Trial Outcomes & Findings for A Study To Evaluate The Effect Of CP-690,550 On Measures Of Kidney Function In Patients With Active Rheumatoid Arthritis (NCT NCT01484561)

Results Overview

Glomerular filtration rate (GFR) is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 meters squared (m\^2) body surface area. A normal GFR is greater than (\>)90 milliliters per minute (mL/min), although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR \<15 mL/min is consistent with kidney failure. Baseline was defined as the mean of the values obtained at Run-in and on predose in Period 1/Day 1.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

148 participants

Primary outcome timeframe

Day 1 of Period 1, Day 43 of Period 1

Results posted on

2014-04-02

Participant Flow

Participant milestones

Participant milestones
Measure	CP-690,550/Placebo Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Study STARTED	97	51
Overall Study COMPLETED	88	45
Overall Study NOT COMPLETED	9	6

Reasons for withdrawal

Reasons for withdrawal
Measure	CP-690,550/Placebo Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Overall Study Lack of Efficacy	3	1
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	3	0
Overall Study Other	1	1
Overall Study Adverse Event	1	4

Baseline Characteristics

A Study To Evaluate The Effect Of CP-690,550 On Measures Of Kidney Function In Patients With Active Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CP-690,550/Placebo n=97 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=51 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)	Total n=148 Participants Total of all reporting groups
Age, Continuous	51.9 years STANDARD_DEVIATION 12.7 • n=5 Participants	47.3 years STANDARD_DEVIATION 11.8 • n=7 Participants	50.3 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	36 Participants n=7 Participants	111 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	15 Participants n=7 Participants	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 of Period 1, Day 43 of Period 1

Population: Full Analysis Set (FAS): all randomized participants who received at least 1 dose of the test article (CP-690,550 or placebo). Observed Case (OC): missing data were not imputed. One participant was excluded (took wrong treatment) from FAS analysis of change at end of Period 1 from baseline in mGFR.

Glomerular filtration rate (GFR) is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 meters squared (m\^2) body surface area. A normal GFR is greater than (\>)90 milliliters per minute (mL/min), although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR \<15 mL/min is consistent with kidney failure. Baseline was defined as the mean of the values obtained at Run-in and on predose in Period 1/Day 1.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=91 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=46 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Adjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (mGFR)	0.91 fold change Interval 0.88 to 0.95	0.99 fold change Interval 0.94 to 1.04

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 29 of Period 2

Population: FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in mGFR.

mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 m\^2 body surface area. Baseline was defined as the mean of the values obtained at Run-in and on predose in Period 1/Day 1.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=86 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=45 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Adjusted Geometric Mean-Fold Change at the End of Period 2 From Baseline in mGFR	0.96 fold change Interval 0.92 to 1.0	0.92 fold change Interval 0.87 to 0.97

SECONDARY outcome

Timeframe: Day 43 of Period 1, Day 29 of Period 2

Population: FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in mGFR.

mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 m\^2 body surface area.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=86 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=45 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in mGFR	1.03 fold change Interval 0.99 to 1.07	0.95 fold change Interval 0.9 to 0.99

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 43 of Period 1

Population: FAS (OC); one participant was excluded (took wrong treatment) from the FAS analysis of change at end of Period 1 from baseline in eGFR (MDRD).

eGFR was calculated using the MDRD equation and normalized to 1.73 m\^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=92 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=46 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using Modified Diet in Renal Disease (MDRD)	0.96 fold change Interval 0.94 to 0.97	1.01 fold change Interval 0.99 to 1.04

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 29 of Period 2

Population: FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in eGFR (MDRD).

eGFR was calculated using the MDRD equation with eGFR values normalized to 1.73 m\^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=87 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=44 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using MDRD	0.99 fold change Interval 0.98 to 1.01	1.01 fold change Interval 0.98 to 1.03

SECONDARY outcome

Timeframe: Day 43 of Period 1, Day 29 of Period 2

Population: FAS (OC); three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in eGFR (MDRD).

eGFR was calculated using the MDRD equation with eGFR values normalized to 1.73 m\^2 body surface area.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=87 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=44 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using MDRD	1.04 fold change Interval 1.02 to 1.06	1.00 fold change Interval 0.97 to 1.03

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 43 of Period 1

Population: FAS OC; one participant was excluded (took wrong treatment) from the FAS analysis of change at end of Period 1 from baseline in eGFR (Cockcroft-Gault).

eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m\^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=92 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=46 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in eGFR Using the Cockcroft-Gault Equation	0.96 fold change Interval 0.95 to 0.98	1.01 fold change Interval 0.99 to 1.04

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 29 of Period 2

Population: FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in eGFR (Cockcroft-Gault).

eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m\^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=87 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=44 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using the Cockcroft-Gault Equation	1.00 fold change Interval 0.98 to 1.01	1.01 fold change Interval 0.98 to 1.03

SECONDARY outcome

Timeframe: Day 43 of Period 1, Day 29 of Period 2

Population: FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in eGFR (Cockcroft-Gault).

eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m\^2 body surface area.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=87 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=44 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using the Cockcroft-Gault Equation	1.03 fold change Interval 1.01 to 1.05	1.00 fold change Interval 0.97 to 1.02

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 43 of Period 1

Population: FAS OC; one participant was excluded (took wrong treatment) from the FAS analysis of change at end of Period 1 from baseline in serum creatinine.

Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in milligrams per deciliter (mg/dL) reported by the central laboratory were used. Baseline for serum creatinine was defined as the mean of values obtained at screening and predose on Day 1 of Period 1.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=92 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=46 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Serum Creatinine	1.04 fold change Interval 1.02 to 1.06	0.99 fold change Interval 0.97 to 1.01

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 29 of Period 2

Population: FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in serum creatinine.

Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in mg/dL reported by the central laboratory were used. Baseline for serum creatinine was defined as the mean of values obtained at screening and predose on Day 1 of Period 1.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=87 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=44 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Adjusted Geometric Mean-Fold Change From End of Period 2 From Baseline in Serum Creatinine	1.00 fold change Interval 0.99 to 1.02	1.00 fold change Interval 0.97 to 1.02

SECONDARY outcome

Timeframe: Day 43 of Period 1, Day 29 of Period 2

Population: FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in serum creatinine.

Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in mg/dL reported by the central laboratory were used.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=87 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=44 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in Serum Creatinine	0.97 fold change Interval 0.95 to 0.99	1.00 fold change Interval 0.98 to 1.03

SECONDARY outcome

Timeframe: Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2

Population: FAS, missing values while participant was still enrolled utilized last observation carried forward (LOCF) imputation while participants with missing values after a participant was discontinued from study participation (for any reason) were considered to be nonresponders (nonresponder imputation \[NRI\])

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

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=97 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=51 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Percentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response End of Period 1 (Day 43)	57.73 percentage of participants	21.57 percentage of participants
Percentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response End of Period 2 (Day 29)	45.36 percentage of participants	29.41 percentage of participants

SECONDARY outcome

Timeframe: Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2

Population: FAS (NRI, LOCF)

ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a HAQ, and 5) CRP at each visit.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=97 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=51 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response End of Period 1 (Day 43)	28.87 percentage of participants	7.84 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response End of Period 2 (Day 29)	26.80 percentage of participants	9.80 percentage of participants

SECONDARY outcome

Timeframe: Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2

Population: FAS (NRI, LOCF)

ACR70 response: ≥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant' assessment of functional disability via a HAQ, and 5) CRP at each visit.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=97 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=51 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response End of Period 1 (Day 43)	18.56 percentage of participants	0.00 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response End of Period 2 (Day 29)	9.28 percentage of participants	1.96 percentage of participants

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 43 of Period 1

Population: FAS

DAS28 calculated from the tender/painful joint count, swollen joint count (SJC) using the 28 joints count, and CRP value. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (\>)3.2 to 5.1 = moderate to high disease activity.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=93 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=45 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Least Squares (LS) Mean Change at End of Period 1 From Baseline in Disease Activity Score Based on 28-Joint Count CRP (DAS28-3 [CRP])	-1.71 score on a scale Standard Error 0.13	-0.55 score on a scale Standard Error 0.19

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 29 of Period 2

Population: FAS

DAS28 calculated from the tender/painful joint count, SJC using the 28 joints count, and CRP value. DAS28 ≤3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=90 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=44 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 2 From Baseline in DAS28-3 (CRP)	-1.36 score on a scale Standard Error 0.12	-0.89 score on a scale Standard Error 0.17

SECONDARY outcome

Timeframe: Day 43 of Period 1, Day 29 of Period 2

Population: FAS

DAS28 calculated from the tender/painful joint count, SJC using the 28 joints count, and CRP value. DAS28 ≤3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=90 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=43 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 2 From End of Period 1 in DAS28-3 (CRP)	0.35 score on a scale Standard Error 0.12	-0.34 score on a scale Standard Error 0.18

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 43 of Period 1

Population: FAS

DAS28 calculated from the number of SJC and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=93 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=44 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 1 From Baseline DAS28-4 (CRP)	-1.88 score on a scale Standard Error 0.14	-0.62 score on a scale Standard Error 0.21

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 29 of Period 2

Population: FAS

DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=90 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=44 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 2 From Baseline DAS28-4 (CRP)	-1.46 score on a scale Standard Error 0.13	-0.96 score on a scale Standard Error 0.19

SECONDARY outcome

Timeframe: Day 43 of Period 1, Day 29 of Period 2

Population: FAS

DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=90 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=42 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 2 From End of Period 1 DAS28-4 (CRP)	0.42 score on a scale Standard Error 0.14	-0.34 score on a scale Standard Error 0.20

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 43 of Period 1

Population: FAS

68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb interphalangeal \[IP\], PIP, and distal interphalangeals \[DIP\]), and lower extremity (hip, knee, ankle, tarsus, metatarsophalangeals \[MTP\], great toe IP, proximal and distal interphalangeals combined \[PIP\]).

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=93 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=45 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 1 From Baseline in Tender/Painful Joint Count	-9.88 tender/painful joints Standard Error 1.16	-5.79 tender/painful joints Standard Error 1.66

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 29 of Period 2

Population: FAS

68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (hip, knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined \[PIP\]).

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=90 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=45 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 2 From Baseline in Tender/Painful Joint Count	-8.13 tender/painful joints Standard Error 1.02	-8.27 tender/painful joints Standard Error 1.44

SECONDARY outcome

Timeframe: Day 43 of Period 1, Day 29 of Period 2

Population: FAS

68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (hip, knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined \[PIP\]).

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=90 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=44 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 2 From End of Period 1 in Tender/Painful Joint Count	1.75 tender/painful joints Standard Error 1.11	-2.48 tender/painful joints Standard Error 1.58

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 43 of Period 1

Population: FAS

Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined \[PIP\]).

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=93 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=45 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 1 From Baseline in Swollen Joint Count	-7.07 swollen joints Standard Error 0.59	-4.81 swollen joints Standard Error 0.84

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 29 of Period 2

Population: FAS

Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined \[PIP\]).

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=90 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=45 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 2 From Baseline in Swollen Joint Count	-6.63 swollen joints Standard Error 0.64	-5.83 swollen joints Standard Error 0.91

SECONDARY outcome

Timeframe: Day 43 of Period 1, Day 29 of Period 2

Population: FAS

Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined \[PIP\]).

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=90 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=44 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 2 From End of Period 1 in Swollen Joint Count	0.43 swollen joints Standard Error 0.59	-1.02 swollen joints Standard Error 0.84

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 43 of Period 1

Population: FAS

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=93 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=46 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 1 From Baseline in CRP	-13.81 mg/L Standard Error 2.17	-0.08 mg/L Standard Error 3.01

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 29 of Period 2

Population: FAS

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=90 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=44 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 2 From Baseline in CRP	-8.37 mg/L Standard Error 2.34	0.53 mg/L Standard Error 3.29

SECONDARY outcome

Timeframe: Day 43 of Period 1, Day 29 of Period 2

Population: FAS

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=90 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=44 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 2 From End of Period 1 in CRP	5.44 mg/L Standard Error 1.71	0.61 mg/L Standard Error 2.44

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 43 of Period 1

Population: FAS

Participants answered the following question, "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.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=93 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=45 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 1 From Baseline in Patient Global Assessment of Arthritis (PGAA)	-23.28 mm Standard Error 2.81	-7.38 mm Standard Error 3.98

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 29 of Period 2

Population: FAS

Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participants responses were recorded using a 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=90 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=45 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 2 From Baseline in PGAA	-16.12 mm Standard Error 2.87	-10.41 mm Standard Error 4.03

SECONDARY outcome

Timeframe: Day 43 of Period 1, Day 29 of Period 2

Population: FAS

Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participants responses were recorded using a 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=90 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=44 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 2 From End of Period 1 in PGAA	7.16 mm Standard Error 2.54	-3.03 mm Standard Error 3.62

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 43 of Period 1

Population: FAS

A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician's response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=93 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=45 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 1 From Baseline in Physician Global Assessment of Arthritis	-29.83 mm Standard Error 2.24	-14.71 mm Standard Error 3.19

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 29 of Period 2

Population: FAS

A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician's response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=90 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=45 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 2 From Baseline in Physician Global Assessment of Arthritis	-24.61 mm Standard Error 2.76	-22.21 mm Standard Error 3.89

SECONDARY outcome

Timeframe: Day 43 of Period 1, Day 29 of Period 1

Population: FAS

A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician's response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=90 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=44 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 2 From End of Period 1 in Physician Global Assessment of Arthritis	5.22 mm Standard Error 2.39	-7.50 mm Standard Error 3.41

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 43 of Period 1

Population: FAS

Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=93 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=46 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 1 From Baseline in Patient Assessment of Arthritis Pain	-23.53 mm Standard Error 2.61	-8.23 mm Standard Error 3.69

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 29 of Period 2

Population: FAS

Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=90 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=45 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 2 From Baseline in Patient Assessment of Arthritis Pain	-14.70 mm Standard Error 2.80	-9.08 mm Standard Error 3.94

SECONDARY outcome

Timeframe: Day 43 of Period 2, Day 29 of Period 2

Population: FAS

Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=90 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=45 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 2 From End of Period 1 in Patient Assessment of Arthritis Pain	8.83 mm Standard Error 2.69	-0.85 mm Standard Error 3.81

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 43 of Period 1

Population: FAS

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.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=93 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=46 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 1 From Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) Score	-0.44 score on a scale Standard Error 0.06	-0.04 score on a scale Standard Error 0.08

SECONDARY outcome

Timeframe: Day 1 of Period 1, Day 29 of Period 2

Population: FAS

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.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=90 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=45 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 2 From Baseline HAQ-DI Score	-0.34 score on a scale Standard Error 0.05	-0.17 score on a scale Standard Error 0.07

SECONDARY outcome

Timeframe: Day 43 of Period 1, Day 29 of Period 2

Population: FAS

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.

Outcome measures

Outcome measures
Measure	CP-690,550/Placebo n=90 Participants Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=45 Participants Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
LS Mean Change at End of Period 2 From End of Period 1 HAQ-DI Score	0.09 score on a scale Standard Error 0.04	-0.13 score on a scale Standard Error 0.06

Adverse Events

CP-690,550/Placebo

Serious events: 2 serious events

Other events: 32 other events

Deaths: 0 deaths

Placebo/Placebo

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CP-690,550/Placebo n=97 participants at risk Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2	Placebo/Placebo n=51 participants at risk Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
Infections and infestations Bronchopneumonia	1.0% 1/97 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Pelvic fracture	1.0% 1/97 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.

Other adverse events

Additional Information

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Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER