Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis

August 12, 2024 updated by: Pfizer

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
323

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving a 20% Improvement in American College of Rheumatology (ACR) Criteria at Week 8
Time Frame: 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)
Time Frame: Week 8
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)
Time Frame: Week 8
Change from baseline in uNTx/uCr at week 8 is presented in this outcome measure.
Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
Time Frame: Weeks 2, 4, and 12 (taper period)
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)
Time Frame: Weeks 2, 4, 6, 8, and 12 (taper period)
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)
Time Frame: Weeks 2, 4, 6, 8, and 12 (taper period)
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)
Time Frame: Weeks 2, 4, 6, and 8
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)
Time Frame: Week 12
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)
Time Frame: Weeks 2, 4, 6, and 8
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)
Time Frame: Week 12
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)
Time Frame: Weeks 2, 4, 6, and 8
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)
Time Frame: Week 12
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)
Time Frame: Weeks 2, 4, 6, and 8
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)
Time Frame: Week 12
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)
Time Frame: Weeks 2, 4, 6, and 8
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)
Time Frame: Week 12
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)
Time Frame: Weeks 2, 4, 6, and 8
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)
Time Frame: Week 12
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)
Time Frame: Weeks 2, 4, 6, and 8
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)
Time Frame: Week 12
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)
Time Frame: Weeks 2, 4, 6, and 8
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)
Time Frame: Week 12
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)
Time Frame: Weeks 2, 4, 6, and 8
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)
Time Frame: Week 12
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)
Time Frame: Weeks 4 and 8
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)
Time Frame: Week 12
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)
Time Frame: Weeks 4 and 8
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)
Time Frame: Week 12
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 27, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 3, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 9, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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