Clinical trial NCT00847613: A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
Official title: Phase 3 Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Keywords: double-blind placebo-controlled investigational drug oral therapy safety and efficacy hand and feet x-rays
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate.


Eligibility criteria: Inclusion Criteria:

* Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate

Exclusion Criteria:

* Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.

Primary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6
timeFrame: Month 6
measure: Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3
timeFrame: Baseline, Month 3
measure: Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6
timeFrame: Month 6
Secondary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3
timeFrame: Month 1, 3
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24
timeFrame: Month 9, 12, 15, 18, 21, 24
measure: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6
timeFrame: Month 1, 3, 6
measure: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24
timeFrame: Month 9, 12, 15, 18, 21, 24
measure: Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6
timeFrame: Month 1, 3, 6
measure: Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24
timeFrame: Month 9, 12, 15, 18, 21, 24
measure: Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6
timeFrame: Baseline, Month 1, 3, 6
measure: Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9, 12, 15, 18, 21 and 24
timeFrame: Month 9, 12, 15, 18, 21, 24
measure: Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6
timeFrame: Baseline, Month 1, 3, 6
measure: Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9, 12, 15, 18, 21 and 24
timeFrame: Month 9, 12, 15, 18, 21, 24
measure: Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
timeFrame: Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24
measure: Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
timeFrame: Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24
measure: Modified Total Sharp Scores (mTSS) at Baseline
timeFrame: Baseline
measure: Modified Total Sharp Scores (mTSS) at Month 12 and 24
timeFrame: Month 12, 24
measure: Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6
timeFrame: Baseline, Month 1, 3, 6
measure: Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24
timeFrame: Month 9, 12, 15, 18, 21, 24
measure: Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6
timeFrame: Baseline, Month 1, 3, 6
measure: Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24
timeFrame: Month 9, 12, 15, 18, 21, 24
measure: Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6
timeFrame: Baseline, Month 1, 3, 6
measure: Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24
timeFrame: Month 9, 12, 15, 18, 21, 24
measure: Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6
timeFrame: Baseline, Month 1, 3, 6
measure: Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24
timeFrame: Month 9, 12, 15, 18, 21, 24
measure: 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
timeFrame: Baseline, Month 1, 3, 6
measure: 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24
timeFrame: Month 9, 12, 15, 18, 21, 24
measure: Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
timeFrame: Baseline, Month 1, 3, 6
measure: Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
timeFrame: Baseline, Month 1, 3, 6
measure: Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24
timeFrame: Month 12, 18, 24
measure: Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24
timeFrame: Month 12, 18, 24
measure: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6
timeFrame: Baseline, Month 1, 3, 6
measure: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12, 18 and 24
timeFrame: Month 12, 18, 24
measure: Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6
timeFrame: Baseline, Month 3, 6
measure: Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12, 18 and 24
timeFrame: Month 12, 18, 24
measure: Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6
timeFrame: Baseline, Month 3, 6
measure: Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24
timeFrame: Month 12, 18, 24
measure: Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
timeFrame: Baseline, Month 3, 6
measure: Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24
timeFrame: Month 12, 18, 24
measure: Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
timeFrame: Baseline, Month 3, 6
measure: Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24
timeFrame: Month 12, 18, 24
measure: Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
timeFrame: Baseline, Month 1, 3, 6
measure: Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24
timeFrame: Month 12, 18, 24
measure: Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
timeFrame: Baseline, Month 1, 3, 6
measure: Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24
timeFrame: Month 12, 18, 24
measure: Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6
timeFrame: Baseline, Month 1, 3, 6
measure: Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12, 18 and 24
timeFrame: Month 12, 18, 24
Other outcomes:
measure: Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response
timeFrame: Baseline through Month 12, Month 24
measure: Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response
timeFrame: Baseline through Month 12, Month 24
measure: Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response
timeFrame: Baseline through Month 12, Month 24
measure: Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6
timeFrame: Baseline through Month 12, Month 24
measure: Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6
timeFrame: Baseline through Month 12, Month 24
measure: Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 1, 3 and 6
timeFrame: Month 1, 3, 6
measure: Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24
timeFrame: Month 9, 12, 15, 18, 21, 24
measure: Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 1, 3 and 6
timeFrame: Month 1, 3, 6
measure: Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24
timeFrame: Month 9, 12, 15, 18, 21, 24
measure: Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 1, 3 and 6
timeFrame: Month 1, 3, 6
measure: Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24
timeFrame: Month 9, 12, 15, 18, 21, 24
measure: Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 1, 3 and 6
timeFrame: Month 1, 3, 6
measure: Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24
timeFrame: Month 9, 12, 15, 18, 21, 24
measure: Association Between Genomic and Metabonomic Variation
timeFrame: Month 24
measure: Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6
timeFrame: Baseline, Month 1, 3, 6
measure: Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24
timeFrame: Baseline, Month 9, 12, 15, 18, 21, 24
measure: Change From Baseline in Heart Rate at Month 1, 3, 6, 9, 12, 15, 18, 21 and 24
timeFrame: Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24
measure: Change From Baseline in Body Temperature at Month 1, 3, 6, 9, 12, 15, 18, 21 and 24
timeFrame: Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24
Locations:
city: Huntsville
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Maria
country: United States
facility: Pfizer Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Zephyrhills
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Morton Grove
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Dubuque
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Wheaton
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Worcester
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Bingham Farms
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Edina
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Lee's Summit
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Albany
country: United States
facility: Pfizer Investigational Site
state: New York
city: Binghamton
country: United States
facility: Pfizer Investigational Site
state: New York
city: Syracuse
country: United States
facility: Pfizer Investigational Site
state: New York
city: Dayton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Wyomissing
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Clarksburg
country: United States
facility: Pfizer Investigational Site
state: West Virginia
city: Franklin
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Maroochydore
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Woodville
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Malvern East
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Goiania
country: Brazil
facility: Pfizer Investigational Site
state: GO
city: Curitiba
country: Brazil
facility: Pfizer Investigational Site
state: PR
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: Rio Grande Do Sul
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Plovdiv
country: Bulgaria
facility: Pfizer Investigational Site
city: Plovdiv
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Victoria
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: St. John's
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Newmarket
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Medellin
country: Colombia
facility: Pfizer Investigational Site
state: Antioquia
city: Barranquilla
country: Colombia
facility: Pfizer Investigational Site
state: Atlantico
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Bucaramanga
country: Colombia
facility: Pfizer Investigational Site
state: Santander
city: Brno - Zidenice
country: Czechia
facility: Pfizer Investigational Site
city: Brno
country: Czechia
facility: Pfizer Investigational Site
city: Hostivice
country: Czechia
facility: Pfizer Investigational Site
city: Pardubice
country: Czechia
facility: Pfizer Investigational Site
city: Praha 11 - Chodov
country: Czechia
facility: Pfizer Investigational Site
city: Praha 1
country: Czechia
facility: Pfizer Investigational Site
city: Praha 2
country: Czechia
facility: Pfizer Investigational Site
city: Zlin
country: Czechia
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
city: Secunderabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andra Pradesh
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Mangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Kitakyusyu
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Higashihiroshima
country: Japan
facility: Pfizer Investigational Site
state: Hiroshima
city: Hitachi-shi
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Sagamihara
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Koushi
country: Japan
facility: Pfizer Investigational Site
state: Kumamoto
city: Sendai
country: Japan
facility: Pfizer Investigational Site
state: Miyagi
city: Ohmura
country: Japan
facility: Pfizer Investigational Site
state: Nagasaki
city: Sasebo
country: Japan
facility: Pfizer Investigational Site
state: Nagasaki
city: Ureshino-shi
country: Japan
facility: Pfizer Investigational Site
state: Saga
city: Kawagoe-shi
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Hamamatsu
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinjuku-ku, Tokyo
country: Japan
facility: Pfizer Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Incheon
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: Morelia
country: Mexico
facility: Pfizer Investigational Site
state: Michoacan
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Wroclaw
country: Poland
facility: Pfizer Investigational Site
city: Kaohsiung
country: Taiwan
facility: Pfizer Investigational Site
city: Kweishan, Taoyuan County
country: Taiwan
facility: Pfizer Investigational Site
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Tainan
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Simferopol
country: Ukraine
facility: Pfizer Investigational Site
state: Crimea
city: Kharkiv
country: Ukraine
facility: Pfizer Investigational Site
city: Kyiv
country: Ukraine
facility: Pfizer Investigational Site
city: Lviv
country: Ukraine
facility: Pfizer Investigational Site
city: Vinnitsa
country: Ukraine
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Dikranian AH, Gonzalez-Gay MA, Wellborne F, Alvaro-Gracia JM, Takiya L, Stockert L, Paulissen J, Shi H, Tatulych S, Curtis JR. Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by baseline body mass index: an analysis of pooled data from phase 3 studies. RMD Open. 2022 May;8(1):e002103. doi: 10.1136/rmdopen-2021-002103.
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