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

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ClinicalTrials.gov Identifier: NCT01484561
Recruitment Status : Completed
First Posted : December 2, 2011
Results First Posted : April 2, 2014
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Arthritis, Rheumatoid
Interventions Drug: CP-690,550 or Placebo
Drug: Placebo
Enrollment 148
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description 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 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)
Period Title: Overall Study
Started 97 51
Completed 88 45
Not Completed 9 6
Reason Not Completed
Lack of Efficacy             3             1
Lost to Follow-up             1             0
Withdrawal by Subject             3             0
Other             1             1
Adverse Event             1             4
Arm/Group Title CP-690,550/Placebo Placebo/Placebo Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 97 51 148
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 97 participants 51 participants 148 participants
51.9  (12.7) 47.3  (11.8) 50.3  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 51 participants 148 participants
Female
75
  77.3%
36
  70.6%
111
  75.0%
Male
22
  22.7%
15
  29.4%
37
  25.0%
1.Primary Outcome
Title Adjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (mGFR)
Hide Description 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.
Time Frame Day 1 of Period 1, Day 43 of Period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 91 46
Geometric Mean (90% Confidence Interval)
Unit of Measure: fold change
0.91
(0.88 to 0.95)
0.99
(0.94 to 1.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments Ratio of adjusted geometric mean-fold Change (CP-690,550-placebo vs. placebo-placebo)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Geo Mean-Fold Change
Estimated Value 0.92
Confidence Interval (2-Sided) 90%
0.86 to 0.98
Estimation Comments Analysis of covariance (ANCOVA) with change in logarithmic mGFR from baseline as dependent variable, treatment and logarithmic baseline as covariate.
2.Secondary Outcome
Title Adjusted Geometric Mean-Fold Change at the End of Period 2 From Baseline in mGFR
Hide Description 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.
Time Frame Day 1 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in mGFR.
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 86 45
Geometric Mean (90% Confidence Interval)
Unit of Measure: fold change
0.96
(0.92 to 1.00)
0.92
(0.87 to 0.97)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Geo Mean-Fold Change
Estimated Value 1.04
Confidence Interval (2-Sided) 90%
0.97 to 1.11
Estimation Comments ANCOVA with change in logarithmic mGFR from baseline as dependent variable, treatment and logarithmic baseline as covariate.
3.Secondary Outcome
Title Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in mGFR
Hide Description 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.
Time Frame Day 43 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 86 45
Geometric Mean (90% Confidence Interval)
Unit of Measure: fold change
1.03
(0.99 to 1.07)
0.95
(0.90 to 0.99)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Geo Mean-Fold Change
Estimated Value 1.09
Confidence Interval (2-Sided) 90%
1.02 to 1.16
Estimation Comments ANCOVA with change in logarithmic mGFR from Period 2 baseline/the end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/the end of Period 1 as covariate.
4.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Day 1 of Period 1, Day 43 of Period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 92 46
Geometric Mean (90% Confidence Interval)
Unit of Measure: fold change
0.96
(0.94 to 0.97)
1.01
(0.99 to 1.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Geo Mean-Fold Change
Estimated Value 0.94
Confidence Interval (2-Sided) 90%
0.91 to 0.97
Estimation Comments ANCOVA with change in logarithmic eGFR (MDRD) from baseline as dependent variable, treatment and logarithmic baseline as covariate.
5.Secondary Outcome
Title Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using MDRD
Hide Description 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.
Time Frame Day 1 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 87 44
Geometric Mean (90% Confidence Interval)
Unit of Measure: fold change
0.99
(0.98 to 1.01)
1.01
(0.98 to 1.03)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Geo Mean-Fold Change
Estimated Value 0.99
Confidence Interval (2-Sided) 90%
0.96 to 1.02
Estimation Comments ANCOVA with change in logarithmic eGFR (MDRD) from baseline as dependent variable, treatment and logarithmic baseline as covariate.
6.Secondary Outcome
Title Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using MDRD
Hide Description eGFR was calculated using the MDRD equation with eGFR values normalized to 1.73 m^2 body surface area.
Time Frame Day 43 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 87 44
Geometric Mean (90% Confidence Interval)
Unit of Measure: fold change
1.04
(1.02 to 1.06)
1.00
(0.97 to 1.03)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Geo Mean-Fold Change
Estimated Value 1.04
Confidence Interval (2-Sided) 90%
1.00 to 1.08
Estimation Comments ANCOVA with change in logarithmic eGFR (MDRD) from Period 2 baseline/end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/end of Period 1 as covariate.
7.Secondary Outcome
Title Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in eGFR Using the Cockcroft-Gault Equation
Hide Description 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.
Time Frame Day 1 of Period 1, Day 43 of Period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 92 46
Geometric Mean (90% Confidence Interval)
Unit of Measure: fold change
0.96
(0.95 to 0.98)
1.01
(0.99 to 1.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Geo Mean-Fold Change
Estimated Value 0.95
Confidence Interval (2-Sided) 90%
0.92 to 0.98
Estimation Comments ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from baseline as dependent variable, treatment and logarithmic baseline as covariate.
8.Secondary Outcome
Title Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using the Cockcroft-Gault Equation
Hide Description 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.
Time Frame Day 1 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 87 44
Geometric Mean (90% Confidence Interval)
Unit of Measure: fold change
1.00
(0.98 to 1.01)
1.01
(0.98 to 1.03)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Geo Mean-Fold Change
Estimated Value 0.99
Confidence Interval (2-Sided) 90%
0.97 to 1.02
Estimation Comments ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from baseline as dependent variable, treatment and logarithmic baseline as covariate.
9.Secondary Outcome
Title Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using the Cockcroft-Gault Equation
Hide Description eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m^2 body surface area.
Time Frame Day 43 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 87 44
Geometric Mean (90% Confidence Interval)
Unit of Measure: fold change
1.03
(1.01 to 1.05)
1.00
(0.97 to 1.02)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Geo Mean-Fold Change
Estimated Value 1.04
Confidence Interval (2-Sided) 90%
1.01 to 1.07
Estimation Comments ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from Period 2 baseline/end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/end of Period 1 as covariate.
10.Secondary Outcome
Title Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Serum Creatinine
Hide Description 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.
Time Frame Day 1 of Period 1, Day 43 of Period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 92 46
Geometric Mean (90% Confidence Interval)
Unit of Measure: fold change
1.04
(1.02 to 1.06)
0.99
(0.97 to 1.01)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Geo Mean-Fold Change
Estimated Value 1.05
Confidence Interval (2-Sided) 90%
1.02 to 1.08
Estimation Comments ANCOVA with change in logarithmic creatinine from baseline as dependent variable, treatment and logarithmic baseline as covariate.
11.Secondary Outcome
Title Adjusted Geometric Mean-Fold Change From End of Period 2 From Baseline in Serum Creatinine
Hide Description 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.
Time Frame Day 1 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 87 44
Geometric Mean (90% Confidence Interval)
Unit of Measure: fold change
1.00
(0.99 to 1.02)
1.00
(0.97 to 1.02)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Geo Mean-Fold Change
Estimated Value 1.01
Confidence Interval (2-Sided) 90%
0.98 to 1.04
Estimation Comments ANCOVA with change in logarithmic creatinine from baseline as dependent variable, treatment and logarithmic baseline as covariate.
12.Secondary Outcome
Title Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in Serum Creatinine
Hide Description 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.
Time Frame Day 43 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 87 44
Geometric Mean (90% Confidence Interval)
Unit of Measure: fold change
0.97
(0.95 to 0.99)
1.00
(0.98 to 1.03)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Geo Mean-Fold Change
Estimated Value 0.97
Confidence Interval (2-Sided) 90%
0.94 to 1.00
Estimation Comments ANCOVA with change in logarithmic creatinine from Period 2 baseline/the end of Period 1 as dependent variable, treatment and Period 2 baseline/the end of Period 1 as covariate.
13.Secondary Outcome
Title Percentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response
Hide Description 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).
Time Frame Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
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])
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 97 51
Measure Type: Number
Unit of Measure: percentage of participants
End of Period 1 (Day 43) 57.73 21.57
End of Period 2 (Day 29) 45.36 29.41
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments Between-group difference in ACR20 Response at End of Period 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Two-sided test at 5% significance level.
Method Normal approximation for proportions
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 36.16
Confidence Interval (2-Sided) 90%
23.60 to 48.73
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.64
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments Between-group difference in ACR20 Response at End of Period 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.050
Comments Two-sided test at 5% significance level.
Method Normal approximation for proportions
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 15.95
Confidence Interval (2-Sided) 90%
2.56 to 29.34
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.14
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Hide Description 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.
Time Frame Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (NRI, LOCF)
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 97 51
Measure Type: Number
Unit of Measure: percentage of participants
End of Period 1 (Day 43) 28.87 7.84
End of Period 2 (Day 29) 26.80 9.80
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments Between-group difference in ACR50 Response at End of Period 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Two-sided test at 5% significance level.
Method Normal approximation for proportions
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 21.02
Confidence Interval (2-Sided) 90%
11.24 to 30.80
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.94
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments Between-group difference in ACR50 Response at End of Period 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments Two-sided test at 5% significance level.
Method Normal approximation for proportions
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 17.00
Confidence Interval (2-Sided) 90%
6.92 to 27.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.13
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Hide Description 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.
Time Frame Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (NRI, LOCF)
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 97 51
Measure Type: Number
Unit of Measure: percentage of participants
End of Period 1 (Day 43) 18.56 0.00
End of Period 2 (Day 29) 9.28 1.96
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments Between-group difference in ACR70 Response at End of Period 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Two-sided test at 5% significance level.
Method Normal approximation for proportions
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 18.56
Confidence Interval (2-Sided) 90%
12.06 to 25.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.95
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments Between-group difference in ACR70 Response at End of Period 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments Two-sided test at 5% significance level.
Method Normal approximation for proportions
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.32
Confidence Interval (2-Sided) 90%
1.51 to 13.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.53
Estimation Comments [Not Specified]
16.Secondary Outcome
Title 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])
Hide Description 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.
Time Frame Day 1 of Period 1, Day 43 of Period 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 93 45
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-1.71  (0.13) -0.55  (0.19)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.16
Confidence Interval (2-Sided) 90%
-1.53 to -0.78
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.23
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
17.Secondary Outcome
Title LS Mean Change at End of Period 2 From Baseline in DAS28-3 (CRP)
Hide Description 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.
Time Frame Day 1 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 90 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-1.36  (0.12) -0.89  (0.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.47
Confidence Interval (2-Sided) 90%
-0.83 to -0.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.21
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
18.Secondary Outcome
Title LS Mean Change at End of Period 2 From End of Period 1 in DAS28-3 (CRP)
Hide Description 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.
Time Frame Day 43 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 90 43
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.35  (0.12) -0.34  (0.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.68
Confidence Interval (2-Sided) 90%
0.32 to 1.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.22
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
19.Secondary Outcome
Title LS Mean Change at End of Period 1 From Baseline DAS28-4 (CRP)
Hide Description 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.
Time Frame Day 1 of Period 1, Day 43 of Period 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 93 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-1.88  (0.14) -0.62  (0.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.26
Confidence Interval (2-Sided) 90%
-1.67 to -0.84
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.25
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
20.Secondary Outcome
Title LS Mean Change at End of Period 2 From Baseline DAS28-4 (CRP)
Hide Description 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.
Time Frame Day 1 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 90 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-1.46  (0.13) -0.96  (0.19)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.50
Confidence Interval (2-Sided) 90%
-0.88 to -0.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.23
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
21.Secondary Outcome
Title LS Mean Change at End of Period 2 From End of Period 1 DAS28-4 (CRP)
Hide Description 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.
Time Frame Day 43 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 90 42
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.42  (0.14) -0.34  (0.20)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.76
Confidence Interval (2-Sided) 90%
0.36 to 1.15
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.24
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
22.Secondary Outcome
Title LS Mean Change at End of Period 1 From Baseline in Tender/Painful Joint Count
Hide Description 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]).
Time Frame Day 1 of Period 1, Day 43 of Period 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 93 45
Least Squares Mean (Standard Error)
Unit of Measure: tender/painful joints
-9.88  (1.16) -5.79  (1.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.09
Confidence Interval (2-Sided) 90%
-7.44 to -0.74
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.02
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
23.Secondary Outcome
Title LS Mean Change at End of Period 2 From Baseline in Tender/Painful Joint Count
Hide Description 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]).
Time Frame Day 1 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 90 45
Least Squares Mean (Standard Error)
Unit of Measure: tender/painful joints
-8.13  (1.02) -8.27  (1.44)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.936
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.14
Confidence Interval (2-Sided) 90%
-2.78 to 3.06
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.76
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
24.Secondary Outcome
Title LS Mean Change at End of Period 2 From End of Period 1 in Tender/Painful Joint Count
Hide Description 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]).
Time Frame Day 43 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 90 44
Least Squares Mean (Standard Error)
Unit of Measure: tender/painful joints
1.75  (1.11) -2.48  (1.58)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.23
Confidence Interval (2-Sided) 90%
1.04 to 7.42
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.93
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
25.Secondary Outcome
Title LS Mean Change at End of Period 1 From Baseline in Swollen Joint Count
Hide Description 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]).
Time Frame Day 1 of Period 1, Day 43 of Period 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 93 45
Least Squares Mean (Standard Error)
Unit of Measure: swollen joints
-7.07  (0.59) -4.81  (0.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.26
Confidence Interval (2-Sided) 90%
-3.96 to -0.55
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.03
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
26.Secondary Outcome
Title LS Mean Change at End of Period 2 From Baseline in Swollen Joint Count
Hide Description 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]).
Time Frame Day 1 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 90 45
Least Squares Mean (Standard Error)
Unit of Measure: swollen joints
-6.63  (0.64) -5.83  (0.91)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.472
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.80
Confidence Interval (2-Sided) 90%
-2.64 to 1.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.11
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
27.Secondary Outcome
Title LS Mean Change at End of Period 2 From End of Period 1 in Swollen Joint Count
Hide Description 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]).
Time Frame Day 43 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 90 44
Least Squares Mean (Standard Error)
Unit of Measure: swollen joints
0.43  (0.59) -1.02  (0.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.158
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.46
Confidence Interval (2-Sided) 90%
-0.24 to 3.15
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.03
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
28.Secondary Outcome
Title LS Mean Change at End of Period 1 From Baseline in CRP
Hide Description [Not Specified]
Time Frame Day 1 of Period 1, Day 43 of Period 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 93 46
Least Squares Mean (Standard Error)
Unit of Measure: mg/L
-13.81  (2.17) -0.08  (3.01)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.73
Confidence Interval (2-Sided) 90%
-19.87 to -7.59
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.71
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
29.Secondary Outcome
Title LS Mean Change at End of Period 2 From Baseline in CRP
Hide Description [Not Specified]
Time Frame Day 1 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 90 44
Least Squares Mean (Standard Error)
Unit of Measure: mg/L
-8.37  (2.34) 0.53  (3.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.89
Confidence Interval (2-Sided) 90%
-15.58 to -2.21
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.04
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
30.Secondary Outcome
Title LS Mean Change at End of Period 2 From End of Period 1 in CRP
Hide Description [Not Specified]
Time Frame Day 43 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 90 44
Least Squares Mean (Standard Error)
Unit of Measure: mg/L
5.44  (1.71) 0.61  (2.44)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.107
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.84
Confidence Interval (2-Sided) 90%
-0.10 to 9.77
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.98
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
31.Secondary Outcome
Title LS Mean Change at End of Period 1 From Baseline in Patient Global Assessment of Arthritis (PGAA)
Hide Description 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.
Time Frame Day 1 of Period 1, Day 43 of Period 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 93 45
Least Squares Mean (Standard Error)
Unit of Measure: mm
-23.28  (2.81) -7.38  (3.98)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15.90
Confidence Interval (2-Sided) 90%
-23.96 to -7.84
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.87
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
32.Secondary Outcome
Title LS Mean Change at End of Period 2 From Baseline in PGAA
Hide Description 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.
Time Frame Day 1 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 90 45
Least Squares Mean (Standard Error)
Unit of Measure: mm
-16.12  (2.87) -10.41  (4.03)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.251
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.70
Confidence Interval (2-Sided) 90%
-13.90 to 2.50
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.95
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
33.Secondary Outcome
Title LS Mean Change at End of Period 2 From End of Period 1 in PGAA
Hide Description 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.
Time Frame Day 43 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 90 44
Least Squares Mean (Standard Error)
Unit of Measure: mm
7.16  (2.54) -3.03  (3.62)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10.19
Confidence Interval (2-Sided) 90%
2.87 to 17.52
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.42
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
34.Secondary Outcome
Title LS Mean Change at End of Period 1 From Baseline in Physician Global Assessment of Arthritis
Hide Description 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.
Time Frame Day 1 of Period 1, Day 43 of Period 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 93 45
Least Squares Mean (Standard Error)
Unit of Measure: mm
-29.83  (2.24) -14.71  (3.19)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15.12
Confidence Interval (2-Sided) 90%
-21.58 to -8.67
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.90
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
35.Secondary Outcome
Title LS Mean Change at End of Period 2 From Baseline in Physician Global Assessment of Arthritis
Hide Description 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.
Time Frame Day 1 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 90 45
Least Squares Mean (Standard Error)
Unit of Measure: mm
-24.61  (2.76) -22.21  (3.89)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.616
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.40
Confidence Interval (2-Sided) 90%
-10.30 to 5.50
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.77
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
36.Secondary Outcome
Title LS Mean Change at End of Period 2 From End of Period 1 in Physician Global Assessment of Arthritis
Hide Description 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.
Time Frame Day 43 of Period 1, Day 29 of Period 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 90 44
Least Squares Mean (Standard Error)
Unit of Measure: mm
5.22  (2.39) -7.50  (3.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 12.72
Confidence Interval (2-Sided) 90%
5.82 to 19.62
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.17
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
37.Secondary Outcome
Title LS Mean Change at End of Period 1 From Baseline in Patient Assessment of Arthritis Pain
Hide Description 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.
Time Frame Day 1 of Period 1, Day 43 of Period 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 93 46
Least Squares Mean (Standard Error)
Unit of Measure: mm
-23.53  (2.61) -8.23  (3.69)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15.30
Confidence Interval (2-Sided) 90%
-22.78 to -7.82
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.52
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
38.Secondary Outcome
Title LS Mean Change at End of Period 2 From Baseline in Patient Assessment of Arthritis Pain
Hide Description 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.
Time Frame Day 1 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 90 45
Least Squares Mean (Standard Error)
Unit of Measure: mm
-14.70  (2.80) -9.08  (3.94)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.247
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.62
Confidence Interval (2-Sided) 90%
-13.62 to 2.38
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.83
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
39.Secondary Outcome
Title LS Mean Change at End of Period 2 From End of Period 1 in Patient Assessment of Arthritis Pain
Hide Description 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.
Time Frame Day 43 of Period 2, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 90 45
Least Squares Mean (Standard Error)
Unit of Measure: mm
8.83  (2.69) -0.85  (3.81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.040
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.68
Confidence Interval (2-Sided) 90%
1.95 to 17.41
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.67
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
40.Secondary Outcome
Title LS Mean Change at End of Period 1 From Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) Score
Hide Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time Frame Day 1 of Period 1, Day 43 of Period 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 93 46
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.44  (0.06) -0.04  (0.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.39
Confidence Interval (2-Sided) 90%
-0.56 to -0.23
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
41.Secondary Outcome
Title LS Mean Change at End of Period 2 From Baseline HAQ-DI Score
Hide Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time Frame Day 1 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 90 45
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.34  (0.05) -0.17  (0.07)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.17
Confidence Interval (2-Sided) 90%
-0.31 to -0.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
42.Secondary Outcome
Title LS Mean Change at End of Period 2 From End of Period 1 HAQ-DI Score
Hide Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time Frame Day 43 of Period 1, Day 29 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 90 45
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.09  (0.04) -0.13  (0.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550/Placebo, Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments Two-sided test at 5% significance level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.22
Confidence Interval (2-Sided) 90%
0.10 to 0.35
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title CP-690,550/Placebo Placebo/Placebo
Hide Arm/Group Description 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 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)
All-Cause Mortality
CP-690,550/Placebo Placebo/Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
CP-690,550/Placebo Placebo/Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/97 (2.06%)   0/51 (0.00%) 
Infections and infestations     
Bronchopneumonia  1  1/97 (1.03%)  0/51 (0.00%) 
Injury, poisoning and procedural complications     
Pelvic fracture  1  1/97 (1.03%)  0/51 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
CP-690,550/Placebo Placebo/Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   32/97 (32.99%)   26/51 (50.98%) 
Blood and lymphatic system disorders     
Anemia  1  0/97 (0.00%)  1/51 (1.96%) 
Lymph node pain  1  0/97 (0.00%)  1/51 (1.96%) 
Lymphopenia  1  0/97 (0.00%)  1/51 (1.96%) 
Thrombocytosis  1  0/97 (0.00%)  1/51 (1.96%) 
Ear and labyrinth disorders     
Ear pain  1  0/97 (0.00%)  1/51 (1.96%) 
Gastrointestinal disorders     
Abdominal pain upper  1  3/97 (3.09%)  0/51 (0.00%) 
Abdominal tenderness  1  0/97 (0.00%)  1/51 (1.96%) 
Diarrhoea  1  1/97 (1.03%)  1/51 (1.96%) 
Gastritis  1  0/97 (0.00%)  1/51 (1.96%) 
Gastrooesophageal reflux disease  1  0/97 (0.00%)  3/51 (5.88%) 
Nausea  1  5/97 (5.15%)  2/51 (3.92%) 
Vomiting  1  2/97 (2.06%)  0/51 (0.00%) 
General disorders     
Medical device complication  1  0/97 (0.00%)  1/51 (1.96%) 
Infections and infestations     
Gastroenteritis  1  1/97 (1.03%)  1/51 (1.96%) 
Nasopharyngitis  1  8/97 (8.25%)  3/51 (5.88%) 
Oral herpes  1  2/97 (2.06%)  0/51 (0.00%) 
Upper respiratory tract infection  1  1/97 (1.03%)  1/51 (1.96%) 
Urinary tract infection  1  3/97 (3.09%)  2/51 (3.92%) 
Injury, poisoning and procedural complications     
Contusion  1  0/97 (0.00%)  1/51 (1.96%) 
Soft tissue injury  1  0/97 (0.00%)  1/51 (1.96%) 
Tooth fracture  1  0/97 (0.00%)  1/51 (1.96%) 
Investigations     
Alanine aminotransferase increased  1  2/97 (2.06%)  0/51 (0.00%) 
Blood creatine phosphokinase increased  1  2/97 (2.06%)  0/51 (0.00%) 
Blood creatinine increased  1  0/97 (0.00%)  1/51 (1.96%) 
Blood pressure increased  1  2/97 (2.06%)  0/51 (0.00%) 
Blood urea increased  1  0/97 (0.00%)  1/51 (1.96%) 
Metabolism and nutrition disorders     
Impaired fasting glucose  1  1/97 (1.03%)  1/51 (1.96%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  2/97 (2.06%)  0/51 (0.00%) 
Joint contracture  1  0/97 (0.00%)  1/51 (1.96%) 
Musculoskeletal chest pain  1  0/97 (0.00%)  1/51 (1.96%) 
Osteoarthritis  1  2/97 (2.06%)  0/51 (0.00%) 
Rheumatoid arthritis  1  0/97 (0.00%)  1/51 (1.96%) 
Nervous system disorders     
Headache  1  6/97 (6.19%)  1/51 (1.96%) 
Somnolence  1  0/97 (0.00%)  1/51 (1.96%) 
Syncope  1  0/97 (0.00%)  1/51 (1.96%) 
Psychiatric disorders     
Anxiety  1  1/97 (1.03%)  1/51 (1.96%) 
Insomnia  1  0/97 (0.00%)  1/51 (1.96%) 
Reproductive system and breast disorders     
Menorrhagia  1  0/97 (0.00%)  1/51 (1.96%) 
Respiratory, thoracic and mediastinal disorders     
Rhinitis seasonal  1  0/97 (0.00%)  1/51 (1.96%) 
Skin and subcutaneous tissue disorders     
Urticaria  1  0/97 (0.00%)  1/51 (1.96%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01484561    
Other Study ID Numbers: A3921152
First Submitted: November 30, 2011
First Posted: December 2, 2011
Results First Submitted: January 11, 2014
Results First Posted: April 2, 2014
Last Update Posted: April 2, 2014