Clinical trial NCT00856544: A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications
Official title: Phase 3, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background DMARDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Keywords: Arthritis
Rheumatoid
Antirheumatic Agents
Clinical Trial
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-05
Enrollment: 795
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 Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheumatic drugs in adult patients with 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 the Phase 2 rheumatoid arthritis studies.


Eligibility criteria: Inclusion Criteria:

* The patient has a diagnosis of Rheumatoid Arthritis based on the American College of Rheumatology (ACR) 1987 Revised Criteria.
* The patient has active disease as defined by both \>=4 tender or painful joints on motion and \>= 4 joints swollen; and either an erythrocyte sedimentation rate (ESR) \> 28 mm or a C-reactive protein (CRP) concentration \> 7 mg/dL.
* Patient had an inadequate response to at least one disease modifying antirheumatic drug (traditional or biologic) due to lack of efficacy or toxicity.
* Patient must remain on at least one background traditional disease modifying antirheumatic drug.
* No evidence of inadequately treated latent or active infection with Mycobacterium tuberculosis.

Exclusion Criteria:

* Blood dyscrasias including confirmed: Hemoglobin \<9 g/dL or Hematocrit \<30%; White blood cell count \<3.0 x 109/L; Absolute neutrophil count \<1.2 x 109/L; Platelet count \<100 x 109/L.
* History of any other rheumatic autoimmune 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.

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 Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3
timeFrame: Baseline, Month 3
measure: Percentage of Participants Achieving 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 Week 2, Month 1, 2, 3, 4.5 and 6
timeFrame: Week 2, Month 1, 2, 3, 4.5, 6
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12
timeFrame: Month 9, 12
measure: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6
timeFrame: Week 2, Month 1, 2, 3, 4.5, 6
measure: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12
timeFrame: Month 9, 12
measure: Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6
timeFrame: Week 2, Month 1, 2, 3, 4.5, 6
measure: Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) 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, Week 2, Month 1, 2, 3, 4.5 and 6
timeFrame: Week 2, Month 1, 2, 3, 4.5, 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 3 and 6
timeFrame: Baseline, Month 3, 6
measure: Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 12
timeFrame: Month 12
measure: Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
timeFrame: Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12
measure: Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
timeFrame: Baseline, Month 3, 6, 12
measure: Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
timeFrame: Baseline, Week 2, Month 1, 2, 3, 4.5, 6
measure: Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12
timeFrame: Month 9, Month 12
measure: Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
timeFrame: Baseline, Week 2, Month 1, 2, 3, 4.5, 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, Week 2, Month 1, 2, 3, 4.5 and 6
timeFrame: Baseline, Week 2, Month 1, 2, 3, 4.5, 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, Week 2, Month 1, 2, 3, 4.5 and 6
timeFrame: Baseline, Week 2, Month 1, 2, 3, 4.5, 6
measure: Physician Global Assessment (PGA) of Arthritis 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: 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 Outcome Study (MOS) Sleep Scale at Month 12
timeFrame: Month 12
measure: Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12
timeFrame: Month 12
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
timeFrame: Month 12
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
timeFrame: Month 12
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
timeFrame: 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:
measure: Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis
timeFrame: 2 weeks
measure: Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain
timeFrame: 2 weeks
Locations:
city: Huntsville
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Jonesboro
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Palo Alto
country: United States
facility: Pfizer Investigational Site
state: California
city: Stanford
country: United States
facility: Pfizer Investigational Site
state: California
city: Boulder
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Danbury
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Hamden
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Trumbull
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Plantation
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tamarac
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: Maywood
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Rockford
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Vernon Hills
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
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: Leominster
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Worcester
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Edina
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Albany
country: United States
facility: Pfizer Investigational Site
state: New York
city: Orchard Park
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Asheville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Bethlehem
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: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Clarksburg
country: United States
facility: Pfizer Investigational Site
state: West Virginia
city: Campsie
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: Woodville
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Malvern East
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Shenton Park
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
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: Vina del Mar
country: Chile
facility: Pfizer Investigational Site
state: V Region
city: Vina del Mar
country: Chile
facility: Pfizer Investigational Site
city: Hefei
country: China
facility: Pfizer Investigational Site
state: Anhui
city: Hefei
country: China
facility: Pfizer Investigational Site
state: Anhui
city: Guangzhou
country: China
facility: Pfizer Investigational Site
state: Guangdong
city: Guangzhou
country: China
facility: Pfizer Investigational Site
state: Guangdong
city: Wuhan
country: China
facility: Pfizer Investigational Site
state: Hubei
city: Changsha
country: China
facility: Pfizer Investigational Site
state: Hunan
city: Nanjing
country: China
facility: Pfizer Investigational Site
state: Jiangsu
city: Suzhou
country: China
facility: Pfizer Investigational Site
state: Jiangsu
city: Jinan
country: China
facility: Pfizer Investigational Site
state: Shandong
city: Qingdao
country: China
facility: Pfizer Investigational Site
state: Shandong
city: Xi'an
country: China
facility: Pfizer Investigational Site
state: Shanxi
city: Chengdu
country: China
facility: Pfizer Investigational Site
state: Sichuan
city: Hangzhou
country: China
facility: Pfizer Investigational Site
state: Zhejiang
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Tianjin
country: China
facility: Pfizer Investigational Site
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: Opatija
country: Croatia
facility: Pfizer Investigational Site
city: Zagreb
country: Croatia
facility: Pfizer Investigational Site
city: Frederiksberg
country: Denmark
facility: Pfizer Investigational Site
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Hyvinkaa
country: Finland
facility: Pfizer Investigational Site
city: Tampere
country: Finland
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Dresden
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Nuernberg
country: Germany
facility: Pfizer Investigational Site
city: Rheine
country: Germany
facility: Pfizer Investigational Site
city: Maroussi Athens
country: Greece
facility: Pfizer Investigational Site
city: Seremban
country: Malaysia
facility: Pfizer Investigational Site
state: Negeri Sembilan
city: Batu Caves
country: Malaysia
facility: Pfizer Investigational Site
state: Selangor
city: Subang Jaya
country: Malaysia
facility: Pfizer Investigational Site
state: Selangor
city: Putrajaya
country: Malaysia
facility: Pfizer Investigational Site
state: Wilayah Persekutuan
city: Torreon
country: Mexico
facility: Pfizer Investigational Site
state: Coahuila
city: Morelia
country: Mexico
facility: Pfizer Investigational Site
state: Michoacan
city: Cuernavaca
country: Mexico
facility: Pfizer Investigational Site
state: Morelos
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: Queretaro
city: Merida
country: Mexico
facility: Pfizer Investigational Site
state: Yucatan
city: Bialystok
country: Poland
facility: Pfizer Investigational Site
city: Bialystok
country: Poland
facility: Pfizer Investigational Site
city: Koscian
country: Poland
facility: Pfizer Investigational Site
city: Poznan
country: Poland
facility: Pfizer Investigational Site
city: Torun
country: Poland
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Petrozavodsk
country: Russian Federation
facility: Pfizer Investigational Site
city: Nove Zamky
country: Slovakia
facility: Pfizer Investigational Site
city: Poprad
country: Slovakia
facility: Pfizer Investigational Site
city: Povazska Bystrica
country: Slovakia
facility: Pfizer Investigational Site
city: Rimavska Sobota
country: Slovakia
facility: Pfizer Investigational Site
city: Senica
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: A Coruña
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Malaga
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Falun
country: Sweden
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Uppsala
country: Sweden
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: Muang District
country: Thailand
facility: Pfizer Investigational Site
state: Khonkaen
city: Wirral
country: United Kingdom
facility: Pfizer Investigational Site
state: Merseyside
city: Cannock
country: United Kingdom
facility: Pfizer Investigational Site
state: Staffs
city: Solihull
country: United Kingdom
facility: Pfizer Investigational Site
state: West Midlands
city: Newcastle Upon Tyne
country: United Kingdom
facility: Pfizer Investigational Site
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
state: DC/ Municipio Libertados
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
state: Distrito Capital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
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