Back to resultsStudy Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-04171327
PF-04171327
PF-04171327
PF-04171327
prednisone
prednisone
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring treatment of rheumatoid arthritis, treatment of RA, patients on methotrexate for rheumatoid arthritis, prednisone for rheumatoid arthritis
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.
Sites / Locations
- Catalina Pointe Clinical Research, Inc.
- C. Michael Neuwelt, MD, Inc.
- Javed Rheumatology Associates, Inc.
- Allergy, Asthma, Arthritis, and Lung Center
- Millennium Research
- Alastair C. Kennedy, MD
- The Center for Arthritis and Rheumatism
- Arthritis and Osteoporosis Medical Associates, PLLC
- Cincinnati Rheumatic Disease Study Group, Inc.
- Altoona Center for Clinical Research
- Low Country Rheumatology, PA
- Tricounty Radiology
- Accurate Clinical Research, Inc.
- Arthritis Northwest, PLLC
- Revmatologichen kabinet, DKTs Sv. Pantaleimon OOD
- Revmatologichno Otdelenie, MBAL - Plovdiv
- MBAL "Sveti Ivan Rilski" Sofia; Klinika po Revmatologia
- MBAL Sveti Ivan Rilski Sofia; Klinika po Revmatologia
- Hospital Pablo Tobon Uribe
- Reumalab S.A.S
- Centro Integral de Reumatologia e Inmunologia CIREI
- Preventive Care SAS
- Revmatologie Bruntal, S.R.O.
- Revmatologicka ambulance
- Revmatologicka ambulance
- Thomayerova nemocnice
- Charite Universitaetsmedizin Berlin, Klinik fuer Rheumatologie
- Klinische Forschung Berlin-Buch GmbH
- CIRI GmbH
- Dr. Rethy Pal Korhaz es Rendelointezet, II. Reumatologia Szakrendeles
- Budai Irgalmasrendi Korhaz, Reumatologia I.
- Revita Reumatologiai Rendelo
- Qualiclinic Kft.
- Fejer Megyei Szent Gyorgy Korhaz Reumatologia
- MAV Korhaz es Rendelointezet, Reumatologiai szakrendeles
- Krishna Institute of Medical Sciences Ltd
- Shirdi Sai Hospital
- Dapartment of Rheumatology
- KyungHee University Hospital
- Daegu Catholic University Medical Center, Department of Rheumatology
- Inha University Hospital, Medicine/Rheumatology
- Seoul National University Hospital, Rheumatology, Internal Medicine
- Konkuk University Medical Center, Department of Rheumatology
- Hospital Raja Permaisuri Bainun
- Sunway Medical Centre
- Centro de Estudios de Investigacion Basica y Clinica SC.
- Unidad de Investigacion Biomedica del CEM
- Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.
- Centrum Kliniczno-Badawcze J. Brzezicki, B. Górniakiewicz-Brzezicka Lekarze Spółka Partnerska
- Nzoz "Lecznica Mak-Med S.C."
- Wojewodzki Zespol Reumatologiczny im. dr J. Titz-Kosko
- Spitalul Clinic "Sfanta Maria", Clinica de Medicina Interna si Reumatologie
- Spitalul Clinic Judetean de Urgenta "Sfantul Apostol Andrei"
- Spitalul Clinic de Recuperare
- Spitalul Clinic Judetean de Urgenta Targu Mures, Reumatologic
- Territorial Clinical Hospital
- Sverdlovsk Regional Clinical Hospital # 1
- Municilap Institution Central Clinical Hospital 6
- GBUZ of Kemerovo region Regional clinical hospital for was veterans
- Kemerovo Regional Clinical Hospital
- FSBI Scientific - Research Institute of Rheumatology RAMS n.a. V.A. Nasonova.
- LLC Consultative and Diagnostic Rheumatological Center Healthy Joints
- GBOU VPO "Orenburg State Medical Academy of Ministry of Healthcare of Russian Federation"
- Republican Hospital V.A.Baranov
- Ryazan Regional Clinical Cardiological Dispensary
- Clinical Rheumatological Hospital #25
- Clinical Hospital #122 L.G. Sokolov
- MUZ City Clinical Hospital #12
- Smolensk Regional Clinical Hospital
- Tomsk Regional Clinical Hospital
- Vladimir Regional Clinical Hospital
- Clinical Hospital of Emergency Care N.V. Soloviev
- Yaroslavl Regional Clinical Hospital
- Institute of Rheumatology
- Institute for treatment and rehabilitation Niska Banja
- AAGS, s.r.o. , nestatne zdravotnicke zariadenie
- Nestatna reumatologicka ambulancia
- Reumatologicka ambulancia, REUMEX, s.r.o.
- Reumaglobal s.r.o.
- Nestatna reumatologicka ambulancia
- Panorama Medical Centre
- Emmed Research
- Hospital SANITAS CIMA.
- Complejo Hospitalario Universitario A Coruña. Hospital Materno Infantil Teresa Herrera
- Municipal Medical Institution "City Clinical Hospital #3"
- Municipal Medicoprophylactic Institution "Donetsk City Clinical Hospital #5".
- National Scientific Centre "Institute of Cardiology n.a. M.D. Strazheska of NAMS of Ukraine".
- Komunalnyi zaklad Kyivskoi oblasnoi rady "Kyivska oblasna klinichna likarnia"
- Komunalnyi zaklad Lvivskoi oblasnoi rady "Lvivskyi oblasnyi klinichnyi diahnostychnyi tsentr"
- Komunalna ustanova "Odeska oblasna klinichna likarnia"
- Municipal Establishment "City Clinical Hospital #9 n.a. O.I. Minakov", Department of Rheumatology
- Vinnytsya regional clinical hospital named after M.I. Pyrogova; Department of rheumatology
- Municipal Institution:"Zaporizhzhya Regional Clinical Hospital",Rheumatology Dep.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
PF-04171327 1 mg QD
PF-04171327 5 mg QD
PF-04171327 10 mg QD
PF-04171327 15 mg QD
prednisone 5 mg QD
prednisone 10 mg QD
placebo
Arm Description
Outcomes
Primary Outcome Measures
Number of participants achieving a 20% improvement in American College of Rheumatology (ACR) criteria
Change in levels of dissociation biomarker P1NP measured in blood
Change in levels of dissociation biomarker urinary N-telopeptide/urinary creatinine ration (UNTx/Ucr) measure in blood
Secondary Outcome Measures
Number of participants achieving a 20% improvement according to ACR criteria from baseline to multiple timepoints listed in timeframe
Number of participants achieving a 50% improvement according to ACR criteria from baseline to multiple timepoints listed in timeframe
Change in Disease Activity Score (DAS) 28-3 using C-reactive protein (CRP) from baseline to multiple timepoints listed in timeframe
Change in SF-36 (Quality of Life) score from baseline to multiple timepoints listed in timeframe
Number of participants achieving a 70% improvement according to ACR criteria from baseline to multiple timepoints listed in timeframe
Change in Disease Activity Score (DAS)-4 using C-reactive protein(CRP) from baseline to multiple timepoints listed in timeframe
Number of participants achieving improvement according to ACR hybrid criteria from baseline to multiple timepoints listed in timeframe
Number of participants achieving improvement in individual components of the ACR criteria from baseline to multiple timepoints listed in timeframe
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01393639
Brief Title
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
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (Actual)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
treatment of rheumatoid arthritis, treatment of RA, patients on methotrexate for rheumatoid arthritis, prednisone for rheumatoid arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
323 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PF-04171327 1 mg QD
Arm Type
Experimental
Arm Title
PF-04171327 5 mg QD
Arm Type
Experimental
Arm Title
PF-04171327 10 mg QD
Arm Type
Experimental
Arm Title
PF-04171327 15 mg QD
Arm Type
Experimental
Arm Title
prednisone 5 mg QD
Arm Type
Active Comparator
Arm Title
prednisone 10 mg QD
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PF-04171327
Intervention Description
1 mg tablet once daily (QD) for 8 weeks
Intervention Type
Drug
Intervention Name(s)
PF-04171327
Intervention Description
5 mg tablet once daily (QD) for 8 weeks
Intervention Type
Drug
Intervention Name(s)
PF-04171327
Intervention Description
10 mg tablet once daily (QD) for 8 weeks
Intervention Type
Drug
Intervention Name(s)
PF-04171327
Intervention Description
15 mg tablet once daily (QD) for 8 weeks
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
5 mg capsule once daily for 8 weeks
Intervention Type
Other
Intervention Name(s)
prednisone
Intervention Description
10 mg capsule once daily for 8 weeks
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo (tablet or capsule) once daily (QD) for 8 weeks
Primary Outcome Measure Information:
Title
Number of participants achieving a 20% improvement in American College of Rheumatology (ACR) criteria
Time Frame
baseline and week 8
Title
Change in levels of dissociation biomarker P1NP measured in blood
Time Frame
baseline and week 8
Title
Change in levels of dissociation biomarker urinary N-telopeptide/urinary creatinine ration (UNTx/Ucr) measure in blood
Time Frame
baseline and week 8
Secondary Outcome Measure Information:
Title
Number of participants achieving a 20% improvement according to ACR criteria from baseline to multiple timepoints listed in timeframe
Time Frame
baseline and Week 2, 4, 12
Title
Number of participants achieving a 50% improvement according to ACR criteria from baseline to multiple timepoints listed in timeframe
Time Frame
baseline and Week 2,4,6,8,12
Title
Change in Disease Activity Score (DAS) 28-3 using C-reactive protein (CRP) from baseline to multiple timepoints listed in timeframe
Time Frame
baseline and Week 2,4,6,8,12
Title
Change in SF-36 (Quality of Life) score from baseline to multiple timepoints listed in timeframe
Time Frame
baseline and Week 4,8,12
Title
Number of participants achieving a 70% improvement according to ACR criteria from baseline to multiple timepoints listed in timeframe
Time Frame
baseline and Week 2,4,6,8,12
Title
Change in Disease Activity Score (DAS)-4 using C-reactive protein(CRP) from baseline to multiple timepoints listed in timeframe
Time Frame
baseline and Week 2,4,6,8,12
Title
Number of participants achieving improvement according to ACR hybrid criteria from baseline to multiple timepoints listed in timeframe
Time Frame
baseline and Week 2,4,6,8,12
Title
Number of participants achieving improvement in individual components of the ACR criteria from baseline to multiple timepoints listed in timeframe
Time Frame
baseline and Week 2,4,6,8,12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Catalina Pointe Clinical Research, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
C. Michael Neuwelt, MD, Inc.
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
Javed Rheumatology Associates, Inc.
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Allergy, Asthma, Arthritis, and Lung Center
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Millennium Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Alastair C. Kennedy, MD
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
The Center for Arthritis and Rheumatism
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Arthritis and Osteoporosis Medical Associates, PLLC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Cincinnati Rheumatic Disease Study Group, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Low Country Rheumatology, PA
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Tricounty Radiology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Accurate Clinical Research, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Arthritis Northwest, PLLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Revmatologichen kabinet, DKTs Sv. Pantaleimon OOD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Revmatologichno Otdelenie, MBAL - Plovdiv
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
MBAL "Sveti Ivan Rilski" Sofia; Klinika po Revmatologia
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
MBAL Sveti Ivan Rilski Sofia; Klinika po Revmatologia
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Reumalab S.A.S
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Centro Integral de Reumatologia e Inmunologia CIREI
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Preventive Care SAS
City
Chía
State/Province
Cundinamarca
ZIP/Postal Code
250001
Country
Colombia
Facility Name
Revmatologie Bruntal, S.R.O.
City
Bruntal
ZIP/Postal Code
79201
Country
Czechia
Facility Name
Revmatologicka ambulance
City
Ostrava - Poruba
ZIP/Postal Code
70800
Country
Czechia
Facility Name
Revmatologicka ambulance
City
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Thomayerova nemocnice
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Charite Universitaetsmedizin Berlin, Klinik fuer Rheumatologie
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Klinische Forschung Berlin-Buch GmbH
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
CIRI GmbH
City
Frankfurt am Main
ZIP/Postal Code
60528
Country
Germany
Facility Name
Dr. Rethy Pal Korhaz es Rendelointezet, II. Reumatologia Szakrendeles
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Budai Irgalmasrendi Korhaz, Reumatologia I.
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Revita Reumatologiai Rendelo
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Qualiclinic Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Korhaz Reumatologia
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
MAV Korhaz es Rendelointezet, Reumatologiai szakrendeles
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Krishna Institute of Medical Sciences Ltd
City
Secunderabad
State/Province
Andra Pradesh
ZIP/Postal Code
500 003
Country
India
Facility Name
Shirdi Sai Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 054
Country
India
Facility Name
Dapartment of Rheumatology
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226 018
Country
India
Facility Name
KyungHee University Hospital
City
Seoul
State/Province
Korea
ZIP/Postal Code
130-872
Country
Korea, Republic of
Facility Name
Daegu Catholic University Medical Center, Department of Rheumatology
City
Daegu
ZIP/Postal Code
705-718
Country
Korea, Republic of
Facility Name
Inha University Hospital, Medicine/Rheumatology
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Seoul National University Hospital, Rheumatology, Internal Medicine
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center, Department of Rheumatology
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
Facility Name
Hospital Raja Permaisuri Bainun
City
Ipoh
State/Province
Perak
ZIP/Postal Code
30990
Country
Malaysia
Facility Name
Sunway Medical Centre
City
Petaling Jaya
State/Province
Selangor Darul Ehsan
ZIP/Postal Code
46150
Country
Malaysia
Facility Name
Centro de Estudios de Investigacion Basica y Clinica SC.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44690
Country
Mexico
Facility Name
Unidad de Investigacion Biomedica del CEM
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.
City
San Luis Potosi
ZIP/Postal Code
78200
Country
Mexico
Facility Name
Centrum Kliniczno-Badawcze J. Brzezicki, B. Górniakiewicz-Brzezicka Lekarze Spółka Partnerska
City
Elbląg
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Nzoz "Lecznica Mak-Med S.C."
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Facility Name
Wojewodzki Zespol Reumatologiczny im. dr J. Titz-Kosko
City
Sopot
ZIP/Postal Code
81-759
Country
Poland
Facility Name
Spitalul Clinic "Sfanta Maria", Clinica de Medicina Interna si Reumatologie
City
Bucuresti
ZIP/Postal Code
800578
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta "Sfantul Apostol Andrei"
City
Galati
ZIP/Postal Code
800578
Country
Romania
Facility Name
Spitalul Clinic de Recuperare
City
Iasi
ZIP/Postal Code
700656
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Targu Mures, Reumatologic
City
Tg Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Territorial Clinical Hospital
City
Barnaul
ZIP/Postal Code
656024
Country
Russian Federation
Facility Name
Sverdlovsk Regional Clinical Hospital # 1
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Municilap Institution Central Clinical Hospital 6
City
Ekaterinburg
ZIP/Postal Code
620149
Country
Russian Federation
Facility Name
GBUZ of Kemerovo region Regional clinical hospital for was veterans
City
Kemerovo
ZIP/Postal Code
650000
Country
Russian Federation
Facility Name
Kemerovo Regional Clinical Hospital
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
FSBI Scientific - Research Institute of Rheumatology RAMS n.a. V.A. Nasonova.
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
LLC Consultative and Diagnostic Rheumatological Center Healthy Joints
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
GBOU VPO "Orenburg State Medical Academy of Ministry of Healthcare of Russian Federation"
City
Orenburg
ZIP/Postal Code
460000
Country
Russian Federation
Facility Name
Republican Hospital V.A.Baranov
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Ryazan Regional Clinical Cardiological Dispensary
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
Clinical Rheumatological Hospital #25
City
Saint-Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
Clinical Hospital #122 L.G. Sokolov
City
Saint-Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
MUZ City Clinical Hospital #12
City
Saratov
ZIP/Postal Code
410039
Country
Russian Federation
Facility Name
Smolensk Regional Clinical Hospital
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
Tomsk Regional Clinical Hospital
City
Tomsk
ZIP/Postal Code
634063
Country
Russian Federation
Facility Name
Vladimir Regional Clinical Hospital
City
Vladimir
ZIP/Postal Code
600023
Country
Russian Federation
Facility Name
Clinical Hospital of Emergency Care N.V. Soloviev
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Yaroslavl Regional Clinical Hospital
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Institute of Rheumatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute for treatment and rehabilitation Niska Banja
City
Niska Banja
ZIP/Postal Code
18205
Country
Serbia
Facility Name
AAGS, s.r.o. , nestatne zdravotnicke zariadenie
City
Dunajska Streda
ZIP/Postal Code
92901
Country
Slovakia
Facility Name
Nestatna reumatologicka ambulancia
City
Povazska Bystrica
ZIP/Postal Code
017 01
Country
Slovakia
Facility Name
Reumatologicka ambulancia, REUMEX, s.r.o.
City
Rimavska Sobota
ZIP/Postal Code
979 01
Country
Slovakia
Facility Name
Reumaglobal s.r.o.
City
Trnava
ZIP/Postal Code
917 01
Country
Slovakia
Facility Name
Nestatna reumatologicka ambulancia
City
Zilina
ZIP/Postal Code
010 01
Country
Slovakia
Facility Name
Panorama Medical Centre
City
Panorama
State/Province
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Emmed Research
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0084
Country
South Africa
Facility Name
Hospital SANITAS CIMA.
City
Barcelona
ZIP/Postal Code
08034
Country
Spain
Facility Name
Complejo Hospitalario Universitario A Coruña. Hospital Materno Infantil Teresa Herrera
City
La Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Municipal Medical Institution "City Clinical Hospital #3"
City
Chernivtsi
ZIP/Postal Code
58022
Country
Ukraine
Facility Name
Municipal Medicoprophylactic Institution "Donetsk City Clinical Hospital #5".
City
Donetsk
ZIP/Postal Code
83001
Country
Ukraine
Facility Name
National Scientific Centre "Institute of Cardiology n.a. M.D. Strazheska of NAMS of Ukraine".
City
Kiev
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Komunalnyi zaklad Kyivskoi oblasnoi rady "Kyivska oblasna klinichna likarnia"
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Komunalnyi zaklad Lvivskoi oblasnoi rady "Lvivskyi oblasnyi klinichnyi diahnostychnyi tsentr"
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Komunalna ustanova "Odeska oblasna klinichna likarnia"
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Municipal Establishment "City Clinical Hospital #9 n.a. O.I. Minakov", Department of Rheumatology
City
Odesa
ZIP/Postal Code
65026
Country
Ukraine
Facility Name
Vinnytsya regional clinical hospital named after M.I. Pyrogova; Department of rheumatology
City
Vinnytsya
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Municipal Institution:"Zaporizhzhya Regional Clinical Hospital",Rheumatology Dep.
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine
12. IPD Sharing Statement
Citations:
PubMed Identifier
31168411
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9391010&StudyName=Study%20Comparing%20Doses%20Of%20An%20Experimental%20Glucocorticoid%20Compound%20To%20Prednisone%20And%20Placebo%20In%20Rheumatoid%20Arthritis%20
Description
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Learn more about this trial
Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis
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