Clinical trial NCT00814307: A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis
Official title: Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 Monotherapy In Patients With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Keywords: Antirheumatic Agents Clinical Trial
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-24
Enrollment: 611
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 of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day as monotherapy 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 the Phase 2 Rheumatoid Arthritis studies.


Eligibility criteria: Inclusion Criteria:

* The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
* The patient has active disease at both Screening and Baseline, 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
* Patient had an inadequate response to at least one DMARD (traditional or biologic) due to lack of efficacy or toxicity.
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
* Patient has washed out of all DMARDs other that antimalarials

Exclusion Criteria:

* Blood dyscrasias including confirmed: 1. Hemoglobin \<9 g/dL or Hematocrit \<30%; 2. White blood cell count \<3.0 x 109/L; 3. Absolute neutrophil count \<1.2 x 109/L; 4. Platelet count \<100 x 109/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

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 Participant With Disease Activity Score Using 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, Month 1 and 2
timeFrame: Week 2, Month 1, 2
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, 2 and 3
timeFrame: Week 2, Month 1, 2, 3
measure: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6
timeFrame: Month 4, 5, 6
measure: Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3
timeFrame: Week 2, Month 1, 2, 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 Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3
timeFrame: Baseline, Month 3
measure: Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6
timeFrame: Month 6
measure: Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3
timeFrame: Baseline, Week 2, Month 1, 2, 3
measure: Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6
timeFrame: Month 4, 5, 6
measure: Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3
timeFrame: Baseline, Week 2, Month 1, 2, 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, 2 and 3
timeFrame: Baseline, Week 2, Month 1, 2, 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, 2 and 3
timeFrame: Baseline, Week 2, Month 1, 2, 3
measure: Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6
timeFrame: Month 4, 5, 6
measure: Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
timeFrame: Baseline, Week 2, Month 1, 2, 3
measure: Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6
timeFrame: Month 4, 5, 6
measure: 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
timeFrame: Baseline, Month 3
measure: 36-Item Short-Form Health Survey (SF-36) at Month 6
timeFrame: Month 6
measure: Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3
timeFrame: Baseline, Month 3
measure: Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 3
timeFrame: Baseline, Month 3
measure: Medical Outcome 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 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 (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3
timeFrame: Baseline, Month 3
measure: Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 6
timeFrame: Month 6
measure: Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and 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 Days as Assessed Using 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: Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain
timeFrame: 2 weeks
measure: Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis
timeFrame: 2 weeks
Locations:
city: Gilbert
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Hot Springs
country: United States
facility: Pfizer Investigational Site
state: Arkansas
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: Venice
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Zephyr Hills
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Rockford
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Frederick
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Hyannis
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Teaneck
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Albany
country: United States
facility: Pfizer Investigational Site
state: New York
city: Olean
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Rocky Mount
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Minot
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Dayton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Bethlehem
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Duncansville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: West Reading
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Myrtle Beach
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Dallas
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: Goiania
country: Brazil
facility: Pfizer Investigational Site
state: GO
city: Curitiba
country: Brazil
facility: Pfizer Investigational Site
state: PR
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: 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: Pleven
country: Bulgaria
facility: Pfizer Investigational Site
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: 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: Bucaramanga
country: Colombia
facility: Pfizer Investigational Site
state: Santander
city: Barranquilla
country: Colombia
facility: Pfizer Investigational Site
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Ceska Lipa
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 2
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 4
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: Santo Domingo
country: Dominican Republic
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Halle
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Nuernberg
country: Germany
facility: Pfizer Investigational Site
city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
city: Secunderabad
country: India
facility: Pfizer Investigational Site
state: Andra Pradesh
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
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: Mangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Kota Kinabalu
country: Malaysia
facility: Pfizer Investigational Site
state: Sabah
city: Kuching
country: Malaysia
facility: Pfizer Investigational Site
state: Sarawak
city: Petaling Jaya
country: Malaysia
facility: Pfizer Investigational Site
state: Selangor Darul Ehsan
city: Putrajaya
country: Malaysia
facility: Pfizer Investigational Site
state: Wilayah Persekutuan
city: Tijuana
country: Mexico
facility: Pfizer Investigational Site
state: Baja California
city: Guadalajara
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Chihuahua
country: Mexico
facility: Pfizer Investigational Site
city: Dasmarinas
country: Philippines
facility: Pfizer Investigational Site
state: Cavite
city: Bajada, Davao City
country: Philippines
facility: Pfizer Investigational Site
state: Phlippines
city: Las Piñas City
country: Philippines
facility: Pfizer Investigational Site
city: Manila
country: Philippines
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Wroclaw
country: Poland
facility: Pfizer Investigational Site
city: San Juan
country: Puerto Rico
facility: Pfizer Investigational Site
city: Petrozavodsk
country: Russian Federation
facility: Pfizer Investigational Site
city: Smolensk
country: Russian Federation
facility: Pfizer Investigational Site
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: Simferopol, Crimea
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
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