Clinical trial NCT00853385: A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis
Official title: Phase 3 Randomized, Double-Blind, Active Comparator, 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: Rheumatoid Arthritis
Keywords: oral DMARD
JAK inhibitor
clinical trial
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-02
Enrollment: 717
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 is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background methotrexate in patients with Rheumatoid Arthritis. The study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day on background methotrexate in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in Rheumatoid Arthritis. An active comparator, adalimumab, is also included.


Eligibility criteria: Inclusion Criteria:

* The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
* The patient must have had an inadequate response to methotrexate and have active disease, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) \>28 mm in the local laboratory. 2. CRP \>7 mg/L in the central laboratory.
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
* The patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate and washed out of all other DMARDs.

Exclusion Criteria:

* Blood dyscrasias including confirmed: 1. Hemoglobin \<9 g/dL or Hematocrit \<30%; 2. White blood cell count \<3,000 cu.mm. Absolute neutrophil count \<1,200 cu.mm; 4. Platelet count \<100,000/L
* History of any other autoimmune rheumatic disease other than Sjogren's syndrome
* No malignancy or history of malignancy.
* History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
* Patients who have failed any TNFi for either lack of efficacy or a TNFi mechanism related adverse event.
* Patients who have previously received adalimumab therapy for any reason.
* Patients who are contraindicated for treatment with adalimumab in accordance with the approved local label.
* Patients meeting the New York Heart Association Class III and Class IV Congestive Heart failure

Primary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6
timeFrame: Month 6
measure: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3
timeFrame: Baseline, Month 3
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 6
timeFrame: Month 6
Secondary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3
timeFrame: Month 1, 3
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12
timeFrame: Month 9, 12
measure: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6
timeFrame: Month 1, 3, 6
measure: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12
timeFrame: Month 9, 12
measure: Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6
timeFrame: Month 1, 3, 6
measure: Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12
timeFrame: Month 9, 12
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 and 12
timeFrame: Month 9, 12
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 and 12
timeFrame: Month 9, 12
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
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
measure: Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6
timeFrame: Month 1, 3, 6
measure: Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12
timeFrame: Month 9, 12
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 and 12
timeFrame: Month 9, 12
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 and 12
timeFrame: Month 9, 12
measure: Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6
timeFrame: Baseline, Month 1, 3, 6
measure: Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12
timeFrame: Month 9, 12
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 and 12
timeFrame: Month 9, 12
measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6
timeFrame: Baseline, Month 1, 3, 6
measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12
timeFrame: Month 12
measure: 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
timeFrame: Month 12
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: Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12
timeFrame: Month 12
measure: Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6
timeFrame: Baseline, Month 1, 3, 6
measure: Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12
timeFrame: Month 12
measure: Work Limitations Questionnaire (WLQ) Score at Month 3 and 6
timeFrame: Month 3, 6
measure: Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12
timeFrame: Baseline, Month 12
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
timeFrame: Month 12
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
timeFrame: Month 12
measure: Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
timeFrame: Baseline, Month 3, 6
measure: Number of Days as Assessed Using RA-HCRU at Month 12
timeFrame: Month 12
measure: Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
timeFrame: Baseline, Month 3, 6
measure: Number of Hours Per Day as Assessed RA-HCRU at Month 12
timeFrame: Month 12
measure: Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6
timeFrame: Baseline, Month 3, 6
measure: Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12
timeFrame: Month 12
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Mesa
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Paradise Valley
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Jonesboro
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Fair Oaks
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Boulder
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Largo
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Naples
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Palm Harbor
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pinellas Park
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Plantation
country: United States
facility: Pfizer Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Marietta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Rockford
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Haverhill
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Worcester
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Grand Rapids
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Greenville
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Lubbock
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Mesquite
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Clarksburg
country: United States
facility: Pfizer Investigational Site
state: West Virginia
city: St Leonards
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Cairns
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Maroochydore
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Malvern East
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Sarajevo
country: Bosnia and Herzegovina
facility: Pfizer Investigational Site
city: Pleven
country: Bulgaria
facility: Pfizer Investigational Site
city: Plovdiv
country: Bulgaria
facility: Pfizer Investigational Site
city: Plovdiv
country: Bulgaria
facility: Pfizer Investigational Site
city: Sevlievo
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Lunenburg
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Trois-Rivieres
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Santiago
country: Chile
facility: Pfizer Investigational Site
state: RM
city: Santiago
country: Chile
facility: Pfizer Investigational Site
state: RM
city: Providencia
country: Chile
facility: Pfizer Investigational Site
state: Santiago, RM
city: Rancagua
country: Chile
facility: Pfizer Investigational Site
state: VI Region
city: Cartago
country: Costa Rica
facility: Pfizer Investigational Site
city: San Jose
country: Costa Rica
facility: Pfizer Investigational Site
city: San Jose
country: Costa Rica
facility: Pfizer Investigational Site
city: Osijek
country: Croatia
facility: Pfizer Investigational Site
city: Split
country: Croatia
facility: Pfizer Investigational Site
city: Zagreb
country: Croatia
facility: Pfizer Investigational Site
city: Brno - Zidenice
country: Czech Republic
facility: Pfizer Investigational Site
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Hlucin
country: Czech Republic
facility: Pfizer Investigational Site
city: Pardubice
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 11 - Chodov
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 11
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 2
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 4
country: Czech Republic
facility: Pfizer Investigational Site
city: Zlin
country: Czech Republic
facility: Pfizer Investigational Site
city: Frederiksberg
country: Denmark
facility: Pfizer Investigational Site
city: Randers NOE
country: Denmark
facility: Pfizer Investigational Site
city: Santo Domingo
country: Dominican Republic
facility: Pfizer Investigational Site
city: Hyvinkaa
country: Finland
facility: Pfizer Investigational Site
city: Aachen
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Frankfurt am Main
country: Germany
facility: Pfizer Investigational Site
city: Halle
country: Germany
facility: Pfizer Investigational Site
city: Halle
country: Germany
facility: Pfizer Investigational Site
city: Herne
country: Germany
facility: Pfizer Investigational Site
city: Ratingen
country: Germany
facility: Pfizer Investigational Site
city: Wuerzburg
country: Germany
facility: Pfizer Investigational Site
city: Daegu
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Gwangju
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: Guadalajara
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Morelia
country: Mexico
facility: Pfizer Investigational Site
state: Michoacan
city: San Luis Potosi
country: Mexico
facility: Pfizer Investigational Site
state: SLP
city: Lipa City
country: Philippines
facility: Pfizer Investigational Site
state: Batangas
city: Angeles City
country: Philippines
facility: Pfizer Investigational Site
state: Pampanga
city: Cebu City
country: Philippines
facility: Pfizer Investigational Site
city: Bialystok
country: Poland
facility: Pfizer Investigational Site
city: Cieszyn
country: Poland
facility: Pfizer Investigational Site
city: Koscian
country: Poland
facility: Pfizer Investigational Site
city: Krakow
country: Poland
facility: Pfizer Investigational Site
city: Sopot
country: Poland
facility: Pfizer Investigational Site
city: Torun
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Dunajska Streda
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Nove Zamky
country: Slovakia
facility: Pfizer Investigational Site
city: Povazska Dystrica
country: Slovakia
facility: Pfizer Investigational Site
city: Zilina
country: Slovakia
facility: Pfizer Investigational Site
city: Santiago de Compostela
country: Spain
facility: Pfizer Investigational Site
state: A Coruña
city: Vigo
country: Spain
facility: Pfizer Investigational Site
state: Pontevedra
city: A Coruña
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Rajathevee
country: Thailand
facility: Pfizer Investigational Site
state: Bangkok
city: Amphoe Muang
country: Thailand
facility: Pfizer Investigational Site
state: Chiang Mai
city: Wirral
country: United Kingdom
facility: Pfizer Investigational Site
state: Merseyside
city: Cannock
country: United Kingdom
facility: Pfizer Investigational Site
state: Staffs
city: Dudley, West Midlands
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
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