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

Time frame: Baseline (Week 6), Week 12

Population: 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.

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

Population: 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).

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

Population: 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).

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

Population: 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).

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

Population: 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).

Time frame: Baseline (Week 6), Week 12

Population: 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.

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

Population: 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).

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

Population: 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).

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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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).

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

Population: 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).

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

Population: 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).

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

Population: 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).

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

Population: 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).

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

Population: 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).

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

Population: 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).

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

Population: 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).

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

Population: 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).

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

Population: 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).