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

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	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg)	ACR20 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and 90% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.	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)	ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.	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)	ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.	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)	Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant's safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen.	Weeks 2, 4, 6, and 8
Change From Baseline in Tender-Joint Counts at Week 12 (Descriptive Statistics)	Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant's safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen.	Week 12
Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)	Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant's safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen.	Weeks 2, 4, 6, and 8
Change From Baseline in Swollen-Joint Counts at Week 12 (Descriptive Statistics)	Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant's safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen.	Week 12
Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg)	The CRP was collected at each applicable clinic visit and analyzed by a central laboratory. In order to assist with the data clean-up at the end of the study, the CRP results were unblinded to the sponsor at the time of the last subject's last visit. All statistics presented below are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.	Weeks 2, 4, 6, and 8
Change From Baseline of CRP at Week 12 (Descriptive Statistics)	The CRP was collected at each applicable clinic visit and analyzed by a central laboratory. In order to assist with the data clean-up at the end of the study, the CRP results were unblinded to the sponsor at the time of the last subject's last visit.	Week 12
Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)	Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The subject's response was recorded using a 100 mm Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.	Weeks 2, 4, 6, and 8
Change From Baseline in Patient Global Assessment of Arthritis at Week 12 (Descriptive Statistics)	Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The subject's response was recorded using a 100 mm Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.	Week 12
Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)	The investigator assessed how the participant's overall arthritis appears at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.	Weeks 2, 4, 6, and 8
Change From Baseline in Physician Global Assessment of Arthritis at Week 12 (Descriptive Statistics)	The investigator assessed how the participant's overall arthritis appears at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.	Week 12
Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)	Participants assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain.	Weeks 2, 4, 6, and 8
Change From Baseline in Pain VAS at Week 12 (Descriptive Statistics)	Participants assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain.	Week 12
Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)	Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.	Weeks 2, 4, 6, and 8
Change From Baseline in HAQ-DI at Week 12 (Descriptive Statistics)	Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.	Week 12
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)	DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.	Weeks 2, 4, 6, and 8
Change From Baseline in DAS 28-3 CRP at Week 12 (Descriptive Statistics)	DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.	Week 12
Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)	DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission. All statistics presented below are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.	Weeks 2, 4, 6, and 8
Change From Baseline in DAS28-4(CRP) at Week 12 (Descriptive Statistics)	DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.	Week 12
Change From Baseline in SF-36v2 Mental Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg)	The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness.	Weeks 4 and 8
Change From Baseline in SF-36v2 Mental Component Scores at Week 12 (Descriptive Statistics)	The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness.	Week 12
Change From Baseline in SF-36v2 Physical Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg)	The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness.	Weeks 4 and 8
Change From Baseline in SF-36v2 Physical Component Scores at Week 12 (Descriptive Statistics)	The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness.	Week 12

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2011
• Primary Completion (Actual): June 3, 2014
• Study Completion (Actual): June 9, 2014

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: August 1, 2024

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)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

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