Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in Japan

ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); 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

Population: Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using Last observation carried forward (LOCF) method.

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).

Time frame: Baseline, Week 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.

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 up to Week 12

Population: FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Time frame: Baseline, Week 1, 2, 4, 8, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.

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.

Time frame: Baseline, Week 1, 2, 4, 8, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.

Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 = no pain and 100 = most severe pain.

Time frame: Baseline, Week 1, 2, 4, 8, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.

Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly.

Time frame: Baseline, Week 1, 2, 4, 8, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.

Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 = very good and 100 = very bad.

Time frame: Baseline, Week 1, 2, 4, 8, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.

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.

Time frame: Baseline, Week 1, 2, 4, 8, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.

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.

Time frame: Baseline, Week 1, 2, 4, 8, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Time frame: Baseline, Week 1, 2, 4, 8, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.

DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (=\<) 3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.

Time frame: Baseline, Week 1, 2, 4, 8, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.

DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=\<) 3.2 implied low disease activity, greater than (\>) 3.2 to 5.1 implied moderate to high disease activity and less than (\<) 2.6=remission.

Time frame: Baseline, Week 1, 2, 4, 8, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.

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, selfcare, 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.

Time frame: Baseline, Week 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.

FACIT-F is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.

Time frame: Baseline, Week 2, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.

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.

Time frame: Baseline, Week 1, 2, 4, 8, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.

Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales:sleep disturbance(SD),snoring(Sno),awakened short of breath(ASOB),sleep adequacy(Ade),somnolence(Som)(range:0-100);sleep quantity(Qua)(range:0-24),optimal(Opt) sleep(yes:1,no:0),9 item index measures of sleep disturbance provide composite scores:sleep problem summary(SPS),overall SP(OSP).Except Ade,Opt,Qua,higher scores=more impairment.Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range\*100);total score range:0-100;higher score=more intensity of attribute.

Time frame: Baseline, Week 2, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.

ACR-n = calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the 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.

Time frame: Week 1, 2, 4, 8, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.

Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 = no pain and 100 = most severe pain.

Time frame: Baseline, Week 1, 2, 4, 8, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.

Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly.

Time frame: Baseline, Week 1, 2, 4, 8, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.

ACR20 response: \>= 20% improvement in TJC; \>= 20% improvement in SJC; 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 HAQ); and CRP.

Time frame: Week 1, 2, 4, 8

Population: FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.

ACR50 response: \>= 50% improvement in tender or swollen joint counts 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 HAQ); and CRP.

Time frame: Week 1, 2, 4, 8, 12/End of Treatment (EOT)

Population: FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.

ACR70 response: \>= 70% improvement in tender or swollen joint counts 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 HAQ); and CRP.

Time frame: Week 1, 2, 4, 8, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.

ACR90 response: \>= 90% improvement in tender or swollen joint counts 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 HAQ); and CRP.

Time frame: Week 1, 2, 4, 8, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.

Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 = very good and 100 = very bad.

Time frame: Baseline, Week 1, 2, 4, 8, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.

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.

Time frame: Baseline, Week 1, 2, 4, 8, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.

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.

Time frame: Baseline, Week 1, 2, 4, 8, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.