A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00853385
• Date of registration: 27/02/2009
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis
• Scientific 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
• Date of first enrolment: May 2009
• Target sample size: 717
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00853385
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Australia, Bosnia and Herzegovina, Bulgaria, Canada, Chile, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Finland, Germany, Korea, Republic of, Mexico, Philippines, Poland, Slovakia, Spain, Thailand, United Kingdom, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: Biologic TNFi

Drug: CP 690,550

Other: Placebo

Drug: CP-690,550

Primary Outcome(s)

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 [Time Frame: Month 6]

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 [Time Frame: Month 6]

Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3 [Time Frame: Baseline, Month 3]

Secondary Outcome(s)

Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 [Time Frame: Baseline, Month 1, 3, 6]

Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6 [Time Frame: Baseline, Month 1, 3, 6]

Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 [Time Frame: Baseline, Month 1, 3, 6]

Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 [Time Frame: Month 12]

Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 [Time Frame: Baseline, Month 1, 3, 6]

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3 [Time Frame: Month 1, 3]

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12 [Time Frame: Month 9, 12]

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6 [Time Frame: Month 1, 3, 6]

Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) [Time Frame: Baseline, Month 1, 3, 6, 9, 12]

Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12 [Time Frame: Month 9, 12]

Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 [Time Frame: Baseline, Month 3, 6]

Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 [Time Frame: Baseline, Month 3, 6]

Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 [Time Frame: Baseline, Month 1, 3, 6]

36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 [Time Frame: Month 9, 12]

Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 [Time Frame: Month 12]

Patient Assessment of Arthritis Pain at Month 9 and 12 [Time Frame: Month 9, 12]

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12 [Time Frame: Month 9, 12]

Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 [Time Frame: Baseline, Month 1, 3, 6]

Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 [Time Frame: Month 3, 6]

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12 [Time Frame: Month 9, 12]

Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12 [Time Frame: Month 12]

Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 [Time Frame: Month 12]

Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 [Time Frame: Baseline, Month 3, 6]

Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12 [Time Frame: Month 12]

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 [Time Frame: Baseline, Month 1, 3, 6]

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) [Time Frame: Baseline, Month 1, 3, 6, 9, 12]

Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6 [Time Frame: Baseline, Month 1, 3, 6]

Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6 [Time Frame: Month 1, 3, 6]

Number of Days as Assessed Using RA-HCRU at Month 12 [Time Frame: Month 12]

Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 [Time Frame: Baseline, Month 3, 6]

Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 [Time Frame: Baseline, Month 3, 6]

36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 [Time Frame: Baseline, Month 1, 3, 6]

Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12 [Time Frame: Month 12]

Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12 [Time Frame: Month 9, 12]

Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 [Time Frame: Month 12]

Number of Hours Per Day as Assessed RA-HCRU at Month 12 [Time Frame: Month 12]

Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 [Time Frame: Baseline, Month 1, 3, 6]

Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 [Time Frame: Month 9, 12]

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6 [Time Frame: Month 1, 3, 6]

Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12 [Time Frame: Month 9, 12]

Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 [Time Frame: Baseline, Month 12]

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12 [Time Frame: Month 9, 12]

Secondary ID(s)

A3921064

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/01/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00853385