Study Of The Effects Of Atorvastatin On Cholesterol Level... | NCT01059864

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: CP-690,550 Drug: Atorvastatin
Arm 2	Experimental		Drug: CP-690,550 Drug: Atorvastatin Placebo

Name	Type	Description	Arm Group Labels	Other Names
CP-690,550	Drug	12 week open-label CP-690,550 10 mg oral tablets administered twice daily starting at Day 0 through Week 12	Arm 1

Measure	Description	Time Frame
Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12		Baseline (Week 6), Week 12

Measure	Description	Time Frame
Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12		Baseline (Week 6), Week 12
12-Hours Fasting Lipid Profile	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.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Birmingham	Alabama	35209	United States
Pfizer Investigational Site

PubMed Identifier	Type	Citation	Retractions
39192350	Derived	Hetland ML, Strangfeld A, Bonfanti G, Soudis D, Deuring JJ, Edwards RA. Machine learning prediction and explanatory models of serious infections in patients with rheumatoid arthritis treated with tofacitinib. Arthritis Res Ther. 2024 Aug 27;26(1):153. doi: 10.1186/s13075-024-03376-9.
37453736	Derived	Charles-Schoeman C, Hyde C, Guan S, Parikh N, Wang J, Shahbazian A, Stockert L, Andrews J. Relationship Between Paraoxonase-1 Genotype and Activity, and Major Adverse Cardiovascular Events and Malignancies in Patients With Rheumatoid Arthritis Receiving Tofacitinib. J Rheumatol. 2023 Jul 15:jrheum.2023-0112. doi: 10.3899/jrheum.2023-0112. Online ahead of print.

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	CP-690,550	Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.
FG001	CP-690,550 + Atorvastatin	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.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12

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.

Posted

Least Squares Mean

Standard Error

percent change

Baseline (Week 6), Week 12

ID	Title	Description
OG000	CP-690,550 + Atorvastatin	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.
OG001	CP-690,550 + Placebo	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.

Units	Counts
Participants	OG00046 OG00145

Title

Denominators

Categories

Title	Measurements
	OG000-35.34± 2.25 OG0015.80± 2.27

Secondary

Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12

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.

Posted

Least Squares Mean

Standard Error

milligram per deciliter (mg/dL)

Baseline (Week 6), Week 12

ID	Title	Description
OG000	CP-690,550 + Atorvastatin	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.
OG001	CP-690,550 + Placebo	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.

Units	Counts
Participants

Secondary

12-Hours Fasting Lipid Profile

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.

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).

Posted

Mean

Standard Deviation

mg/dL

Day 0, Week 2, 6 (Baseline), 10, 12

ID	Title	Description
OG000	CP-690,550 + Atorvastatin	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.
OG001	CP-690,550 + Placebo	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.

Secondary

12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins

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.

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).

Posted

Mean

Standard Deviation

nanometer (nm)

Day 0, Week 2, 6 (Baseline), 10, 12

ID	Title	Description
OG000	CP-690,550 + Atorvastatin	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.
OG001	CP-690,550 + Placebo	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.

Units	Counts

Secondary

12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles

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).

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).

Posted

Mean

Standard Deviation

nanomoles per liter (nmol/L)

Day 0, Week 2, 6 (Baseline), 10, 12

ID	Title	Description
OG000	CP-690,550 + Atorvastatin	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.
OG001	CP-690,550 + Placebo	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.

Secondary

12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles

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.

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).

Posted

Mean

Standard Deviation

micromole per liter (mcmol/L)

Day 0, Week 2, 6 (Baseline), 10, 12

ID	Title	Description
OG000	CP-690,550 + Atorvastatin	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.
OG001	CP-690,550 + Placebo	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.

Secondary

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])

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.

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).

Posted

Mean

Standard Deviation

units on a scale

Day 0, Week 6 (Baseline), 12

ID	Title	Description
OG000	CP-690,550 + Atorvastatin	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.
OG001	CP-690,550 + Placebo	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.

Secondary

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])

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.

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.

Posted

Day 0, Week 6 (Baseline), 12

ID	Title	Description
OG000	CP-690,550 + Atorvastatin	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.
OG001	CP-690,550 + Placebo	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.

Secondary

Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])

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.

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.

Posted

Day 0, Week 6 (Baseline), 12

ID	Title	Description
OG000	CP-690,550 + Atorvastatin	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.
OG001	CP-690,550 + Placebo	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.

Secondary

Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])

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.

Posted

Mean

Standard Deviation

units on a scale

Day 0, Week 6 (Baseline), 12

ID	Title	Description
OG000	CP-690,550 + Atorvastatin	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.
OG001	CP-690,550 + Placebo	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.

Secondary

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response

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.

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).

Posted

Number

percentage of participants

Week 6 (Baseline), 12

ID	Title	Description
OG000	CP-690,550 + Atorvastatin	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.
OG001	CP-690,550 + Placebo	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.

Secondary

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response

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.

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).

Posted

Number

percentage of participants

Week 6 (Baseline), 12

ID	Title	Description
OG000	CP-690,550 + Atorvastatin	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.
OG001	CP-690,550 + Placebo	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.

Secondary

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response

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.

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).

Posted

Number

percentage of participants

Week 6 (Baseline), 12

ID	Title	Description
OG000	CP-690,550 + Atorvastatin	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.
OG001	CP-690,550 + Placebo	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.

Secondary

Tender-Joint Count

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).

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).

Posted

Mean

Standard Deviation

tender joints

Day 0, Week 6 (Baseline), 12

ID	Title	Description
OG000	CP-690,550 + Atorvastatin	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.
OG001	CP-690,550 + Placebo	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.

Units

Secondary

Swollen-Joint Count

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).

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).

Posted

Mean

Standard Deviation

swollen joints

Day 0, Week 6 (Baseline), Week 12

ID	Title	Description
OG000	CP-690,550 + Atorvastatin	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.
OG001	CP-690,550 + Placebo	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.

Units

Secondary

C-Reactive Protein (CRP)

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).

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).

Posted

Mean

Standard Deviation

mg/L

Day 0, Week 6 (Baseline), 12

ID	Title	Description
OG000	CP-690,550 + Atorvastatin	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.
OG001	CP-690,550 + Placebo	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.

Units	Counts
Participants

Secondary

Erythrocyte Sedimentation Rate (ESR)

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.

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).

Posted

Mean

Standard Deviation

mm/hr

Day 0, Week 6 (Baseline), 12

ID	Title	Description
OG000	CP-690,550 + Atorvastatin	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.
OG001	CP-690,550 + Placebo	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.

Units

Secondary

Patient Assessment of Arthritis Pain

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.

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).

Posted

Mean

Standard Deviation

Day 0, Week 6 (Baseline), 12

ID	Title	Description
OG000	CP-690,550 + Atorvastatin	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.
OG001	CP-690,550 + Placebo	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.

Units

Secondary

Physician's Global Assessment (PhysGA) of Arthritis Pain

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.

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).

Posted

Mean

Standard Deviation

Day 0, Week 6 (Baseline), Week 12

ID	Title	Description
OG000	CP-690,550 + Atorvastatin	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.
OG001	CP-690,550 + Placebo	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.

Secondary

Patient's Global Assessment (PtGA) of Arthritis Pain

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.

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).

Posted

Mean

Standard Deviation

Day 0, Week 6 (Baseline), Week 12

ID	Title	Description
OG000	CP-690,550 + Atorvastatin	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.
OG001	CP-690,550 + Placebo	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.

Units

Secondary

Health Assessment Questionnaire Disability Index (HAQ-DI)

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.

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).

Posted

Mean

Standard Deviation

units on a scale

Day 0, Week 6 (Baseline), 12

ID	Title	Description
OG000	CP-690,550 + Atorvastatin	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.
OG001	CP-690,550 + Placebo	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.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Thrombocytopenia	Blood and lymphatic system disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0010 affected50 at risk EG0021 affected47 at risk
Otorrhoea	Ear and labyrinth disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0010 affected50 at risk EG0021 affected47 at risk
Cataract	Eye disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0020 affected47 at risk
Ocular vascular disorder	Eye disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0010 affected50 at risk EG0021 affected47 at risk
Abdominal distension	Gastrointestinal disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0010 affected50 at risk EG0021 affected47 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0021 affected47 at risk
Dental caries	Gastrointestinal disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0020 affected47 at risk
Diarrhoea	Gastrointestinal disorders	MedDAR v13.1	Non-systematic Assessment	EG0003 affected111 at risk EG0011 affected50 at risk EG0020 affected47 at risk
Dyspepsia	Gastrointestinal disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0012 affected50 at risk EG0021 affected47 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0010 affected50 at risk EG0021 affected47 at risk
Nausea	Gastrointestinal disorders	MedDAR v13.1	Non-systematic Assessment	EG0004 affected111 at risk EG0011 affected50 at risk EG0020 affected47 at risk
Chest pain	General disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0020 affected47 at risk
Oedema peripheral	General disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0012 affected50 at risk EG0022 affected47 at risk
Pain	General disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0020 affected47 at risk
Bronchitis	Infections and infestations	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0020 affected47 at risk
Gastroenteritis	Infections and infestations	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0020 affected47 at risk
Herpes zoster	Infections and infestations	MedDAR v13.1	Non-systematic Assessment	EG0005 affected111 at risk EG0010 affected50 at risk EG0021 affected47 at risk
Nasopharyngitis	Infections and infestations	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0022 affected47 at risk
Onychomycosis	Infections and infestations	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0010 affected50 at risk EG0021 affected47 at risk
Sinusitis	Infections and infestations	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0010 affected50 at risk EG0021 affected47 at risk
Tinea cruris	Infections and infestations	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0010 affected50 at risk EG0021 affected47 at risk
Tinea pedis	Infections and infestations	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0010 affected50 at risk EG0021 affected47 at risk
Upper respiratory tract infection	Infections and infestations	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0012 affected50 at risk EG0022 affected47 at risk
Contusion	Injury, poisoning and procedural complications	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0020 affected47 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0010 affected50 at risk EG0021 affected47 at risk
Blood cholesterol increased	Investigations	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0010 affected50 at risk EG0022 affected47 at risk
Blood creatine phosphokinase increased	Investigations	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0020 affected47 at risk
Blood potassium decreased	Investigations	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0020 affected47 at risk
Blood triglycerides increased	Investigations	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0020 affected47 at risk
Electrocardiogram abnormal	Investigations	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0020 affected47 at risk
Hepatic enzyme increased	Investigations	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0021 affected47 at risk
Weight increased	Investigations	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0020 affected47 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0010 affected50 at risk EG0021 affected47 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0021 affected47 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0010 affected50 at risk EG0021 affected47 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0020 affected47 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0021 affected47 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0010 affected50 at risk EG0021 affected47 at risk
Headache	Nervous system disorders	MedDAR v13.1	Non-systematic Assessment	EG0003 affected111 at risk EG0010 affected50 at risk EG0021 affected47 at risk
Somnolence	Nervous system disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0010 affected50 at risk EG0021 affected47 at risk
Tinel's sign	Nervous system disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0020 affected47 at risk
Anxiety	Psychiatric disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0010 affected50 at risk EG0021 affected47 at risk
Depression	Psychiatric disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0021 affected47 at risk
Micturition urgency	Renal and urinary disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0020 affected47 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0020 affected47 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0020 affected47 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0010 affected50 at risk EG0021 affected47 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0012 affected50 at risk EG0020 affected47 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0020 affected47 at risk
Rash	Skin and subcutaneous tissue disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0021 affected47 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0010 affected50 at risk EG0021 affected47 at risk
Sinus operation	Surgical and medical procedures	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0010 affected50 at risk EG0021 affected47 at risk
Hypertension	Vascular disorders	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0011 affected50 at risk EG0020 affected47 at risk

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006538	Heptanoic Acids
D005227	Fatty Acids
D008055	Lipids

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CP-690,550	Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.	2	111	15	111
EG001	CP-690,550 + Atorvastatin	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.	0	50	21	50
EG002	CP-690,550 + Placebo	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.	1	47	19	47

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia bacterial	Infections and infestations	MedDAR v13.1	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected50 at risk EG0020 affected47 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDAR v13.1	Non-systematic Assessment	EG0001 affected111 at risk EG0010 affected50 at risk EG0020 affected47 at risk
Pneumonia	Infections and infestations	MedDAR v13.1	Non-systematic Assessment	EG0000 affected111 at risk EG0010 affected50 at risk EG0021 affected47 at risk