Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01059864
Collaborator
(none)
111
15
2
9
7.4
0.8
Study Details
Study Description
Brief Summary
All patients will be in instructed to eat a therapeutic lifestyle diet and will receive CP-690,550 throughout the 12 weeks of this study. After 6 weeks, half will receive the cholesterol lowering agent, atorvastatin, and half a matching placebo. This study will first measure the effects of CP-690,550 on cholesterol levels and then the effects of adding atorvastatin on those levels.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
111 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Phase 2 Study Of The Effects Of Open-Label CP-690,550 And Double-Blind Atorvastatin On Lipids In Patients With Active Rheumatoid Arthritis
Study Start Date
:
Feb 1, 2010
Actual Primary Completion Date
:
Nov 1, 2010
Actual Study Completion Date
:
Nov 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1
|
Drug: CP-690,550
12 week open-label CP-690,550 10 mg oral tablets administered twice daily starting at Day 0 through Week 12
Drug: Atorvastatin
Starting at Week 6 and continuing through Week 12 atorvastatin 10 mg oral tablets administered once daily
|
| Experimental: Arm 2
|
Drug: CP-690,550
12 week open-label CP-690,550 10 mg oral tablets administered twice daily starting at Day 0 through Week 12
Drug: Atorvastatin Placebo
Starting at Week 6 and continuing through Week 12 atorvastatin placebo tablets administered once daily
|
Outcome Measures
Primary Outcome Measures
- Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12 [Baseline (Week 6), Week 12]
Secondary Outcome Measures
- Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 [Baseline (Week 6), Week 12]
- 12-Hours Fasting Lipid Profile [Day 0, Week 2, 6 (Baseline), 10, 12]
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.
- 12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins [Day 0, Week 2, 6 (Baseline), 10, 12]
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.
- 12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles [Day 0, Week 2, 6 (Baseline), 10, 12]
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).
- 12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles [Day 0, Week 2, 6 (Baseline), 10, 12]
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.
- Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) [Day 0, Week 6 (Baseline), 12]
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.
- Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) [Day 0, Week 6 (Baseline), 12]
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.
- Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) [Day 0, Week 6 (Baseline), 12]
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.
- Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) [Day 0, Week 6 (Baseline), 12]
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.
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response [Week 6 (Baseline), 12]
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.
- Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response [Week 6 (Baseline), 12]
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.
- Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response [Week 6 (Baseline), 12]
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.
- Tender-Joint Count [Day 0, Week 6 (Baseline), 12]
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).
- Swollen-Joint Count [Day 0, Week 6 (Baseline), Week 12]
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).
- C-Reactive Protein (CRP) [Day 0, Week 6 (Baseline), 12]
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).
- Erythrocyte Sedimentation Rate (ESR) [Day 0, Week 6 (Baseline), 12]
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.
- Patient Assessment of Arthritis Pain [Day 0, Week 6 (Baseline), 12]
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.
- Physician's Global Assessment (PhysGA) of Arthritis Pain [Day 0, Week 6 (Baseline), Week 12]
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.
- Patient's Global Assessment (PtGA) of Arthritis Pain [Day 0, Week 6 (Baseline), Week 12]
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.
- Health Assessment Questionnaire Disability Index (HAQ-DI) [Day 0, Week 6 (Baseline), 12]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
must be diagnosed as having active rheumatoid arthritis
-
agree to participate in the study and sign and informed consent document
Exclusion Criteria:
-
History of serious infection within the past 6 months
-
test positive for TB
-
have any uncontrolled clinically significant disease or laboratory tests
-
require administration of prohibited medications during the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Birmingham | Alabama | United States | 35209 |
| 2 | Pfizer Investigational Site | Huntsville | Alabama | United States | 35801 |
| 3 | Pfizer Investigational Site | Gilbert | Arizona | United States | 85234 |
| 4 | Pfizer Investigational Site | Scottsdale | Arizona | United States | 85251 |
| 5 | Pfizer Investigational Site | Upland | California | United States | 91786 |
| 6 | Pfizer Investigational Site | Jacksonville | Florida | United States | 32216 |
| 7 | Pfizer Investigational Site | Dayton | Ohio | United States | 45417 |
| 8 | Pfizer Investigational Site | Mayfield Village | Ohio | United States | 44143 |
| 9 | Pfizer Investigational Site | Greenville | South Carolina | United States | 29601 |
| 10 | Pfizer Investigational Site | Allen | Texas | United States | 75013 |
| 11 | Pfizer Investigational Site | Seoul | Korea, Republic of | 110-744 | |
| 12 | Pfizer Investigational Site | Seoul | Korea, Republic of | 120-752 | |
| 13 | Pfizer Investigational Site | Seoul | Korea, Republic of | 133-792 | |
| 14 | Pfizer Investigational Site | Seoul | Korea, Republic of | 137-701 | |
| 15 | Pfizer Investigational Site | Seoul | Korea, Republic of | 143-729 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01059864
Other Study ID Numbers:
- A3921109
First Posted:
Feb 1, 2010
Last Update Posted:
Dec 13, 2012
Last Verified:
Nov 1, 2012
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | CP-690,550 | CP-690,550 + Atorvastatin | CP-690,550 + Placebo |
|---|---|---|---|
| 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 |
| Period Title: Open-Label Run-In Phase | |||
| STARTED | 0 | 50 | 48 |
| Treated | 0 | 50 | 47 |
| COMPLETED | 0 | 47 | 45 |
| NOT COMPLETED | 0 | 3 | 3 |
Baseline Characteristics
| Arm/Group Title | CP-690,550 |
|---|---|
| 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 Participants | 111 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
52.3
(11.5)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
99
89.2%
|
| Male |
12
10.8%
|
Outcome Measures
| Title | Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12 |
|---|---|
| Description | |
| Time Frame | Baseline (Week 6), Week 12 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 46 | 45 |
| Least Squares Mean (Standard Error) [percent change] |
-35.34
(2.25)
|
5.80
(2.27)
|
| Title | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 |
|---|---|
| Description | |
| Time Frame | Baseline (Week 6), Week 12 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 46 | 45 |
| Least Squares Mean (Standard Error) [milligram per deciliter (mg/dL)] |
-51.49
(2.99)
|
5.30
(3.02)
|
| Title | 12-Hours Fasting Lipid Profile |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 50 | 47 |
| 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)
|
| Title | 12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 50 | 47 |
| 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)
|
| Title | 12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 50 | 47 |
| 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)
|
| Title | 12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 50 | 47 |
| 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)
|
| Title | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 50 | 47 |
| 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)
|
| Title | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 0 | 0 |
| Title | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 0 | 0 |
| Title | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 50 | 46 |
| 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)
|
| Title | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 50 | 47 |
| Week 6 (Baseline) |
76.0
68.5%
|
76.6
NaN
|
| Week 12 |
82.6
74.4%
|
65.2
NaN
|
| Title | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 50 | 47 |
| Week 6 (Baseline) |
48.0
43.2%
|
42.6
NaN
|
| Week 12 |
67.4
60.7%
|
45.7
NaN
|
| Title | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 50 | 47 |
| Week 6 (Baseline) |
20.0
18%
|
19.1
NaN
|
| Week 12 |
34.8
31.4%
|
30.4
NaN
|
| Title | Tender-Joint Count |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 50 | 47 |
| 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)
|
| Title | Swollen-Joint Count |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 50 | 47 |
| 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)
|
| Title | C-Reactive Protein (CRP) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 50 | 47 |
| 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)
|
| Title | Erythrocyte Sedimentation Rate (ESR) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 50 | 47 |
| 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)
|
| Title | Patient Assessment of Arthritis Pain |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 50 | 47 |
| 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)
|
| Title | Physician's Global Assessment (PhysGA) of Arthritis Pain |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 50 | 47 |
| 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)
|
| Title | Patient's Global Assessment (PtGA) of Arthritis Pain |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 50 | 47 |
| 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)
|
| Title | Health Assessment Questionnaire Disability Index (HAQ-DI) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 50 | 47 |
| 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)
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| 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 | |||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| CP-690,550 | CP-690,550 + Atorvastatin | CP-690,550 + Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/111 (1.8%) | 0/50 (0%) | 1/47 (2.1%) | |||
| Infections and infestations | ||||||
| Pneumonia bacterial | 1/111 (0.9%) | 0/50 (0%) | 0/47 (0%) | |||
| Pneumonia | 0/111 (0%) | 0/50 (0%) | 1/47 (2.1%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthritis | 1/111 (0.9%) | 0/50 (0%) | 0/47 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| CP-690,550 | CP-690,550 + Atorvastatin | CP-690,550 + Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/111 (13.5%) | 21/50 (42%) | 19/47 (40.4%) | |||
| Blood and lymphatic system disorders | ||||||
| Thrombocytopenia | 0/111 (0%) | 0/50 (0%) | 1/47 (2.1%) | |||
| Ear and labyrinth disorders | ||||||
| Otorrhoea | 0/111 (0%) | 0/50 (0%) | 1/47 (2.1%) | |||
| Eye disorders | ||||||
| Cataract | 0/111 (0%) | 1/50 (2%) | 0/47 (0%) | |||
| Ocular vascular disorder | 0/111 (0%) | 0/50 (0%) | 1/47 (2.1%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal distension | 0/111 (0%) | 0/50 (0%) | 1/47 (2.1%) | |||
| Abdominal pain upper | 0/111 (0%) | 1/50 (2%) | 1/47 (2.1%) | |||
| Dental caries | 0/111 (0%) | 1/50 (2%) | 0/47 (0%) | |||
| Diarrhoea | 3/111 (2.7%) | 1/50 (2%) | 0/47 (0%) | |||
| Dyspepsia | 0/111 (0%) | 2/50 (4%) | 1/47 (2.1%) | |||
| Gastrooesophageal reflux disease | 0/111 (0%) | 0/50 (0%) | 1/47 (2.1%) | |||
| Nausea | 4/111 (3.6%) | 1/50 (2%) | 0/47 (0%) | |||
| General disorders | ||||||
| Chest pain | 0/111 (0%) | 1/50 (2%) | 0/47 (0%) | |||
| Oedema peripheral | 0/111 (0%) | 2/50 (4%) | 2/47 (4.3%) | |||
| Pain | 0/111 (0%) | 1/50 (2%) | 0/47 (0%) | |||
| Infections and infestations | ||||||
| Bronchitis | 0/111 (0%) | 1/50 (2%) | 0/47 (0%) | |||
| Gastroenteritis | 0/111 (0%) | 1/50 (2%) | 0/47 (0%) | |||
| Herpes zoster | 5/111 (4.5%) | 0/50 (0%) | 1/47 (2.1%) | |||
| Nasopharyngitis | 0/111 (0%) | 1/50 (2%) | 2/47 (4.3%) | |||
| Onychomycosis | 0/111 (0%) | 0/50 (0%) | 1/47 (2.1%) | |||
| Sinusitis | 0/111 (0%) | 0/50 (0%) | 1/47 (2.1%) | |||
| Tinea cruris | 0/111 (0%) | 0/50 (0%) | 1/47 (2.1%) | |||
| Tinea pedis | 0/111 (0%) | 0/50 (0%) | 1/47 (2.1%) | |||
| Upper respiratory tract infection | 0/111 (0%) | 2/50 (4%) | 2/47 (4.3%) | |||
| Injury, poisoning and procedural complications | ||||||
| Contusion | 0/111 (0%) | 1/50 (2%) | 0/47 (0%) | |||
| Joint sprain | 0/111 (0%) | 0/50 (0%) | 1/47 (2.1%) | |||
| Investigations | ||||||
| Blood cholesterol increased | 0/111 (0%) | 0/50 (0%) | 2/47 (4.3%) | |||
| Blood creatine phosphokinase increased | 0/111 (0%) | 1/50 (2%) | 0/47 (0%) | |||
| Blood potassium decreased | 0/111 (0%) | 1/50 (2%) | 0/47 (0%) | |||
| Blood triglycerides increased | 0/111 (0%) | 1/50 (2%) | 0/47 (0%) | |||
| Electrocardiogram abnormal | 0/111 (0%) | 1/50 (2%) | 0/47 (0%) | |||
| Hepatic enzyme increased | 0/111 (0%) | 1/50 (2%) | 1/47 (2.1%) | |||
| Weight increased | 0/111 (0%) | 1/50 (2%) | 0/47 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Hypercholesterolaemia | 0/111 (0%) | 0/50 (0%) | 1/47 (2.1%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Muscle spasms | 0/111 (0%) | 1/50 (2%) | 1/47 (2.1%) | |||
| Musculoskeletal pain | 0/111 (0%) | 0/50 (0%) | 1/47 (2.1%) | |||
| Myalgia | 0/111 (0%) | 1/50 (2%) | 0/47 (0%) | |||
| Rheumatoid arthritis | 0/111 (0%) | 1/50 (2%) | 1/47 (2.1%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Skin papilloma | 0/111 (0%) | 0/50 (0%) | 1/47 (2.1%) | |||
| Nervous system disorders | ||||||
| Headache | 3/111 (2.7%) | 0/50 (0%) | 1/47 (2.1%) | |||
| Somnolence | 0/111 (0%) | 0/50 (0%) | 1/47 (2.1%) | |||
| Tinel's sign | 0/111 (0%) | 1/50 (2%) | 0/47 (0%) | |||
| Psychiatric disorders | ||||||
| Anxiety | 0/111 (0%) | 0/50 (0%) | 1/47 (2.1%) | |||
| Depression | 0/111 (0%) | 1/50 (2%) | 1/47 (2.1%) | |||
| Renal and urinary disorders | ||||||
| Micturition urgency | 0/111 (0%) | 1/50 (2%) | 0/47 (0%) | |||
| Reproductive system and breast disorders | ||||||
| Metrorrhagia | 0/111 (0%) | 1/50 (2%) | 0/47 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 0/111 (0%) | 1/50 (2%) | 0/47 (0%) | |||
| Emphysema | 0/111 (0%) | 0/50 (0%) | 1/47 (2.1%) | |||
| Oropharyngeal pain | 0/111 (0%) | 2/50 (4%) | 0/47 (0%) | |||
| Sinus congestion | 0/111 (0%) | 1/50 (2%) | 0/47 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Rash | 0/111 (0%) | 1/50 (2%) | 1/47 (2.1%) | |||
| Rash papular | 0/111 (0%) | 0/50 (0%) | 1/47 (2.1%) | |||
| Surgical and medical procedures | ||||||
| Sinus operation | 0/111 (0%) | 0/50 (0%) | 1/47 (2.1%) | |||
| Vascular disorders | ||||||
| Hypertension | 0/111 (0%) | 1/50 (2%) | 0/47 (0%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01059864
Other Study ID Numbers:
- A3921109
First Posted:
Feb 1, 2010
Last Update Posted:
Dec 13, 2012
Last Verified:
Nov 1, 2012