| Primary | Adjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (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. | 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. | Posted | | Geometric Mean | 90% Confidence Interval | fold change | | Day 1 of Period 1, Day 43 of Period 1 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.91(0.88 to 0.95)
- OG0010.99(0.94 to 1.04)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Ratio of adjusted geometric mean-fold Change (CP-690,550-placebo vs. placebo-placebo) | ANCOVA | | | | Ratio of Adjusted Geo Mean-Fold Change | 0.92 | | | 2-Sided | 90 | 0.86 | 0.98 | | | Analysis of covariance (ANCOVA) with change in logarithmic mGFR from baseline as dependent variable, treatment and logarithmic baseline as covariate. | No | Superiority or Other | | |
|
| Secondary | Adjusted Geometric Mean-Fold Change at the 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. | FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in mGFR. | Posted | | Geometric Mean | 90% Confidence Interval | fold change | | Day 1 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | Adjusted Geometric Mean-Fold 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. | 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. | Posted | | Geometric Mean | 90% Confidence Interval | fold change | | Day 43 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | 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) | 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. | 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). | Posted | | Geometric Mean | 90% Confidence Interval | fold change | | Day 1 of Period 1, Day 43 of Period 1 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using 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. | 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). | Posted | | Geometric Mean | 90% Confidence Interval | fold change | | Day 1 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using MDRD | eGFR was calculated using the MDRD equation with eGFR values normalized to 1.73 m^2 body surface area. | 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). | Posted | | Geometric Mean | 90% Confidence Interval | fold change | | Day 43 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in eGFR Using the Cockcroft-Gault Equation | 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. | 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). | Posted | | Geometric Mean | 90% Confidence Interval | fold change | | Day 1 of Period 1, Day 43 of Period 1 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using the Cockcroft-Gault Equation | 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. | 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). | Posted | | Geometric Mean | 90% Confidence Interval | fold change | | Day 1 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using the Cockcroft-Gault Equation | eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m^2 body surface area. | 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). | Posted | | Geometric Mean | 90% Confidence Interval | fold change | | Day 43 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | Adjusted Geometric Mean-Fold 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. | 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. | Posted | | Geometric Mean | 90% Confidence Interval | fold change | | Day 1 of Period 1, Day 43 of Period 1 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | Adjusted Geometric Mean-Fold Change From 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. | 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. | Posted | | Geometric Mean | 90% Confidence Interval | fold change | | Day 1 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | Adjusted Geometric Mean-Fold 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. | 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. | Posted | | Geometric Mean | 90% Confidence Interval | fold change | | Day 43 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | Percentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response | 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). | 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]) | Posted | | Number | | percentage of participants | | Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
|
| Secondary | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | 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. | | Posted | | Number | | percentage of participants | | Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | 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. | | Posted | | Number | | percentage of participants | | Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | 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]) | 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. | | Posted | | Least Squares Mean | Standard Error | score on a scale | | Day 1 of Period 1, Day 43 of Period 1 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 2 From Baseline in DAS28-3 (CRP) | 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. | | Posted | | Least Squares Mean | Standard Error | score on a scale | | Day 1 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 2 From End of Period 1 in DAS28-3 (CRP) | 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. | | Posted | | Least Squares Mean | Standard Error | score on a scale | | Day 43 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 1 From Baseline DAS28-4 (CRP) | 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. | | Posted | | Least Squares Mean | Standard Error | score on a scale | | Day 1 of Period 1, Day 43 of Period 1 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 2 From Baseline DAS28-4 (CRP) | 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. | | Posted | | Least Squares Mean | Standard Error | score on a scale | | Day 1 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 2 From End of Period 1 DAS28-4 (CRP) | 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. | | Posted | | Least Squares Mean | Standard Error | score on a scale | | Day 43 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 1 From Baseline in Tender/Painful Joint Count | 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]). | | Posted | | Least Squares Mean | Standard Error | tender/painful joints | | Day 1 of Period 1, Day 43 of Period 1 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 2 From Baseline in Tender/Painful Joint Count | 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]). | | Posted | | Least Squares Mean | Standard Error | tender/painful joints | | Day 1 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 2 From End of Period 1 in Tender/Painful Joint Count | 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]). | | Posted | | Least Squares Mean | Standard Error | tender/painful joints | | Day 43 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 1 From Baseline in Swollen Joint Count | 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]). | | Posted | | Least Squares Mean | Standard Error | swollen joints | | Day 1 of Period 1, Day 43 of Period 1 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 2 From Baseline in Swollen Joint Count | 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]). | | Posted | | Least Squares Mean | Standard Error | swollen joints | | Day 1 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 2 From End of Period 1 in Swollen Joint Count | 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]). | | Posted | | Least Squares Mean | Standard Error | swollen joints | | Day 43 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 1 From Baseline in CRP | | | Posted | | Least Squares Mean | Standard Error | mg/L | | Day 1 of Period 1, Day 43 of Period 1 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 2 From Baseline in CRP | | | Posted | | Least Squares Mean | Standard Error | mg/L | | Day 1 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 2 From End of Period 1 in CRP | | | Posted | | Least Squares Mean | Standard Error | mg/L | | Day 43 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 1 From Baseline in Patient Global Assessment of Arthritis (PGAA) | 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. | | Posted | | Least Squares Mean | Standard Error | mm | | Day 1 of Period 1, Day 43 of Period 1 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 2 From Baseline in PGAA | 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. | | Posted | | Least Squares Mean | Standard Error | mm | | Day 1 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 2 From End of Period 1 in PGAA | 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. | | Posted | | Least Squares Mean | Standard Error | mm | | Day 43 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 1 From Baseline in Physician Global Assessment of Arthritis | 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. | | Posted | | Least Squares Mean | Standard Error | mm | | Day 1 of Period 1, Day 43 of Period 1 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 2 From Baseline in Physician Global Assessment of Arthritis | 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. | | Posted | | Least Squares Mean | Standard Error | mm | | Day 1 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 2 From End of Period 1 in Physician Global Assessment of Arthritis | 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. | | Posted | | Least Squares Mean | Standard Error | mm | | Day 43 of Period 1, Day 29 of Period 1 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 1 From Baseline in Patient Assessment of Arthritis Pain | 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. | | Posted | | Least Squares Mean | Standard Error | mm | | Day 1 of Period 1, Day 43 of Period 1 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 2 From Baseline in Patient Assessment of Arthritis Pain | 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. | | Posted | | Least Squares Mean | Standard Error | mm | | Day 1 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 2 From End of Period 1 in Patient Assessment of Arthritis Pain | 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. | | Posted | | Least Squares Mean | Standard Error | mm | | Day 43 of Period 2, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 1 From Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) Score | 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. | | Posted | | Least Squares Mean | Standard Error | score on a scale | | Day 1 of Period 1, Day 43 of Period 1 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 2 From Baseline HAQ-DI Score | 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. | | Posted | | Least Squares Mean | Standard Error | score on a scale | | Day 1 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |
| Secondary | LS Mean Change at End of Period 2 From End of Period 1 HAQ-DI Score | 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. | | Posted | | Least Squares Mean | Standard Error | score on a scale | | Day 43 of Period 1, Day 29 of Period 2 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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) |
| |