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Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550

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ClinicalTrials.gov Identifier: NCT01059864
Recruitment Status : Completed
First Posted : February 1, 2010
Results First Posted : December 13, 2012
Last Update Posted : December 13, 2012
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: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: CP-690,550
Drug: Atorvastatin
Drug: Atorvastatin Placebo
Enrollment 111
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CP-690,550 CP-690,550 + Atorvastatin CP-690,550 + Placebo
Hide Arm/Group Description Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase. Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase. Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Period Title: Open-Label Run-In Phase
Started 111 0 0
Completed 98 0 0
Not Completed 13 0 0
Reason Not Completed
Adverse Event             7             0             0
Lack of Efficacy             1             0             0
Lost to Follow-up             2             0             0
Withdrawal by Subject             1             0             0
Protocol Violation             2             0             0
Period Title: Double-Blind Treatment Phase
Started 0 50 48
Treated 0 50 47
Completed 0 47 45
Not Completed 0 3 3
Reason Not Completed
Adverse Event             0             3             3
Arm/Group Title CP-690,550
Hide Arm/Group Description Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.
Overall Number of Baseline Participants 111
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 111 participants
52.3  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
Female
99
  89.2%
Male
12
  10.8%
1.Primary Outcome
Title Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12
Hide Description [Not Specified]
Time Frame Baseline (Week 6), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo). Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title CP-690,550 + Atorvastatin CP-690,550 + Placebo
Hide Arm/Group Description:
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Overall Number of Participants Analyzed 46 45
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-35.34  (2.25) 5.80  (2.27)
2.Secondary Outcome
Title Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12
Hide Description [Not Specified]
Time Frame Baseline (Week 6), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo). Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title CP-690,550 + Atorvastatin CP-690,550 + Placebo
Hide Arm/Group Description:
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Overall Number of Participants Analyzed 46 45
Least Squares Mean (Standard Error)
Unit of Measure: milligram per deciliter (mg/dL)
-51.49  (2.99) 5.30  (3.02)
3.Secondary Outcome
Title 12-Hours Fasting Lipid Profile
Hide Description Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: LDL-C, high-density lipoprotein-cholesterol (HDL-C), very low density lipoprotein-cholesterol (VLDL-C), total cholesterol, apolipoprotein A-1, apolipoprotein B, triglycerides (TGs) and Non-HDL-C.
Time Frame Day 0, Week 2, 6 (Baseline), 10, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Arm/Group Title CP-690,550 + Atorvastatin CP-690,550 + Placebo
Hide Arm/Group Description:
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Overall Number of Participants Analyzed 50 47
Mean (Standard Deviation)
Unit of Measure: mg/dL
Day 0: LDL-C 111.99  (30.21) 114.68  (30.54)
Week 2: LDL-C 124.87  (30.97) 132.94  (34.90)
Week 6 (Baseline): LDL-C 135.83  (39.39) 138.26  (39.07)
Week 10: LDL-C 80.58  (24.45) 141.52  (35.17)
Week 12: LDL-C 84.03  (21.94) 142.61  (35.72)
Day 0: HDL-C 54.96  (14.96) 56.20  (14.18)
Week 2: HDL-C 61.11  (17.00) 65.35  (15.12)
Week 6 (Baseline): HDL-C 67.39  (18.35) 70.58  (18.00)
Week 10: HDL-C 70.12  (19.35) 70.31  (18.42)
Week 12: HDL-C 71.09  (17.61) 71.73  (16.40)
Day 0: Total Cholesterol 189.62  (39.26) 196.58  (34.41)
Week 2: Total Cholesterol 213.11  (43.02) 222.85  (40.50)
Week 6 (Baseline): Total Cholesterol 228.22  (47.93) 234.27  (43.99)
Week 10: Total Cholesterol 174.42  (32.10) 238.16  (40.18)
Week 12: Total Cholesterol 175.18  (29.24) 240.49  (42.14)
Day 0: Apolipoprotein A-1 139.48  (27.70) 148.36  (26.25)
Week 2: Apolipoprotein A-1 153.80  (31.11) 168.13  (24.43)
Week 6 (Baseline): Apolipoprotein A-1 164.18  (29.76) 171.81  (28.02)
Week 10: Apolipoprotein A-1 171.87  (30.47) 172.30  (29.00)
Week 12: Apolipoprotein A-1 171.02  (30.93) 178.36  (28.55)
Day 0: Apolipoprotein B 90.30  (21.89) 94.09  (20.04)
Week 2: Apolipoprotein B 96.18  (23.35) 101.74  (22.78)
Week 6 (Baseline): Apolipoprotein B 100.28  (26.64) 100.38  (22.05)
Week 10: Apolipoprotein B 69.32  (20.33) 103.96  (23.63)
Week 12: Apolipoprotein B 70.35  (15.06) 105.84  (23.48)
Day 0: TGs 113.54  (52.17) 128.76  (69.17)
Week 2: TGs 135.69  (76.80) 123.18  (62.51)
Week 6 (Baseline): TGs 127.16  (77.16) 127.63  (58.48)
Week 10: TGs 117.90  (78.04) 133.63  (84.23)
Week 12: TGs 100.78  (35.87) 131.48  (56.66)
Day 0: VLDL-C 57.73  (49.23) 70.41  (68.55)
Week 2: VLDL-C 81.48  (73.57) 74.89  (65.42)
Week 6 (Baseline): VLDL-C 76.10  (71.63) 75.30  (58.91)
Week 10: VLDL-C 69.00  (75.49) 79.43  (66.86)
Week 12: VLDL-C 51.59  (33.38) 78.64  (53.10)
Day 0: Non-HDL-C 134.66  (35.32) 140.39  (33.75)
Week 2: Non-HDL-C 152.00  (39.84) 157.50  (39.61)
Week 6 (Baseline): Non-HDL-C 160.83  (47.50) 163.69  (41.96)
Week 10: Non-HDL-C 104.30  (32.65) 167.85  (40.22)
Week 12: Non-HDL-C 104.09  (25.49) 168.76  (39.90)
4.Secondary Outcome
Title 12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins
Hide Description Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: plasma lipoprotein VLDL-C, LDL-C and HDL-C particles size.
Time Frame Day 0, Week 2, 6 (Baseline), 10, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Arm/Group Title CP-690,550 + Atorvastatin CP-690,550 + Placebo
Hide Arm/Group Description:
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Overall Number of Participants Analyzed 50 47
Mean (Standard Deviation)
Unit of Measure: nanometer (nm)
Day 0: VLDL-C Particles 42.08  (6.68) 46.15  (10.12)
Week 2: VLDL-C Particles 47.41  (11.86) 47.31  (8.28)
Week 6 (Baseline): VLDL-C Particles 44.75  (6.41) 48.67  (9.09)
Week 10: VLDL-C Particles 48.29  (8.65) 47.48  (7.34)
Week 12: VLDL-C Particles 47.35  (7.40) 47.58  (8.18)
Day 0: LDL-C Particles 21.19  (0.90) 21.14  (0.74)
Week 2: LDL-C Particles 21.44  (0.77) 21.55  (0.79)
Week 6 (Baseline): LDL-C Particles 21.65  (0.92) 21.66  (0.81)
Week 10: LDL-C Particles 21.67  (0.86) 21.45  (0.91)
Week 12: LDL-C Particles 21.74  (0.80) 21.51  (0.80)
Day 0: HDL-C Particles 9.29  (0.44) 9.21  (0.48)
Week 2: HDL-C Particles 9.25  (0.46) 9.26  (0.48)
Week 6 (Baseline): HDL-C Particles 9.31  (0.50) 9.30  (0.50)
Week 10: HDL-C Particles 9.33  (0.47) 9.22  (0.53)
Week 12: HDL-C Particles 9.36  (0.45) 9.25  (0.49)
5.Secondary Outcome
Title 12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Hide Description Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: total and large VLDL-C and chylomicron particles (VLDLCP), medium and small VLDL-C particles; total, large, medium and small LDL-C particles; and intermediate density lipoprotein (IDL).
Time Frame Day 0, Week 2, 6 (Baseline), 10, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Arm/Group Title CP-690,550 + Atorvastatin CP-690,550 + Placebo
Hide Arm/Group Description:
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Overall Number of Participants Analyzed 50 47
Mean (Standard Deviation)
Unit of Measure: nanomoles per liter (nmol/L)
Day 0: Total VLDLCP 61.00  (38.88) 56.20  (37.29)
Week 2: Total VLDLCP 68.89  (43.74) 65.24  (41.56)
Week 6(Baseline): Total VLDLCP 73.23  (48.34) 65.51  (41.39)
Week 10: Total VLDLCP 53.22  (42.36) 70.07  (43.11)
Week 12: Total VLDLCP 45.07  (27.93) 72.11  (37.22)
Day 0: Large VLDLCP 1.25  (2.14) 2.79  (4.80)
Week 2: Large VLDLCP 3.09  (4.58) 2.50  (3.63)
Week 6(Baseline): Large VLDLCP 2.43  (4.34) 2.53  (3.63)
Week 10: Large VLDLCP 2.47  (4.57) 2.85  (4.66)
Week 12: Large VLDLCP 1.45  (1.84) 2.63  (3.48)
Day 0: Medium VLDL-C Particles 22.11  (22.14) 23.26  (24.79)
Week 2: Medium VLDL-C Particles 27.20  (25.39) 25.75  (27.62)
Week 6 (Baseline): Medium VLDL-C Particles 26.54  (23.72) 24.59  (22.43)
Week 10: Medium VLDL-C Particles 25.36  (28.17) 25.27  (21.74)
Week 12: Medium VLDL-C Particles 20.67  (12.95) 25.46  (20.40)
Day 0: Small VLDL-C Particles 37.64  (19.93) 30.15  (19.02)
Week 2: Small VLDL-C Particles 38.61  (20.27) 36.98  (21.89)
Week 6 (Baseline): Small VLDL-C Particles 44.26  (27.94) 38.39  (21.85)
Week 10: Small VLDL-C Particles 25.38  (18.80) 41.94  (23.77)
Week 12: Small VLDL-C Particles 22.94  (17.39) 44.01  (23.51)
Day 0: Total LDL-C Particles 1111.8  (336.45) 1222.2  (350.51)
Week 2: Total LDL-C Particles 1175.9  (365.28) 1201.7  (342.82)
Week 6 (Baseline): Total LDL-C Particles 1154.3  (440.45) 1195.0  (352.53)
Week 10: Total LDL-C Particles 787.24  (282.87) 1271.2  (381.29)
Week 12: Total LDL-C Particles 801.39  (285.35) 1264.9  (410.30)
Day 0: IDL Particles 27.12  (31.90) 30.98  (37.49)
Week 2: IDL Particles 36.58  (42.24) 55.74  (55.78)
Week 6 (Baseline): IDL Particles 43.37  (52.14) 53.94  (51.70)
Week 10: IDL Particles 24.46  (38.14) 69.78  (74.08)
Week 12: IDL Particles 22.22  (39.47) 66.91  (62.54)
Day 0: Large LDL-C Particles 451.88  (247.55) 468.67  (191.87)
Week 2: Large LDL-C Particles 543.28  (225.96) 589.28  (243.27)
Week 6 (Baseline): Large LDL-C Particles 581.73  (239.90) 631.55  (266.98)
Week 10: Large LDL-C Particles 400.11  (175.75) 582.04  (268.41)
Week 12: Large LDL-C Particles 424.26  (161.19) 598.34  (241.53)
Day 0: Total Small LDL-C Particles 632.73  (401.86) 722.46  (373.82)
Week 2: Total Small LDL-C Particles 596.12  (415.78) 556.67  (399.91)
Week 6 (Baseline): Total Small LDL-C Particles 528.94  (501.32) 509.45  (385.73)
Week 10: Total Small LDL-C Particles 362.72  (309.76) 619.43  (445.00)
Week 12: Total Small LDL-C Particles 354.96  (313.20) 599.77  (456.21)
Day 0: Medium Small LDL-C Particles 127.08  (83.27) 149.43  (78.23)
Week 2: Medium Small LDL-C Particles 117.42  (83.36) 114.74  (83.82)
Week 6 (Baseline): Medium Small LDL-C Particles 104.94  (99.40) 108.19  (82.11)
Week 10: Medium Small LDL-C Particles 78.78  (64.95) 130.57  (96.04)
Week 12: Medium Small LDL-C Particles 77.96  (66.36) 124.20  (97.98)
Day 0: Very Small LDL-C Particles 505.59  (319.41) 572.98  (296.63)
Week 2: Very Small LDL-C Particles 478.62  (333.47) 441.93  (317.36)
Week 6 (Baseline): Very Small LDL-C Particles 424.02  (402.68) 401.21  (305.54)
Week 10: Very Small LDL-C Particles 283.76  (246.26) 489.00  (350.20)
Week 12: Very Small LDL-C Particles 276.93  (249.02) 475.55  (359.14)
6.Secondary Outcome
Title 12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
Hide Description Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: total, large, medium and small HDL-C particles.
Time Frame Day 0, Week 2, 6 (Baseline), 10, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Arm/Group Title CP-690,550 + Atorvastatin CP-690,550 + Placebo
Hide Arm/Group Description:
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Overall Number of Participants Analyzed 50 47
Mean (Standard Deviation)
Unit of Measure: micromole per liter (mcmol/L)
Day 0: Total HDL-C Particles 27.08  (5.74) 29.58  (5.97)
Week 2: Total HDL-C Particles 30.89  (5.81) 33.68  (5.74)
Week 6 (Baseline): Total HDL-C Particles 32.90  (5.94) 35.44  (5.99)
Week 10: Total HDL-C Particles 34.57  (6.03) 36.07  (6.89)
Week 12: Total HDL-C Particles 34.20  (5.63) 35.77  (6.26)
Day 0: Large HDL-C Particles 8.88  (3.64) 8.75  (4.13)
Week 2: Large HDL-C Particles 9.08  (4.17) 9.56  (4.34)
Week 6 (Baseline): Large HDL-C Particles 10.04  (4.67) 10.63  (4.69)
Week 10: Large HDL-C Particles 10.98  (4.39) 9.93  (4.81)
Week 12: Large HDL-C Particles 11.23  (4.43) 10.23  (4.34)
Day 0: Medium HDL-C Particles 3.74  (3.94) 4.01  (3.63)
Week 2: Medium HDL-C Particles 3.87  (4.31) 4.43  (4.41)
Week 6 (Baseline): Medium HDL-C Particles 3.89  (4.86) 3.98  (3.90)
Week 10: Medium HDL-C Particles 4.57  (5.58) 4.52  (4.12)
Week 12: Medium HDL-C Particles 3.85  (3.97) 4.74  (4.59)
Day 0: Small HDL-C Particles 14.44  (6.15) 16.80  (6.46)
Week 2: Small HDL-C Particles 17.94  (6.27) 19.70  (6.83)
Week 6 (Baseline): Small HDL-C Particles 18.97  (6.35) 20.83  (6.95)
Week 10: Small HDL-C Particles 19.04  (7.30) 21.63  (6.17)
Week 12: Small HDL-C Particles 19.15  (6.19) 20.79  (7.10)
7.Secondary Outcome
Title Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Hide Description DAS28-3 (CRP) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count and the CRP (milligram per liter [mg/L]). DAS28-3 (CRP) less than or equal to (<=)3.2 indicated low disease activity, DAS28-3 (CRP) more than (>) 3.2 to 5.1 indicated moderate to high disease activity.
Time Frame Day 0, Week 6 (Baseline), 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Arm/Group Title CP-690,550 + Atorvastatin CP-690,550 + Placebo
Hide Arm/Group Description:
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Overall Number of Participants Analyzed 50 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 0 5.38  (1.24) 5.23  (1.00)
Week 6 (Baseline) 3.44  (1.28) 3.33  (1.10)
Week 12 3.06  (1.26) 2.99  (1.09)
8.Secondary Outcome
Title Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
Hide Description DAS28-4 (CRP) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, C-reactive protein (CRP) [mg/L] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-4 [CRP] <=3.2 indicated low disease activity, DAS28-4 [CRP] >3.2 to 5.1 indicated moderate to high disease activity and DAS28 less than 2.6 indicates remission.
Time Frame Day 0, Week 6 (Baseline), 12
Hide Outcome Measure Data
Hide Analysis Population Description
Since DAS28-3(CRP) and DAS28-4(ESR) are summarized, data for DAS28-4(CRP) was collected and reported in individual participant listings, but not statistically summarized for analysis as planned.
Arm/Group Title CP-690,550 + Atorvastatin CP-690,550 + Placebo
Hide Arm/Group Description:
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
Hide Description DAS28-3 (ESR) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]). DAS28-3 (ESR) <=3.2 indicated low disease activity, DAS28-3 (ESR) >3.2 to 5.1 indicated moderate to high disease activity.
Time Frame Day 0, Week 6 (Baseline), 12
Hide Outcome Measure Data
Hide Analysis Population Description
Since DAS28-3(CRP) and DAS28-4(ESR) are summarized, data for DAS28-3(ESR) was collected and reported in individual participant listings, but not statistically summarized for analysis as planned.
Arm/Group Title CP-690,550 + Atorvastatin CP-690,550 + Placebo
Hide Arm/Group Description:
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
Hide Description DAS28-4 (ESR) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) [mm/hr] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging from 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-4 (ESR) <=3.2 indicated low disease activity, DAS28-4 (ESR) >3.2 to 5.1 indicated moderate to high disease activity.
Time Frame Day 0, Week 6 (Baseline), 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo). Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title CP-690,550 + Atorvastatin CP-690,550 + Placebo
Hide Arm/Group Description:
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Overall Number of Participants Analyzed 50 46
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 0 6.60  (1.32) 6.44  (1.04)
Week 6 (Baseline) 4.33  (1.44) 4.26  (1.15)
Week 12 3.84  (1.57) 3.81  (1.29)
11.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
Hide Description ACR20 responses were defined as greater than or equal to 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Time Frame Week 6 (Baseline), 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Arm/Group Title CP-690,550 + Atorvastatin CP-690,550 + Placebo
Hide Arm/Group Description:
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Overall Number of Participants Analyzed 50 47
Measure Type: Number
Unit of Measure: percentage of participants
Week 6 (Baseline) 76.0 76.6
Week 12 82.6 65.2
12.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Hide Description ACR50 responses were defined as greater than or equal to 50% improvement in tender or swollen joint counts and 50% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Time Frame Week 6 (Baseline), 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Arm/Group Title CP-690,550 + Atorvastatin CP-690,550 + Placebo
Hide Arm/Group Description:
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Overall Number of Participants Analyzed 50 47
Measure Type: Number
Unit of Measure: percentage of participants
Week 6 (Baseline) 48.0 42.6
Week 12 67.4 45.7
13.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Hide Description ACR70 responses were defined as greater than or equal to 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Time Frame Week 6 (Baseline), 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Arm/Group Title CP-690,550 + Atorvastatin CP-690,550 + Placebo
Hide Arm/Group Description:
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Overall Number of Participants Analyzed 50 47
Measure Type: Number
Unit of Measure: percentage of participants
Week 6 (Baseline) 20.0 19.1
Week 12 34.8 30.4
14.Secondary Outcome
Title Tender-Joint Count
Hide Description Tender joint count (TJC) is an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint’s response to pressure/motion was assessed using the following scale: Present/Absent/Not Done/Not Applicable (for artificial joints).
Time Frame Day 0, Week 6 (Baseline), 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Arm/Group Title CP-690,550 + Atorvastatin CP-690,550 + Placebo
Hide Arm/Group Description:
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Overall Number of Participants Analyzed 50 47
Mean (Standard Deviation)
Unit of Measure: tender joints
Day 0 23.20  (18.15) 21.38  (14.80)
Week 6 (Baseline) 10.48  (12.56) 10.99  (13.22)
Week 12 8.57  (12.83) 7.83  (9.71)
15.Secondary Outcome
Title Swollen-Joint Count
Hide Description Swollen joint count (SJC): an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling using the following scale: Present/Absent/Not Done/Not Applicable (for artificial joints).
Time Frame Day 0, Week 6 (Baseline), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Arm/Group Title CP-690,550 + Atorvastatin CP-690,550 + Placebo
Hide Arm/Group Description:
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Overall Number of Participants Analyzed 50 47
Mean (Standard Deviation)
Unit of Measure: swollen joints
Day 0 16.90  (12.67) 15.34  (11.34)
Week 6 (Baseline) 6.36  (7.08) 5.68  (5.94)
Week 12 4.85  (5.51) 5.15  (6.04)
16.Secondary Outcome
Title C-Reactive Protein (CRP)
Hide Description The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. Normal range is 1-3 milligram per liter (mg/L).
Time Frame Day 0, Week 6 (Baseline), 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Arm/Group Title CP-690,550 + Atorvastatin CP-690,550 + Placebo
Hide Arm/Group Description:
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Overall Number of Participants Analyzed 50 47
Mean (Standard Deviation)
Unit of Measure: mg/L
Day 0 33.17  (38.22) 22.25  (26.96)
Week 6 (Baseline) 6.31  (11.76) 3.34  (5.11)
Week 12 6.04  (12.23) 3.32  (5.23)
17.Secondary Outcome
Title Erythrocyte Sedimentation Rate (ESR)
Hide Description ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
Time Frame Day 0, Week 6 (Baseline), 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Arm/Group Title CP-690,550 + Atorvastatin CP-690,550 + Placebo
Hide Arm/Group Description:
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Overall Number of Participants Analyzed 50 47
Mean (Standard Deviation)
Unit of Measure: mm/hr
Day 0 69.76  (36.40) 60.32  (33.96)
Week 6 (Baseline) 37.42  (28.81) 29.98  (20.46)
Week 12 34.43  (27.02) 30.31  (20.72)
18.Secondary Outcome
Title Patient Assessment of Arthritis Pain
Hide Description Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.
Time Frame Day 0, Week 6 (Baseline), 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Arm/Group Title CP-690,550 + Atorvastatin CP-690,550 + Placebo
Hide Arm/Group Description:
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Overall Number of Participants Analyzed 50 47
Mean (Standard Deviation)
Unit of Measure: mm
Day 0 65.66  (20.13) 64.41  (27.40)
Week 6 (Baseline) 30.18  (21.91) 31.26  (25.68)
Week 12 25.72  (21.33) 29.09  (25.11)
19.Secondary Outcome
Title Physician's Global Assessment (PhysGA) of Arthritis Pain
Hide Description The physician evaluated participants disease signs, functional capacity and physical examination independent of the patient’s global assessment of arthritis. Physician’s response was recorded using 0-100 mm visual analog scale (VAS), where 0=no pain and 100=most severe pain.
Time Frame Day 0, Week 6 (Baseline), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Arm/Group Title CP-690,550 + Atorvastatin CP-690,550 + Placebo
Hide Arm/Group Description:
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Overall Number of Participants Analyzed 50 47
Mean (Standard Deviation)
Unit of Measure: mm
Day 0 63.28  (20.18) 65.38  (24.86)
Week 6 (Baseline) 30.80  (22.09) 31.85  (26.12)
Week 12 24.30  (21.02) 29.70  (25.17)
20.Secondary Outcome
Title Patient's Global Assessment (PtGA) of Arthritis Pain
Hide Description Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0-100 mm visual analog scale where 0=no pain and 100=most severe pain.
Time Frame Day 0, Week 6 (Baseline), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Arm/Group Title CP-690,550 + Atorvastatin CP-690,550 + Placebo
Hide Arm/Group Description:
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Overall Number of Participants Analyzed 50 47
Mean (Standard Deviation)
Unit of Measure: mm
Day 0 68.10  (17.17) 61.67  (18.72)
Week 6 (Baseline) 27.66  (18.03) 28.08  (16.52)
Week 12 23.33  (20.15) 24.15  (15.91)
21.Secondary Outcome
Title Health Assessment Questionnaire Disability Index (HAQ-DI)
Hide Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional 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, 0=least functional difficulty and 3=extreme functional difficulty.
Time Frame Day 0, Week 6 (Baseline), 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).
Arm/Group Title CP-690,550 + Atorvastatin CP-690,550 + Placebo
Hide Arm/Group Description:
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
Overall Number of Participants Analyzed 50 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 0 1.54  (0.74) 1.46  (0.74)
Week 6 (Baseline) 0.88  (0.71) 0.88  (0.72)
Week 12 0.74  (0.69) 0.92  (0.78)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title CP-690,550 CP-690,550 + Atorvastatin CP-690,550 + Placebo
Hide Arm/Group Description Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase. Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase. Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
All-Cause Mortality
CP-690,550 CP-690,550 + Atorvastatin CP-690,550 + Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CP-690,550 CP-690,550 + Atorvastatin CP-690,550 + Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/111 (1.80%)   0/50 (0.00%)   1/47 (2.13%) 
Infections and infestations       
Pneumonia bacterial * 1  1/111 (0.90%)  0/50 (0.00%)  0/47 (0.00%) 
Pneumonia * 1  0/111 (0.00%)  0/50 (0.00%)  1/47 (2.13%) 
Musculoskeletal and connective tissue disorders       
Arthritis * 1  1/111 (0.90%)  0/50 (0.00%)  0/47 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDAR v13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
CP-690,550 CP-690,550 + Atorvastatin CP-690,550 + Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/111 (13.51%)   21/50 (42.00%)   19/47 (40.43%) 
Blood and lymphatic system disorders       
Thrombocytopenia * 1  0/111 (0.00%)  0/50 (0.00%)  1/47 (2.13%) 
Ear and labyrinth disorders       
Otorrhoea * 1  0/111 (0.00%)  0/50 (0.00%)  1/47 (2.13%) 
Eye disorders       
Cataract * 1  0/111 (0.00%)  1/50 (2.00%)  0/47 (0.00%) 
Ocular vascular disorder * 1  0/111 (0.00%)  0/50 (0.00%)  1/47 (2.13%) 
Gastrointestinal disorders       
Abdominal distension * 1  0/111 (0.00%)  0/50 (0.00%)  1/47 (2.13%) 
Abdominal pain upper * 1  0/111 (0.00%)  1/50 (2.00%)  1/47 (2.13%) 
Dental caries * 1  0/111 (0.00%)  1/50 (2.00%)  0/47 (0.00%) 
Diarrhoea * 1  3/111 (2.70%)  1/50 (2.00%)  0/47 (0.00%) 
Dyspepsia * 1  0/111 (0.00%)  2/50 (4.00%)  1/47 (2.13%) 
Gastrooesophageal reflux disease * 1  0/111 (0.00%)  0/50 (0.00%)  1/47 (2.13%) 
Nausea * 1  4/111 (3.60%)  1/50 (2.00%)  0/47 (0.00%) 
General disorders       
Chest pain * 1  0/111 (0.00%)  1/50 (2.00%)  0/47 (0.00%) 
Oedema peripheral * 1  0/111 (0.00%)  2/50 (4.00%)  2/47 (4.26%) 
Pain * 1  0/111 (0.00%)  1/50 (2.00%)  0/47 (0.00%) 
Infections and infestations       
Bronchitis * 1  0/111 (0.00%)  1/50 (2.00%)  0/47 (0.00%) 
Gastroenteritis * 1  0/111 (0.00%)  1/50 (2.00%)  0/47 (0.00%) 
Herpes zoster * 1  5/111 (4.50%)  0/50 (0.00%)  1/47 (2.13%) 
Nasopharyngitis * 1  0/111 (0.00%)  1/50 (2.00%)  2/47 (4.26%) 
Onychomycosis * 1  0/111 (0.00%)  0/50 (0.00%)  1/47 (2.13%) 
Sinusitis * 1  0/111 (0.00%)  0/50 (0.00%)  1/47 (2.13%) 
Tinea cruris * 1  0/111 (0.00%)  0/50 (0.00%)  1/47 (2.13%) 
Tinea pedis * 1  0/111 (0.00%)  0/50 (0.00%)  1/47 (2.13%) 
Upper respiratory tract infection * 1  0/111 (0.00%)  2/50 (4.00%)  2/47 (4.26%) 
Injury, poisoning and procedural complications       
Contusion * 1  0/111 (0.00%)  1/50 (2.00%)  0/47 (0.00%) 
Joint sprain * 1  0/111 (0.00%)  0/50 (0.00%)  1/47 (2.13%) 
Investigations       
Blood cholesterol increased * 1  0/111 (0.00%)  0/50 (0.00%)  2/47 (4.26%) 
Blood creatine phosphokinase increased * 1  0/111 (0.00%)  1/50 (2.00%)  0/47 (0.00%) 
Blood potassium decreased * 1  0/111 (0.00%)  1/50 (2.00%)  0/47 (0.00%) 
Blood triglycerides increased * 1  0/111 (0.00%)  1/50 (2.00%)  0/47 (0.00%) 
Electrocardiogram abnormal * 1  0/111 (0.00%)  1/50 (2.00%)  0/47 (0.00%) 
Hepatic enzyme increased * 1  0/111 (0.00%)  1/50 (2.00%)  1/47 (2.13%) 
Weight increased * 1  0/111 (0.00%)  1/50 (2.00%)  0/47 (0.00%) 
Metabolism and nutrition disorders       
Hypercholesterolaemia * 1  0/111 (0.00%)  0/50 (0.00%)  1/47 (2.13%) 
Musculoskeletal and connective tissue disorders       
Muscle spasms * 1  0/111 (0.00%)  1/50 (2.00%)  1/47 (2.13%) 
Musculoskeletal pain * 1  0/111 (0.00%)  0/50 (0.00%)  1/47 (2.13%) 
Myalgia * 1  0/111 (0.00%)  1/50 (2.00%)  0/47 (0.00%) 
Rheumatoid arthritis * 1  0/111 (0.00%)  1/50 (2.00%)  1/47 (2.13%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Skin papilloma * 1  0/111 (0.00%)  0/50 (0.00%)  1/47 (2.13%) 
Nervous system disorders       
Headache * 1  3/111 (2.70%)  0/50 (0.00%)  1/47 (2.13%) 
Somnolence * 1  0/111 (0.00%)  0/50 (0.00%)  1/47 (2.13%) 
Tinel’s sign * 1  0/111 (0.00%)  1/50 (2.00%)  0/47 (0.00%) 
Psychiatric disorders       
Anxiety * 1  0/111 (0.00%)  0/50 (0.00%)  1/47 (2.13%) 
Depression * 1  0/111 (0.00%)  1/50 (2.00%)  1/47 (2.13%) 
Renal and urinary disorders       
Micturition urgency * 1  0/111 (0.00%)  1/50 (2.00%)  0/47 (0.00%) 
Reproductive system and breast disorders       
Metrorrhagia * 1  0/111 (0.00%)  1/50 (2.00%)  0/47 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  0/111 (0.00%)  1/50 (2.00%)  0/47 (0.00%) 
Emphysema * 1  0/111 (0.00%)  0/50 (0.00%)  1/47 (2.13%) 
Oropharyngeal pain * 1  0/111 (0.00%)  2/50 (4.00%)  0/47 (0.00%) 
Sinus congestion * 1  0/111 (0.00%)  1/50 (2.00%)  0/47 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash * 1  0/111 (0.00%)  1/50 (2.00%)  1/47 (2.13%) 
Rash papular * 1  0/111 (0.00%)  0/50 (0.00%)  1/47 (2.13%) 
Surgical and medical procedures       
Sinus operation * 1  0/111 (0.00%)  0/50 (0.00%)  1/47 (2.13%) 
Vascular disorders       
Hypertension * 1  0/111 (0.00%)  1/50 (2.00%)  0/47 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDAR v13.1
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
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01059864     History of Changes
Other Study ID Numbers: A3921109
First Submitted: January 28, 2010
First Posted: February 1, 2010
Results First Submitted: November 14, 2012
Results First Posted: December 13, 2012
Last Update Posted: December 13, 2012