Back to resultsComparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In Japan
Primary Purpose
Arthritis, Rheumatoid
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Placebo
CP-690,550
CP-690,550
CP-690,550
CP-690,550
CP-690,550
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Phase 2 monotherapy in Japan
Eligibility Criteria
Inclusion Criteria:
- Subjects must have failed an adequate trial of therapy with at least 1 DMARD due to lack of efficacy or toxicity.
Exclusion Criteria:
- Current therapy with any DMARD
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Placebo
CP-690,550, 10mg
CP-690,550, 15mg
CP-690,550, 1mg
CP-690,550, 3mg
CP-690,550, 5mg
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in painful and tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Secondary Outcome Measures
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4 and 8
ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in painful and tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP)at each visit.
Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response
ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in painful and tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP) at each visit.
Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response
ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in painful and tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP) at each visit.
Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response
ACR90 response: greater than or equal to (>=) 90 percent (%) improvement in painful and tender joint count; >= 90% improvement in swollen joint count; and >= 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP) at each visit.
Change From Baseline in Disease Activity Score Based on 28-Joints Count Using C-reactive Protein [DAS28-3(CRP)]
The DAS28-3 (CRP) score is a measure of the perticipant's disease activity. It is based on the painful and tender joint count (28 joints), swollen joint count (28 joints) and CRP. DAS28-3 (CRP) scores range from 0 - 10; higher scores indicated greater affectation due to disease activity.
Change = value at observation minus value at baseline
Change From Baseline in Disease Activity Score Based on 28-Joints Count Using Erythrocyte Sedimentation Rate [DAS28-4(ESR)]
The DAS28-4 (ESR) score is a measure of the participant's disease activity. It is based on the painful and tender joint count (28 joints), swollen joint count (28 joints), participant's global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10; higher scores indicated greater affectation due to disease activity.
Change = score at observation minus score at baseline.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Change = score at observation minus score at baseline.
Change From Baseline in Painful and Tender Joint Counts
Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement. Change = value at observation minus value at baseline.
Change From Baseline in Swollen Joint Count (SJC)
Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement. Change = value at observation minus value at baseline.
Change From Baseline in Patient's Assessment of Pain
Change from Baseline in Patient's Assessment of Arthritis Pain -VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) was computed as Week 2, 4, 8 or 12 values minus baseline value. A negative value in change from baseline indicates an improvement.
Change = value at observation minus value at baseline.
Change From Baseline in Patient's Global Assessment of Arthritis
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly. Change = score at observation minus score at baseline.
Change From Baseline in Physician's Global Assessment of Arthritis
Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity; very good and 100 mm = worst disease activity; very poor. Change = score at observation minus score at baseline.
Change From Baseline in C- Reactive Protein (CRP) (mg/L)
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change = value at observation minus value at baseline.
Area Under Curve (AUC) for Change From Baseline in American College of Rheumatology-N (ACR-N)
ACR-N = calculated for each participant by taking lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of remaining 5 components of ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The AUC for ACR-N is measure of the area under the curve of the mean change from baseline in ACR-N. The trapezoidal rule was used to compute AUC.
Change From Baseline in Euro Quality of Life (EQ-5D)
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Change = score at Week 12 minus score at baseline.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Physical Functioning Domain
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Physical Domain
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Bodily Pain Domain
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -General Health Domain
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Vitality Domain
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change =score at Week 12 minus score at baseline
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Social Functioning Domain
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Emotional Domain
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Mental Health Domain
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Physical Component Summary (PCS)
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Mental Component Summary (MCS)
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00687193
Brief Title
Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In Japan
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Confirm Dose Responsiveness Following 12 Weeks Of The Administration Of CP-690,550 (5 Doses) Or Placebo In Subjects With Active Rheumatoid Arthritis Inadequately Responding To At Least 1 DMARD
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the dose-response relationship of 5 dose of CP-690,550, compared to placebo for the treatment of signs and symptoms in patients with active RA who failed an adequate trial of therapy with at least 1 DMARD in a 12-week therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Phase 2 monotherapy in Japan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
318 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
CP-690,550, 10mg
Arm Type
Experimental
Arm Title
CP-690,550, 15mg
Arm Type
Experimental
Arm Title
CP-690,550, 1mg
Arm Type
Experimental
Arm Title
CP-690,550, 3mg
Arm Type
Experimental
Arm Title
CP-690,550, 5mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo BID, 3 blinded tablets administered BID for 12 weeks
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
10mg BID, 3 blinded tablets administered BID for 12 weeks
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
15mg BID, 3 blinded tablets administered BID for 12 weeks
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
1mg BID, 3 blinded tablets administered BID for 12 weeks
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
3mg BID, 3 blinded tablets administered BID for 12 weeks
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
5mg BID, 3 blinded tablets administered BID for 12 weeks
Primary Outcome Measure Information:
Title
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
Description
ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in painful and tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4 and 8
Description
ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in painful and tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP)at each visit.
Time Frame
Week 2, 4, and 8
Title
Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Description
ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in painful and tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP) at each visit.
Time Frame
Week 2, 4, 8 and 12
Title
Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Description
ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in painful and tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP) at each visit.
Time Frame
Week 2, 4, 8 and 12
Title
Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response
Description
ACR90 response: greater than or equal to (>=) 90 percent (%) improvement in painful and tender joint count; >= 90% improvement in swollen joint count; and >= 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP) at each visit.
Time Frame
Week 2, 4, 8 and 12
Title
Change From Baseline in Disease Activity Score Based on 28-Joints Count Using C-reactive Protein [DAS28-3(CRP)]
Description
The DAS28-3 (CRP) score is a measure of the perticipant's disease activity. It is based on the painful and tender joint count (28 joints), swollen joint count (28 joints) and CRP. DAS28-3 (CRP) scores range from 0 - 10; higher scores indicated greater affectation due to disease activity.
Change = value at observation minus value at baseline
Time Frame
Baseline, Week 2, 4, 8 and 12
Title
Change From Baseline in Disease Activity Score Based on 28-Joints Count Using Erythrocyte Sedimentation Rate [DAS28-4(ESR)]
Description
The DAS28-4 (ESR) score is a measure of the participant's disease activity. It is based on the painful and tender joint count (28 joints), swollen joint count (28 joints), participant's global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10; higher scores indicated greater affectation due to disease activity.
Change = score at observation minus score at baseline.
Time Frame
Baseline, Week 2, 4, 8 and 12
Title
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Description
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Change = score at observation minus score at baseline.
Time Frame
Baseline, Week 2, 4, 8 and 12
Title
Change From Baseline in Painful and Tender Joint Counts
Description
Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement. Change = value at observation minus value at baseline.
Time Frame
Baseline, Weeks 2, 4, 8 and 12
Title
Change From Baseline in Swollen Joint Count (SJC)
Description
Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement. Change = value at observation minus value at baseline.
Time Frame
Baseline, Week 2, 4, 8 and 12
Title
Change From Baseline in Patient's Assessment of Pain
Description
Change from Baseline in Patient's Assessment of Arthritis Pain -VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) was computed as Week 2, 4, 8 or 12 values minus baseline value. A negative value in change from baseline indicates an improvement.
Change = value at observation minus value at baseline.
Time Frame
Baseline, Week 2, 4, 8 and 12
Title
Change From Baseline in Patient's Global Assessment of Arthritis
Description
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly. Change = score at observation minus score at baseline.
Time Frame
Baseline, Week 2, 4, 8 and 12
Title
Change From Baseline in Physician's Global Assessment of Arthritis
Description
Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity; very good and 100 mm = worst disease activity; very poor. Change = score at observation minus score at baseline.
Time Frame
Baseline, Week 2, 4, 8 and 12
Title
Change From Baseline in C- Reactive Protein (CRP) (mg/L)
Description
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change = value at observation minus value at baseline.
Time Frame
Baseline, Week 2, 4, 8 and 12
Title
Area Under Curve (AUC) for Change From Baseline in American College of Rheumatology-N (ACR-N)
Description
ACR-N = calculated for each participant by taking lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of remaining 5 components of ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The AUC for ACR-N is measure of the area under the curve of the mean change from baseline in ACR-N. The trapezoidal rule was used to compute AUC.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Euro Quality of Life (EQ-5D)
Description
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Change = score at Week 12 minus score at baseline.
Time Frame
Baseline, Week 12
Title
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Physical Functioning Domain
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline.
Time Frame
Baseline, Week 12
Title
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Physical Domain
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline.
Time Frame
Baseline, Week 12
Title
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Bodily Pain Domain
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline.
Time Frame
Baseline, Week 12
Title
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -General Health Domain
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline.
Time Frame
Baseline, Week 12
Title
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Vitality Domain
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change =score at Week 12 minus score at baseline
Time Frame
Baseline, Week 12
Title
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Social Functioning Domain
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline.
Time Frame
Baseline, Week 12
Title
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Emotional Domain
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline.
Time Frame
Baseline, Week 12
Title
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Mental Health Domain
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline.
Time Frame
Baseline, Week 12
Title
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Physical Component Summary (PCS)
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline.
Time Frame
Baseline, Week 12
Title
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Mental Component Summary (MCS)
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change = score at Week 12 minus score at baseline.
Time Frame
Baseline, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must have failed an adequate trial of therapy with at least 1 DMARD due to lack of efficacy or toxicity.
Exclusion Criteria:
Current therapy with any DMARD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Narashino
State/Province
Chiba
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yotukaidou
State/Province
Chiba
Country
Japan
Facility Name
Pfizer Investigational Site
City
Iiduka
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kitakyusyu
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kurume
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sawara-ku
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Takasaki
State/Province
Gunma
Country
Japan
Facility Name
Pfizer Investigational Site
City
Higashihiroshima
State/Province
Hiroshima
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hiroshima-city
State/Province
Hiroshima
Country
Japan
Facility Name
Pfizer Investigational Site
City
Asahikawa
State/Province
Hokkaido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nishinomiya
State/Province
Hyogo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tsukuba
State/Province
Ibaraki
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sagamihara
State/Province
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Koushi
State/Province
Kumamoto
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tsu
State/Province
Mie
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Ohmura
State/Province
Nagasaki
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sasebo
State/Province
Nagasaki
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kashihara
State/Province
Nara
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kawachinagano
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Ureshino-shi
State/Province
Saga
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kawagoe-shi
State/Province
Saitama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kitamoto
State/Province
Saitama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Arakawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Musashimurayama-shi
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shinjyuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Takaoka
State/Province
Toyama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chiba
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukusima
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hiroshima
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kumamoto
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kyoto
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nagasaki
Country
Japan
Facility Name
Pfizer Investigational Site
City
Oita
Country
Japan
Facility Name
Pfizer Investigational Site
City
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Saitama
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
34870800
Citation
Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.
Results Reference
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PubMed Identifier
33127856
Citation
Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.
Results Reference
derived
PubMed Identifier
32816215
Citation
Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:
Results Reference
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PubMed Identifier
31512746
Citation
Suzuki M, Shoji S, Miyoshi S, Krishnaswami S. Model-Based Comparison of Dose-Response Profiles of Tofacitinib in Japanese Versus Western Rheumatoid Arthritis Patients. J Clin Pharmacol. 2020 Feb;60(2):198-208. doi: 10.1002/jcph.1514. Epub 2019 Sep 12.
Results Reference
derived
PubMed Identifier
28143815
Citation
Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.
Results Reference
derived
PubMed Identifier
26275429
Citation
Charles-Schoeman C, Burmester G, Nash P, Zerbini CA, Soma K, Kwok K, Hendrikx T, Bananis E, Fleischmann R. Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2016 Jul;75(7):1293-301. doi: 10.1136/annrheumdis-2014-207178. Epub 2015 Aug 14. Erratum In: Ann Rheum Dis. 2017 Mar;76(3):611.
Results Reference
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PubMed Identifier
25496464
Citation
Tanaka Y, Takeuchi T, Yamanaka H, Nakamura H, Toyoizumi S, Zwillich S. Efficacy and safety of tofacitinib as monotherapy in Japanese patients with active rheumatoid arthritis: a 12-week, randomized, phase 2 study. Mod Rheumatol. 2015 Jul;25(4):514-21. doi: 10.3109/14397595.2014.995875.
Results Reference
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PubMed Identifier
25047021
Citation
Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921040&StudyName=Comparison%20Of%205%20CP-690%2C550%20Doses%20Vs.%20Placebo%2C%20For%20The%20Treatment%20Of%20Rheumatoid%20Arthritis%20In%20Japan
Description
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Learn more about this trial
Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In Japan
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