Trial Outcomes & Findings for Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In Japan (NCT NCT00687193)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

318 participants

Primary outcome timeframe

Week 12

Results posted on

2013-03-25

Participant Flow

Participant milestones

Participant milestones
Measure	CP-690,550 1 mg Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Study STARTED	53	53	52	53	54	52
Overall Study COMPLETED	51	49	50	49	52	48
Overall Study NOT COMPLETED	2	4	2	4	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	CP-690,550 1 mg Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Study Adverse Event	0	1	2	3	0	2
Overall Study Lack of Efficacy	1	1	0	0	0	2
Overall Study Protocol Violation	1	2	0	1	2	0

Baseline Characteristics

Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In Japan

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CP-690,550 1 mg n=53 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=53 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=52 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=53 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=54 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=52 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.	Total n=317 Participants Total of all reporting groups
Age, Customized < 18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Customized Between 18 and 44 years	8 Participants n=5 Participants	11 Participants n=7 Participants	13 Participants n=5 Participants	9 Participants n=4 Participants	12 Participants n=21 Participants	14 Participants n=8 Participants	67 Participants n=8 Participants
Age, Customized Between 45 and 64 years	39 Participants n=5 Participants	33 Participants n=7 Participants	31 Participants n=5 Participants	32 Participants n=4 Participants	30 Participants n=21 Participants	29 Participants n=8 Participants	194 Participants n=8 Participants
Age, Customized >= 65 years	6 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	12 Participants n=4 Participants	12 Participants n=21 Participants	9 Participants n=8 Participants	56 Participants n=8 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	47 Participants n=7 Participants	44 Participants n=5 Participants	44 Participants n=4 Participants	44 Participants n=21 Participants	43 Participants n=8 Participants	264 Participants n=8 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	9 Participants n=4 Participants	10 Participants n=21 Participants	9 Participants n=8 Participants	53 Participants n=8 Participants

PRIMARY outcome

Timeframe: Week 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.

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).

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=53 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=53 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=52 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=53 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=54 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=52 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12	20 participants	36 participants	38 participants	45 participants	49 participants	8 participants

SECONDARY outcome

Timeframe: Week 2, 4, and 8

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=53 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=53 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=52 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=53 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=54 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=52 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4 and 8 Week 2 (LOCF)	10 participants	18 participants	18 participants	35 participants	29 participants	3 participants
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4 and 8 Week 4 (LOCF)	19 participants	25 participants	32 participants	43 participants	42 participants	5 participants
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4 and 8 Week 8 (LOCF)	20 participants	33 participants	35 participants	46 participants	47 participants	6 participants

SECONDARY outcome

Timeframe: Week 2, 4, 8 and 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=52 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=53 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=52 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=53 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=54 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=52 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response Week 2 (LOCF)	1 participants	5 participants	6 participants	17 participants	12 participants	0 participants
Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response Week 4 (LOCF)	5 participants	12 participants	15 participants	29 participants	25 participants	1 participants
Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response Week 8 (LOCF)	6 participants	20 participants	23 participants	33 participants	36 participants	1 participants
Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response Week 12 (LOCF)	7 participants	14 participants	24 participants	37 participants	39 participants	4 participants

SECONDARY outcome

Timeframe: Week 2, 4, 8 and 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=53 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=53 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=52 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=53 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=54 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=52 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 2 (LOCF)	0 participants	0 participants	1 participants	5 participants	4 participants	0 participants
Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 4 (LOCF)	1 participants	2 participants	9 participants	14 participants	9 participants	0 participants
Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 8 (LOCF)	3 participants	7 participants	13 participants	20 participants	22 participants	1 participants
Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 12 (LOCF)	4 participants	7 participants	14 participants	26 participants	28 participants	1 participants

SECONDARY outcome

Timeframe: Week 2, 4, 8 and 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=53 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=53 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=52 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=53 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=54 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=52 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response Week 2 (LOCF)	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response Week 4 (LOCF)	0 participants	0 participants	0 participants	2 participants	3 participants	0 participants
Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response Week 8 (LOCF)	0 participants	0 participants	3 participants	7 participants	5 participants	0 participants
Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response Week 12 (LOCF)	0 participants	0 participants	2 participants	8 participants	6 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8 and 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

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

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=53 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=53 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=52 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=53 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=54 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=52 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in Disease Activity Score Based on 28-Joints Count Using C-reactive Protein [DAS28-3(CRP)] Week 2 (n=53, 53, 51, 52, 54, 52)	-0.56 Units on a scale Standard Error 0.13	-1.03 Units on a scale Standard Error 0.13	-1.01 Units on a scale Standard Error 0.13	-1.65 Units on a scale Standard Error 0.13	-1.63 Units on a scale Standard Error 0.13	-0.20 Units on a scale Standard Error 0.13
Change From Baseline in Disease Activity Score Based on 28-Joints Count Using C-reactive Protein [DAS28-3(CRP)] Week 4 (n=52, 51, 51, 52, 52, 52)	-0.82 Units on a scale Standard Error 0.13	-1.29 Units on a scale Standard Error 0.13	-1.65 Units on a scale Standard Error 0.13	-2.33 Units on a scale Standard Error 0.13	-2.14 Units on a scale Standard Error 0.13	-0.23 Units on a scale Standard Error 0.13
Change From Baseline in Disease Activity Score Based on 28-Joints Count Using C-reactive Protein [DAS28-3(CRP)] Week 8 (n=51, 51, 51, 52, 52, 50)	-0.98 Units on a scale Standard Error 0.13	-1.63 Units on a scale Standard Error 0.13	-1.95 Units on a scale Standard Error 0.13	-2.62 Units on a scale Standard Error 0.13	-2.55 Units on a scale Standard Error 0.13	-0.15 Units on a scale Standard Error 0.13
Change From Baseline in Disease Activity Score Based on 28-Joints Count Using C-reactive Protein [DAS28-3(CRP)] Week 12 (n=51, 49, 50, 49, 52, 48)	-1.09 Units on a scale Standard Error 0.13	-1.71 Units on a scale Standard Error 0.13	-2.02 Units on a scale Standard Error 0.13	-2.81 Units on a scale Standard Error 0.13	-2.70 Units on a scale Standard Error 0.13	-0.12 Units on a scale Standard Error 0.13

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8 and 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=53 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=53 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=52 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=53 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=54 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=52 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in Disease Activity Score Based on 28-Joints Count Using Erythrocyte Sedimentation Rate [DAS28-4(ESR)] Week 2 (n=52, 53, 50, 52, 54, 52)	-0.52 Units on a scale Standard Error 0.15	-0.93 Units on a scale Standard Error 0.14	-1.00 Units on a scale Standard Error 0.15	-1.66 Units on a scale Standard Error 0.15	-1.58 Units on a scale Standard Error 0.14	-0.25 Units on a scale Standard Error 0.15
Change From Baseline in Disease Activity Score Based on 28-Joints Count Using Erythrocyte Sedimentation Rate [DAS28-4(ESR)] Week 4 (n=52, 51, 51, 52, 52, 51)	-0.79 Units on a scale Standard Error 0.15	-1.32 Units on a scale Standard Error 0.15	-1.69 Units on a scale Standard Error 0.15	-2.42 Units on a scale Standard Error 0.15	-2.31 Units on a scale Standard Error 0.14	-0.23 Units on a scale Standard Error 0.15
Change From Baseline in Disease Activity Score Based on 28-Joints Count Using Erythrocyte Sedimentation Rate [DAS28-4(ESR)] Week 8 (n=51, 50, 51, 52, 52, 50)	-1.03 Units on a scale Standard Error 0.15	-1.68 Units on a scale Standard Error 0.15	-2.05 Units on a scale Standard Error 0.15	-2.92 Units on a scale Standard Error 0.15	-2.87 Units on a scale Standard Error 0.14	-0.12 Units on a scale Standard Error 0.15
Change From Baseline in Disease Activity Score Based on 28-Joints Count Using Erythrocyte Sedimentation Rate [DAS28-4(ESR)] Week 12 (n=51, 49, 50, 49, 52, 48)	-1.10 Units on a scale Standard Error 0.15	-1.74 Units on a scale Standard Error 0.15	-2.20 Units on a scale Standard Error 0.15	-3.05 Units on a scale Standard Error 0.15	-2.98 Units on a scale Standard Error 0.14	-0.10 Units on a scale Standard Error 0.15

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8 and 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=53 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=53 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=52 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=53 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=54 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=52 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 2 (n=53, 53, 51, 52, 54, 52)	-0.10 Units on a scale Standard Error 0.06	-0.15 Units on a scale Standard Error 0.06	-0.28 Units on a scale Standard Error 0.06	-0.39 Units on a scale Standard Error 0.06	-0.40 Units on a scale Standard Error 0.06	0.06 Units on a scale Standard Error 0.06
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 4 (n=52, 51, 51, 52, 52, 52)	-0.07 Units on a scale Standard Error 0.06	-0.25 Units on a scale Standard Error 0.06	-0.38 Units on a scale Standard Error 0.06	-0.54 Units on a scale Standard Error 0.06	-0.51 Units on a scale Standard Error 0.06	0.03 Units on a scale Standard Error 0.06
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 8 (n=51, 50, 51, 52, 52, 50)	-0.17 Units on a scale Standard Error 0.06	-0.36 Units on a scale Standard Error 0.06	-0.49 Units on a scale Standard Error 0.06	-0.59 Units on a scale Standard Error 0.06	-0.63 Units on a scale Standard Error 0.06	0.18 Units on a scale Standard Error 0.06
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 12 (n=51, 49, 50, 49, 52, 48)	-0.19 Units on a scale Standard Error 0.06	-0.38 Units on a scale Standard Error 0.06	-0.55 Units on a scale Standard Error 0.06	-0.67 Units on a scale Standard Error 0.06	-0.68 Units on a scale Standard Error 0.06	0.18 Units on a scale Standard Error 0.06

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8 and 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=53 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=53 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=52 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=53 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=54 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=52 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in Painful and Tender Joint Counts Week 2 (n=53, 53, 51, 52, 54, 52)	-4.14 units on a scale Standard Error 0.98	-5.13 units on a scale Standard Error 0.97	-5.29 units on a scale Standard Error 0.99	-8.48 units on a scale Standard Error 0.98	-7.73 units on a scale Standard Error 0.96	-2.03 units on a scale Standard Error 0.98
Change From Baseline in Painful and Tender Joint Counts Week 8 (n=51, 51, 51, 52, 52, 50)	-6.27 units on a scale Standard Error 0.98	-8.80 units on a scale Standard Error 0.98	-9.65 units on a scale Standard Error 0.99	-12.89 units on a scale Standard Error 0.98	-12.16 units on a scale Standard Error 0.97	-0.49 units on a scale Standard Error 0.99
Change From Baseline in Painful and Tender Joint Counts Week 12 (n=51, 49, 50, 49, 52, 48)	-7.05 units on a scale Standard Error 0.98	-10.01 units on a scale Standard Error 0.99	-10.08 units on a scale Standard Error 1.00	-13.67 units on a scale Standard Error 0.99	-12.81 units on a scale Standard Error 0.97	-0.67 units on a scale Standard Error 1.00
Change From Baseline in Painful and Tender Joint Counts Week 4 (n=52, 51, 51, 52, 52, 52)	-5.92 units on a scale Standard Error 0.98	-6.95 units on a scale Standard Error 0.98	-8.41 units on a scale Standard Error 0.99	-11.35 units on a scale Standard Error 0.98	-10.41 units on a scale Standard Error 0.97	-1.12 units on a scale Standard Error 0.98

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8 and 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=53 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=53 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=52 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=53 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=54 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=52 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in Swollen Joint Count (SJC) Week 2 (n=53, 53, 51, 52, 54, 52)	-3.19 units on a scale Standard Error 0.69	-3.85 units on a scale Standard Error 0.68	-2.58 units on a scale Standard Error 0.70	-6.93 units on a scale Standard Error 0.69	-5.95 units on a scale Standard Error 0.68	-1.58 units on a scale Standard Error 0.69
Change From Baseline in Swollen Joint Count (SJC) Week 12 (n=51, 49, 50, 49, 52, 48)	-5.76 units on a scale Standard Error 0.69	-7.94 units on a scale Standard Error 0.70	-7.75 units on a scale Standard Error 0.70	-10.44 units on a scale Standard Error 0.70	-10.73 units on a scale Standard Error 0.68	-1.29 units on a scale Standard Error 0.70
Change From Baseline in Swollen Joint Count (SJC) Week 4 (n=52, 51, 51, 52, 52, 52)	-4.57 units on a scale Standard Error 0.69	-6.10 units on a scale Standard Error 0.69	-6.15 units on a scale Standard Error 0.70	-8.85 units on a scale Standard Error 0.69	-8.15 units on a scale Standard Error 0.68	-1.87 units on a scale Standard Error 0.69
Change From Baseline in Swollen Joint Count (SJC) Week 8 (n=51, 51, 51, 52, 52, 50)	-5.25 units on a scale Standard Error 0.69	-7.08 units on a scale Standard Error 0.69	-7.15 units on a scale Standard Error 0.70	-10.04 units on a scale Standard Error 0.69	-10.52 units on a scale Standard Error 0.68	-1.70 units on a scale Standard Error 0.70

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8 and 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=53 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=53 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=52 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=53 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=54 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=52 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in Patient's Assessment of Pain Week 2 (n=53, 53, 51, 52, 54, 52)	-8.63 Units on a scale Standard Error 2.94	-16.70 Units on a scale Standard Error 2.94	-19.13 Units on a scale Standard Error 3.01	-29.03 Units on a scale Standard Error 2.97	-26.45 Units on a scale Standard Error 2.92	-1.46 Units on a scale Standard Error 2.98
Change From Baseline in Patient's Assessment of Pain Week 4 (n=52, 51, 51, 52, 52, 52)	-12.97 Units on a scale Standard Error 2.96	-21.19 Units on a scale Standard Error 2.98	-26.06 Units on a scale Standard Error 3.01	-36.65 Units on a scale Standard Error 2.97	-35.16 Units on a scale Standard Error 2.95	-2.73 Units on a scale Standard Error 2.98
Change From Baseline in Patient's Assessment of Pain Week 8 (n=51, 50, 51, 52, 52, 50)	-17.57 Units on a scale Standard Error 2.97	-26.15 Units on a scale Standard Error 2.99	-30.37 Units on a scale Standard Error 3.01	-41.84 Units on a scale Standard Error 2.97	-43.08 Units on a scale Standard Error 2.95	1.65 Units on a scale Standard Error 3.01
Change From Baseline in Patient's Assessment of Pain Week 12 (n=51, 49, 50, 49, 52, 48)	-18.38 Units on a scale Standard Error 2.97	-22.33 Units on a scale Standard Error 3.00	-34.37 Units on a scale Standard Error 3.02	-42.91 Units on a scale Standard Error 3.01	-43.79 Units on a scale Standard Error 2.95	-1.06 Units on a scale Standard Error 3.03

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8 and 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=53 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=53 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=52 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=53 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=54 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=52 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in Patient's Global Assessment of Arthritis Week 4 (n=52, 51, 51, 52, 52, 52)	-11.22 Units on a scale Standard Error 2.98	-23.17 Units on a scale Standard Error 3.00	-27.03 Units on a scale Standard Error 3.04	-36.64 Units on a scale Standard Error 2.99	-35.96 Units on a scale Standard Error 2.97	-3.31 Units on a scale Standard Error 3.00
Change From Baseline in Patient's Global Assessment of Arthritis Week 2 (n=53, 53, 51, 52, 54, 52)	-7.66 Units on a scale Standard Error 2.96	-15.25 Units on a scale Standard Error 2.97	-20.32 Units on a scale Standard Error 3.04	-27.06 Units on a scale Standard Error 2.99	-26.80 Units on a scale Standard Error 2.94	-1.73 Units on a scale Standard Error 3.00
Change From Baseline in Patient's Global Assessment of Arthritis Week 8 (n=51, 50, 51, 52, 52, 50)	-16.66 Units on a scale Standard Error 2.99	-24.60 Units on a scale Standard Error 3.01	-28.78 Units on a scale Standard Error 3.04	-41.97 Units on a scale Standard Error 2.99	-41.13 Units on a scale Standard Error 2.97	0.79 Units on a scale Standard Error 3.03
Change From Baseline in Patient's Global Assessment of Arthritis Week 12 (n=51, 49, 50, 49, 52, 48)	-16.29 Units on a scale Standard Error 2.99	-20.91 Units on a scale Standard Error 3.03	-34.59 Units on a scale Standard Error 3.05	-43.55 Units on a scale Standard Error 3.03	-41.86 Units on a scale Standard Error 2.97	-1.02 Units on a scale Standard Error 3.05

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8 and 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=53 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=53 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=52 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=53 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=54 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=52 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in Physician's Global Assessment of Arthritis Week 4 (n=52, 51, 51, 52, 52, 52)	-23.31 Units on a scale Standard Error 2.65	-26.22 Units on a scale Standard Error 2.67	-30.45 Units on a scale Standard Error 2.70	-41.21 Units on a scale Standard Error 2.66	-37.07 Units on a scale Standard Error 2.64	-9.70 Units on a scale Standard Error 2.66
Change From Baseline in Physician's Global Assessment of Arthritis Week 8 (n=51, 51, 51, 52, 52, 50)	-21.99 Units on a scale Standard Error 2.66	-32.04 Units on a scale Standard Error 2.67	-36.92 Units on a scale Standard Error 2.70	-45.98 Units on a scale Standard Error 2.66	-44.66 Units on a scale Standard Error 2.64	-6.84 Units on a scale Standard Error 2.69
Change From Baseline in Physician's Global Assessment of Arthritis Week 2 (n=53, 53, 51, 52, 54, 52)	-13.97 Units on a scale Standard Error 2.64	-15.86 Units on a scale Standard Error 2.63	-18.10 Units on a scale Standard Error 2.70	-31.59 Units on a scale Standard Error 2.66	-25.93 Units on a scale Standard Error 2.61	-6.09 Units on a scale Standard Error 2.66
Change From Baseline in Physician's Global Assessment of Arthritis Week 12 (n=51, 49, 50, 49, 52, 48)	-25.38 Units on a scale Standard Error 2.66	-33.47 Units on a scale Standard Error 2.69	-36.89 Units on a scale Standard Error 2.71	-49.38 Units on a scale Standard Error 2.70	-48.36 Units on a scale Standard Error 2.64	-8.35 Units on a scale Standard Error 2.72

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8 and 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=53 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=53 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=52 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=53 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=54 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=52 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in C- Reactive Protein (CRP) (mg/L) Week 2 (n=53, 53, 51, 52, 54, 52)	-5.69 mg/L Standard Error 2.24	-16.61 mg/L Standard Error 2.24	-17.32 mg/L Standard Error 2.29	-22.50 mg/L Standard Error 2.26	-24.95 mg/L Standard Error 2.22	1.02 mg/L Standard Error 2.26
Change From Baseline in C- Reactive Protein (CRP) (mg/L) Week 4 (n=52, 51, 51, 52, 52, 52)	-5.56 mg/L Standard Error 2.25	-16.26 mg/L Standard Error 2.27	-22.20 mg/L Standard Error 2.29	-24.47 mg/L Standard Error 2.26	-24.59 mg/L Standard Error 2.25	0.59 mg/L Standard Error 2.26
Change From Baseline in C- Reactive Protein (CRP) (mg/L) Week 8 (n=51, 51, 51, 52, 52, 50)	-9.79 mg/L Standard Error 2.27	-16.71 mg/L Standard Error 2.27	-23.80 mg/L Standard Error 2.29	-23.56 mg/L Standard Error 2.26	-26.03 mg/L Standard Error 2.25	5.27 mg/L Standard Error 2.29
Change From Baseline in C- Reactive Protein (CRP) (mg/L) Week 12 (n=51, 49, 50, 49, 52, 48)	-8.88 mg/L Standard Error 2.27	-18.34 mg/L Standard Error 2.30	-23.97 mg/L Standard Error 2.30	-25.11 mg/L Standard Error 2.30	-26.14 mg/L Standard Error 2.25	8.22 mg/L Standard Error 2.32

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=53 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=53 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=52 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=53 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=54 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=52 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Area Under Curve (AUC) for Change From Baseline in American College of Rheumatology-N (ACR-N)	498.47 units on a scale Standard Error 341.96	1876.4 units on a scale Standard Error 341.96	2573.0 units on a scale Standard Error 345.23	3887.4 units on a scale Standard Error 341.96	3628.9 units on a scale Standard Error 338.78	-2415 units on a scale Standard Error 345.23

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=51 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=49 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=50 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=49 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=52 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=48 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in Euro Quality of Life (EQ-5D)	0.10 Units on a scale Standard Error 0.03	0.21 Units on a scale Standard Error 0.03	0.28 Units on a scale Standard Error 0.03	0.33 Units on a scale Standard Error 0.03	0.33 Units on a scale Standard Error 0.03	-0.04 Units on a scale Standard Error 0.03

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=51 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=49 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=50 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=49 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=52 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=48 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Physical Functioning Domain	2.62 Units on a scale Standard Error 1.09	6.23 Units on a scale Standard Error 1.11	5.83 Units on a scale Standard Error 1.13	9.59 Units on a scale Standard Error 1.11	8.61 Units on a scale Standard Error 1.08	-2.53 Units on a scale Standard Error 1.12

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=51 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=49 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=50 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=49 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=52 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=48 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Physical Domain	3.15 Units on a scale Standard Error 1.18	4.42 Units on a scale Standard Error 1.20	6.17 Units on a scale Standard Error 1.21	8.91 Units on a scale Standard Error 1.20	7.77 Units on a scale Standard Error 1.17	-0.72 Units on a scale Standard Error 1.22

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=51 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=49 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=50 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=49 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=52 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=48 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Bodily Pain Domain	5.94 Units on a scale Standard Error 1.08	7.81 Units on a scale Standard Error 1.10	9.74 Units on a scale Standard Error 1.11	12.58 Units on a scale Standard Error 1.10	13.90 Units on a scale Standard Error 1.07	0.27 Units on a scale Standard Error 1.12

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=51 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=49 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=50 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=49 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=52 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=48 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -General Health Domain	2.12 Units on a scale Standard Error 0.84	4.76 Units on a scale Standard Error 0.86	5.37 Units on a scale Standard Error 0.86	7.57 Units on a scale Standard Error 0.86	7.61 Units on a scale Standard Error 0.83	0.16 Units on a scale Standard Error 0.87

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

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

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=51 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=49 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=50 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=49 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=52 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=48 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Vitality Domain	3.67 Units on a scale Standard Error 0.74	6.11 Units on a scale Standard Error 0.76	6.58 Units on a scale Standard Error 0.77	11.98 Units on a scale Standard Error 0.77	9.49 Units on a scale Standard Error 0.74	3.38 Units on a scale Standard Error 0.79

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=51 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=49 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=50 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=49 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=52 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=48 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Social Functioning Domain	2.22 Units on a scale Standard Error 1.21	4.88 Units on a scale Standard Error 1.24	4.65 Units on a scale Standard Error 1.24	4.56 Units on a scale Standard Error 1.24	7.62 Units on a scale Standard Error 1.20	-0.67 Units on a scale Standard Error 1.25

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=51 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=49 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=50 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=49 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=52 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=48 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Emotional Domain	3.83 Units on a scale Standard Error 1.41	4.20 Units on a scale Standard Error 1.44	5.64 Units on a scale Standard Error 1.44	7.99 Units on a scale Standard Error 1.44	6.42 Units on a scale Standard Error 1.40	-1.50 Units on a scale Standard Error 1.47

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=51 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=49 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=50 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=49 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=52 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=48 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Mental Health Domain	3.29 Units on a scale Standard Error 1.29	5.02 Units on a scale Standard Error 1.32	8.62 Units on a scale Standard Error 1.32	7.64 Units on a scale Standard Error 1.32	6.27 Units on a scale Standard Error 1.28	0.59 Units on a scale Standard Error 1.34

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=51 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=49 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=50 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=49 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=52 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=48 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Physical Component Summary (PCS)	3.27 Units on a scale Standard Error 0.86	6.03 Units on a scale Standard Error 0.88	6.22 Units on a scale Standard Error 0.89	10.25 Units on a scale Standard Error 0.88	10.27 Units on a scale Standard Error 0.85	-1.04 Units on a scale Standard Error 0.89

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=51 Participants Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=49 Participants Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=50 Participants Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=49 Participants Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=52 Participants Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=48 Participants Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Mental Component Summary (MCS)	3.00 Units on a scale Standard Error 1.27	3.99 Units on a scale Standard Error 1.30	7.09 Units on a scale Standard Error 1.30	6.15 Units on a scale Standard Error 1.30	5.52 Units on a scale Standard Error 1.26	0.15 Units on a scale Standard Error 1.32

Adverse Events

CP-690,550 1 mg

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

CP-690,550 3 mg

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

CP-690,550 5 mg

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

CP-690,550 10 mg

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

CP-690,550 15 mg

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CP-690,550 1 mg n=53 participants at risk Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=53 participants at risk Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=52 participants at risk Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=53 participants at risk Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=54 participants at risk Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=52 participants at risk Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Gastrointestinal disorders Gastric ulcer perforation	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Herpes zoster	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Herpes zoster oticus	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase increased	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Aspartate aminotransferase increased	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood creatine phosphokinase increased	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Post herpetic neuralgia	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Rheumatoid vasculitis	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Other adverse events
Measure	CP-690,550 1 mg n=53 participants at risk Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 3 mg n=53 participants at risk Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 5 mg n=52 participants at risk Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 10 mg n=53 participants at risk Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	CP-690,550 15 mg n=54 participants at risk Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Placebo n=52 participants at risk Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Gastrointestinal disorders Abdominal discomfort	3.8% 2/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 3/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 2/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dental caries	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 2/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 2/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastritis	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 2/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gingivitis	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 2/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Stomatitis	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 2/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Bronchitis	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 2/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Herpes zoster	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 2/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	11.3% 6/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.5% 4/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	11.5% 6/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.7% 3/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.8% 8/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	11.5% 6/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pharyngitis	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.7% 3/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 2/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Upper respiratory tract infection	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.7% 3/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Contusion	3.8% 2/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Fall	5.7% 3/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase increased	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.8% 3/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Aspartate aminotransferase increased	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.8% 3/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood cholesterol increased	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 2/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Low density lipoprotein increased	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	11.1% 6/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 2/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.7% 3/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperlipidaemia	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 2/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	11.3% 6/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 3/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 2/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.7% 3/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 2/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.8% 3/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 1/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/53 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/54 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 2/52 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER