Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00413660
• Date of registration: 18/12/2006
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis
• Scientific title: A Phase 2B, Randomized, Double Blind, Placebo-Controlled, Multicenter Study To Compare 6 Dose Regimens Of CP-690,550 Vs. Placebo, Each Combined With Methotrexate, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate Alone
• Date of first enrolment: January 2007
• Target sample size: 509
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00413660
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Argentina, Brazil, Bulgaria, Chile, Czech Republic, Hungary, Mexico, Poland, Slovakia, Spain, Sweden, Turkey, United States

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Active rheumatoid arthritis

- Inadequate response to stably dosed methotrexate

Exclusion Criteria:

- Current therapy with any DMARD or biologic other than methotrexate



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

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: CP-690,550

Other: placebo

Primary Outcome(s)

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

Secondary Outcome(s)

36-Item Short-Form Health Survey (SF-36) [Time Frame: Baseline, Week 12, 24/ET]

Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

Change From Baseline in Swollen Joints Count (SJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

Health Assessment Questionnaire-Disability Index (HAQ-DI) [Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response [Time Frame: Week 2, 4, 6, 8, 16, 20, 24/Early Termination (ET)]

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response [Time Frame: Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response [Time Frame: Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

Change From Baseline in Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility at Week 12 and 24/ET [Time Frame: Baseline, Week 12, 24/ET]

Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) [Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

C-Reactive Protein (CRP) [Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET [Time Frame: Baseline, Week 2, 12, 24/ET]

Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET [Time Frame: Baseline, Week 2, 12, 24/ET]

Change From Baseline in Physician Global Assessment of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve [Time Frame: Baseline up to Week 2, 4, 6, 8, 12]

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET [Time Frame: Baseline, Week 12, 24/ET]

Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility Score [Time Frame: Baseline, Week 12, 24/ET]

Tender Joints Count (TJC) [Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

Medical Outcome Study- Sleep Scale (MOS-SS) [Time Frame: Baseline, Week 2, 12, 24/ET]

Patient Global Assessment (PtGA) of Arthritis [Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) [Time Frame: Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

Patient Assessment of Arthritis Pain [Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

Percentage of Participants With Disease Remission Based on DAS28-3 (CRP) [Time Frame: Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale [Time Frame: Baseline, Week 2, 12, 24/ET]

Change From Baseline in C-Reactive Protein (CRP) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

Swollen Joints Count (SJC) [Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

Physician Global Assessment of Arthritis [Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

Secondary ID(s)

A3921025

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 08/01/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00413660