary Creatinine (uNTx/uCr) at Week 8 (Comparisons to Prednisone 5 mg)
timeFrame: Week 8
Secondary outcomes:
measure: Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg)
timeFrame: Weeks 2, 4, and 12 (taper period)
measure: Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg)
timeFrame: Weeks 2, 4, 6, 8, and 12 (taper period)
measure: Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg)
timeFrame: Weeks 2, 4, 6, 8, and 12 (taper period)
measure: Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg)
timeFrame: Weeks 2, 4, 6, and 8
measure: Change From Baseline in Tender-Joint Counts at Week 12 (Descriptive Statistics)
timeFrame: Week 12
measure: Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
timeFrame: Weeks 2, 4, 6, and 8
measure: Change From Baseline in Swollen-Joint Counts at Week 12 (Descriptive Statistics)
timeFrame: Week 12
measure: Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg)
timeFrame: Weeks 2, 4, 6, and 8
measure: Change From Baseline of CRP at Week 12 (Descriptive Statistics)
timeFrame: Week 12
measure: Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
timeFrame: Weeks 2, 4, 6, and 8
measure: Change From Baseline in Patient Global Assessment of Arthritis at Week 12 (Descriptive Statistics)
timeFrame: Week 12
measure: Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
timeFrame: Weeks 2, 4, 6, and 8
measure: Change From Baseline in Physician Global Assessment of Arthritis at Week 12 (Descriptive Statistics)
timeFrame: Week 12
measure: Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
timeFrame: Weeks 2, 4, 6, and 8
measure: Change From Baseline in Pain VAS at Week 12 (Descriptive Statistics)
timeFrame: Week 12
measure: Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
timeFrame: Weeks 2, 4, 6, and 8
measure: Change From Baseline in HAQ-DI at Week 12 (Descriptive Statistics)
timeFrame: Week 12
measure: Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
timeFrame: Weeks 2, 4, 6, and 8
measure: Change From Baseline in DAS 28-3 CRP at Week 12 (Descriptive Statistics)
timeFrame: Week 12
measure: Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
timeFrame: Weeks 2, 4, 6, and 8
measure: Change From Baseline in DAS28-4(CRP) at Week 12 (Descriptive Statistics)
timeFrame: Week 12
measure: Change From Baseline in SF-36v2 Mental Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg)
timeFrame: Weeks 4 and 8
measure: Change From Baseline in SF-36v2 Mental Component Scores at Week 12 (Descriptive Statistics)
timeFrame: Week 12
measure: Change From Baseline in SF-36v2 Physical Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg)
timeFrame: Weeks 4 and 8
measure: Change From Baseline in SF-36v2 Physical Component Scores at Week 12 (Descriptive Statistics)
timeFrame: Week 12
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Catalina Pointe Clinical Research, Inc.
state: Arizona
city: San Leandro
country: United States
facility: C. Michael Neuwelt, MD, Inc.
state: California
city: Newark
country: United States
facility: Javed Rheumatology Associates, Inc.
state: Delaware
city: Daytona Beach
country: United States
facility: Allergy, Asthma, Arthritis, and Lung Center
state: Florida
city: Ormond Beach
country: United States
facility: Millennium Research
state: Florida
city: Vero Beach
country: United States
facility: Alastair C. Kennedy, MD
state: Florida
city: Vero Beach
country: United States
facility: The Center for Arthritis and Rheumatism
state: Florida
city: Brooklyn
country: United States
facility: Arthritis and Osteoporosis Medical Associates, PLLC
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Rheumatic Disease Study Group, Inc.
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Charleston
country: United States
facility: Low Country Rheumatology, PA
state: South Carolina
city: Charleston
country: United States
facility: Tricounty Radiology
state: South Carolina
city: Houston
country: United States
facility: Accurate Clinical Research, Inc.
state: Texas
city: Spokane
country: United States
facility: Arthritis Northwest, PLLC
state: Washington
city: Pleven
country: Bulgaria
facility: Revmatologichen kabinet, DKTs Sv. Pantaleimon OOD
city: Plovdiv
country: Bulgaria
facility: Revmatologichno Otdelenie, MBAL - Plovdiv
city: Sofia
country: Bulgaria
facility: MBAL "Sveti Ivan Rilski" Sofia; Klinika po Revmatologia
city: Sofia
country: Bulgaria
facility: MBAL Sveti Ivan Rilski Sofia; Klinika po Revmatologia
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
state: Antioquia
city: Medellin
country: Colombia
facility: Reumalab S.A.S
state: Antioquia
city: Bogota
country: Colombia
facility: Centro Integral de Reumatologia e Inmunologia CIREI
state: Cundinamarca
city: Chía
country: Colombia
facility: Preventive Care SAS
state: Cundinamarca
city: Bruntal
country: Czechia
facility: Revmatologie Bruntal, S.R.O.
city: Ostrava - Poruba
country: Czechia
facility: Revmatologicka ambulance
city: Praha 4
country: Czechia
facility: Revmatologicka ambulance
city: Praha 4
country: Czechia
facility: Thomayerova nemocnice
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin, Klinik fuer Rheumatologie
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Buch GmbH
city: Frankfurt am Main
country: Germany
facility: CIRI GmbH
city: Bekescsaba
country: Hungary
facility: Dr. Rethy Pal Korhaz es Rendelointezet, II. Reumatologia Szakrendeles
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Korhaz, Reumatologia I.
city: Budapest
country: Hungary
facility: Revita Reumatologiai Rendelo
city: Budapest
country: Hungary
facility: Qualiclinic Kft.
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Korhaz Reumatologia
city: Szolnok
country: Hungary
facility: MAV Korhaz es Rendelointezet, Reumatologiai szakrendeles
city: Secunderabad
country: India
facility: Krishna Institute of Medical Sciences Ltd
state: Andra Pradesh
city: Bangalore
country: India
facility: Shirdi Sai Hospital
state: Karnataka
city: Lucknow
country: India
facility: Dapartment of Rheumatology
state: Uttar Pradesh
city: Seoul
country: Korea, Republic of
facility: KyungHee University Hospital
state: Korea
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center, Department of Rheumatology
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital, Medicine/Rheumatology
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital, Rheumatology, Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center, Department of Rheumatology
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
state: Perak
city: Petaling Jaya
country: Malaysia
facility: Sunway Medical Centre
state: Selangor Darul Ehsan
city: Guadalajara
country: Mexico
facility: Centro de Estudios de Investigacion Basica y Clinica SC.
state: Jalisco
city: Merida
country: Mexico
facility: Unidad de Investigacion Biomedica del CEM
state: Yucatan
city: San Luis Potosi
country: Mexico
facility: Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.
city: Elbląg
country: Poland
facility: Centrum Kliniczno-Badawcze J. Brzezicki, B. Górniakiewicz-Brzezicka Lekarze Spółka Partnerska
city: Nadarzyn
country: Poland
facility: Nzoz "Lecznica Mak-Med S.C."
city: Sopot
country: Poland
facility: Wojewodzki Zespol Reumatologiczny im. dr J. Titz-Kosko
city: Bucuresti
country: Romania
facility: Spitalul Clinic "Sfanta Maria", Clinica de Medicina Interna si Reumatologie
city: Galati
country: Romania
facility: Spitalul Clinic Judetean de Urgenta "Sfantul Apostol Andrei"
city: Iasi
country: Romania
facility: Spitalul Clinic de Recuperare
city: Tg Mures
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Targu Mures, Reumatologic
city: Barnaul
country: Russian Federation
facility: Territorial Clinical Hospital
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Clinical Hospital # 1
city: Ekaterinburg
country: Russian Federation
facility: Municilap Institution Central Clinical Hospital 6
city: Kemerovo
country: Russian Federation
facility: GBUZ of Kemerovo region Regional clinical hospital for was veterans
city: Kemerovo
country: Russian Federation
facility: Kemerovo Regional Clinical Hospital
city: Moscow
country: Russian Federation
facility: FSBI Scientific - Research Institute of Rheumatology RAMS n.a. V.A. Nasonova.
city: Novosibirsk
country: Russian Federation
facility: LLC Consultative and Diagnostic Rheumatological Center Healthy Joints
city: Orenburg
country: Russian Federation
facility: GBOU VPO "Orenburg State Medical Academy of Ministry of Healthcare of Russian Federation"
city: Petrozavodsk
country: Russian Federation
facility: Republican Hospital V.A.Baranov
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Cardiological Dispensary
city: Saint-Petersburg
country: Russian Federation
facility: Clinical Rheumatological Hospital #25
city: Saint-Petersburg
country: Russian Federation
facility: Clinical Hospital #122 L.G. Sokolov
city: Saratov
country: Russian Federation
facility: MUZ City Clinical Hospital #12
city: Smolensk
country: Russian Federation
facility: Smolensk Regional Clinical Hospital
city: Tomsk
country: Russian Federation
facility: Tomsk Regional Clinical Hospital
city: Vladimir
country: Russian Federation
facility: Vladimir Regional Clinical Hospital
city: Yaroslavl
country: Russian Federation
facility: Clinical Hospital of Emergency Care N.V. Soloviev
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Clinical Hospital
city: Belgrade
country: Serbia
facility: Institute of Rheumatology
city: Niska Banja
country: Serbia
facility: Institute for treatment and rehabilitation Niska Banja
city: Dunajska Streda
country: Slovakia
facility: AAGS, s.r.o. , nestatne zdravotnicke zariadenie
city: Povazska Bystrica
country: Slovakia
facility: Nestatna reumatologicka ambulancia
city: Rimavska Sobota
country: Slovakia
facility: Reumatologicka ambulancia, REUMEX, s.r.o.
city: Trnava
country: Slovakia
facility: Reumaglobal s.r.o.
city: Zilina
country: Slovakia
facility: Nestatna reumatologicka ambulancia
city: Panorama
country: South Africa
facility: Panorama Medical Centre
state: Cape Town
city: Pretoria
country: South Africa
facility: Emmed Research
state: Gauteng
city: Barcelona
country: Spain
facility: Hospital SANITAS CIMA.
city: La Coruna
country: Spain
facility: Complejo Hospitalario Universitario A Coruña. Hospital Materno Infantil Teresa Herrera
city: Chernivtsi
country: Ukraine
facility: Municipal Medical Institution "City Clinical Hospital #3"
city: Donetsk
country: Ukraine
facility: Municipal Medicoprophylactic Institution "Donetsk City Clinical Hospital #5".
city: Kiev
country: Ukraine
facility: National Scientific Centre "Institute of Cardiology n.a. M.D. Strazheska of NAMS of Ukraine".
city: Kyiv
country: Ukraine
facility: Komunalnyi zaklad Kyivskoi oblasnoi rady "Kyivska oblasna klinichna likarnia"
city: Lviv
country: Ukraine
facility: Komunalnyi zaklad Lvivskoi oblasnoi rady "Lvivskyi oblasnyi klinichnyi diahnostychnyi tsentr"
city: Odesa
country: Ukraine
facility: Komunalna ustanova "Odeska oblasna klinichna likarnia"
city: Odesa
country: Ukraine
facility: Municipal Establishment "City Clinical Hospital #9 n.a. O.I. Minakov", Department of Rheumatology
city: Vinnytsya
country: Ukraine
facility: Vinnytsya regional clinical hospital named after M.I. Pyrogova; Department of rheumatology
city: Zaporizhzhya
country: Ukraine
facility: Municipal Institution:"Zaporizhzhya Regional Clinical Hospital",Rheumatology Dep.
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.