Three Dose Levels of CP-690,550 Monotherapy Versus Placebo, Administered Orally Twice Daily (BID) for 6 Weeks

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Compare 3 Dose Levels Of CP-690,550 Versus Placebo, Administered Orally Twice Daily (BID) For 6 Weeks, In The Treatment Of The Signs And Symptoms Of Subjects With Active Rheumatoid Arthritis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00147498

Enrollment

264

Registered

2005-09-07

Start date

2005-01-31

Completion date

2006-06-30

Last updated

2013-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

oral JAK inhibitor, clinical trial, joint diseases, anti-Inflammatory agents, rheumatic diseases, DMARD, Antirheumatic Agents, Autoimmune Diseases, Immune System Diseases

Brief summary

The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550 monotherapy (5 mg, 15 mg, and 30 mg twice daily \[BID\]) versus placebo administered over 6 weeks for the treatment of the signs and symptoms of subjects with active rheumatoid arthritis (RA).

Interventions

DRUGCP-690,550

Oral tablets administered at a dose of 5 mg BID for 6 weeks

OTHERPlacebo

Placebo tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* The subject has a history of inadequate response to at least 1, but no more than 4, of the following DMARDs: sulfasalazine, injectable gold, methotrexate, leflunomide, cyclosporine, or a thiopurine derivative (azathioprine or 6-mercaptopurine)

Exclusion criteria

* Current Therapy With Any DMARD Or Biologic

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6	Week 6	ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joints count (TJC); \>= 20% improvement in swollen joints count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).

Secondary

Measure	Time frame	Description
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response	Week 1, 2, 4, 6, and 8	ACR50 response: \>= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	Week 1, 2, 4, 6, and 8	ACR70 response: \>= 70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve	Baseline up to Week 6	ACR-n: calculated by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The area under the curve (AUC) for ACR-n is the measure of the AUC of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.
Tender Joints Count (TJC)	Baseline, Week 1, 2, 4, 6, and 8	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.
Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8	Baseline, Week 1, 2, 4, 6, and 8	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 indicated an improvement.
Swollen Joints Count (SJC)	Baseline, Week 1, 2, 4, 6, and 8	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.
Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8	Baseline, Week 1, 2, 4, 6, and 8	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.
Patient Global Assessment (PtGA) of Arthritis	Baseline, Week 1, 2, 4, 6, and 8	Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 millimeter (mm) Visual Analog Scale (VAS) where 0 mm = very well and 100 mm = very poorly.
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8	Baseline, Week 1, 2, 4, 6, and 8	Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.
Physician Global Assessment of Arthritis	Baseline, Week 1, 2, 4, 6, and 8	Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response	Week 1, 2, 4, and 8	ACR20 response: \>=20% improvement in TJC; \>= 20% improvement in SJC; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Patient Assessment of Arthritis Pain	Baseline, Week 1, 2, 4, 6, and 8	Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8	Baseline, Week 1, 2, 4, 6, and 8	Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
Health Assessment Questionnaire-Disability Index (HAQ-DI)	Baseline, Week 1, 2, 4, 6, and 8	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 From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8	Baseline, Week 1, 2, 4, 6, and 8	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.
C-Reactive Protein (CRP)	Baseline, Week 1, 2, 4, 6, and 8	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 100 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8	Baseline, Week 1, 2, 4, 6, and 8	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 mg/L to 100 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Baseline, Week 1, 2, 4, 6, and 8	DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score ranging 0 to 9.4; higher scores indicated greater affectation due to disease activity. DAS 28-3 (CRP) less than or equal to (\<=) 3.2 implied low disease activity and greater than (\>) 3.2 to 5.1 implied moderate to high disease activity, and less than (\<) 2.6 = remission.
Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8	Baseline, Week 1, 2, 4, 6, and 8	DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score ranging 0 to 9.4; higher scores indicated greater affectation due to disease activity. DAS 28-3 (CRP) \<=3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and \<2.6 = remission.
Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Baseline, Week 1, 2, 4, 6, and 8	Disease improvement was classified as good, moderate, and no change based on improvement in DAS 28-3 (CRP) from baseline and present DAS 28-3 (CRP) score. Good: an improvement from baseline of \>1.2 and a present score of \<=3.2; none: an improvement of \<=0.6 or \>0.6 to \<=1.2 with a present score of \>5.1; remaining participants were classified as having moderate improvement. Scores of good and moderate were considered to have therapeutic response.
Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8	Baseline, Week 1, 2, 4, 6, and 8	Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

Countries

Belgium, Brazil, Canada, Germany, Italy, Mexico, Slovakia, Spain, United States

Participant flow

Participants by arm

Arm	Count
CP 690,550 5 mg CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.	61
CP-690,550 15 mg CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.	69
CP-690,550 30 mg CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.	69
Placebo Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.	65
Total	264

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Adverse Event	1	6	7	3
Overall Study	Laboratory abnormality	0	0	2	0
Overall Study	Lack of Efficacy	1	1	1	8
Overall Study	Other	1	1	3	3
Overall Study	Participant defaulted	0	1	4	3

Baseline characteristics

Characteristic	CP 690,550 5 mg	CP-690,550 15 mg	CP-690,550 30 mg	Placebo	Total
Age Continuous	47.9 years STANDARD_DEVIATION 10.8	51.8 years STANDARD_DEVIATION 13	51.1 years STANDARD_DEVIATION 10.6	51.3 years STANDARD_DEVIATION 12.1	50.6 years STANDARD_DEVIATION 11.7
Sex: Female, Male Female	53 Participants	58 Participants	60 Participants	55 Participants	226 Participants
Sex: Female, Male Male	8 Participants	11 Participants	9 Participants	10 Participants	38 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	34 / 61	38 / 69	46 / 69	37 / 65
serious Total, serious adverse events	1 / 61	5 / 69	3 / 69	1 / 65

Outcome results

Primary

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6

ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joints count (TJC); \>= 20% improvement in swollen joints count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).

Time frame: Week 6

Population: Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study treatment.

Arm	Measure	Value (NUMBER)
CP 690,550 5 mg	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6	70.49 percentage of participants
CP-690,550 15 mg	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6	81.16 percentage of participants
CP-690,550 30 mg	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6	76.81 percentage of participants
Placebo	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6	29.23 percentage of participants

Secondary

Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve

ACR-n: calculated by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The area under the curve (AUC) for ACR-n is the measure of the AUC of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.

Time frame: Baseline up to Week 6

Arm	Measure	Value (MEAN)	Dispersion
CP 690,550 5 mg	Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve	857.50 units on a scale*weeks	Standard Deviation 1151.36
CP-690,550 15 mg	Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve	1086.90 units on a scale*weeks	Standard Deviation 1664.77
CP-690,550 30 mg	Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve	1211.93 units on a scale*weeks	Standard Deviation 2107.65
Placebo	Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve	-546.41 units on a scale*weeks	Standard Deviation 1721.78

Secondary

Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 mg/L to 100 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Time frame: Baseline, Week 1, 2, 4, 6, and 8

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
CP 690,550 5 mg	Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=45,49,41,41)	-17.83 mg/L	Standard Deviation 35.92
CP 690,550 5 mg	Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=46,52,53,48)	-16.74 mg/L	Standard Deviation 32.94
CP 690,550 5 mg	Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=45,45,41,37)	-7.06 mg/L	Standard Deviation 35.75
CP 690,550 5 mg	Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=46,49,47,39)	-17.76 mg/L	Standard Deviation 33.31
CP 690,550 5 mg	Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=50,54,55,48)	-15.28 mg/L	Standard Deviation 26.65
CP-690,550 15 mg	Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=46,49,47,39)	-22.02 mg/L	Standard Deviation 31.29
CP-690,550 15 mg	Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=45,49,41,41)	-18.08 mg/L	Standard Deviation 25.99
CP-690,550 15 mg	Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=45,45,41,37)	-13.24 mg/L	Standard Deviation 27.69
CP-690,550 15 mg	Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=46,52,53,48)	-18.89 mg/L	Standard Deviation 31.87
CP-690,550 15 mg	Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=50,54,55,48)	-18.29 mg/L	Standard Deviation 28.98
CP-690,550 30 mg	Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=46,49,47,39)	-20.70 mg/L	Standard Deviation 25.69
CP-690,550 30 mg	Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=50,54,55,48)	-21.38 mg/L	Standard Deviation 25.56
CP-690,550 30 mg	Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=46,52,53,48)	-23.06 mg/L	Standard Deviation 31.49
CP-690,550 30 mg	Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=45,49,41,41)	-17.58 mg/L	Standard Deviation 24.76
CP-690,550 30 mg	Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=45,45,41,37)	-11.81 mg/L	Standard Deviation 29.46
Placebo	Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=45,49,41,41)	0.67 mg/L	Standard Deviation 16.81
Placebo	Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=46,52,53,48)	1.79 mg/L	Standard Deviation 15.56
Placebo	Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=50,54,55,48)	-0.24 mg/L	Standard Deviation 15.4
Placebo	Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=46,49,47,39)	-0.67 mg/L	Standard Deviation 19.17
Placebo	Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=45,45,41,37)	1.32 mg/L	Standard Deviation 27.26

Secondary

Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8

DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score ranging 0 to 9.4; higher scores indicated greater affectation due to disease activity. DAS 28-3 (CRP) \<=3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and \<2.6 = remission.

Time frame: Baseline, Week 1, 2, 4, 6, and 8

Population: FAS included all participants who were randomized to study treatment. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable for a particular time-point for each treatment arm, respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
CP 690,550 5 mg	Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8	Change at Week 6 (n=45,49,39,39)	-1.99 units on a scale	Standard Deviation 1.28
CP 690,550 5 mg	Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8	Change at Week 2 (n=46,52,50,46)	-1.19 units on a scale	Standard Deviation 0.89
CP 690,550 5 mg	Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8	Change at Week 8 (n=45,44,41,35)	-1.36 units on a scale	Standard Deviation 1.32
CP 690,550 5 mg	Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8	Change at Week 4 (n=46,49,46,37)	-1.64 units on a scale	Standard Deviation 1.16
CP 690,550 5 mg	Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8	Change at Week 1 (n=49,53,52,45)	-0.84 units on a scale	Standard Deviation 0.74
CP-690,550 15 mg	Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8	Change at Week 4 (n=46,49,46,37)	-2.18 units on a scale	Standard Deviation 1.25
CP-690,550 15 mg	Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8	Change at Week 6 (n=45,49,39,39)	-2.28 units on a scale	Standard Deviation 1.33
CP-690,550 15 mg	Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8	Change at Week 8 (n=45,44,41,35)	-1.60 units on a scale	Standard Deviation 1.32
CP-690,550 15 mg	Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8	Change at Week 2 (n=46,52,50,46)	-1.91 units on a scale	Standard Deviation 1.23
CP-690,550 15 mg	Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8	Change at Week 1 (n=49,53,52,45)	-1.28 units on a scale	Standard Deviation 0.99
CP-690,550 30 mg	Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8	Change at Week 4 (n=46,49,46,37)	-2.47 units on a scale	Standard Deviation 1.39
CP-690,550 30 mg	Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8	Change at Week 1 (n=49,53,52,45)	-1.65 units on a scale	Standard Deviation 0.99
CP-690,550 30 mg	Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8	Change at Week 2 (n=46,52,50,46)	-2.05 units on a scale	Standard Deviation 1.25
CP-690,550 30 mg	Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8	Change at Week 6 (n=45,49,39,39)	-2.73 units on a scale	Standard Deviation 1.32
CP-690,550 30 mg	Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8	Change at Week 8 (n=45,44,41,35)	-1.99 units on a scale	Standard Deviation 1.38
Placebo	Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8	Change at Week 6 (n=45,49,39,39)	-1.20 units on a scale	Standard Deviation 1.17
Placebo	Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8	Change at Week 2 (n=46,52,50,46)	-0.59 units on a scale	Standard Deviation 0.98
Placebo	Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8	Change at Week 1 (n=49,53,52,45)	-0.39 units on a scale	Standard Deviation 0.86
Placebo	Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8	Change at Week 4 (n=46,49,46,37)	-1.04 units on a scale	Standard Deviation 1.04
Placebo	Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8	Change at Week 8 (n=45,44,41,35)	-0.89 units on a scale	Standard Deviation 1.07

Secondary

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Time frame: Baseline, Week 1, 2, 4, 6, and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
CP 690,550 5 mg	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=55,59,51,47)	-0.60 units on a scale	Standard Error 0.068
CP 690,550 5 mg	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=56,66,63,57)	-0.39 units on a scale	Standard Error 0.067
CP 690,550 5 mg	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=56,56,51,43)	-0.43 units on a scale	Standard Error 0.07
CP 690,550 5 mg	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=56,57,57,44)	-0.55 units on a scale	Standard Error 0.067
CP 690,550 5 mg	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=59,68,64,55)	-0.25 units on a scale	Standard Error 0.066
CP-690,550 15 mg	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=56,57,57,44)	-0.60 units on a scale	Standard Error 0.064
CP-690,550 15 mg	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=55,59,51,47)	-0.72 units on a scale	Standard Error 0.063
CP-690,550 15 mg	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=56,56,51,43)	-0.60 units on a scale	Standard Error 0.06
CP-690,550 15 mg	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=56,66,63,57)	-0.50 units on a scale	Standard Error 0.062
CP-690,550 15 mg	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=59,68,64,55)	-0.30 units on a scale	Standard Error 0.061
CP-690,550 30 mg	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=56,57,57,44)	-0.69 units on a scale	Standard Error 0.065
CP-690,550 30 mg	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=59,68,64,55)	-0.44 units on a scale	Standard Error 0.063
CP-690,550 30 mg	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=56,66,63,57)	-0.56 units on a scale	Standard Error 0.063
CP-690,550 30 mg	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=55,59,51,47)	-0.74 units on a scale	Standard Error 0.067
CP-690,550 30 mg	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=56,56,51,43)	-0.70 units on a scale	Standard Error 0.07
Placebo	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=55,59,51,47)	-0.20 units on a scale	Standard Error 0.07
Placebo	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=56,66,63,57)	-0.15 units on a scale	Standard Error 0.067
Placebo	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=59,68,64,55)	-0.05 units on a scale	Standard Error 0.067
Placebo	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=56,57,57,44)	-0.13 units on a scale	Standard Error 0.071
Placebo	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=56,56,51,43)	-0.17 units on a scale	Standard Error 0.07

Secondary

Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8

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

Time frame: Baseline, Week 1, 2, 4, 6, and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
CP 690,550 5 mg	Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=54,58,51,49)	-31.42 mm	Standard Error 3.159
CP 690,550 5 mg	Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=55,65,63,59)	-21.44 mm	Standard Error 3.142
CP 690,550 5 mg	Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=55,56,51,45)	-24.90 mm	Standard Error 3.14
CP 690,550 5 mg	Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=55,57,56,48)	-29.27 mm	Standard Error 3.137
CP 690,550 5 mg	Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=57,67,63,58)	-15.01 mm	Standard Error 3.102
CP-690,550 15 mg	Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=55,57,56,48)	-35.47 mm	Standard Error 2.996
CP-690,550 15 mg	Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=54,58,51,49)	-37.67 mm	Standard Error 2.983
CP-690,550 15 mg	Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=55,56,51,45)	-28.70 mm	Standard Error 3.02
CP-690,550 15 mg	Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=55,65,63,59)	-26.10 mm	Standard Error 2.87
CP-690,550 15 mg	Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=57,67,63,58)	-19.74 mm	Standard Error 2.843
CP-690,550 30 mg	Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=55,57,56,48)	-40.10 mm	Standard Error 3.05
CP-690,550 30 mg	Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=57,67,63,58)	-29.66 mm	Standard Error 2.932
CP-690,550 30 mg	Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=55,65,63,59)	-35.85 mm	Standard Error 2.936
CP-690,550 30 mg	Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=54,58,51,49)	-42.89 mm	Standard Error 3.144
CP-690,550 30 mg	Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=55,56,51,45)	-35.35 mm	Standard Error 3.15
Placebo	Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=54,58,51,49)	-12.26 mm	Standard Error 3.223
Placebo	Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=55,65,63,59)	-4.79 mm	Standard Error 3.027
Placebo	Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=57,67,63,58)	-3.30 mm	Standard Error 3.027
Placebo	Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=55,57,56,48)	-8.40 mm	Standard Error 3.242
Placebo	Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=55,56,51,45)	-16.28 mm	Standard Error 3.31

Secondary

Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8

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

Time frame: Baseline, Week 1, 2, 4, 6, and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
CP 690,550 5 mg	Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=52,57,49,48)	-31.64 mm	Standard Error 3.203
CP 690,550 5 mg	Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=53,63,60,59)	-22.06 mm	Standard Error 3.184
CP 690,550 5 mg	Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=53,55,48,45)	-27.83 mm	Standard Error 3.18
CP 690,550 5 mg	Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=53,57,55,47)	-30.23 mm	Standard Error 3.176
CP 690,550 5 mg	Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=56,66,62,57)	-17.98 mm	Standard Error 3.121
CP-690,550 15 mg	Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=53,57,55,47)	-37.35 mm	Standard Error 3.001
CP-690,550 15 mg	Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=52,57,49,48)	-37.78 mm	Standard Error 3.005
CP-690,550 15 mg	Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=53,55,48,45)	-28.79 mm	Standard Error 3.04
CP-690,550 15 mg	Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=53,63,60,59)	-25.71 mm	Standard Error 2.9
CP-690,550 15 mg	Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=56,66,62,57)	-21.56 mm	Standard Error 2.859
CP-690,550 30 mg	Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=53,57,55,47)	-38.71 mm	Standard Error 3.072
CP-690,550 30 mg	Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=56,66,62,57)	-26.16 mm	Standard Error 2.948
CP-690,550 30 mg	Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=53,63,60,59)	-33.33 mm	Standard Error 2.984
CP-690,550 30 mg	Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=52,57,49,48)	-40.50 mm	Standard Error 3.191
CP-690,550 30 mg	Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=53,55,48,45)	-34.30 mm	Standard Error 3.21
Placebo	Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=52,57,49,48)	-15.06 mm	Standard Error 3.219
Placebo	Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=53,63,60,59)	-8.14 mm	Standard Error 2.998
Placebo	Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=56,66,62,57)	-5.18 mm	Standard Error 3.022
Placebo	Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=53,57,55,47)	-13.17 mm	Standard Error 3.238
Placebo	Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=53,55,48,45)	-14.96 mm	Standard Error 3.28

Secondary

Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8

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

Time frame: Baseline, Week 1, 2, 4, 6, and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
CP 690,550 5 mg	Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=55,58,50,49)	-35.97 mm	Standard Error 2.69
CP 690,550 5 mg	Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=56,66,63,59)	-25.43 mm	Standard Error 2.675
CP 690,550 5 mg	Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=56,57,50,45)	-29.19 mm	Standard Error 2.67
CP 690,550 5 mg	Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=55,58,56,48)	-33.29 mm	Standard Error 2.686
CP 690,550 5 mg	Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=59,67,62,57)	-17.13 mm	Standard Error 2.626
CP-690,550 15 mg	Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=55,58,56,48)	-38.44 mm	Standard Error 2.563
CP-690,550 15 mg	Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=55,58,50,49)	-43.69 mm	Standard Error 2.566
CP-690,550 15 mg	Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=56,57,50,45)	-35.11 mm	Standard Error 2.58
CP-690,550 15 mg	Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=56,66,63,59)	-36.60 mm	Standard Error 2.456
CP-690,550 15 mg	Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=59,67,62,57)	-28.25 mm	Standard Error 2.445
CP-690,550 30 mg	Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=55,58,56,48)	-42.65 mm	Standard Error 2.627
CP-690,550 30 mg	Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=59,67,62,57)	-30.89 mm	Standard Error 2.534
CP-690,550 30 mg	Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=56,66,63,59)	-34.56 mm	Standard Error 2.525
CP-690,550 30 mg	Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=55,58,50,49)	-46.70 mm	Standard Error 2.73
CP-690,550 30 mg	Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=56,57,50,45)	-39.81 mm	Standard Error 2.73
Placebo	Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=55,58,50,49)	-19.87 mm	Standard Error 2.786
Placebo	Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=56,66,63,59)	-14.29 mm	Standard Error 2.611
Placebo	Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=59,67,62,57)	-12.25 mm	Standard Error 2.636
Placebo	Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=55,58,56,48)	-20.91 mm	Standard Error 2.803
Placebo	Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=56,57,50,45)	-24.78 mm	Standard Error 2.87

Secondary

Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8

Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement.

Time frame: Baseline, Week 1, 2, 4, 6, and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
CP 690,550 5 mg	Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=56,59,52,50)	-12.10 swollen joints	Standard Error 0.931
CP 690,550 5 mg	Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=57,66,65,60)	-7.83 swollen joints	Standard Error 0.927
CP 690,550 5 mg	Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=57,56,52,45)	-9.54 swollen joints	Standard Error 0.93
CP 690,550 5 mg	Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=56,58,58,49)	-11.03 swollen joints	Standard Error 0.93
CP 690,550 5 mg	Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=60,68,65,59)	-5.02 swollen joints	Standard Error 0.913
CP-690,550 15 mg	Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=56,58,58,49)	-12.10 swollen joints	Standard Error 0.894
CP-690,550 15 mg	Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=56,59,52,50)	-13.13 swollen joints	Standard Error 0.891
CP-690,550 15 mg	Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=57,56,52,45)	-12.02 swollen joints	Standard Error 0.9
CP-690,550 15 mg	Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=57,66,65,60)	-11.33 swollen joints	Standard Error 0.863
CP-690,550 15 mg	Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=60,68,65,59)	-8.20 swollen joints	Standard Error 0.855
CP-690,550 30 mg	Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=56,58,58,49)	-12.58 swollen joints	Standard Error 0.897
CP-690,550 30 mg	Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=60,68,65,59)	-9.00 swollen joints	Standard Error 0.866
CP-690,550 30 mg	Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=57,66,65,60)	-11.11 swollen joints	Standard Error 0.868
CP-690,550 30 mg	Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=56,59,52,50)	-13.91 swollen joints	Standard Error 0.925
CP-690,550 30 mg	Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=57,56,52,45)	-12.14 swollen joints	Standard Error 0.93
Placebo	Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=56,59,52,50)	-8.06 swollen joints	Standard Error 0.95
Placebo	Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=57,66,65,60)	-5.23 swollen joints	Standard Error 0.9
Placebo	Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=60,68,65,59)	-3.19 swollen joints	Standard Error 0.9
Placebo	Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=56,58,58,49)	-7.73 swollen joints	Standard Error 0.954
Placebo	Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=57,56,52,45)	-7.00 swollen joints	Standard Error 0.98

Secondary

Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8

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 indicated an improvement.

Time frame: Baseline, Week 1, 2, 4, 6, and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
CP 690,550 5 mg	Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=56,59,52,50)	-18.35 tender joints	Standard Error 1.466
CP 690,550 5 mg	Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=57,66,65,60)	-11.68 tender joints	Standard Error 1.459
CP 690,550 5 mg	Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=57,56,52,45)	-14.26 tender joints	Standard Error 1.46
CP 690,550 5 mg	Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=56,58,58,49)	-15.23 tender joints	Standard Error 1.465
CP 690,550 5 mg	Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=60,68,65,59)	-7.06 tender joints	Standard Error 1.435
CP-690,550 15 mg	Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=56,58,58,49)	-18.33 tender joints	Standard Error 1.403
CP-690,550 15 mg	Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=56,59,52,50)	-19.81 tender joints	Standard Error 1.398
CP-690,550 15 mg	Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=57,56,52,45)	-16.89 tender joints	Standard Error 1.42
CP-690,550 15 mg	Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=57,66,65,60)	-15.66 tender joints	Standard Error 1.35
CP-690,550 15 mg	Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=60,68,65,59)	-11.70 tender joints	Standard Error 1.338
CP-690,550 30 mg	Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=56,58,58,49)	-18.66 tender joints	Standard Error 1.413
CP-690,550 30 mg	Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=60,68,65,59)	-14.14 tender joints	Standard Error 1.362
CP-690,550 30 mg	Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=57,66,65,60)	-15.78 tender joints	Standard Error 1.365
CP-690,550 30 mg	Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=56,59,52,50)	-21.37 tender joints	Standard Error 1.461
CP-690,550 30 mg	Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=57,56,52,45)	-17.78 tender joints	Standard Error 1.46
Placebo	Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8	Change at Week 6 (n=56,59,52,50)	-9.69 tender joints	Standard Error 1.5
Placebo	Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8	Change at Week 2 (n=57,66,65,60)	-5.13 tender joints	Standard Error 1.416
Placebo	Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8	Change at Week 1 (n=60,68,65,59)	-2.74 tender joints	Standard Error 1.417
Placebo	Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8	Change at Week 4 (n=56,58,58,49)	-10.09 tender joints	Standard Error 1.508
Placebo	Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8	Change at Week 8 (n=57,56,52,45)	-9.34 tender joints	Standard Error 1.55

Secondary

C-Reactive Protein (CRP)

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 100 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Time frame: Baseline, Week 1, 2, 4, 6, and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
CP 690,550 5 mg	C-Reactive Protein (CRP)	Baseline (n=50,57,58,53)	31.25 mg/L	Standard Deviation 35
CP 690,550 5 mg	C-Reactive Protein (CRP)	Week 1 (n=50,55,55,49)	15.98 mg/L	Standard Deviation 16.72
CP 690,550 5 mg	C-Reactive Protein (CRP)	Week 2 (n=46,53,53,48)	13.18 mg/L	Standard Deviation 12.97
CP 690,550 5 mg	C-Reactive Protein (CRP)	Week 4 (n=46,49,47,39)	11.83 mg/L	Standard Deviation 11.1
CP 690,550 5 mg	C-Reactive Protein (CRP)	Week 6 (n=45,49,41,41)	12.57 mg/L	Standard Deviation 21.01
CP 690,550 5 mg	C-Reactive Protein (CRP)	Week 8 (n=45,45,41,37)	23.37 mg/L	Standard Deviation 22.72
CP-690,550 15 mg	C-Reactive Protein (CRP)	Week 8 (n=45,45,41,37)	12.06 mg/L	Standard Deviation 12.2
CP-690,550 15 mg	C-Reactive Protein (CRP)	Week 4 (n=46,49,47,39)	5.17 mg/L	Standard Deviation 6.72
CP-690,550 15 mg	C-Reactive Protein (CRP)	Baseline (n=50,57,58,53)	25.47 mg/L	Standard Deviation 31.06
CP-690,550 15 mg	C-Reactive Protein (CRP)	Week 2 (n=46,53,53,48)	7.25 mg/L	Standard Deviation 11.83
CP-690,550 15 mg	C-Reactive Protein (CRP)	Week 1 (n=50,55,55,49)	7.57 mg/L	Standard Deviation 9.79
CP-690,550 15 mg	C-Reactive Protein (CRP)	Week 6 (n=45,49,41,41)	6.59 mg/L	Standard Deviation 16.37
CP-690,550 30 mg	C-Reactive Protein (CRP)	Week 1 (n=50,55,55,49)	7.57 mg/L	Standard Deviation 11.32
CP-690,550 30 mg	C-Reactive Protein (CRP)	Week 2 (n=46,53,53,48)	6.50 mg/L	Standard Deviation 14.81
CP-690,550 30 mg	C-Reactive Protein (CRP)	Week 4 (n=46,49,47,39)	5.88 mg/L	Standard Deviation 10.98
CP-690,550 30 mg	C-Reactive Protein (CRP)	Week 8 (n=45,45,41,37)	13.95 mg/L	Standard Deviation 14.68
CP-690,550 30 mg	C-Reactive Protein (CRP)	Week 6 (n=45,49,41,41)	6.08 mg/L	Standard Deviation 11.8
CP-690,550 30 mg	C-Reactive Protein (CRP)	Baseline (n=50,57,58,53)	28.10 mg/L	Standard Deviation 28.43
Placebo	C-Reactive Protein (CRP)	Week 6 (n=45,49,41,41)	22.94 mg/L	Standard Deviation 20.79
Placebo	C-Reactive Protein (CRP)	Week 8 (n=45,45,41,37)	23.64 mg/L	Standard Deviation 29.47
Placebo	C-Reactive Protein (CRP)	Week 1 (n=50,55,55,49)	25.40 mg/L	Standard Deviation 30.04
Placebo	C-Reactive Protein (CRP)	Week 4 (n=46,49,47,39)	22.26 mg/L	Standard Deviation 21.07
Placebo	C-Reactive Protein (CRP)	Baseline (n=50,57,58,53)	22.28 mg/L	Standard Deviation 18.52
Placebo	C-Reactive Protein (CRP)	Week 2 (n=46,53,53,48)	24.41 mg/L	Standard Deviation 21.38

Secondary

Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])

DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score ranging 0 to 9.4; higher scores indicated greater affectation due to disease activity. DAS 28-3 (CRP) less than or equal to (\<=) 3.2 implied low disease activity and greater than (\>) 3.2 to 5.1 implied moderate to high disease activity, and less than (\<) 2.6 = remission.

Time frame: Baseline, Week 1, 2, 4, 6, and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
CP 690,550 5 mg	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Baseline (n=50,57,56,51)	6.17 units on a scale	Standard Deviation 0.89
CP 690,550 5 mg	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Week 1 (n=49,54,54,47)	5.29 units on a scale	Standard Deviation 1.08
CP 690,550 5 mg	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Week 2 (n=46,53,51,48)	4.93 units on a scale	Standard Deviation 1.08
CP 690,550 5 mg	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Week 4 (n=46,49,47,39)	4.44 units on a scale	Standard Deviation 1.2
CP 690,550 5 mg	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Week 6 (n=45,49,40,41)	4.18 units on a scale	Standard Deviation 1.29
CP 690,550 5 mg	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Week 8 (n=45,44,41,36)	4.75 units on a scale	Standard Deviation 1.37
CP-690,550 15 mg	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Week 8 (n=45,44,41,36)	4.08 units on a scale	Standard Deviation 1.32
CP-690,550 15 mg	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Week 4 (n=46,49,47,39)	3.56 units on a scale	Standard Deviation 1.12
CP-690,550 15 mg	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Baseline (n=50,57,56,51)	5.69 units on a scale	Standard Deviation 0.92
CP-690,550 15 mg	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Week 2 (n=46,53,51,48)	3.80 units on a scale	Standard Deviation 1.17
CP-690,550 15 mg	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Week 1 (n=49,54,54,47)	4.42 units on a scale	Standard Deviation 1.12
CP-690,550 15 mg	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Week 6 (n=45,49,40,41)	3.42 units on a scale	Standard Deviation 1.16
CP-690,550 30 mg	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Week 1 (n=49,54,54,47)	4.28 units on a scale	Standard Deviation 1.21
CP-690,550 30 mg	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Week 2 (n=46,53,51,48)	3.90 units on a scale	Standard Deviation 1.17
CP-690,550 30 mg	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Week 4 (n=46,49,47,39)	3.46 units on a scale	Standard Deviation 1.33
CP-690,550 30 mg	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Week 8 (n=45,44,41,36)	3.93 units on a scale	Standard Deviation 1.38
CP-690,550 30 mg	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Week 6 (n=45,49,40,41)	3.10 units on a scale	Standard Deviation 1.17
CP-690,550 30 mg	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Baseline (n=50,57,56,51)	5.91 units on a scale	Standard Deviation 0.91
Placebo	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Week 6 (n=45,49,40,41)	4.78 units on a scale	Standard Deviation 1.05
Placebo	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Week 8 (n=45,44,41,36)	5.02 units on a scale	Standard Deviation 1.1
Placebo	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Week 1 (n=49,54,54,47)	5.66 units on a scale	Standard Deviation 1.1
Placebo	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Week 4 (n=46,49,47,39)	4.91 units on a scale	Standard Deviation 1.22
Placebo	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Baseline (n=50,57,56,51)	6.00 units on a scale	Standard Deviation 0.9
Placebo	Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	Week 2 (n=46,53,51,48)	5.37 units on a scale	Standard Deviation 1.15

Secondary

Health Assessment Questionnaire-Disability Index (HAQ-DI)

Time frame: Baseline, Week 1, 2, 4, 6, and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
CP 690,550 5 mg	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Baseline (n=60,69,67,62)	1.75 units on a scale	Standard Error 0.086
CP 690,550 5 mg	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Week 1 (n=60,68,65,58)	1.46 units on a scale	Standard Error 0.086
CP 690,550 5 mg	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Week 2 (n=57,66,64,60)	1.32 units on a scale	Standard Error 0.087
CP 690,550 5 mg	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Week 4 (n=57,57,59,47)	1.17 units on a scale	Standard Error 0.087
CP 690,550 5 mg	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Week 6 (n=54,59,53,50)	1.12 units on a scale	Standard Error 0.088
CP 690,550 5 mg	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Week 8 (n=57,56,52,45)	1.30 units on a scale	Standard Error 0.09
CP-690,550 15 mg	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Week 8 (n=57,56,52,45)	1.06 units on a scale	Standard Error 0.08
CP-690,550 15 mg	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Week 4 (n=57,57,59,47)	1.07 units on a scale	Standard Error 0.083
CP-690,550 15 mg	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Baseline (n=60,69,67,62)	1.66 units on a scale	Standard Error 0.08
CP-690,550 15 mg	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Week 2 (n=57,66,64,60)	1.17 units on a scale	Standard Error 0.081
CP-690,550 15 mg	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Week 1 (n=60,68,65,58)	1.37 units on a scale	Standard Error 0.08
CP-690,550 15 mg	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Week 6 (n=54,59,53,50)	0.95 units on a scale	Standard Error 0.082
CP-690,550 30 mg	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Week 1 (n=60,68,65,58)	1.19 units on a scale	Standard Error 0.082
CP-690,550 30 mg	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Week 2 (n=57,66,64,60)	1.06 units on a scale	Standard Error 0.082
CP-690,550 30 mg	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Week 4 (n=57,57,59,47)	0.92 units on a scale	Standard Error 0.083
CP-690,550 30 mg	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Week 8 (n=57,56,52,45)	0.92 units on a scale	Standard Error 0.08
CP-690,550 30 mg	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Week 6 (n=54,59,53,50)	0.86 units on a scale	Standard Error 0.084
CP-690,550 30 mg	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Baseline (n=60,69,67,62)	1.61 units on a scale	Standard Error 0.081
Placebo	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Week 6 (n=54,59,53,50)	1.47 units on a scale	Standard Error 0.087
Placebo	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Week 8 (n=57,56,52,45)	1.52 units on a scale	Standard Error 0.09
Placebo	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Week 1 (n=60,68,65,58)	1.63 units on a scale	Standard Error 0.084
Placebo	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Week 4 (n=57,57,59,47)	1.54 units on a scale	Standard Error 0.088
Placebo	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Baseline (n=60,69,67,62)	1.71 units on a scale	Standard Error 0.083
Placebo	Health Assessment Questionnaire-Disability Index (HAQ-DI)	Week 2 (n=57,66,64,60)	1.53 units on a scale	Standard Error 0.084

Secondary

Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)

Disease improvement was classified as good, moderate, and no change based on improvement in DAS 28-3 (CRP) from baseline and present DAS 28-3 (CRP) score. Good: an improvement from baseline of \>1.2 and a present score of \<=3.2; none: an improvement of \<=0.6 or \>0.6 to \<=1.2 with a present score of \>5.1; remaining participants were classified as having moderate improvement. Scores of good and moderate were considered to have therapeutic response.

Time frame: Baseline, Week 1, 2, 4, 6, and 8

Arm	Measure	Group	Value (NUMBER)
CP 690,550 5 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 1, No Change (n=49,53,52,45)	31 participants
CP 690,550 5 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 6, Moderate (n=45,49,39,39)	34 participants
CP 690,550 5 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 4, Moderate (n=46,49,46,37)	32 participants
CP 690,550 5 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 1, Moderate (n=49,53,52,45)	18 participants
CP 690,550 5 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 6, No Change (n=45,49,39,39)	11 participants
CP 690,550 5 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 6, Good (n=45,49,39,39)	0 participants
CP 690,550 5 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 2, No Change (n=46,52,50,46)	20 participants
CP 690,550 5 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 1, Good (n=49,53,52,45)	0 participants
CP 690,550 5 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 8, Good (n=45,44,41,35)	0 participants
CP 690,550 5 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 2, Good (n=46,52,50,46)	0 participants
CP 690,550 5 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 2, Moderate (n=46,52,50,46)	26 participants
CP 690,550 5 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 8, No Change (n=45,44,41,35)	21 participants
CP 690,550 5 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 4, No Change (n=46,49,46,37)	14 participants
CP 690,550 5 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 8, Moderate (n=45,44,41,35)	24 participants
CP 690,550 5 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 4, Good (n=46,49,46,37)	0 participants
CP-690,550 15 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 4, Good (n=46,49,46,37)	0 participants
CP-690,550 15 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 6, Moderate (n=45,49,39,39)	41 participants
CP-690,550 15 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 2, Good (n=46,52,50,46)	0 participants
CP-690,550 15 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 4, Moderate (n=46,49,46,37)	42 participants
CP-690,550 15 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 1, Good (n=49,53,52,45)	0 participants
CP-690,550 15 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 6, Good (n=45,49,39,39)	0 participants
CP-690,550 15 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 8, No Change (n=45,44,41,35)	16 participants
CP-690,550 15 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 6, No Change (n=45,49,39,39)	8 participants
CP-690,550 15 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 1, Moderate (n=49,53,52,45)	28 participants
CP-690,550 15 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 4, No Change (n=46,49,46,37)	7 participants
CP-690,550 15 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 8, Moderate (n=45,44,41,35)	28 participants
CP-690,550 15 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 8, Good (n=45,44,41,35)	0 participants
CP-690,550 15 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 2, Moderate (n=46,52,50,46)	39 participants
CP-690,550 15 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 2, No Change (n=46,52,50,46)	13 participants
CP-690,550 15 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 1, No Change (n=49,53,52,45)	25 participants
CP-690,550 30 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 4, Good (n=46,49,46,37)	0 participants
CP-690,550 30 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 1, No Change (n=49,53,52,45)	17 participants
CP-690,550 30 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 1, Good (n=49,53,52,45)	0 participants
CP-690,550 30 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 1, Moderate (n=49,53,52,45)	35 participants
CP-690,550 30 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 2, No Change (n=46,52,50,46)	12 participants
CP-690,550 30 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 2, Good (n=46,52,50,46)	0 participants
CP-690,550 30 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 2, Moderate (n=46,52,50,46)	38 participants
CP-690,550 30 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 4, No Change (n=46,49,46,37)	8 participants
CP-690,550 30 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 4, Moderate (n=46,49,46,37)	38 participants
CP-690,550 30 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 6, No Change (n=45,49,39,39)	3 participants
CP-690,550 30 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 6, Good (n=45,49,39,39)	0 participants
CP-690,550 30 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 6, Moderate (n=45,49,39,39)	36 participants
CP-690,550 30 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 8, No Change (n=45,44,41,35)	11 participants
CP-690,550 30 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 8, Good (n=45,44,41,35)	0 participants
CP-690,550 30 mg	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 8, Moderate (n=45,44,41,35)	30 participants
Placebo	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 4, No Change (n=46,49,46,37)	22 participants
Placebo	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 1, Good (n=49,53,52,45)	0 participants
Placebo	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 6, Moderate (n=45,49,39,39)	19 participants
Placebo	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 2, Moderate (n=46,52,50,46)	13 participants
Placebo	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 2, Good (n=46,52,50,46)	0 participants
Placebo	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 1, No Change (n=49,53,52,45)	35 participants
Placebo	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 8, No Change (n=45,44,41,35)	24 participants
Placebo	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 2, No Change (n=46,52,50,46)	33 participants
Placebo	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 1, Moderate (n=49,53,52,45)	10 participants
Placebo	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 8, Moderate (n=45,44,41,35)	11 participants
Placebo	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 6, No Change (n=45,49,39,39)	20 participants
Placebo	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 4, Moderate (n=46,49,46,37)	15 participants
Placebo	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 8, Good (n=45,44,41,35)	0 participants
Placebo	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 6, Good (n=45,49,39,39)	0 participants
Placebo	Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Week 4, Good (n=46,49,46,37)	0 participants

Secondary

Patient Assessment of Arthritis Pain

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

Time frame: Baseline, Week 1, 2, 4, 6, and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
CP 690,550 5 mg	Patient Assessment of Arthritis Pain	Week 4 (n=57,58,59,49)	37.77 mm	Standard Error 3.15
CP 690,550 5 mg	Patient Assessment of Arthritis Pain	Week 1 (n=59,68,65,59)	51.76 mm	Standard Error 3.114
CP 690,550 5 mg	Patient Assessment of Arthritis Pain	Week 8 (n=57,57,52,45)	42.44 mm	Standard Error 3.15
CP 690,550 5 mg	Patient Assessment of Arthritis Pain	Week 2 (n=57,65,65,60)	45.59 mm	Standard Error 3.154
CP 690,550 5 mg	Patient Assessment of Arthritis Pain	Week 6 (n=55,59,53,50)	35.57 mm	Standard Error 3.191
CP 690,550 5 mg	Patient Assessment of Arthritis Pain	Baseline (n=59,68,66,64)	69.46 mm	Standard Error 3.112
CP-690,550 15 mg	Patient Assessment of Arthritis Pain	Week 6 (n=55,59,53,50)	28.35 mm	Standard Error 3.043
CP-690,550 15 mg	Patient Assessment of Arthritis Pain	Week 1 (n=59,68,65,59)	46.11 mm	Standard Error 2.897
CP-690,550 15 mg	Patient Assessment of Arthritis Pain	Week 8 (n=57,57,52,45)	37.62 mm	Standard Error 3.08
CP-690,550 15 mg	Patient Assessment of Arthritis Pain	Baseline (n=59,68,66,64)	67.47 mm	Standard Error 2.894
CP-690,550 15 mg	Patient Assessment of Arthritis Pain	Week 2 (n=57,65,65,60)	40.14 mm	Standard Error 2.94
CP-690,550 15 mg	Patient Assessment of Arthritis Pain	Week 4 (n=57,58,59,49)	30.42 mm	Standard Error 3.057
CP-690,550 30 mg	Patient Assessment of Arthritis Pain	Week 1 (n=59,68,65,59)	37.71 mm	Standard Error 2.953
CP-690,550 30 mg	Patient Assessment of Arthritis Pain	Baseline (n=59,68,66,64)	68.13 mm	Standard Error 2.936
CP-690,550 30 mg	Patient Assessment of Arthritis Pain	Week 6 (n=55,59,53,50)	23.39 mm	Standard Error 3.169
CP-690,550 30 mg	Patient Assessment of Arthritis Pain	Week 4 (n=57,58,59,49)	26.76 mm	Standard Error 3.053
CP-690,550 30 mg	Patient Assessment of Arthritis Pain	Week 8 (n=57,57,52,45)	31.12 mm	Standard Error 3.19
CP-690,550 30 mg	Patient Assessment of Arthritis Pain	Week 2 (n=57,65,65,60)	30.83 mm	Standard Error 2.956
Placebo	Patient Assessment of Arthritis Pain	Week 8 (n=57,57,52,45)	49.06 mm	Standard Error 3.39
Placebo	Patient Assessment of Arthritis Pain	Baseline (n=59,68,66,64)	64.17 mm	Standard Error 2.98
Placebo	Patient Assessment of Arthritis Pain	Week 4 (n=57,58,59,49)	56.96 mm	Standard Error 3.287
Placebo	Patient Assessment of Arthritis Pain	Week 1 (n=59,68,65,59)	62.51 mm	Standard Error 3.072
Placebo	Patient Assessment of Arthritis Pain	Week 2 (n=57,65,65,60)	60.65 mm	Standard Error 3.062
Placebo	Patient Assessment of Arthritis Pain	Week 6 (n=55,59,53,50)	52.75 mm	Standard Error 3.266

Secondary

Patient Global Assessment (PtGA) of Arthritis

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

Time frame: Baseline, Week 1, 2, 4, 6, and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
CP 690,550 5 mg	Patient Global Assessment (PtGA) of Arthritis	Baseline (n=57,67,65,63)	71.03 mm	Standard Error 3.126
CP 690,550 5 mg	Patient Global Assessment (PtGA) of Arthritis	Week 1 (n=58,67,64,58)	49.89 mm	Standard Error 3.111
CP 690,550 5 mg	Patient Global Assessment (PtGA) of Arthritis	Week 2 (n=55,65,62,60)	46.18 mm	Standard Error 3.171
CP 690,550 5 mg	Patient Global Assessment (PtGA) of Arthritis	Week 4 (n=56,58,58,48)	38.67 mm	Standard Error 3.146
CP 690,550 5 mg	Patient Global Assessment (PtGA) of Arthritis	Week 6 (n=55,59,52,49)	37.11 mm	Standard Error 3.165
CP 690,550 5 mg	Patient Global Assessment (PtGA) of Arthritis	Week 8 (n=57,57,50,45)	40.29 mm	Standard Error 3.13
CP-690,550 15 mg	Patient Global Assessment (PtGA) of Arthritis	Week 8 (n=57,57,50,45)	37.56 mm	Standard Error 3.05
CP-690,550 15 mg	Patient Global Assessment (PtGA) of Arthritis	Week 4 (n=56,58,58,48)	29.53 mm	Standard Error 3.033
CP-690,550 15 mg	Patient Global Assessment (PtGA) of Arthritis	Baseline (n=57,67,65,63)	69.37 mm	Standard Error 2.887
CP-690,550 15 mg	Patient Global Assessment (PtGA) of Arthritis	Week 2 (n=55,65,62,60)	41.09 mm	Standard Error 2.917
CP-690,550 15 mg	Patient Global Assessment (PtGA) of Arthritis	Week 1 (n=58,67,64,58)	45.36 mm	Standard Error 2.889
CP-690,550 15 mg	Patient Global Assessment (PtGA) of Arthritis	Week 6 (n=55,59,52,49)	28.82 mm	Standard Error 3.018
CP-690,550 30 mg	Patient Global Assessment (PtGA) of Arthritis	Week 1 (n=58,67,64,58)	39.79 mm	Standard Error 2.958
CP-690,550 30 mg	Patient Global Assessment (PtGA) of Arthritis	Week 2 (n=55,65,62,60)	32.09 mm	Standard Error 2.992
CP-690,550 30 mg	Patient Global Assessment (PtGA) of Arthritis	Week 4 (n=56,58,58,48)	26.16 mm	Standard Error 3.062
CP-690,550 30 mg	Patient Global Assessment (PtGA) of Arthritis	Week 8 (n=57,57,50,45)	30.63 mm	Standard Error 3.23
CP-690,550 30 mg	Patient Global Assessment (PtGA) of Arthritis	Week 6 (n=55,59,52,49)	24.52 mm	Standard Error 3.18
CP-690,550 30 mg	Patient Global Assessment (PtGA) of Arthritis	Baseline (n=57,67,65,63)	63.99 mm	Standard Error 2.941
Placebo	Patient Global Assessment (PtGA) of Arthritis	Week 6 (n=55,59,52,49)	50.04 mm	Standard Error 3.273
Placebo	Patient Global Assessment (PtGA) of Arthritis	Week 8 (n=57,57,50,45)	50.76 mm	Standard Error 3.37
Placebo	Patient Global Assessment (PtGA) of Arthritis	Week 1 (n=58,67,64,58)	61.48 mm	Standard Error 3.076
Placebo	Patient Global Assessment (PtGA) of Arthritis	Week 4 (n=56,58,58,48)	52.55 mm	Standard Error 3.294
Placebo	Patient Global Assessment (PtGA) of Arthritis	Baseline (n=57,67,65,63)	65.73 mm	Standard Error 2.985
Placebo	Patient Global Assessment (PtGA) of Arthritis	Week 2 (n=55,65,62,60)	58.02 mm	Standard Error 3.046

Secondary

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response

ACR20 response: \>=20% improvement in TJC; \>= 20% improvement in SJC; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

Time frame: Week 1, 2, 4, and 8

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF) at Week 1, 2, and 4. Here 'n' is number of participants evaluable at specific time points for each arm group, respectively.

Arm	Measure	Group	Value (NUMBER)
CP 690,550 5 mg	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response	Week 1 (n=61,69,69,65)	27.87 percentage of participants
CP 690,550 5 mg	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response	Week 2 (n=61,69,69,65)	50.82 percentage of participants
CP 690,550 5 mg	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response	Week 4 (n=61,69,69,65)	63.93 percentage of participants
CP 690,550 5 mg	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response	Week 8 (n=56,56,51,45)	50.00 percentage of participants
CP-690,550 15 mg	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response	Week 2 (n=61,69,69,65)	71.01 percentage of participants
CP-690,550 15 mg	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response	Week 4 (n=61,69,69,65)	75.36 percentage of participants
CP-690,550 15 mg	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response	Week 8 (n=56,56,51,45)	66.07 percentage of participants
CP-690,550 15 mg	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response	Week 1 (n=61,69,69,65)	43.48 percentage of participants
CP-690,550 30 mg	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response	Week 4 (n=61,69,69,65)	75.36 percentage of participants
CP-690,550 30 mg	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response	Week 2 (n=61,69,69,65)	68.12 percentage of participants
CP-690,550 30 mg	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response	Week 8 (n=56,56,51,45)	70.59 percentage of participants
CP-690,550 30 mg	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response	Week 1 (n=61,69,69,65)	56.52 percentage of participants
Placebo	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response	Week 8 (n=56,56,51,45)	28.89 percentage of participants
Placebo	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response	Week 2 (n=61,69,69,65)	20.00 percentage of participants
Placebo	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response	Week 1 (n=61,69,69,65)	12.31 percentage of participants
Placebo	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response	Week 4 (n=61,69,69,65)	30.77 percentage of participants

Secondary

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response

ACR50 response: \>= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

Time frame: Week 1, 2, 4, 6, and 8

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF) at Week 1, 2, 4, and 6. Here 'n' is number of participants evaluable at specific time points for each arm group, respectively.

Arm	Measure	Group	Value (NUMBER)
CP 690,550 5 mg	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response	Week 6 (n= 61,69,69,65)	32.79 percentage of participants
CP 690,550 5 mg	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response	Week 2 (n= 61,69,69,65)	9.84 percentage of participants
CP 690,550 5 mg	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response	Week 8 (n=56,56,51,45)	17.86 percentage of participants
CP 690,550 5 mg	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response	Week 4 (n= 61,69,69,65)	32.79 percentage of participants
CP 690,550 5 mg	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response	Week 1 (n= 61,69,69,65)	6.56 percentage of participants
CP-690,550 15 mg	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response	Week 4 (n= 61,69,69,65)	42.03 percentage of participants
CP-690,550 15 mg	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response	Week 6 (n= 61,69,69,65)	53.62 percentage of participants
CP-690,550 15 mg	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response	Week 8 (n=56,56,51,45)	30.36 percentage of participants
CP-690,550 15 mg	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response	Week 2 (n= 61,69,69,65)	23.19 percentage of participants
CP-690,550 15 mg	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response	Week 1 (n= 61,69,69,65)	8.70 percentage of participants
CP-690,550 30 mg	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response	Week 4 (n= 61,69,69,65)	42.03 percentage of participants
CP-690,550 30 mg	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response	Week 1 (n= 61,69,69,65)	18.84 percentage of participants
CP-690,550 30 mg	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response	Week 2 (n= 61,69,69,65)	28.99 percentage of participants
CP-690,550 30 mg	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response	Week 6 (n= 61,69,69,65)	50.72 percentage of participants
CP-690,550 30 mg	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response	Week 8 (n=56,56,51,45)	45.10 percentage of participants
Placebo	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response	Week 6 (n= 61,69,69,65)	6.15 percentage of participants
Placebo	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response	Week 2 (n= 61,69,69,65)	3.08 percentage of participants
Placebo	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response	Week 1 (n= 61,69,69,65)	3.08 percentage of participants
Placebo	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response	Week 4 (n= 61,69,69,65)	6.15 percentage of participants
Placebo	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response	Week 8 (n=56,56,51,45)	13.33 percentage of participants

Secondary

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response

ACR70 response: \>= 70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

Time frame: Week 1, 2, 4, 6, and 8

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF) at Week 1, 2, 4, and 6. Here 'n' is number of participants evaluable at specific time points for each arm group, respectively.

Arm	Measure	Group	Value (NUMBER)
CP 690,550 5 mg	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	Week 6 (n= 61,69,69,65)	13.11 percentage of participants
CP 690,550 5 mg	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	Week 2 (n= 61,69,69,65)	4.92 percentage of participants
CP 690,550 5 mg	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	Week 8 (n=56,56,51,45)	8.93 percentage of participants
CP 690,550 5 mg	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	Week 4 (n= 61,69,69,65)	9.84 percentage of participants
CP 690,550 5 mg	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	Week 1 (n= 61,69,69,65)	1.64 percentage of participants
CP-690,550 15 mg	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	Week 4 (n= 61,69,69,65)	17.39 percentage of participants
CP-690,550 15 mg	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	Week 6 (n= 61,69,69,65)	21.74 percentage of participants
CP-690,550 15 mg	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	Week 8 (n=56,56,51,45)	14.29 percentage of participants
CP-690,550 15 mg	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	Week 2 (n= 61,69,69,65)	4.35 percentage of participants
CP-690,550 15 mg	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	Week 1 (n= 61,69,69,65)	4.35 percentage of participants
CP-690,550 30 mg	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	Week 4 (n= 61,69,69,65)	21.74 percentage of participants
CP-690,550 30 mg	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	Week 1 (n= 61,69,69,65)	4.35 percentage of participants
CP-690,550 30 mg	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	Week 2 (n= 61,69,69,65)	10.14 percentage of participants
CP-690,550 30 mg	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	Week 6 (n= 61,69,69,65)	27.54 percentage of participants
CP-690,550 30 mg	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	Week 8 (n=56,56,51,45)	27.45 percentage of participants
Placebo	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	Week 6 (n= 61,69,69,65)	3.08 percentage of participants
Placebo	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	Week 2 (n= 61,69,69,65)	1.54 percentage of participants
Placebo	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	Week 1 (n= 61,69,69,65)	0.00 percentage of participants
Placebo	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	Week 4 (n= 61,69,69,65)	1.54 percentage of participants
Placebo	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	Week 8 (n=56,56,51,45)	8.89 percentage of participants

Secondary

Physician Global Assessment of Arthritis

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

Time frame: Baseline, Week 1, 2, 4, 6, and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
CP 690,550 5 mg	Physician Global Assessment of Arthritis	Week 1 (n=60,67,64,58)	49.85 mm	Standard Error 2.568
CP 690,550 5 mg	Physician Global Assessment of Arthritis	Week 4 (n=56,58,59,49)	34.18 mm	Standard Error 2.631
CP 690,550 5 mg	Physician Global Assessment of Arthritis	Baseline (n=60,69,66,64)	69.39 mm	Standard Error 2.566
CP 690,550 5 mg	Physician Global Assessment of Arthritis	Week 8 (n=57,57,52,45)	39.10 mm	Standard Error 2.62
CP 690,550 5 mg	Physician Global Assessment of Arthritis	Week 2 (n=57,66,65,60)	41.65 mm	Standard Error 2.618
CP 690,550 5 mg	Physician Global Assessment of Arthritis	Week 6 (n=55,58,53,50)	31.42 mm	Standard Error 2.651
CP-690,550 15 mg	Physician Global Assessment of Arthritis	Week 2 (n=57,66,65,60)	29.54 mm	Standard Error 2.43
CP-690,550 15 mg	Physician Global Assessment of Arthritis	Week 4 (n=56,58,59,49)	27.45 mm	Standard Error 2.547
CP-690,550 15 mg	Physician Global Assessment of Arthritis	Baseline (n=60,69,66,64)	64.11 mm	Standard Error 2.388
CP-690,550 15 mg	Physician Global Assessment of Arthritis	Week 8 (n=57,57,52,45)	30.78 mm	Standard Error 2.57
CP-690,550 15 mg	Physician Global Assessment of Arthritis	Week 1 (n=60,67,64,58)	37.80 mm	Standard Error 2.417
CP-690,550 15 mg	Physician Global Assessment of Arthritis	Week 6 (n=55,58,53,50)	22.22 mm	Standard Error 2.549
CP-690,550 30 mg	Physician Global Assessment of Arthritis	Week 2 (n=57,66,65,60)	32.24 mm	Standard Error 2.453
CP-690,550 30 mg	Physician Global Assessment of Arthritis	Baseline (n=60,69,66,64)	66.65 mm	Standard Error 2.436
CP-690,550 30 mg	Physician Global Assessment of Arthritis	Week 6 (n=55,58,53,50)	19.26 mm	Standard Error 2.643
CP-690,550 30 mg	Physician Global Assessment of Arthritis	Week 1 (n=60,67,64,58)	36.30 mm	Standard Error 2.464
CP-690,550 30 mg	Physician Global Assessment of Arthritis	Week 4 (n=56,58,59,49)	23.91 mm	Standard Error 2.54
CP-690,550 30 mg	Physician Global Assessment of Arthritis	Week 8 (n=57,57,52,45)	26.24 mm	Standard Error 2.66
Placebo	Physician Global Assessment of Arthritis	Week 2 (n=57,66,65,60)	52.76 mm	Standard Error 2.546
Placebo	Physician Global Assessment of Arthritis	Week 6 (n=55,58,53,50)	46.52 mm	Standard Error 2.727
Placebo	Physician Global Assessment of Arthritis	Week 1 (n=60,67,64,58)	55.54 mm	Standard Error 2.575
Placebo	Physician Global Assessment of Arthritis	Baseline (n=60,69,66,64)	67.75 mm	Standard Error 2.471
Placebo	Physician Global Assessment of Arthritis	Week 8 (n=57,57,52,45)	42.04 mm	Standard Error 2.84
Placebo	Physician Global Assessment of Arthritis	Week 4 (n=56,58,59,49)	46.01 mm	Standard Error 2.746

Secondary

Swollen Joints Count (SJC)

Time frame: Baseline, Week 1, 2, 4, 6, and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
CP 690,550 5 mg	Swollen Joints Count (SJC)	Baseline (n=61,69,68,65)	21.33 swollen joints	Standard Error 1.052
CP 690,550 5 mg	Swollen Joints Count (SJC)	Week 1 (n=60,68,66,59)	14.77 swollen joints	Standard Error 1.058
CP 690,550 5 mg	Swollen Joints Count (SJC)	Week 2 (n=57,66,65,60)	12.04 swollen joints	Standard Error 1.074
CP 690,550 5 mg	Swollen Joints Count (SJC)	Week 4 (n=56,58,59,49)	8.83 swollen joints	Standard Error 1.079
CP 690,550 5 mg	Swollen Joints Count (SJC)	Week 6 (n=56,59,53,50)	7.74 swollen joints	Standard Error 1.08
CP 690,550 5 mg	Swollen Joints Count (SJC)	Week 8 (n=57,56,52,45)	10.31 swollen joints	Standard Error 1.07
CP-690,550 15 mg	Swollen Joints Count (SJC)	Week 8 (n=57,56,52,45)	6.02 swollen joints	Standard Error 1.05
CP-690,550 15 mg	Swollen Joints Count (SJC)	Week 4 (n=56,58,59,49)	5.95 swollen joints	Standard Error 1.035
CP-690,550 15 mg	Swollen Joints Count (SJC)	Week 2 (n=57,66,65,60)	6.84 swollen joints	Standard Error 0.997
CP-690,550 15 mg	Swollen Joints Count (SJC)	Baseline (n=61,69,68,65)	16.42 swollen joints	Standard Error 0.984
CP-690,550 15 mg	Swollen Joints Count (SJC)	Week 1 (n=60,68,66,59)	9.90 swollen joints	Standard Error 0.989
CP-690,550 15 mg	Swollen Joints Count (SJC)	Week 6 (n=56,59,53,50)	4.93 swollen joints	Standard Error 1.031
CP-690,550 30 mg	Swollen Joints Count (SJC)	Week 1 (n=60,68,66,59)	10.18 swollen joints	Standard Error 1.001
CP-690,550 30 mg	Swollen Joints Count (SJC)	Week 2 (n=57,66,65,60)	7.99 swollen joints	Standard Error 1.006
CP-690,550 30 mg	Swollen Joints Count (SJC)	Week 8 (n=57,56,52,45)	6.77 swollen joints	Standard Error 1.08
CP-690,550 30 mg	Swollen Joints Count (SJC)	Week 4 (n=56,58,59,49)	6.42 swollen joints	Standard Error 1.035
CP-690,550 30 mg	Swollen Joints Count (SJC)	Week 6 (n=56,59,53,50)	4.95 swollen joints	Standard Error 1.069
CP-690,550 30 mg	Swollen Joints Count (SJC)	Baseline (n=61,69,68,65)	19.53 swollen joints	Standard Error 0.993
Placebo	Swollen Joints Count (SJC)	Week 6 (n=56,59,53,50)	11.15 swollen joints	Standard Error 1.101
Placebo	Swollen Joints Count (SJC)	Week 4 (n=56,58,59,49)	11.78 swollen joints	Standard Error 1.107
Placebo	Swollen Joints Count (SJC)	Week 1 (n=60,68,66,59)	16.46 swollen joints	Standard Error 1.044
Placebo	Swollen Joints Count (SJC)	Baseline (n=61,69,68,65)	19.97 swollen joints	Standard Error 1.013
Placebo	Swollen Joints Count (SJC)	Week 8 (n=57,56,52,45)	12.36 swollen joints	Standard Error 1.14
Placebo	Swollen Joints Count (SJC)	Week 2 (n=57,66,65,60)	14.30 swollen joints	Standard Error 1.041

Secondary

Tender Joints Count (TJC)

Time frame: Baseline, Week 1, 2, 4, 6, and 8

Arm	Measure	Group	Value (MEAN)	Dispersion
CP 690,550 5 mg	Tender Joints Count (TJC)	Week 8 (n=57,56,52,45)	16.32 tender joints	Standard Error 1.62
CP 690,550 5 mg	Tender Joints Count (TJC)	Week 4 (n=56,58,59,49)	15.33 tender joints	Standard Error 1.628
CP 690,550 5 mg	Tender Joints Count (TJC)	Week 2 (n=57,66,65,60)	18.90 tender joints	Standard Error 1.622
CP 690,550 5 mg	Tender Joints Count (TJC)	Baseline (n=61,69,68,65)	32.37 tender joints	Standard Error 1.588
CP 690,550 5 mg	Tender Joints Count (TJC)	Week 6 (n=56,59,53,50)	12.21 tender joints	Standard Error 1.63
CP 690,550 5 mg	Tender Joints Count (TJC)	Week 1 (n=60,68,66,59)	23.49 tender joints	Standard Error 1.597
CP-690,550 15 mg	Tender Joints Count (TJC)	Week 6 (n=56,59,53,50)	8.58 tender joints	Standard Error 1.556
CP-690,550 15 mg	Tender Joints Count (TJC)	Week 8 (n=57,56,52,45)	11.50 tender joints	Standard Error 1.58
CP-690,550 15 mg	Tender Joints Count (TJC)	Week 1 (n=60,68,66,59)	16.62 tender joints	Standard Error 1.492
CP-690,550 15 mg	Tender Joints Count (TJC)	Week 2 (n=57,66,65,60)	12.72 tender joints	Standard Error 1.505
CP-690,550 15 mg	Tender Joints Count (TJC)	Baseline (n=61,69,68,65)	26.98 tender joints	Standard Error 1.485
CP-690,550 15 mg	Tender Joints Count (TJC)	Week 4 (n=56,58,59,49)	9.97 tender joints	Standard Error 1.562
CP-690,550 30 mg	Tender Joints Count (TJC)	Week 1 (n=60,68,66,59)	15.75 tender joints	Standard Error 1.511
CP-690,550 30 mg	Tender Joints Count (TJC)	Week 6 (n=56,59,53,50)	7.41 tender joints	Standard Error 1.612
CP-690,550 30 mg	Tender Joints Count (TJC)	Week 4 (n=56,58,59,49)	10.17 tender joints	Standard Error 1.562
CP-690,550 30 mg	Tender Joints Count (TJC)	Baseline (n=61,69,68,65)	29.52 tender joints	Standard Error 1.499
CP-690,550 30 mg	Tender Joints Count (TJC)	Week 2 (n=57,66,65,60)	13.51 tender joints	Standard Error 1.519
CP-690,550 30 mg	Tender Joints Count (TJC)	Week 8 (n=57,56,52,45)	11.21 tender joints	Standard Error 1.62
Placebo	Tender Joints Count (TJC)	Week 8 (n=57,56,52,45)	20.37 tender joints	Standard Error 1.71
Placebo	Tender Joints Count (TJC)	Baseline (n=61,69,68,65)	30.61 tender joints	Standard Error 1.529
Placebo	Tender Joints Count (TJC)	Week 2 (n=57,66,65,60)	24.71 tender joints	Standard Error 1.572
Placebo	Tender Joints Count (TJC)	Week 4 (n=56,58,59,49)	19.78 tender joints	Standard Error 1.67
Placebo	Tender Joints Count (TJC)	Week 6 (n=56,59,53,50)	19.81 tender joints	Standard Error 1.661
Placebo	Tender Joints Count (TJC)	Week 1 (n=60,68,66,59)	27.39 tender joints	Standard Error 1.576

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026

Three Dose Levels of CP-690,550 Monotherapy Versus Placebo, Administered Orally Twice Daily (BID) for 6 Weeks

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6

Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve

Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8

Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8

Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8

Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8

Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8

Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8

Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8

C-Reactive Protein (CRP)

Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])

Health Assessment Questionnaire-Disability Index (HAQ-DI)

Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)

Patient Assessment of Arthritis Pain

Patient Global Assessment (PtGA) of Arthritis

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response

Physician Global Assessment of Arthritis

Swollen Joints Count (SJC)

Tender Joints Count (TJC)