Clinical trial NCT00960440: Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors
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 Methotrexate With Inadequate Response To TNF Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Keywords: randomized double-blind placebo-controlled investigational drug oral therapy safety and efficacy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-08-17
Enrollment: 399
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 will test if CP-690,550 is safe and effective in rheumatoid arthritis patients taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor treatment.


Eligibility criteria: Inclusion Criteria:

* Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate who have inadequate response to Tumor Necrosis Factor (TNF) inhibitors.

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 3
timeFrame: Month 3
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3
timeFrame: Baseline, Month 3
measure: Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3
timeFrame: Month 3
Secondary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1
timeFrame: Week 2, Month 1
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4.5 and 6
timeFrame: Month 4.5, 6
measure: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3
timeFrame: Week 2, Month 1, 3
measure: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4.5 and 6
timeFrame: Month 4.5 and 6
measure: Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3
timeFrame: Week 2, Month 1, 3
measure: Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4.5 and 6
timeFrame: Month 4.5, 6
measure: Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3
timeFrame: Baseline, Week 2, Month 1, 3
measure: Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6
timeFrame: Month 4.5, 6
measure: Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3
timeFrame: Baseline, Month 3
measure: Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6
timeFrame: Month 6
measure: Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3
timeFrame: Week 2, Month 1, 3
measure: Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6
timeFrame: Month 4.5, 6
measure: Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3
timeFrame: Baseline, Week 2, Month 1, 3
measure: Patient Assessment of Arthritis Pain at Month 4.5 and 6
timeFrame: Month 4.5, 6
measure: Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3
timeFrame: Baseline, Week 2, Month 1, 3
measure: Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6
timeFrame: Month 4.5, 6
measure: Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3
timeFrame: Baseline, Week 2, Month 1, 3
measure: Physician Global Assessment of Arthritis at Month 4.5 and 6
timeFrame: Month 4.5, 6
measure: 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
timeFrame: Baseline, Week 2, Month 1, 3
measure: 36-Item Short-Form Health Survey (SF-36) at Month 6
timeFrame: Month 6
measure: Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
timeFrame: Baseline, Week 2, Month 1, 3
measure: Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6
timeFrame: Month 6
measure: Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3
timeFrame: Baseline, Week 2, Month 1, 3
measure: Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6
timeFrame: Month 6
measure: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3
timeFrame: Baseline, Month 3
measure: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6
timeFrame: Month 6
measure: Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3
timeFrame: Baseline, Month 1, 3
measure: Euro Quality of Life - 5 Dimensions (EQ-5D) - Health State Profile Utility Score at Month 6
timeFrame: Month 6
measure: Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
timeFrame: Baseline, Month 3
measure: Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
timeFrame: Month 6
measure: Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
timeFrame: Baseline, Month 3
measure: Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
timeFrame: Month 6
measure: Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
timeFrame: Baseline, Month 3
measure: Number of Days as Assessed Using RA-HCRU at Month 6
timeFrame: Month 6
measure: Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
timeFrame: Baseline, Month 3
measure: Number of Hours Per Day as Assessed RA-HCRU at Month 6
timeFrame: Month 6
measure: Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3
timeFrame: Baseline, Month 3
measure: Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6
timeFrame: Month 6
measure: Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
timeFrame: Baseline, Month 3
measure: Work Limitations Questionnaire (WLQ) Score at Month 6
timeFrame: Month 6
Other outcomes:
measure: Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3
timeFrame: Week 2, Month 1, 3
measure: Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6
timeFrame: Month 4.5, 6
measure: Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3
timeFrame: Month 3
measure: Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6
timeFrame: Month 6
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Farmington
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Trumbull
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Aventura
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Idaho Falls
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Maine
city: Cumberland
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Worcester
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Flowood
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Tupelo
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Lebanon
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: Voorhees
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Rocky Mount
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Bethlehem
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Willow Grove
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Wyomissing
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Hixson
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
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: Vancouver
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Vancouver
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Vancouver
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Kogarah
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Daw Park
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Heidelberg
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Genk
country: Belgium
facility: Pfizer Investigational Site
city: Hasselt
country: Belgium
facility: Pfizer Investigational Site
city: Kortrijk
country: Belgium
facility: Pfizer Investigational Site
city: Liège
country: Belgium
facility: Pfizer Investigational Site
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: RS
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Pointe Claire
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Amiens
country: France
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Orleans Cedex 1
country: France
facility: Pfizer Investigational Site
city: Orleans
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Erlangen
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: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Koeln
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Rheine
country: Germany
facility: Pfizer Investigational Site
city: Wuerzburg
country: Germany
facility: Pfizer Investigational Site
city: Croom
country: Ireland
facility: Pfizer Investigational Site
state: Co. Limerick
city: Dublin
country: Ireland
facility: Pfizer Investigational Site
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Jesi
country: Italy
facility: Pfizer Investigational Site
city: Busan
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Daegu
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: San Juan
country: Puerto Rico
facility: Pfizer Investigational Site
city: Santiago de Compostela
country: Spain
facility: Pfizer Investigational Site
state: A Coruña
city: Merida
country: Spain
facility: Pfizer Investigational Site
state: Badajoz
city: Bilbao
country: Spain
facility: Pfizer Investigational Site
state: Bizkaia
city: Santander
country: Spain
facility: Pfizer Investigational Site
state: Cantabria
city: Baracaldo
country: Spain
facility: Pfizer Investigational Site
state: Vizcaya
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Niao Sung Hsiang
country: Taiwan
facility: Pfizer Investigational Site
state: Kaohsiung County
city: Kweishan
country: Taiwan
facility: Pfizer Investigational Site
state: Taoyuan County
city: Changhua
country: Taiwan
facility: Pfizer Investigational Site
city: Kaohsiung
country: Taiwan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
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