Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis Glucocorticoids Prednisone
Brief summary
This study will investigate the safety and efficacy of an investigational drug, PF-04171327 on the signs and symptoms of rheumatoid arthritis in patients that require glucocorticoids while on background methotrexate. This study will also look at the response of chemical and biological markers in rheumatoid arthritis patients. Lastly, this study will measure the PK (amount of drug in the blood) of methotrexate while patients may be taking PF-04171327.
Interventions
DRUGPF-04171327 10 mg
PF-04171327 10 mg tablet every day for 14 days
OTHERPrednisone Placebo
Placebo for Prednisone 5 mg tablet every day for 14 days
PF-04171327 25 mg tablet every day for 14 days
DRUGPrednisone 5 mg
Prednisone 5 mg tablet every day for 14 days
OTHERPlacebo for PF-04171327
Placebo for PF-04171327 every day for 14 days
OTHERPlacebo
Placebo tablet every day for 14 days
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥ 18 years of age, diagnosed with rheumatoid arthritis for a minimum duration of 3 months * On stable dose of methotrexate for at least 6 weeks prior to screening * Patient must have minimum disease activity level of ≥ 6 tender/painful joints, ≥ 6 swollen joints and CRP ≥ 0.7 mg/dL * Not currently receiving steroid medication
Exclusion criteria
* Pregnant or nursing women * Patients that have active infections, TB, HIV and/or Hepatitis B or C * Patients that have a history of intolerance or significant adverse effects with the use of glucocorticoids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 14 | Baseline, Day 14 | DAS28-4 (CRP) examines progression or improvement of RA. It was assessed from swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, CRP (normal range of CRP is less than (\<) 10 milligram per liter \[mg/L\], decrease in the level of CRP indicates reduction in inflammation) and participant global assessment (PGA) of disease activity (participant global assessment of diseases condition scores ranging from 0 \[very well condition\] to 100 \[very poor condition\], higher scores indicated greater affectation due to disease activity). Total DAS28-4 (CRP) transformed score range: 0 (least severe) to 10 (most severe), higher scores indicate more severe disease activity. DAS28-4 (CRP) scores: less than equal to (\<=) 3.2 implied low disease activity; greater than (\>) 3.2 to 5.1 implied moderate to high disease activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Swollen Joints Count at Day 7, 14 and 42 | Baseline, Day 7, 14, 42 | Number of swollen joints was determined by examination of 28 joints and identifying if swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. |
| Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42 | Baseline, Day 7, 14, 42 | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is less than (\<) 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Day 7 and 14 | Baseline, Day 7, 14 | HAQ-DI assessed the ability of participants to perform task in 8 domains of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene, and common activities. Each item was scored on a 4-point scale ranging from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do, higher scores indicate more difficulty. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible HAQ-DI score range: 0 (no difficulty) to 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities. |
| Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14 | Baseline, Day 7, 14 | Participant assessment of arthritis pain included assessment of severity of arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). Participants placed a mark on the VAS between 0 mm (no pain) and 100 mm (most severe pain), which corresponded to the magnitude of their pain, higher scores indicate more pain. |
| Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Day 7 and 14 | Baseline, Day 7, 14 | PGA was a questionnaire where participants answered the following question, Considering all the ways your arthritis affects you, how are you feeling today? The participants' response were recorded using a 100 mm visual analog scale placing a mark on the scale, between 0 mm (very well condition) to 100 mm (very poor condition). Higher scores indicate higher degree of arthritis. |
| Change From Baseline in Physician Global Assessment (PhGA) of Arthritis at Day 7 and 14 | Baseline, Day 7, 14 | PhGA included assessment of severity of arthritis pain where physicians were asked to rate the severity of the participant's overall arthritis. The physician's response was recorded using a visual analog scale between 0 mm (very good condition) to 100 mm (very poor condition). Higher scores indicate higher degree of arthritis. |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline, Day 14 (D14) | SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. Score for each of the 8 aspects are scaled from 0 (worst condition) to 100 (best condition), where higher scores indicate better health status. These 8 domains were also reported as two summary scores: physical component scores and mental component scores. Score range for each of the 2 summary scores = 0 (worst condition) to 100 (best condition), where higher scores represent better health status. |
| Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42 | Baseline, Day 7, 14, 42 | DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (normal range of CRP is \<10 mg/L, decrease in the level of CRP indicates reduction in inflammation). Total DAS28-3 (CRP) score range: 0 (least severe) to 9.4 (most severe), higher scores indicate more disease activity. |
| Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 7 | Baseline, Day 7 | DAS28-4 (CRP) examines progression or improvement of RA. It was assessed from SJC and TJC using the 28 joints count, CRP (normal range of CRP is \<10 mg/L, decrease in the level of CRP indicates reduction in inflammation) and PGA of disease activity (participant global assessment of diseases condition scores ranging from 0 \[very well condition\] to 100 \[very poor condition\], higher scores indicated greater affectation due to disease activity). Total DAS28-4 (CRP) transformed score range: 0 (least severe) to 10 (most severe), higher scores indicate more severe disease activity. DAS28-4 (CRP) scores: \<=3.2 implied low disease activity; \>3.2 to 5.1 implied moderate to high disease activity. |
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Day 7 and 14 | Day 7, 14 | ACR20 responder: participants who achieved at =20% improvement in tender and swollen 28-joints count, and \>=20% improvement in at least 3 of the following 5 measures: 1) participant's assessment of arthritis pain (participant's self-assessed severity of arthritis pain, score range from 0\[no pain\] to 100\[most severe pain\], higher scores=more pain), 2) PGA of arthritis (participant's assessed overall arthritis activity, score range from 0\[no arthritis\] to 100\[extreme arthritis\], higher scores=higher degree of arthritis), 3) PhGA of arthritis (physician rated severity of participants overall arthritis activity, score range from 0\[no arthritis\] to 100\[extreme arthritis\], higher scores=higher degree of arthritis), 4) HAQ-DI (assessment of functional disability, score range from 0\[no difficulty\] to 3\[extreme difficulty\], higher scores=more functional limitation) and 5) CRP (assessment of inflammation, normal range of CRP is \<10 mg/L, decrease in the level of CRP=reduction in inflammation). |
| Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 7 and 14 | Day 7, 14 | ACR50 responder: participants who achieved at =50% improvement in tender and swollen 28-joints count, and \>=50% improvement in at least 3 of the following 5 measures: 1) participant's assessment of arthritis pain (participant's self-assessed severity of arthritis pain, score range from 0\[no pain\] to 100\[most severe pain\], higher scores=more pain), 2) PGA of arthritis (participant's assessed overall arthritis activity, score range from 0\[no arthritis\] to 100\[extreme arthritis\], higher scores=higher degree of arthritis), 3) PhGA of arthritis (physician rated severity of participants overall arthritis activity, score range from 0\[no arthritis\] to 100\[extreme arthritis\], higher scores=higher degree of arthritis), 4) HAQ-DI (assessment of functional disability, score range from 0\[no difficulty\] to 3\[extreme difficulty\], higher scores=more functional limitation) and 5) CRP (assessment of inflammation, normal range of CRP is \<10 mg/L, decrease in the level of CRP=reduction in inflammation). |
| Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Day 7 and 14 | Day 7, 14 | ACR70 responder: participants who achieved at =70% improvement in tender and swollen 28-joints count, and \>=70% improvement in at least 3 of the following 5 measures: 1) participant's assessment of arthritis pain (participant's self-assessed severity of arthritis pain, score range from 0\[no pain\] to 100\[most severe pain\], higher scores=more pain), 2) PGA of arthritis (participant's assessed overall arthritis activity, score range from 0\[no arthritis\] to 100\[extreme arthritis\], higher scores=higher degree of arthritis), 3) PhGA of arthritis (physician rated severity of participants overall arthritis activity, score range from 0\[no arthritis\] to 100\[extreme arthritis\], higher scores=higher degree of arthritis), 4) HAQ-DI (assessment of functional disability, score range from 0\[no difficulty\] to 3\[extreme difficulty\], higher scores=more functional limitation) and 5) CRP (assessment of inflammation, normal range of CRP is \<10 mg/L, decrease in the level of CRP=reduction in inflammation). |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Day 45 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 31 days after last dose (Day 45) that were absent before treatment or that worsened relative to pretreatment state. |
| Change From Baseline in Tender Joints Count at Day 7, 14, 42 | Baseline, Day 7, 14, 42 | Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. |
| Change From Baseline in Body Weight at Day 7 and 14 | Baseline, Day 7, 14 | — |
| Number of Participants With Clinically Significant Vital Signs Abnormalities | Baseline up to Day 45 | Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, heart rate and body temperature. Vital sign measurements were performed with the participant in the seated position. Clinical significance vital sign abnormality was determined by investigator. |
| Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14 | — |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Baseline up to Day 45 | Clinically significant ECG findings included PR interval \>=300 milliseconds (msec) or \>=25% increase from baseline (if baseline PR interval \>200 msec) or \>=50% increase (if baseline PR interval less than or equal to \[\<=\] 200 msec); QRS interval \>=200 msec or \>=25% increase from baseline (if baseline PR interval \>100 msec) or \>=50% increase (if baseline PR interval \<= 100 msec); QT interval \>=500 msec, corrected QT interval \>=500 msec. |
| Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14 | 0, 1, 2, 3 and 4 hours post-dose on Day 7, 14 | Plasma concentration of PF-00251802 versus time summary, a metabolite of PF-04171327 was reported in this outcome measure. |
| Ratio of Apparent Oral Clearance on Day 1 to Day 14 of Methotrexate | Pre-dose (0 hour), 1, 2, 3 and 4 hours post-dose | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Methotrexate was used as a background therapy by participants. |
| Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14 | — |
| Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14 | — |
| Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14 | — |
| Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14 | — |
| Change From Baseline in Ratio of Urinary N-terminal Telopeptide of Type 1 Collagen (uNTX-I) Level to Urinary Creatinine (uCr) Level at Day 7 and 14 | Baseline, Day 7 and 14 | Unit of ratio of urinary N-terminal telopeptide of type 1 collagen (uNTX-I) level to urinary creatinine (uCr) level was nanomoles bone collagen equivalents (nmol bce) per millimole creatinine (mmol cr). |
| Change From Baseline in Adiponectin Level at Day 7 and 14 | Baseline, Day 7 and 14 | — |
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities | Baseline up to Day 45 | Criteria for laboratory abnormalities: Hematology (hemoglobin, hematocrit \<0.8\*baseline; platelet count \<75 or \>700\*10\^3 per mm\^3; leucocytes \<2.5 or \>17.5\*10\^3 per mm\^3); chemistry (total bilirubin \>1.5\*upper limit of reference range \[ULN\]; aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase, alkaline phosphatase, \>3.0\*ULN; total protein, albumin \<0.8\*lower limit of reference range \[LLN\] or \>1.2\*ULN; blood urea nitrogen \[BUN\]/urea, creatinine \>1.3\*ULN; glucose \[fasting\] \<0.6\*LLN or \>1.5\*ULN; uric acid \>1.2\*ULN; sodium \<0.95\*LLN or \>1.05\*ULN; potassium, calcium \<0.9\*LLN or \>1.1\*ULN; albumin, total protein \<0.8\*LLN or \>1.2\*ULN; urinalysis (urine white blood cell (WBC) =\>6/ high power field (hpf); urine red blood cell (RBC) =\>6/hpf). Number of participants with clinically significant change from baseline in laboratory abnormalities identified by investigator were reported. |
Countries
Czechia, Hong Kong, Hungary, Russia, Serbia, Singapore, Slovakia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PF-04171327 10 mg + Placebo Participants with rheumatoid arthritis (RA) received single oral dose of PF-04171327 10 milligram (mg) tablet and placebo matched to prednisone 5 mg capsule, once daily from Day 1 to Day 14. Participants were followed up to 31 days after last dose of study medication. | 21 |
| PF-04171327 25 mg + Placebo Participants with RA received single oral dose of PF-04171327 25 mg tablet and placebo matched to prednisone 5 mg capsule, once daily from Day 1 to Day 14. Participants were followed up to 31 days after last dose of study medication. | 22 |
| Prednisone 5 mg + Placebo Participants with RA received single oral dose of prednisone 5 mg capsule and placebo matched to PF-04171327 tablet, once daily from Day 1 to Day 14. Participants were followed up to 31 days after last dose of study medication. | 21 |
| Placebo Participants with RA received single oral dose of placebo, matched to PF-04171327 tablet and prednisone capsule, once daily from Day 1 to Day 14. Participants were followed up to 31 days after last dose of study medication. | 22 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 0 | 2 |
| Overall Study | Did not meet entrance criteria | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | PF-04171327 10 mg + Placebo | PF-04171327 25 mg + Placebo | Prednisone 5 mg + Placebo | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 56.5 years STANDARD_DEVIATION 12.2 | 55.6 years STANDARD_DEVIATION 11.4 | 56.0 years STANDARD_DEVIATION 8.4 | 53.8 years STANDARD_DEVIATION 11.9 | 55.5 years STANDARD_DEVIATION 10.9 |
| Sex: Female, Male Female | 14 Participants | 12 Participants | 15 Participants | 20 Participants | 61 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 6 Participants | 2 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 21 | 3 / 22 | 4 / 21 | 12 / 22 |
| serious Total, serious adverse events | 0 / 21 | 0 / 22 | 0 / 21 | 0 / 22 |
Outcome results
Primary
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 14
DAS28-4 (CRP) examines progression or improvement of RA. It was assessed from swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, CRP (normal range of CRP is less than (\<) 10 milligram per liter \[mg/L\], decrease in the level of CRP indicates reduction in inflammation) and participant global assessment (PGA) of disease activity (participant global assessment of diseases condition scores ranging from 0 \[very well condition\] to 100 \[very poor condition\], higher scores indicated greater affectation due to disease activity). Total DAS28-4 (CRP) transformed score range: 0 (least severe) to 10 (most severe), higher scores indicate more severe disease activity. DAS28-4 (CRP) scores: less than equal to (\<=) 3.2 implied low disease activity; greater than (\>) 3.2 to 5.1 implied moderate to high disease activity.
Time frame: Baseline, Day 14
Population: The full analysis set (FAS) included all randomized participants who received at least 1 dose of the randomized investigational drug. Here, 'n' signifies those participants who were evaluable at specified time points, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 10 mg + Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 14 | Baseline | 6.04 units on a scale | Standard Deviation 0.869 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 14 | Change at Day 14 | -1.79 units on a scale | Standard Deviation 0.916 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 14 | Change at Day 14 | -2.22 units on a scale | Standard Deviation 1.307 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 14 | Baseline | 6.14 units on a scale | Standard Deviation 0.755 |
| Prednisone 5 mg + Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 14 | Baseline | 5.92 units on a scale | Standard Deviation 0.658 |
| Prednisone 5 mg + Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 14 | Change at Day 14 | -1.15 units on a scale | Standard Deviation 0.935 |
| Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 14 | Baseline | 6.03 units on a scale | Standard Deviation 0.81 |
| Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 14 | Change at Day 14 | -0.96 units on a scale | Standard Deviation 0.97 |
Comparison: Day 14: Treatment difference and its corresponding 90 percent (%) confidence interval (CI) was based on least squares (LS) mean difference using mixed-model repeated measure (MMRM) where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and compound symmetry (CS) as covariance structure.p-value: 0.014190% CI: [-1.21, -0.24]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90 % CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: <0.000190% CI: [-1.73, -0.79]MMRM
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14
SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. Score for each of the 8 aspects are scaled from 0 (worst condition) to 100 (best condition), where higher scores indicate better health status. These 8 domains were also reported as two summary scores: physical component scores and mental component scores. Score range for each of the 2 summary scores = 0 (worst condition) to 100 (best condition), where higher scores represent better health status.
Time frame: Baseline, Day 14 (D14)
Population: FAS included all randomized participants who received at least 1 dose of the randomized investigational drug. Here, 'n' signifies those participants who were evaluable at specified time points, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 10 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Mental health | 7.00 units on a scale | Standard Deviation 15.072 |
| PF-04171327 10 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Social functioning | 4.25 units on a scale | Standard Deviation 10.988 |
| PF-04171327 10 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Role physical | 4.27 units on a scale | Standard Deviation 12.182 |
| PF-04171327 10 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Mental health | 37.71 units on a scale | Standard Deviation 14.742 |
| PF-04171327 10 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Role emotional | 36.39 units on a scale | Standard Deviation 13.164 |
| PF-04171327 10 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Physical functioning | 29.92 units on a scale | Standard Deviation 9.624 |
| PF-04171327 10 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Role emotional | 5.18 units on a scale | Standard Deviation 15.873 |
| PF-04171327 10 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Physical functioning | 4.52 units on a scale | Standard Deviation 9.142 |
| PF-04171327 10 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Mental component | 41.19 units on a scale | Standard Deviation 14.648 |
| PF-04171327 10 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Bodily pain | 31.41 units on a scale | Standard Deviation 7.473 |
| PF-04171327 10 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Bodily pain | 11.25 units on a scale | Standard Deviation 11.394 |
| PF-04171327 10 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Physical component | 5.74 units on a scale | Standard Deviation 6.611 |
| PF-04171327 10 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: General health | 30.91 units on a scale | Standard Deviation 9.564 |
| PF-04171327 10 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Mental component | 5.91 units on a scale | Standard Deviation 14.065 |
| PF-04171327 10 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: General health | 4.40 units on a scale | Standard Deviation 6.604 |
| PF-04171327 10 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Role physical | 35.72 units on a scale | Standard Deviation 9.452 |
| PF-04171327 10 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Physical component | 30.89 units on a scale | Standard Deviation 7.342 |
| PF-04171327 10 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Vitality | 38.98 units on a scale | Standard Deviation 10.166 |
| PF-04171327 10 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Vitality | 7.88 units on a scale | Standard Deviation 11.603 |
| PF-04171327 10 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Social functioning | 39.50 units on a scale | Standard Deviation 10.384 |
| PF-04171327 25 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Mental health | 4.62 units on a scale | Standard Deviation 9.368 |
| PF-04171327 25 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Social functioning | 39.05 units on a scale | Standard Deviation 12.411 |
| PF-04171327 25 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Mental component | 44.42 units on a scale | Standard Deviation 13.036 |
| PF-04171327 25 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Mental health | 42.40 units on a scale | Standard Deviation 11.681 |
| PF-04171327 25 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Bodily pain | 11.60 units on a scale | Standard Deviation 7.609 |
| PF-04171327 25 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Social functioning | 7.68 units on a scale | Standard Deviation 9.09 |
| PF-04171327 25 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Physical functioning | 30.69 units on a scale | Standard Deviation 8.305 |
| PF-04171327 25 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Mental component | 5.72 units on a scale | Standard Deviation 9.743 |
| PF-04171327 25 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Vitality | 7.70 units on a scale | Standard Deviation 7.183 |
| PF-04171327 25 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Role emotional | 37.95 units on a scale | Standard Deviation 12.978 |
| PF-04171327 25 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: General health | 37.33 units on a scale | Standard Deviation 11.005 |
| PF-04171327 25 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Role emotional | 6.31 units on a scale | Standard Deviation 12.051 |
| PF-04171327 25 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Vitality | 42.43 units on a scale | Standard Deviation 9.891 |
| PF-04171327 25 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Role physical | 7.27 units on a scale | Standard Deviation 9.378 |
| PF-04171327 25 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Physical component | 32.05 units on a scale | Standard Deviation 6.627 |
| PF-04171327 25 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Role physical | 35.69 units on a scale | Standard Deviation 8.68 |
| PF-04171327 25 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: General health | 3.96 units on a scale | Standard Deviation 5.853 |
| PF-04171327 25 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Bodily pain | 32.88 units on a scale | Standard Deviation 6.234 |
| PF-04171327 25 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Physical functioning | 4.58 units on a scale | Standard Deviation 6.66 |
| PF-04171327 25 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Physical component | 7.10 units on a scale | Standard Deviation 4.351 |
| Prednisone 5 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Role emotional | 35.49 units on a scale | Standard Deviation 12.287 |
| Prednisone 5 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Physical functioning | 29.14 units on a scale | Standard Deviation 7.187 |
| Prednisone 5 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Physical functioning | 4.71 units on a scale | Standard Deviation 6.543 |
| Prednisone 5 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Role physical | 33.10 units on a scale | Standard Deviation 7.288 |
| Prednisone 5 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Role physical | 5.01 units on a scale | Standard Deviation 6.789 |
| Prednisone 5 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Bodily pain | 31.35 units on a scale | Standard Deviation 4.159 |
| Prednisone 5 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Bodily pain | 7.73 units on a scale | Standard Deviation 6.435 |
| Prednisone 5 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: General health | 35.36 units on a scale | Standard Deviation 8.423 |
| Prednisone 5 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: General health | 3.31 units on a scale | Standard Deviation 5.652 |
| Prednisone 5 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Vitality | 39.70 units on a scale | Standard Deviation 8.671 |
| Prednisone 5 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Vitality | 4.79 units on a scale | Standard Deviation 7.229 |
| Prednisone 5 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Social functioning | 34.89 units on a scale | Standard Deviation 9.468 |
| Prednisone 5 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Social functioning | 5.65 units on a scale | Standard Deviation 5.647 |
| Prednisone 5 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Role emotional | 2.65 units on a scale | Standard Deviation 12.888 |
| Prednisone 5 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Mental health | 37.97 units on a scale | Standard Deviation 11.807 |
| Prednisone 5 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Mental health | 5.13 units on a scale | Standard Deviation 8.54 |
| Prednisone 5 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Physical component | 30.91 units on a scale | Standard Deviation 5.185 |
| Prednisone 5 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Physical component | 5.49 units on a scale | Standard Deviation 5.219 |
| Prednisone 5 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Mental component | 40.30 units on a scale | Standard Deviation 12.464 |
| Prednisone 5 mg + Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Mental component | 3.78 units on a scale | Standard Deviation 8.358 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Vitality | 4.19 units on a scale | Standard Deviation 10.962 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Vitality | 39.98 units on a scale | Standard Deviation 8.567 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Mental component | 38.55 units on a scale | Standard Deviation 13.064 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Mental health | 2.49 units on a scale | Standard Deviation 11.819 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: General health | 4.09 units on a scale | Standard Deviation 6.74 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: General health | 35.43 units on a scale | Standard Deviation 9.408 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Physical functioning | 0.51 units on a scale | Standard Deviation 10.968 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Physical component | 33.93 units on a scale | Standard Deviation 6.554 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Bodily pain | 4.33 units on a scale | Standard Deviation 11.369 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Bodily pain | 33.43 units on a scale | Standard Deviation 6.851 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Physical functioning | 32.74 units on a scale | Standard Deviation 9.904 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Physical component | 3.73 units on a scale | Standard Deviation 8.594 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Role physical | 5.97 units on a scale | Standard Deviation 10.516 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Role emotional | 35.37 units on a scale | Standard Deviation 14.477 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Role physical | 34.28 units on a scale | Standard Deviation 10.031 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Role emotional | 2.65 units on a scale | Standard Deviation 14.538 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Social functioning | 4.57 units on a scale | Standard Deviation 10.934 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Social functioning | 35.87 units on a scale | Standard Deviation 11.809 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Change at D14: Mental component | 3.24 units on a scale | Standard Deviation 12.812 |
| Placebo | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 | Baseline: Mental health | 36.23 units on a scale | Standard Deviation 12.871 |
Comparison: Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.789990% CI: [-3.89, 5.38]ANCOVA
Comparison: Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using analysis of covariance (ANCOVA) where treatment as fixed effect, baseline as the covariate.p-value: 0.962490% CI: [-4.64, 4.38]ANCOVA
Comparison: Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.949390% CI: [-4.24, 4.58]ANCOVA
Comparison: Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.2190% CI: [-1.1, 8.02]ANCOVA
Comparison: Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.160290% CI: [-0.66, 8.18]ANCOVA
Comparison: Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.189290% CI: [-0.92, 8.1]ANCOVA
Comparison: Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.14990% CI: [-0.56, 8.49]ANCOVA
Comparison: Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.623890% CI: [-5.97, 3.24]ANCOVA
Comparison: Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.493390% CI: [-2.64, 6.35]ANCOVA
Comparison: Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.444590% CI: [-6.67, 2.46]ANCOVA
Comparison: Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.228890% CI: [-1.31, 8.34]ANCOVA
Comparison: Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariatep-value: 0.09890% CI: [0.03, 9.5]ANCOVA
Comparison: Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariatep-value: 0.063790% CI: [0.64, 10.43]ANCOVA
Comparison: Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.01990% CI: [2.07, 11.5]ANCOVA
Comparison: Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.488690% CI: [-2.81, 6.86]ANCOVA
Comparison: General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.995190% CI: [-3.12, 3.14]ANCOVA
Comparison: General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.472190% CI: [-1.71, 4.34]ANCOVA
Comparison: General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.683590% CI: [-3.9, 2.36]ANCOVA
Comparison: General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.770190% CI: [-2.49, 3.56]ANCOVA
Comparison: General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.67190% CI: [-3.83, 2.27]ANCOVA
Comparison: Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.288690% CI: [-1.69, 7.73]ANCOVA
Comparison: Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.13490% CI: [-0.42, 8.86]ANCOVA
Comparison: Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.256390% CI: [-1.48, 7.95]ANCOVA
Comparison: Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.113890% CI: [-0.18, 9.05]ANCOVA
Comparison: Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.938690% CI: [-4.44, 4.87]ANCOVA
Comparison: Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.881490% CI: [-4.09, 4.9]ANCOVA
Comparison: Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.136390% CI: [-0.42, 8.37]ANCOVA
Comparison: Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.786490% CI: [-3.74, 5.2]ANCOVA
Comparison: Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.104890% CI: [-0.06, 8.66]ANCOVA
Comparison: Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.902490% CI: [-4.08, 4.73]ANCOVA
Comparison: Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.495490% CI: [-3.74, 8.98]ANCOVA
Comparison: Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.172990% CI: [-1.08, 11.36]ANCOVA
Comparison: Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.56590% CI: [-4.15, 8.57]ANCOVA
Comparison: Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.208790% CI: [-1.48, 10.94]ANCOVA
Comparison: Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.913990% CI: [-6.69, 5.87]ANCOVA
Comparison: Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.655990% CI: [-4.11, 7.12]ANCOVA
Comparison: Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.730490% CI: [-4.37, 6.67]ANCOVA
Comparison: Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.172990% CI: [-0.98, 10.25]ANCOVA
Comparison: Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.203890% CI: [-1.28, 9.83]ANCOVA
Comparison: Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.350390% CI: [-2.41, 8.67]ANCOVA
Comparison: Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.887590% CI: [-3.06, 3.63]ANCOVA
Comparison: Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.320390% CI: [-1.31, 5.25]ANCOVA
Comparison: Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.523290% CI: [-2.09, 4.72]ANCOVA
Comparison: Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.132490% CI: [-0.28, 6.28]ANCOVA
Comparison: Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.613490% CI: [-2.34, 4.4]ANCOVA
Comparison: Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.505990% CI: [-3.38, 7.91]ANCOVA
Comparison: Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.304290% CI: [-2.1, 8.99]ANCOVA
Comparison: Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.351990% CI: [-2.47, 8.82]ANCOVA
Comparison: Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.196690% CI: [-1.21, 9.92]ANCOVA
Comparison: Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.p-value: 0.78690% CI: [-4.66, 6.48]ANCOVA
Secondary
Change From Baseline in Adiponectin Level at Day 7 and 14
Time frame: Baseline, Day 7 and 14
Population: Analysis set included all randomized participants who received at least 1 dose of the randomized investigational drug. Here, 'n' signifies those participants who were evaluable at specified time points, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 10 mg + Placebo | Change From Baseline in Adiponectin Level at Day 7 and 14 | Baseline | 7251.43 ng/mL | Standard Deviation 3651.564 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Adiponectin Level at Day 7 and 14 | Change at Day 14 | 1023.16 ng/mL | Standard Deviation 2203.248 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Adiponectin Level at Day 7 and 14 | Change at Day 7 | -434.21 ng/mL | Standard Deviation 3895.367 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Adiponectin Level at Day 7 and 14 | Baseline | 8349.09 ng/mL | Standard Deviation 3105.632 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Adiponectin Level at Day 7 and 14 | Change at Day 14 | 2692.86 ng/mL | Standard Deviation 2409.083 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Adiponectin Level at Day 7 and 14 | Change at Day 7 | 1664.76 ng/mL | Standard Deviation 1651.925 |
| Prednisone 5 mg + Placebo | Change From Baseline in Adiponectin Level at Day 7 and 14 | Change at Day 7 | -12.00 ng/mL | Standard Deviation 1274.931 |
| Prednisone 5 mg + Placebo | Change From Baseline in Adiponectin Level at Day 7 and 14 | Baseline | 7732.38 ng/mL | Standard Deviation 3428.231 |
| Prednisone 5 mg + Placebo | Change From Baseline in Adiponectin Level at Day 7 and 14 | Change at Day 14 | 438.50 ng/mL | Standard Deviation 951.189 |
| Placebo | Change From Baseline in Adiponectin Level at Day 7 and 14 | Baseline | 10080.95 ng/mL | Standard Deviation 5136.66 |
| Placebo | Change From Baseline in Adiponectin Level at Day 7 and 14 | Change at Day 14 | 193.16 ng/mL | Standard Deviation 1965.254 |
| Placebo | Change From Baseline in Adiponectin Level at Day 7 and 14 | Change at Day 7 | -430.95 ng/mL | Standard Deviation 3049.383 |
Secondary
Change From Baseline in Body Weight at Day 7 and 14
Time frame: Baseline, Day 7, 14
Population: Safety analysis set included all randomized participants who received at least 1 dose of the randomized investigational drug. Here, 'n' signifies those participants who were evaluable at specified time points, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 10 mg + Placebo | Change From Baseline in Body Weight at Day 7 and 14 | Change at Day 14 | 0.35 kilogram | Standard Deviation 1.064 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Body Weight at Day 7 and 14 | Baseline | 83.7 kilogram | Standard Deviation 17 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Body Weight at Day 7 and 14 | Change at Day 7 | 0.12 kilogram | Standard Deviation 0.733 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Body Weight at Day 7 and 14 | Change at Day 7 | -0.04 kilogram | Standard Deviation 1.256 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Body Weight at Day 7 and 14 | Baseline | 74.1 kilogram | Standard Deviation 16.1 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Body Weight at Day 7 and 14 | Change at Day 14 | 0.20 kilogram | Standard Deviation 1.158 |
| Prednisone 5 mg + Placebo | Change From Baseline in Body Weight at Day 7 and 14 | Change at Day 7 | -0.02 kilogram | Standard Deviation 1.036 |
| Prednisone 5 mg + Placebo | Change From Baseline in Body Weight at Day 7 and 14 | Baseline | 78.4 kilogram | Standard Deviation 15.4 |
| Prednisone 5 mg + Placebo | Change From Baseline in Body Weight at Day 7 and 14 | Change at Day 14 | 0.18 kilogram | Standard Deviation 1.467 |
| Placebo | Change From Baseline in Body Weight at Day 7 and 14 | Baseline | 75.0 kilogram | Standard Deviation 17.2 |
| Placebo | Change From Baseline in Body Weight at Day 7 and 14 | Change at Day 14 | -0.04 kilogram | Standard Deviation 0.903 |
| Placebo | Change From Baseline in Body Weight at Day 7 and 14 | Change at Day 7 | -0.05 kilogram | Standard Deviation 0.858 |
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.540390% CI: [-0.34, 0.75]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.837490% CI: [-0.61, 0.48]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.430590% CI: [-0.28, 0.8]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.973390% CI: [-0.55, 0.53]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.861390% CI: [-0.48, 0.6]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.524590% CI: [-0.35, 0.78]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.891790% CI: [-0.6, 0.51]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.169590% CI: [-0.09, 1.03]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.533990% CI: [-0.34, 0.75]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.45290% CI: [-0.3, 0.8]MMRM
Secondary
Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is less than (\<) 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Baseline, Day 7, 14, 42
Population: FAS included all randomized participants who received at least 1 dose of the randomized investigational drug. Here, 'n' signifies those participants who were evaluable at specified time points, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 10 mg + Placebo | Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42 | Baseline | 20.24 mg/L | Standard Deviation 16.431 |
| PF-04171327 10 mg + Placebo | Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42 | Change at Day 7 | -13.78 mg/L | Standard Deviation 18.208 |
| PF-04171327 10 mg + Placebo | Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42 | Change at Day 14 | -18.13 mg/L | Standard Deviation 17.519 |
| PF-04171327 10 mg + Placebo | Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42 | Change at Day 42 | 3.14 mg/L | Standard Deviation 28.198 |
| PF-04171327 25 mg + Placebo | Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42 | Change at Day 7 | -23.60 mg/L | Standard Deviation 32.808 |
| PF-04171327 25 mg + Placebo | Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42 | Change at Day 14 | -24.12 mg/L | Standard Deviation 33.273 |
| PF-04171327 25 mg + Placebo | Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42 | Change at Day 42 | -13.09 mg/L | Standard Deviation 27.448 |
| PF-04171327 25 mg + Placebo | Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42 | Baseline | 30.15 mg/L | Standard Deviation 35.396 |
| Prednisone 5 mg + Placebo | Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42 | Change at Day 14 | -7.63 mg/L | Standard Deviation 16.876 |
| Prednisone 5 mg + Placebo | Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42 | Change at Day 7 | -4.64 mg/L | Standard Deviation 18.487 |
| Prednisone 5 mg + Placebo | Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42 | Change at Day 42 | -8.02 mg/L | Standard Deviation 13.85 |
| Prednisone 5 mg + Placebo | Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42 | Baseline | 20.02 mg/L | Standard Deviation 14.022 |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42 | Change at Day 42 | -5.11 mg/L | Standard Deviation 23.304 |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42 | Change at Day 7 | 1.31 mg/L | Standard Deviation 16.374 |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42 | Baseline | 16.97 mg/L | Standard Deviation 19.58 |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42 | Change at Day 14 | -1.32 mg/L | Standard Deviation 10.357 |
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.059990% CI: [-15.87, -1.07]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.00390% CI: [-20.61, -5.96]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.005390% CI: [-20.03, -5.22]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.000190% CI: [-24.78, -10.1]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.349290% CI: [-11.46, 3.16]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structurep-value: 0.038990% CI: [-17.38, -1.98]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.014290% CI: [-18.51, -3.68]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.003790% CI: [-21.13, -5.89]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.000990% CI: [-22.27, -7.58]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.393990% CI: [-11.23, 3.57]MMRM
Comparison: Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.012790% CI: [3.95, 19.13]MMRM
Comparison: Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.942590% CI: [-7.09, 7.74]MMRM
Comparison: Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.015590% CI: [3.58, 18.59]MMRM
Comparison: Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.975790% CI: [-7.48, 7.21]MMRM
Comparison: Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.918490% CI: [-7.86, 6.94]MMRM
Secondary
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42
DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (normal range of CRP is \<10 mg/L, decrease in the level of CRP indicates reduction in inflammation). Total DAS28-3 (CRP) score range: 0 (least severe) to 9.4 (most severe), higher scores indicate more disease activity.
Time frame: Baseline, Day 7, 14, 42
Population: FAS included all randomized participants who received at least 1 dose of the randomized investigational drug. Here, 'n' signifies those participants who were evaluable at specified time points, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 10 mg + Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42 | Baseline | 5.80 units on a scale | Standard Deviation 0.731 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42 | Change at Day 7 | -1.07 units on a scale | Standard Deviation 0.8 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42 | Change at Day 42 | -0.81 units on a scale | Standard Deviation 1.007 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42 | Change at Day 14 | -1.57 units on a scale | Standard Deviation 0.749 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42 | Change at Day 7 | -1.51 units on a scale | Standard Deviation 0.845 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42 | Change at Day 42 | -1.26 units on a scale | Standard Deviation 1.199 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42 | Baseline | 5.87 units on a scale | Standard Deviation 0.674 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42 | Change at Day 14 | -2.01 units on a scale | Standard Deviation 1.178 |
| Prednisone 5 mg + Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42 | Change at Day 14 | -0.92 units on a scale | Standard Deviation 0.994 |
| Prednisone 5 mg + Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42 | Baseline | 5.59 units on a scale | Standard Deviation 0.666 |
| Prednisone 5 mg + Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42 | Change at Day 42 | -1.17 units on a scale | Standard Deviation 0.949 |
| Prednisone 5 mg + Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42 | Change at Day 7 | -0.55 units on a scale | Standard Deviation 0.632 |
| Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42 | Change at Day 42 | -1.12 units on a scale | Standard Deviation 1.005 |
| Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42 | Baseline | 5.72 units on a scale | Standard Deviation 0.706 |
| Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42 | Change at Day 7 | -0.50 units on a scale | Standard Deviation 0.609 |
| Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42 | Change at Day 14 | -0.87 units on a scale | Standard Deviation 0.798 |
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.10990% CI: [-0.93, 0.01]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.001490% CI: [-1.38, -0.45]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.050690% CI: [-1.03, -0.09]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.000490% CI: [-1.48, -0.55]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.727290% CI: [-0.56, 0.37]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.060490% CI: [-1.05, -0.07]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.000390% CI: [-1.53, -0.59]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.037790% CI: [-1.09, -0.13]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.000190% CI: [-1.57, -0.65]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.861290% CI: [-0.52, 0.42]MMRM
Comparison: Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.13390% CI: [-0.04, 0.93]MMRM
Comparison: Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.854290% CI: [-0.52, 0.42]MMRM
Comparison: Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.233990% CI: [-0.13, 0.82]MMRM
Comparison: Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.592790% CI: [-0.61, 0.31]MMRM
Comparison: Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.730490% CI: [-0.57, 0.37]MMRM
Secondary
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 7
DAS28-4 (CRP) examines progression or improvement of RA. It was assessed from SJC and TJC using the 28 joints count, CRP (normal range of CRP is \<10 mg/L, decrease in the level of CRP indicates reduction in inflammation) and PGA of disease activity (participant global assessment of diseases condition scores ranging from 0 \[very well condition\] to 100 \[very poor condition\], higher scores indicated greater affectation due to disease activity). Total DAS28-4 (CRP) transformed score range: 0 (least severe) to 10 (most severe), higher scores indicate more severe disease activity. DAS28-4 (CRP) scores: \<=3.2 implied low disease activity; \>3.2 to 5.1 implied moderate to high disease activity.
Time frame: Baseline, Day 7
Population: FAS included all randomized participants who received at least 1 dose of the randomized investigational drug. Here, 'Number of Participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04171327 10 mg + Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 7 | -1.21 units on a scale | Standard Deviation 0.889 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 7 | -1.63 units on a scale | Standard Deviation 1.034 |
| Prednisone 5 mg + Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 7 | -0.67 units on a scale | Standard Deviation 0.639 |
| Placebo | Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 7 | -0.55 units on a scale | Standard Deviation 0.697 |
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.095690% CI: [-0.97, -0.01]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.001690% CI: [-1.4, -0.45]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.025890% CI: [-1.13, -0.17]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.000290% CI: [-1.56, -0.62]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.569290% CI: [-0.63, 0.31]MMRM
Secondary
Change From Baseline in Eosinophil Counts at Day 1, 7 and 14
Time frame: Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14
Population: Analysis set included all randomized participants who received at least 1 dose of the randomized investigational drug. Here, 'n' signifies those participants who were evaluable at specified time points, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 10 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Baseline | 0.19 10^3 cells per microliter | Standard Deviation 0.115 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 14: 1 hour | -0.04 10^3 cells per microliter | Standard Deviation 0.052 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 7: 3 hour | -0.04 10^3 cells per microliter | Standard Deviation 0.063 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 1: 2 hour | -0.01 10^3 cells per microliter | Standard Deviation 0.039 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 7: 4 hour | -0.04 10^3 cells per microliter | Standard Deviation 0.07 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 14: 0 hour | -0.03 10^3 cells per microliter | Standard Deviation 0.048 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 1: 3 hour | -0.01 10^3 cells per microliter | Standard Deviation 0.039 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 1: 1 hour | -0.02 10^3 cells per microliter | Standard Deviation 0.069 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 14: 3 hour | -0.05 10^3 cells per microliter | Standard Deviation 0.063 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 1: 4 hour | -0.01 10^3 cells per microliter | Standard Deviation 0.072 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 7: 0 hour | -0.03 10^3 cells per microliter | Standard Deviation 0.081 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 14: 2 hour | -0.05 10^3 cells per microliter | Standard Deviation 0.063 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 7: 1 hour | -0.02 10^3 cells per microliter | Standard Deviation 0.05 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 14: 4 hour | -0.05 10^3 cells per microliter | Standard Deviation 0.065 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 7: 2 hour | -0.03 10^3 cells per microliter | Standard Deviation 0.059 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 7: 2 hour | -0.07 10^3 cells per microliter | Standard Deviation 0.121 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 14: 1 hour | -0.05 10^3 cells per microliter | Standard Deviation 0.163 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 1: 4 hour | -0.03 10^3 cells per microliter | Standard Deviation 0.079 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 7: 3 hour | -0.08 10^3 cells per microliter | Standard Deviation 0.114 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 1: 1 hour | -0.02 10^3 cells per microliter | Standard Deviation 0.06 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 14: 0 hour | -0.05 10^3 cells per microliter | Standard Deviation 0.167 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 14: 2 hour | -0.07 10^3 cells per microliter | Standard Deviation 0.139 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 7: 4 hour | -0.06 10^3 cells per microliter | Standard Deviation 0.098 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 1: 2 hour | -0.01 10^3 cells per microliter | Standard Deviation 0.042 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 7: 1 hour | -0.03 10^3 cells per microliter | Standard Deviation 0.146 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 14: 4 hour | -0.07 10^3 cells per microliter | Standard Deviation 0.157 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 14: 3 hour | -0.07 10^3 cells per microliter | Standard Deviation 0.139 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 7: 0 hour | -0.04 10^3 cells per microliter | Standard Deviation 0.101 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 1: 3 hour | -0.01 10^3 cells per microliter | Standard Deviation 0.06 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Baseline | 0.19 10^3 cells per microliter | Standard Deviation 0.128 |
| Prednisone 5 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 7: 2 hour | -0.04 10^3 cells per microliter | Standard Deviation 0.078 |
| Prednisone 5 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Baseline | 0.20 10^3 cells per microliter | Standard Deviation 0.094 |
| Prednisone 5 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 1: 1 hour | -0.02 10^3 cells per microliter | Standard Deviation 0.034 |
| Prednisone 5 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 1: 2 hour | -0.03 10^3 cells per microliter | Standard Deviation 0.038 |
| Prednisone 5 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 1: 3 hour | -0.03 10^3 cells per microliter | Standard Deviation 0.039 |
| Prednisone 5 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 1: 4 hour | -0.04 10^3 cells per microliter | Standard Deviation 0.043 |
| Prednisone 5 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 7: 0 hour | -0.02 10^3 cells per microliter | Standard Deviation 0.055 |
| Prednisone 5 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 7: 1 hour | -0.02 10^3 cells per microliter | Standard Deviation 0.056 |
| Prednisone 5 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 7: 3 hour | -0.07 10^3 cells per microliter | Standard Deviation 0.087 |
| Prednisone 5 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 7: 4 hour | -0.09 10^3 cells per microliter | Standard Deviation 0.091 |
| Prednisone 5 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 14: 0 hour | -0.02 10^3 cells per microliter | Standard Deviation 0.073 |
| Prednisone 5 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 14: 1 hour | -0.03 10^3 cells per microliter | Standard Deviation 0.076 |
| Prednisone 5 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 14: 2 hour | -0.05 10^3 cells per microliter | Standard Deviation 0.074 |
| Prednisone 5 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 14: 3 hour | -0.09 10^3 cells per microliter | Standard Deviation 0.091 |
| Prednisone 5 mg + Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 14: 4 hour | -0.11 10^3 cells per microliter | Standard Deviation 0.096 |
| Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 7: 1 hour | -0.01 10^3 cells per microliter | Standard Deviation 0.081 |
| Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 1: 1 hour | -0.00 10^3 cells per microliter | Standard Deviation 0.05 |
| Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 14: 1 hour | -0.01 10^3 cells per microliter | Standard Deviation 0.079 |
| Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 7: 0 hour | 0.00 10^3 cells per microliter | Standard Deviation 0.072 |
| Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 1: 4 hour | -0.01 10^3 cells per microliter | Standard Deviation 0.048 |
| Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Baseline | 0.15 10^3 cells per microliter | Standard Deviation 0.077 |
| Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 14: 2 hour | 0.01 10^3 cells per microliter | Standard Deviation 0.092 |
| Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 1: 3 hour | -0.00 10^3 cells per microliter | Standard Deviation 0.057 |
| Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 1: 2 hour | -0.00 10^3 cells per microliter | Standard Deviation 0.057 |
| Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 14: 4 hour | -0.01 10^3 cells per microliter | Standard Deviation 0.076 |
| Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 7: 4 hour | 0.00 10^3 cells per microliter | Standard Deviation 0.08 |
| Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 7: 3 hour | 0.00 10^3 cells per microliter | Standard Deviation 0.085 |
| Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 14: 3 hour | 0.01 10^3 cells per microliter | Standard Deviation 0.098 |
| Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 14: 0 hour | 0.01 10^3 cells per microliter | Standard Deviation 0.085 |
| Placebo | Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 | Change at Day 7: 2 hour | 0.01 10^3 cells per microliter | Standard Deviation 0.077 |
Secondary
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Day 7 and 14
HAQ-DI assessed the ability of participants to perform task in 8 domains of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene, and common activities. Each item was scored on a 4-point scale ranging from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do, higher scores indicate more difficulty. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible HAQ-DI score range: 0 (no difficulty) to 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.
Time frame: Baseline, Day 7, 14
Population: FAS included all randomized participants who received at least 1 dose of the randomized investigational drug. Here, 'n' signifies those participants who were evaluable at specified time points, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 10 mg + Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Day 7 and 14 | Baseline | 1.76 units on a scale | Standard Deviation 0.831 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Day 7 and 14 | Change at Day 14 | -0.58 units on a scale | Standard Deviation 1.017 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Day 7 and 14 | Change at Day 7 | -0.24 units on a scale | Standard Deviation 0.7 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Day 7 and 14 | Baseline | 1.41 units on a scale | Standard Deviation 0.796 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Day 7 and 14 | Change at Day 14 | -0.43 units on a scale | Standard Deviation 0.87 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Day 7 and 14 | Change at Day 7 | -0.24 units on a scale | Standard Deviation 0.7 |
| Prednisone 5 mg + Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Day 7 and 14 | Change at Day 7 | -0.24 units on a scale | Standard Deviation 0.436 |
| Prednisone 5 mg + Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Day 7 and 14 | Baseline | 1.62 units on a scale | Standard Deviation 0.498 |
| Prednisone 5 mg + Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Day 7 and 14 | Change at Day 14 | -0.25 units on a scale | Standard Deviation 0.55 |
| Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Day 7 and 14 | Baseline | 1.73 units on a scale | Standard Deviation 0.935 |
| Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Day 7 and 14 | Change at Day 14 | -0.24 units on a scale | Standard Deviation 0.768 |
| Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Day 7 and 14 | Change at Day 7 | -0.10 units on a scale | Standard Deviation 0.539 |
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.240390% CI: [-0.38, 0.06]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.02790% CI: [-0.52, -0.08]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.313990% CI: [-0.36, 0.09]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.041590% CI: [-0.5, -0.05]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.858590% CI: [-0.2, 0.25]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.728490% CI: [-0.28, 0.18]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.017190% CI: [-0.55, -0.1]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.227790% CI: [-0.39, 0.06]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.001390% CI: [-0.67, -0.22]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.390890% CI: [-0.34, 0.11]MMRM
Secondary
Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14
Time frame: Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14
Population: Analysis set included all randomized participants who received at least 1 dose of the randomized investigational drug. Here, 'n' signifies those participants who were evaluable at specified time points, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 10 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Baseline | 1.85 10^3 cells per microliter | Standard Deviation 0.51 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 14: 1 hour | 0.81 10^3 cells per microliter | Standard Deviation 0.425 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 7: 3 hour | 0.77 10^3 cells per microliter | Standard Deviation 0.465 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 1: 2 hour | 0.28 10^3 cells per microliter | Standard Deviation 0.315 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 7: 4 hour | 0.72 10^3 cells per microliter | Standard Deviation 0.47 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 14: 0 hour | 0.89 10^3 cells per microliter | Standard Deviation 0.308 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 1: 3 hour | 0.21 10^3 cells per microliter | Standard Deviation 0.322 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 1: 1 hour | -0.01 10^3 cells per microliter | Standard Deviation 0.2 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 14: 3 hour | 0.81 10^3 cells per microliter | Standard Deviation 0.494 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 1: 4 hour | 0.28 10^3 cells per microliter | Standard Deviation 0.408 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 7: 0 hour | 0.79 10^3 cells per microliter | Standard Deviation 0.384 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 14: 2 hour | 0.74 10^3 cells per microliter | Standard Deviation 0.34 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 7: 1 hour | 0.64 10^3 cells per microliter | Standard Deviation 0.477 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 14: 4 hour | 0.77 10^3 cells per microliter | Standard Deviation 0.428 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 7: 2 hour | 0.76 10^3 cells per microliter | Standard Deviation 0.416 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 7: 2 hour | 0.76 10^3 cells per microliter | Standard Deviation 0.463 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 14: 1 hour | 0.66 10^3 cells per microliter | Standard Deviation 0.589 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 1: 4 hour | 0.05 10^3 cells per microliter | Standard Deviation 0.428 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 7: 3 hour | 0.85 10^3 cells per microliter | Standard Deviation 0.563 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 1: 1 hour | 0.02 10^3 cells per microliter | Standard Deviation 0.304 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 14: 0 hour | 0.82 10^3 cells per microliter | Standard Deviation 0.638 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 14: 2 hour | 0.62 10^3 cells per microliter | Standard Deviation 0.68 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 7: 4 hour | 0.69 10^3 cells per microliter | Standard Deviation 0.478 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 1: 2 hour | 0.05 10^3 cells per microliter | Standard Deviation 0.32 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 7: 1 hour | 0.62 10^3 cells per microliter | Standard Deviation 0.438 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 14: 4 hour | 0.57 10^3 cells per microliter | Standard Deviation 0.445 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 14: 3 hour | 0.75 10^3 cells per microliter | Standard Deviation 0.634 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 7: 0 hour | 0.83 10^3 cells per microliter | Standard Deviation 0.342 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 1: 3 hour | 0.07 10^3 cells per microliter | Standard Deviation 0.328 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Baseline | 1.80 10^3 cells per microliter | Standard Deviation 0.856 |
| Prednisone 5 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 7: 2 hour | -0.03 10^3 cells per microliter | Standard Deviation 0.505 |
| Prednisone 5 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Baseline | 1.68 10^3 cells per microliter | Standard Deviation 0.56 |
| Prednisone 5 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 1: 1 hour | 0.13 10^3 cells per microliter | Standard Deviation 0.344 |
| Prednisone 5 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 1: 2 hour | 0.09 10^3 cells per microliter | Standard Deviation 0.326 |
| Prednisone 5 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 1: 3 hour | 0.10 10^3 cells per microliter | Standard Deviation 0.297 |
| Prednisone 5 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 1: 4 hour | 0.07 10^3 cells per microliter | Standard Deviation 0.244 |
| Prednisone 5 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 7: 0 hour | 0.26 10^3 cells per microliter | Standard Deviation 0.441 |
| Prednisone 5 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 7: 1 hour | 0.13 10^3 cells per microliter | Standard Deviation 0.589 |
| Prednisone 5 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 7: 3 hour | -0.25 10^3 cells per microliter | Standard Deviation 0.539 |
| Prednisone 5 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 7: 4 hour | -0.23 10^3 cells per microliter | Standard Deviation 0.431 |
| Prednisone 5 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 14: 0 hour | 0.29 10^3 cells per microliter | Standard Deviation 0.492 |
| Prednisone 5 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 14: 1 hour | 0.22 10^3 cells per microliter | Standard Deviation 0.421 |
| Prednisone 5 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 14: 2 hour | -0.03 10^3 cells per microliter | Standard Deviation 0.467 |
| Prednisone 5 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 14: 3 hour | -0.35 10^3 cells per microliter | Standard Deviation 0.397 |
| Prednisone 5 mg + Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 14: 4 hour | -0.45 10^3 cells per microliter | Standard Deviation 0.396 |
| Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 7: 1 hour | -0.03 10^3 cells per microliter | Standard Deviation 0.275 |
| Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 1: 1 hour | 0.04 10^3 cells per microliter | Standard Deviation 0.218 |
| Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 14: 1 hour | -0.03 10^3 cells per microliter | Standard Deviation 0.294 |
| Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 7: 0 hour | 0.05 10^3 cells per microliter | Standard Deviation 0.27 |
| Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 1: 4 hour | 0.03 10^3 cells per microliter | Standard Deviation 0.45 |
| Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Baseline | 1.79 10^3 cells per microliter | Standard Deviation 0.648 |
| Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 14: 2 hour | 0.04 10^3 cells per microliter | Standard Deviation 0.441 |
| Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 1: 3 hour | 0.04 10^3 cells per microliter | Standard Deviation 0.455 |
| Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 1: 2 hour | 0.09 10^3 cells per microliter | Standard Deviation 0.231 |
| Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 14: 4 hour | 0.08 10^3 cells per microliter | Standard Deviation 0.268 |
| Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 7: 4 hour | 0.19 10^3 cells per microliter | Standard Deviation 0.402 |
| Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 7: 3 hour | 0.15 10^3 cells per microliter | Standard Deviation 0.345 |
| Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 14: 3 hour | 0.20 10^3 cells per microliter | Standard Deviation 0.238 |
| Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 14: 0 hour | -0.07 10^3 cells per microliter | Standard Deviation 0.322 |
| Placebo | Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 | Change at Day 7: 2 hour | 0.10 10^3 cells per microliter | Standard Deviation 0.287 |
Secondary
Change From Baseline in Neutrophil Counts at Day 1, 7 and 14
Time frame: Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14
Population: Analysis set included all randomized participants who received at least 1 dose of the randomized investigational drug. Here, 'n' signifies those participants who were evaluable at specified time points, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 10 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Baseline | 5.43 10^3 cells per microliter | Standard Deviation 2.05 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 14: 1 hour | 0.40 10^3 cells per microliter | Standard Deviation 1.114 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 7: 3 hour | 1.19 10^3 cells per microliter | Standard Deviation 1.304 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 1: 2 hour | 0.01 10^3 cells per microliter | Standard Deviation 0.516 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 7: 4 hour | 1.13 10^3 cells per microliter | Standard Deviation 1.32 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 14: 0 hour | 0.32 10^3 cells per microliter | Standard Deviation 0.954 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 1: 3 hour | -0.06 10^3 cells per microliter | Standard Deviation 0.638 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 1: 1 hour | 0.04 10^3 cells per microliter | Standard Deviation 0.799 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 14: 3 hour | 1.10 10^3 cells per microliter | Standard Deviation 1.56 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 1: 4 hour | -0.28 10^3 cells per microliter | Standard Deviation 0.876 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 7: 0 hour | 0.16 10^3 cells per microliter | Standard Deviation 1.036 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 14: 2 hour | 0.56 10^3 cells per microliter | Standard Deviation 1.172 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 7: 1 hour | 0.63 10^3 cells per microliter | Standard Deviation 1.145 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 14: 4 hour | 1.09 10^3 cells per microliter | Standard Deviation 1.559 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 7: 2 hour | 0.79 10^3 cells per microliter | Standard Deviation 1.195 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 7: 2 hour | 0.80 10^3 cells per microliter | Standard Deviation 2.278 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 14: 1 hour | 1.00 10^3 cells per microliter | Standard Deviation 1.827 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 1: 4 hour | 0.34 10^3 cells per microliter | Standard Deviation 1.625 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 7: 3 hour | 1.19 10^3 cells per microliter | Standard Deviation 2.12 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 1: 1 hour | 0.42 10^3 cells per microliter | Standard Deviation 0.581 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 14: 0 hour | 0.77 10^3 cells per microliter | Standard Deviation 1.881 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 14: 2 hour | 1.11 10^3 cells per microliter | Standard Deviation 2.097 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 7: 4 hour | 0.84 10^3 cells per microliter | Standard Deviation 2.159 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 1: 2 hour | 0.12 10^3 cells per microliter | Standard Deviation 0.621 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 7: 1 hour | 0.21 10^3 cells per microliter | Standard Deviation 1.947 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 14: 4 hour | 1.39 10^3 cells per microliter | Standard Deviation 2.203 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 14: 3 hour | 1.57 10^3 cells per microliter | Standard Deviation 2.076 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 7: 0 hour | 0.06 10^3 cells per microliter | Standard Deviation 1.993 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 1: 3 hour | 0.49 10^3 cells per microliter | Standard Deviation 1.247 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Baseline | 5.53 10^3 cells per microliter | Standard Deviation 3.091 |
| Prednisone 5 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 7: 2 hour | 1.66 10^3 cells per microliter | Standard Deviation 1.764 |
| Prednisone 5 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Baseline | 5.90 10^3 cells per microliter | Standard Deviation 2.127 |
| Prednisone 5 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 1: 1 hour | 0.45 10^3 cells per microliter | Standard Deviation 0.853 |
| Prednisone 5 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 1: 2 hour | 0.38 10^3 cells per microliter | Standard Deviation 1.109 |
| Prednisone 5 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 1: 3 hour | 0.22 10^3 cells per microliter | Standard Deviation 0.999 |
| Prednisone 5 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 1: 4 hour | -0.03 10^3 cells per microliter | Standard Deviation 0.984 |
| Prednisone 5 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 7: 0 hour | 0.22 10^3 cells per microliter | Standard Deviation 1.401 |
| Prednisone 5 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 7: 1 hour | 0.64 10^3 cells per microliter | Standard Deviation 1.776 |
| Prednisone 5 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 7: 3 hour | 2.14 10^3 cells per microliter | Standard Deviation 1.828 |
| Prednisone 5 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 7: 4 hour | 2.01 10^3 cells per microliter | Standard Deviation 1.788 |
| Prednisone 5 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 14: 0 hour | -0.79 10^3 cells per microliter | Standard Deviation 1.291 |
| Prednisone 5 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 14: 1 hour | -0.09 10^3 cells per microliter | Standard Deviation 1.566 |
| Prednisone 5 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 14: 2 hour | 0.74 10^3 cells per microliter | Standard Deviation 1.866 |
| Prednisone 5 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 14: 3 hour | 1.14 10^3 cells per microliter | Standard Deviation 1.788 |
| Prednisone 5 mg + Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 14: 4 hour | 1.07 10^3 cells per microliter | Standard Deviation 1.595 |
| Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 7: 1 hour | 0.07 10^3 cells per microliter | Standard Deviation 1.202 |
| Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 1: 1 hour | 0.09 10^3 cells per microliter | Standard Deviation 0.534 |
| Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 14: 1 hour | -0.16 10^3 cells per microliter | Standard Deviation 0.731 |
| Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 7: 0 hour | -0.21 10^3 cells per microliter | Standard Deviation 1.217 |
| Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 1: 4 hour | -0.25 10^3 cells per microliter | Standard Deviation 0.831 |
| Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Baseline | 5.03 10^3 cells per microliter | Standard Deviation 2.029 |
| Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 14: 2 hour | -0.35 10^3 cells per microliter | Standard Deviation 0.901 |
| Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 1: 3 hour | -0.05 10^3 cells per microliter | Standard Deviation 0.812 |
| Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 1: 2 hour | -0.07 10^3 cells per microliter | Standard Deviation 0.674 |
| Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 14: 4 hour | -0.65 10^3 cells per microliter | Standard Deviation 1.347 |
| Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 7: 4 hour | -0.47 10^3 cells per microliter | Standard Deviation 1.352 |
| Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 7: 3 hour | -0.13 10^3 cells per microliter | Standard Deviation 1.252 |
| Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 14: 3 hour | -0.41 10^3 cells per microliter | Standard Deviation 1.19 |
| Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 14: 0 hour | -0.11 10^3 cells per microliter | Standard Deviation 1.116 |
| Placebo | Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 | Change at Day 7: 2 hour | -0.06 10^3 cells per microliter | Standard Deviation 1.292 |
Secondary
Change From Baseline in Osteocalcin Level at Day 1, 7 and 14
Time frame: Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14
Population: Analysis set included all randomized participants who received at least 1 dose of the randomized investigational drug. Here, 'n' signifies those participants who were evaluable at specified time points, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 10 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Baseline | 21.76 ng/mL | Standard Deviation 13.031 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 14: 1 hour | -6.28 ng/mL | Standard Deviation 6.197 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 7: 3 hour | -5.77 ng/mL | Standard Deviation 7.349 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 1: 2 hour | -2.22 ng/mL | Standard Deviation 2.344 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 7: 4 hour | -5.78 ng/mL | Standard Deviation 6.145 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 14: 0 hour | -6.01 ng/mL | Standard Deviation 6.184 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 1: 3 hour | -2.67 ng/mL | Standard Deviation 3.063 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 1: 1 hour | -1.78 ng/mL | Standard Deviation 2.012 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 14: 3 hour | -6.42 ng/mL | Standard Deviation 6.142 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 1: 4 hour | -3.15 ng/mL | Standard Deviation 2.964 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 7: 0 hour | -5.26 ng/mL | Standard Deviation 5.312 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 14: 2 hour | -5.80 ng/mL | Standard Deviation 5.833 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 7: 1 hour | -5.88 ng/mL | Standard Deviation 4.719 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 14: 4 hour | -7.45 ng/mL | Standard Deviation 7.144 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 7: 2 hour | -5.71 ng/mL | Standard Deviation 4.842 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 7: 2 hour | -4.22 ng/mL | Standard Deviation 4.765 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 14: 1 hour | -4.90 ng/mL | Standard Deviation 5.666 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 1: 4 hour | -1.77 ng/mL | Standard Deviation 1.849 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 7: 3 hour | -3.68 ng/mL | Standard Deviation 5.324 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 1: 1 hour | -1.45 ng/mL | Standard Deviation 3.164 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 14: 0 hour | -4.56 ng/mL | Standard Deviation 6.155 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 14: 2 hour | -5.11 ng/mL | Standard Deviation 6.341 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 7: 4 hour | -3.87 ng/mL | Standard Deviation 5.488 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 1: 2 hour | -2.07 ng/mL | Standard Deviation 3.11 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 7: 1 hour | -4.42 ng/mL | Standard Deviation 7.438 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 14: 4 hour | -5.40 ng/mL | Standard Deviation 6.536 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 14: 3 hour | -5.74 ng/mL | Standard Deviation 6.195 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 7: 0 hour | -3.82 ng/mL | Standard Deviation 5.308 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 1: 3 hour | -1.07 ng/mL | Standard Deviation 2.003 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Baseline | 17.52 ng/mL | Standard Deviation 9.803 |
| Prednisone 5 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 7: 2 hour | -2.74 ng/mL | Standard Deviation 5.384 |
| Prednisone 5 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Baseline | 29.36 ng/mL | Standard Deviation 46.812 |
| Prednisone 5 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 1: 1 hour | -1.94 ng/mL | Standard Deviation 2.897 |
| Prednisone 5 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 1: 2 hour | -1.19 ng/mL | Standard Deviation 4.445 |
| Prednisone 5 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 1: 3 hour | -1.35 ng/mL | Standard Deviation 3.355 |
| Prednisone 5 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 1: 4 hour | -3.10 ng/mL | Standard Deviation 5.281 |
| Prednisone 5 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 7: 0 hour | -3.08 ng/mL | Standard Deviation 3.995 |
| Prednisone 5 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 7: 1 hour | -0.66 ng/mL | Standard Deviation 6.633 |
| Prednisone 5 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 7: 3 hour | -2.83 ng/mL | Standard Deviation 5.194 |
| Prednisone 5 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 7: 4 hour | -2.48 ng/mL | Standard Deviation 6.523 |
| Prednisone 5 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 14: 0 hour | -3.04 ng/mL | Standard Deviation 6.087 |
| Prednisone 5 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 14: 1 hour | -2.66 ng/mL | Standard Deviation 5.289 |
| Prednisone 5 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 14: 2 hour | -4.21 ng/mL | Standard Deviation 5.936 |
| Prednisone 5 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 14: 3 hour | -5.88 ng/mL | Standard Deviation 10.958 |
| Prednisone 5 mg + Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 14: 4 hour | -4.19 ng/mL | Standard Deviation 4.398 |
| Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 7: 1 hour | -0.37 ng/mL | Standard Deviation 2.976 |
| Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 1: 1 hour | -0.50 ng/mL | Standard Deviation 6.877 |
| Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 14: 1 hour | -0.25 ng/mL | Standard Deviation 2.588 |
| Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 7: 0 hour | 0.69 ng/mL | Standard Deviation 3.024 |
| Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 1: 4 hour | -0.93 ng/mL | Standard Deviation 3.006 |
| Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Baseline | 15.29 ng/mL | Standard Deviation 7.156 |
| Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 14: 2 hour | -0.35 ng/mL | Standard Deviation 3.507 |
| Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 1: 3 hour | -1.30 ng/mL | Standard Deviation 4.15 |
| Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 1: 2 hour | -0.73 ng/mL | Standard Deviation 3.662 |
| Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 14: 4 hour | -0.41 ng/mL | Standard Deviation 4.828 |
| Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 7: 4 hour | -1.05 ng/mL | Standard Deviation 4.206 |
| Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 7: 3 hour | -0.33 ng/mL | Standard Deviation 4.304 |
| Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 14: 3 hour | 0.56 ng/mL | Standard Deviation 4.89 |
| Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 14: 0 hour | 0.63 ng/mL | Standard Deviation 2.175 |
| Placebo | Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 | Change at Day 7: 2 hour | -0.52 ng/mL | Standard Deviation 3.901 |
Secondary
Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14
Participant assessment of arthritis pain included assessment of severity of arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). Participants placed a mark on the VAS between 0 mm (no pain) and 100 mm (most severe pain), which corresponded to the magnitude of their pain, higher scores indicate more pain.
Time frame: Baseline, Day 7, 14
Population: FAS included all randomized participants who received at least 1 dose of the randomized investigational drug. Here, 'n' signifies those participants who were evaluable at specified time points, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 10 mg + Placebo | Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14 | Baseline | 62.45 mm | Standard Deviation 25.586 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14 | Change at Day 14 | -25.83 mm | Standard Deviation 31.899 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14 | Change at Day 7 | -12.03 mm | Standard Deviation 23.584 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14 | Baseline | 60.49 mm | Standard Deviation 21.123 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14 | Change at Day 14 | -27.29 mm | Standard Deviation 25.823 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14 | Change at Day 7 | -16.95 mm | Standard Deviation 25.056 |
| Prednisone 5 mg + Placebo | Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14 | Change at Day 7 | -8.67 mm | Standard Deviation 18.343 |
| Prednisone 5 mg + Placebo | Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14 | Baseline | 63.17 mm | Standard Deviation 15.551 |
| Prednisone 5 mg + Placebo | Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14 | Change at Day 14 | -21.47 mm | Standard Deviation 23.627 |
| Placebo | Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14 | Baseline | 66.65 mm | Standard Deviation 15.368 |
| Placebo | Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14 | Change at Day 14 | -14.69 mm | Standard Deviation 23.718 |
| Placebo | Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14 | Change at Day 7 | -11.00 mm | Standard Deviation 21.889 |
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.606790% CI: [-15.43, 8.1]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.181690% CI: [-21.32, 2.23]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.687390% CI: [-14.5, 8.82]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.218890% CI: [-20.42, 2.98]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.906790% CI: [-10.82, 12.47]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.580390% CI: [-16.05, 8]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.24990% CI: [-20.16, 3.57]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.108190% CI: [-23.52, 0.28]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.027190% CI: [-27.66, -4.12]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.288190% CI: [-19.41, 4.21]MMRM
Secondary
Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Day 7 and 14
PGA was a questionnaire where participants answered the following question, Considering all the ways your arthritis affects you, how are you feeling today? The participants' response were recorded using a 100 mm visual analog scale placing a mark on the scale, between 0 mm (very well condition) to 100 mm (very poor condition). Higher scores indicate higher degree of arthritis.
Time frame: Baseline, Day 7, 14
Population: FAS included all randomized participants who received at least 1 dose of the randomized investigational drug. Here, 'n' signifies those participants who were evaluable at specified time points, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 10 mg + Placebo | Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Day 7 and 14 | Baseline | 60.71 mm | Standard Deviation 24.265 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Day 7 and 14 | Change at Day 14 | -22.63 mm | Standard Deviation 30.656 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Day 7 and 14 | Change at Day 7 | -16.05 mm | Standard Deviation 21.8 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Day 7 and 14 | Baseline | 63.55 mm | Standard Deviation 20.589 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Day 7 and 14 | Change at Day 14 | -27.97 mm | Standard Deviation 26.894 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Day 7 and 14 | Change at Day 7 | -18.75 mm | Standard Deviation 25.933 |
| Prednisone 5 mg + Placebo | Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Day 7 and 14 | Change at Day 7 | -11.87 mm | Standard Deviation 17.036 |
| Prednisone 5 mg + Placebo | Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Day 7 and 14 | Baseline | 65.89 mm | Standard Deviation 14.957 |
| Prednisone 5 mg + Placebo | Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Day 7 and 14 | Change at Day 14 | -22.43 mm | Standard Deviation 22.303 |
| Placebo | Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Day 7 and 14 | Baseline | 65.26 mm | Standard Deviation 18.426 |
| Placebo | Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Day 7 and 14 | Change at Day 14 | -11.77 mm | Standard Deviation 27.457 |
| Placebo | Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Day 7 and 14 | Change at Day 7 | -7.94 mm | Standard Deviation 21.281 |
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.357990% CI: [-18.23, 5.19]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.227490% CI: [-20.24, 3.14]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.148290% CI: [-21.72, 1.41]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.082890% CI: [-23.74, -0.64]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.602190% CI: [-15.17, 7.9]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.752890% CI: [-14.24, 9.68]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.252390% CI: [-19.94, 3.6]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.104990% CI: [-23.43, 0.17]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.013890% CI: [-29.14, -5.91]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.187390% CI: [-21.05, 2.34]MMRM
Secondary
Change From Baseline in Physician Global Assessment (PhGA) of Arthritis at Day 7 and 14
PhGA included assessment of severity of arthritis pain where physicians were asked to rate the severity of the participant's overall arthritis. The physician's response was recorded using a visual analog scale between 0 mm (very good condition) to 100 mm (very poor condition). Higher scores indicate higher degree of arthritis.
Time frame: Baseline, Day 7, 14
Population: FAS included all randomized participants who received at least 1 dose of the randomized investigational drug. Here, 'n' signifies those participants who were evaluable at specified time points, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 10 mg + Placebo | Change From Baseline in Physician Global Assessment (PhGA) of Arthritis at Day 7 and 14 | Baseline | 58.10 mm | Standard Deviation 19.917 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Physician Global Assessment (PhGA) of Arthritis at Day 7 and 14 | Change at Day 14 | -22.16 mm | Standard Deviation 23.176 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Physician Global Assessment (PhGA) of Arthritis at Day 7 and 14 | Change at Day 7 | -13.38 mm | Standard Deviation 22.295 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Physician Global Assessment (PhGA) of Arthritis at Day 7 and 14 | Baseline | 62.27 mm | Standard Deviation 13.016 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Physician Global Assessment (PhGA) of Arthritis at Day 7 and 14 | Change at Day 14 | -32.19 mm | Standard Deviation 19.473 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Physician Global Assessment (PhGA) of Arthritis at Day 7 and 14 | Change at Day 7 | -20.42 mm | Standard Deviation 16.487 |
| Prednisone 5 mg + Placebo | Change From Baseline in Physician Global Assessment (PhGA) of Arthritis at Day 7 and 14 | Change at Day 7 | -9.71 mm | Standard Deviation 13.723 |
| Prednisone 5 mg + Placebo | Change From Baseline in Physician Global Assessment (PhGA) of Arthritis at Day 7 and 14 | Baseline | 57.86 mm | Standard Deviation 13.309 |
| Prednisone 5 mg + Placebo | Change From Baseline in Physician Global Assessment (PhGA) of Arthritis at Day 7 and 14 | Change at Day 14 | -20.90 mm | Standard Deviation 18.671 |
| Placebo | Change From Baseline in Physician Global Assessment (PhGA) of Arthritis at Day 7 and 14 | Baseline | 59.87 mm | Standard Deviation 15.194 |
| Placebo | Change From Baseline in Physician Global Assessment (PhGA) of Arthritis at Day 7 and 14 | Change at Day 14 | -14.87 mm | Standard Deviation 21.176 |
| Placebo | Change From Baseline in Physician Global Assessment (PhGA) of Arthritis at Day 7 and 14 | Change at Day 7 | -13.58 mm | Standard Deviation 16.208 |
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.50990% CI: [-12.4, 5.32]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.099890% CI: [-17.78, -0.01]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.886690% CI: [-9.52, 8.01]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.249990% CI: [-14.88, 2.66]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.599590% CI: [-5.99, 11.55]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.911790% CI: [-8.4, 9.61]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.068490% CI: [-18.84, -0.98]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.229290% CI: [-15.39, 2.42]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.001890% CI: [-25.81, -8.19]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.186790% CI: [-15.95, 1.76]MMRM
Secondary
Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14
Time frame: Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14
Population: Analysis set included all randomized participants who received at least 1 dose of the randomized investigational drug. Here, 'n' signifies those participants who were evaluable at specified time points, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 10 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Baseline | 106.85 ng/mL | Standard Deviation 27.404 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 14: 1 hour | -98.93 ng/mL | Standard Deviation 29.046 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 7: 3 hour | -94.81 ng/mL | Standard Deviation 31.049 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 1: 2 hour | -29.12 ng/mL | Standard Deviation 36.305 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 7: 4 hour | -98.82 ng/mL | Standard Deviation 26.955 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 14: 0 hour | -92.02 ng/mL | Standard Deviation 37.108 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 1: 3 hour | -20.05 ng/mL | Standard Deviation 42.714 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 1: 1 hour | -26.40 ng/mL | Standard Deviation 26.238 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 14: 3 hour | -101.78 ng/mL | Standard Deviation 27.765 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 1: 4 hour | -16.47 ng/mL | Standard Deviation 35.633 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 7: 0 hour | -92.06 ng/mL | Standard Deviation 32.334 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 14: 2 hour | -101.65 ng/mL | Standard Deviation 27.335 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 7: 1 hour | -93.92 ng/mL | Standard Deviation 30.165 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 14: 4 hour | -102.85 ng/mL | Standard Deviation 27.21 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 7: 2 hour | -93.69 ng/mL | Standard Deviation 30.42 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 7: 2 hour | -104.96 ng/mL | Standard Deviation 50.522 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 14: 1 hour | -105.41 ng/mL | Standard Deviation 51.193 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 1: 4 hour | -21.05 ng/mL | Standard Deviation 55.572 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 7: 3 hour | -105.01 ng/mL | Standard Deviation 49.683 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 1: 1 hour | -30.94 ng/mL | Standard Deviation 26.083 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 14: 0 hour | -104.86 ng/mL | Standard Deviation 50.721 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 14: 2 hour | -105.70 ng/mL | Standard Deviation 51.242 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 7: 4 hour | -104.69 ng/mL | Standard Deviation 49.771 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 1: 2 hour | -37.17 ng/mL | Standard Deviation 40.26 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 7: 1 hour | -104.69 ng/mL | Standard Deviation 50.229 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 14: 4 hour | -105.25 ng/mL | Standard Deviation 51.263 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 14: 3 hour | -105.29 ng/mL | Standard Deviation 51.583 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 7: 0 hour | -103.76 ng/mL | Standard Deviation 49.618 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 1: 3 hour | -24.19 ng/mL | Standard Deviation 48.793 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Baseline | 110.50 ng/mL | Standard Deviation 48.34 |
| Prednisone 5 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 7: 2 hour | -66.70 ng/mL | Standard Deviation 33.932 |
| Prednisone 5 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Baseline | 106.38 ng/mL | Standard Deviation 41.396 |
| Prednisone 5 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 1: 1 hour | -13.81 ng/mL | Standard Deviation 28.559 |
| Prednisone 5 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 1: 2 hour | -22.81 ng/mL | Standard Deviation 36.158 |
| Prednisone 5 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 1: 3 hour | -14.95 ng/mL | Standard Deviation 41.651 |
| Prednisone 5 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 1: 4 hour | -21.49 ng/mL | Standard Deviation 32.521 |
| Prednisone 5 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 7: 0 hour | 6.72 ng/mL | Standard Deviation 24.388 |
| Prednisone 5 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 7: 1 hour | -51.94 ng/mL | Standard Deviation 32.569 |
| Prednisone 5 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 7: 3 hour | -77.36 ng/mL | Standard Deviation 33.208 |
| Prednisone 5 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 7: 4 hour | -83.46 ng/mL | Standard Deviation 34.019 |
| Prednisone 5 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 14: 0 hour | -14.46 ng/mL | Standard Deviation 29.806 |
| Prednisone 5 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 14: 1 hour | -55.14 ng/mL | Standard Deviation 39.771 |
| Prednisone 5 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 14: 2 hour | -70.60 ng/mL | Standard Deviation 33.658 |
| Prednisone 5 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 14: 3 hour | -81.66 ng/mL | Standard Deviation 35.573 |
| Prednisone 5 mg + Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 14: 4 hour | -86.27 ng/mL | Standard Deviation 37.588 |
| Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 7: 1 hour | -25.39 ng/mL | Standard Deviation 44.117 |
| Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 1: 1 hour | -27.71 ng/mL | Standard Deviation 21.432 |
| Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 14: 1 hour | -25.38 ng/mL | Standard Deviation 17.075 |
| Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 7: 0 hour | 7.20 ng/mL | Standard Deviation 58.163 |
| Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 1: 4 hour | -9.16 ng/mL | Standard Deviation 50.832 |
| Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Baseline | 105.14 ng/mL | Standard Deviation 56.721 |
| Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 14: 2 hour | -33.54 ng/mL | Standard Deviation 30.064 |
| Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 1: 3 hour | -21.80 ng/mL | Standard Deviation 39.042 |
| Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 1: 2 hour | -32.92 ng/mL | Standard Deviation 29.781 |
| Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 14: 4 hour | -24.87 ng/mL | Standard Deviation 38.497 |
| Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 7: 4 hour | -20.38 ng/mL | Standard Deviation 43.739 |
| Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 7: 3 hour | -26.69 ng/mL | Standard Deviation 36.852 |
| Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 14: 3 hour | -23.01 ng/mL | Standard Deviation 38.787 |
| Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 14: 0 hour | 3.49 ng/mL | Standard Deviation 48.156 |
| Placebo | Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 | Change at Day 7: 2 hour | -35.19 ng/mL | Standard Deviation 44.417 |
Secondary
Change From Baseline in Ratio of Urinary N-terminal Telopeptide of Type 1 Collagen (uNTX-I) Level to Urinary Creatinine (uCr) Level at Day 7 and 14
Unit of ratio of urinary N-terminal telopeptide of type 1 collagen (uNTX-I) level to urinary creatinine (uCr) level was nanomoles bone collagen equivalents (nmol bce) per millimole creatinine (mmol cr).
Time frame: Baseline, Day 7 and 14
Population: Analysis set included all randomized participants who received at least 1 dose of the randomized investigational drug. Here, 'n' signifies those participants who were evaluable at specified time points, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 10 mg + Placebo | Change From Baseline in Ratio of Urinary N-terminal Telopeptide of Type 1 Collagen (uNTX-I) Level to Urinary Creatinine (uCr) Level at Day 7 and 14 | Baseline | 63.56 nmol BCE/mmol cr | Standard Deviation 28.239 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Ratio of Urinary N-terminal Telopeptide of Type 1 Collagen (uNTX-I) Level to Urinary Creatinine (uCr) Level at Day 7 and 14 | Change at Day 14 | 11.79 nmol BCE/mmol cr | Standard Deviation 29.1 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Ratio of Urinary N-terminal Telopeptide of Type 1 Collagen (uNTX-I) Level to Urinary Creatinine (uCr) Level at Day 7 and 14 | Change at Day 7 | 7.94 nmol BCE/mmol cr | Standard Deviation 16.482 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Ratio of Urinary N-terminal Telopeptide of Type 1 Collagen (uNTX-I) Level to Urinary Creatinine (uCr) Level at Day 7 and 14 | Baseline | 62.00 nmol BCE/mmol cr | Standard Deviation 26.946 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Ratio of Urinary N-terminal Telopeptide of Type 1 Collagen (uNTX-I) Level to Urinary Creatinine (uCr) Level at Day 7 and 14 | Change at Day 14 | 18.15 nmol BCE/mmol cr | Standard Deviation 19.626 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Ratio of Urinary N-terminal Telopeptide of Type 1 Collagen (uNTX-I) Level to Urinary Creatinine (uCr) Level at Day 7 and 14 | Change at Day 7 | 16.40 nmol BCE/mmol cr | Standard Deviation 23.922 |
| Prednisone 5 mg + Placebo | Change From Baseline in Ratio of Urinary N-terminal Telopeptide of Type 1 Collagen (uNTX-I) Level to Urinary Creatinine (uCr) Level at Day 7 and 14 | Change at Day 7 | -3.58 nmol BCE/mmol cr | Standard Deviation 29.632 |
| Prednisone 5 mg + Placebo | Change From Baseline in Ratio of Urinary N-terminal Telopeptide of Type 1 Collagen (uNTX-I) Level to Urinary Creatinine (uCr) Level at Day 7 and 14 | Baseline | 77.75 nmol BCE/mmol cr | Standard Deviation 51.582 |
| Prednisone 5 mg + Placebo | Change From Baseline in Ratio of Urinary N-terminal Telopeptide of Type 1 Collagen (uNTX-I) Level to Urinary Creatinine (uCr) Level at Day 7 and 14 | Change at Day 14 | -3.84 nmol BCE/mmol cr | Standard Deviation 33.997 |
| Placebo | Change From Baseline in Ratio of Urinary N-terminal Telopeptide of Type 1 Collagen (uNTX-I) Level to Urinary Creatinine (uCr) Level at Day 7 and 14 | Baseline | 79.63 nmol BCE/mmol cr | Standard Deviation 51.794 |
| Placebo | Change From Baseline in Ratio of Urinary N-terminal Telopeptide of Type 1 Collagen (uNTX-I) Level to Urinary Creatinine (uCr) Level at Day 7 and 14 | Change at Day 14 | -9.44 nmol BCE/mmol cr | Standard Deviation 33.369 |
| Placebo | Change From Baseline in Ratio of Urinary N-terminal Telopeptide of Type 1 Collagen (uNTX-I) Level to Urinary Creatinine (uCr) Level at Day 7 and 14 | Change at Day 7 | -13.42 nmol BCE/mmol cr | Standard Deviation 31.783 |
Secondary
Change From Baseline in Swollen Joints Count at Day 7, 14 and 42
Number of swollen joints was determined by examination of 28 joints and identifying if swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.
Time frame: Baseline, Day 7, 14, 42
Population: FAS included all randomized participants who received at least 1 dose of the randomized investigational drug. Here, 'n' signifies those participants who were evaluable at specified time points, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 10 mg + Placebo | Change From Baseline in Swollen Joints Count at Day 7, 14 and 42 | Baseline | 11.95 swollen joints | Standard Deviation 4.717 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Swollen Joints Count at Day 7, 14 and 42 | Change at Day 7 | -3.19 swollen joints | Standard Deviation 3.544 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Swollen Joints Count at Day 7, 14 and 42 | Change at Day 14 | -5.50 swollen joints | Standard Deviation 3.777 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Swollen Joints Count at Day 7, 14 and 42 | Change at Day 42 | -3.26 swollen joints | Standard Deviation 3.679 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Swollen Joints Count at Day 7, 14 and 42 | Change at Day 7 | -5.19 swollen joints | Standard Deviation 4.045 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Swollen Joints Count at Day 7, 14 and 42 | Change at Day 14 | -6.71 swollen joints | Standard Deviation 4.256 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Swollen Joints Count at Day 7, 14 and 42 | Change at Day 42 | -4.81 swollen joints | Standard Deviation 4.167 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Swollen Joints Count at Day 7, 14 and 42 | Baseline | 11.73 swollen joints | Standard Deviation 4.038 |
| Prednisone 5 mg + Placebo | Change From Baseline in Swollen Joints Count at Day 7, 14 and 42 | Change at Day 14 | -4.85 swollen joints | Standard Deviation 3.133 |
| Prednisone 5 mg + Placebo | Change From Baseline in Swollen Joints Count at Day 7, 14 and 42 | Change at Day 7 | -2.90 swollen joints | Standard Deviation 3.048 |
| Prednisone 5 mg + Placebo | Change From Baseline in Swollen Joints Count at Day 7, 14 and 42 | Change at Day 42 | -6.15 swollen joints | Standard Deviation 3.787 |
| Prednisone 5 mg + Placebo | Change From Baseline in Swollen Joints Count at Day 7, 14 and 42 | Baseline | 10.67 swollen joints | Standard Deviation 3.554 |
| Placebo | Change From Baseline in Swollen Joints Count at Day 7, 14 and 42 | Change at Day 42 | -4.71 swollen joints | Standard Deviation 4.9 |
| Placebo | Change From Baseline in Swollen Joints Count at Day 7, 14 and 42 | Change at Day 7 | -2.91 swollen joints | Standard Deviation 3.963 |
| Placebo | Change From Baseline in Swollen Joints Count at Day 7, 14 and 42 | Baseline | 11.64 swollen joints | Standard Deviation 4.065 |
| Placebo | Change From Baseline in Swollen Joints Count at Day 7, 14 and 42 | Change at Day 14 | -5.24 swollen joints | Standard Deviation 4.816 |
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.83790% CI: [-1.63, 2.09]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.081990% CI: [-3.81, -0.11]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.889290% CI: [-1.98, 1.67]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.035390% CI: [-4.17, -0.52]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.728390% CI: [-2.22, 1.45]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.908390% CI: [-1.81, 2.08]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.164190% CI: [-3.45, 0.29]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.81790% CI: [-1.64, 2.18]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.195890% CI: [-3.29, 0.4]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.90790% CI: [-1.74, 2]MMRM
Comparison: Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.002390% CI: [1.67, 5.5]MMRM
Comparison: Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.153190% CI: [-0.25, 3.49]MMRM
Comparison: Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.150690% CI: [-0.24, 3.53]MMRM
Comparison: Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.7890% CI: [-2.16, 1.53]MMRM
Comparison: Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.088390% CI: [-3.8, -0.07]MMRM
Secondary
Change From Baseline in Tender Joints Count at Day 7, 14, 42
Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.
Time frame: Baseline, Day 7, 14, 42
Population: FAS included all randomized participants who received at least 1 dose of the randomized investigational drug. Here, 'n' signifies those participants who were evaluable at specified time points, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 10 mg + Placebo | Change From Baseline in Tender Joints Count at Day 7, 14, 42 | Baseline | 17.10 tender joints | Standard Deviation 6.67 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Tender Joints Count at Day 7, 14, 42 | Change at Day 7 | -5.14 tender joints | Standard Deviation 6.807 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Tender Joints Count at Day 7, 14, 42 | Change at Day 14 | -7.22 tender joints | Standard Deviation 6.367 |
| PF-04171327 10 mg + Placebo | Change From Baseline in Tender Joints Count at Day 7, 14, 42 | Change at Day 42 | -5.21 tender joints | Standard Deviation 6.188 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Tender Joints Count at Day 7, 14, 42 | Change at Day 7 | -5.95 tender joints | Standard Deviation 5.617 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Tender Joints Count at Day 7, 14, 42 | Change at Day 14 | -8.14 tender joints | Standard Deviation 6.755 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Tender Joints Count at Day 7, 14, 42 | Change at Day 42 | -6.52 tender joints | Standard Deviation 6.743 |
| PF-04171327 25 mg + Placebo | Change From Baseline in Tender Joints Count at Day 7, 14, 42 | Baseline | 16.86 tender joints | Standard Deviation 5.375 |
| Prednisone 5 mg + Placebo | Change From Baseline in Tender Joints Count at Day 7, 14, 42 | Change at Day 14 | -4.15 tender joints | Standard Deviation 7.569 |
| Prednisone 5 mg + Placebo | Change From Baseline in Tender Joints Count at Day 7, 14, 42 | Change at Day 7 | -3.05 tender joints | Standard Deviation 4.117 |
| Prednisone 5 mg + Placebo | Change From Baseline in Tender Joints Count at Day 7, 14, 42 | Change at Day 42 | -5.10 tender joints | Standard Deviation 6.703 |
| Prednisone 5 mg + Placebo | Change From Baseline in Tender Joints Count at Day 7, 14, 42 | Baseline | 15.05 tender joints | Standard Deviation 4.489 |
| Placebo | Change From Baseline in Tender Joints Count at Day 7, 14, 42 | Change at Day 42 | -6.81 tender joints | Standard Deviation 5.733 |
| Placebo | Change From Baseline in Tender Joints Count at Day 7, 14, 42 | Change at Day 7 | -4.18 tender joints | Standard Deviation 4.584 |
| Placebo | Change From Baseline in Tender Joints Count at Day 7, 14, 42 | Baseline | 17.09 tender joints | Standard Deviation 6.023 |
| Placebo | Change From Baseline in Tender Joints Count at Day 7, 14, 42 | Change at Day 14 | -5.67 tender joints | Standard Deviation 6.807 |
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.43790% CI: [-4.54, 1.63]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.180290% CI: [-5.58, 0.57]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.601290% CI: [-3.99, 2.07]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.275390% CI: [-5.04, 1.03]MMRM
Comparison: Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.789290% CI: [-2.56, 3.55]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.376590% CI: [-4.92, 1.49]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.057190% CI: [-6.69, -0.49]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.655390% CI: [-3.99, 2.29]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.142790% CI: [-5.78, 0.33]MMRM
Comparison: Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.64390% CI: [-2.23, 3.97]MMRM
Comparison: Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.586890% CI: [-2.13, 4.22]MMRM
Comparison: Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.58690% CI: [-4.12, 2.08]MMRM
Comparison: Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.328890% CI: [-1.27, 4.95]MMRM
Comparison: Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.902790% CI: [-3.28, 2.83]MMRM
Comparison: Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.p-value: 0.67190% CI: [-2.3, 3.89]MMRM
Secondary
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Criteria for laboratory abnormalities: Hematology (hemoglobin, hematocrit \<0.8\*baseline; platelet count \<75 or \>700\*10\^3 per mm\^3; leucocytes \<2.5 or \>17.5\*10\^3 per mm\^3); chemistry (total bilirubin \>1.5\*upper limit of reference range \[ULN\]; aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase, alkaline phosphatase, \>3.0\*ULN; total protein, albumin \<0.8\*lower limit of reference range \[LLN\] or \>1.2\*ULN; blood urea nitrogen \[BUN\]/urea, creatinine \>1.3\*ULN; glucose \[fasting\] \<0.6\*LLN or \>1.5\*ULN; uric acid \>1.2\*ULN; sodium \<0.95\*LLN or \>1.05\*ULN; potassium, calcium \<0.9\*LLN or \>1.1\*ULN; albumin, total protein \<0.8\*LLN or \>1.2\*ULN; urinalysis (urine white blood cell (WBC) =\>6/ high power field (hpf); urine red blood cell (RBC) =\>6/hpf). Number of participants with clinically significant change from baseline in laboratory abnormalities identified by investigator were reported.
Time frame: Baseline up to Day 45
Population: Safety analysis set included all randomized participants who received at least 1 dose of the randomized investigational drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-04171327 10 mg + Placebo | Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities | 0 participants |
| PF-04171327 25 mg + Placebo | Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities | 0 participants |
| Prednisone 5 mg + Placebo | Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities | 0 participants |
| Placebo | Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities | 0 participants |
Secondary
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Clinically significant ECG findings included PR interval \>=300 milliseconds (msec) or \>=25% increase from baseline (if baseline PR interval \>200 msec) or \>=50% increase (if baseline PR interval less than or equal to \[\<=\] 200 msec); QRS interval \>=200 msec or \>=25% increase from baseline (if baseline PR interval \>100 msec) or \>=50% increase (if baseline PR interval \<= 100 msec); QT interval \>=500 msec, corrected QT interval \>=500 msec.
Time frame: Baseline up to Day 45
Population: Safety analysis set included all randomized participants who received at least 1 dose of the randomized investigational drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-04171327 10 mg + Placebo | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | 0 participants |
| PF-04171327 25 mg + Placebo | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | 0 participants |
| Prednisone 5 mg + Placebo | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | 0 participants |
| Placebo | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | 0 participants |
Secondary
Number of Participants With Clinically Significant Vital Signs Abnormalities
Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, heart rate and body temperature. Vital sign measurements were performed with the participant in the seated position. Clinical significance vital sign abnormality was determined by investigator.
Time frame: Baseline up to Day 45
Population: Safety analysis set included all randomized participants who received at least 1 dose of the randomized investigational drug.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| PF-04171327 10 mg + Placebo | Number of Participants With Clinically Significant Vital Signs Abnormalities | 0 participants | 6.55 |
| PF-04171327 25 mg + Placebo | Number of Participants With Clinically Significant Vital Signs Abnormalities | 0 participants | 7.78 |
| Prednisone 5 mg + Placebo | Number of Participants With Clinically Significant Vital Signs Abnormalities | 0 participants | 7.3 |
| Placebo | Number of Participants With Clinically Significant Vital Signs Abnormalities | 0 participants | 7.54 |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 31 days after last dose (Day 45) that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Baseline up to Day 45
Population: Safety analysis set included all randomized participants who received at least 1 dose of the randomized investigational drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04171327 10 mg + Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE | 8 participants |
| PF-04171327 10 mg + Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAE | 0 participants |
| PF-04171327 25 mg + Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAE | 0 participants |
| PF-04171327 25 mg + Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE | 3 participants |
| Prednisone 5 mg + Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE | 4 participants |
| Prednisone 5 mg + Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAE | 0 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE | 12 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAE | 0 participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Day 7 and 14
ACR20 responder: participants who achieved at =20% improvement in tender and swollen 28-joints count, and \>=20% improvement in at least 3 of the following 5 measures: 1) participant's assessment of arthritis pain (participant's self-assessed severity of arthritis pain, score range from 0\[no pain\] to 100\[most severe pain\], higher scores=more pain), 2) PGA of arthritis (participant's assessed overall arthritis activity, score range from 0\[no arthritis\] to 100\[extreme arthritis\], higher scores=higher degree of arthritis), 3) PhGA of arthritis (physician rated severity of participants overall arthritis activity, score range from 0\[no arthritis\] to 100\[extreme arthritis\], higher scores=higher degree of arthritis), 4) HAQ-DI (assessment of functional disability, score range from 0\[no difficulty\] to 3\[extreme difficulty\], higher scores=more functional limitation) and 5) CRP (assessment of inflammation, normal range of CRP is \<10 mg/L, decrease in the level of CRP=reduction in inflammation).
Time frame: Day 7, 14
Population: FAS included all randomized participants who received at least 1 dose of the randomized investigational drug. Here, 'n' signifies those participants who were evaluable at specified time points, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04171327 10 mg + Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Day 7 and 14 | Day 7 | 28.57 percentage of participants |
| PF-04171327 10 mg + Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Day 7 and 14 | Day 14 | 55.56 percentage of participants |
| PF-04171327 25 mg + Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Day 7 and 14 | Day 14 | 66.67 percentage of participants |
| PF-04171327 25 mg + Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Day 7 and 14 | Day 7 | 52.38 percentage of participants |
| Prednisone 5 mg + Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Day 7 and 14 | Day 7 | 14.29 percentage of participants |
| Prednisone 5 mg + Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Day 7 and 14 | Day 14 | 45.00 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Day 7 and 14 | Day 7 | 27.27 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Day 7 and 14 | Day 14 | 38.10 percentage of participants |
Comparison: Day 7p-value: 0.14690% CI: [-8.65, 35.98]Barnard exact test
Comparison: Day 7p-value: 0.005290% CI: [12.25, 59.46]Barnard exact test
Comparison: Day 7p-value: 0.509490% CI: [-22, 24.66]Barnard exact test
Comparison: Day 7p-value: 0.055190% CI: [-0.69, 48.34]Barnard exact test
Comparison: Day 7p-value: 0.999990% CI: [-34.09, 8.78]Barnard exact test
Comparison: Day 14p-value: 0.302790% CI: [-17.18, 37.67]Barnard-Exact test
Comparison: Day 14p-value: 0.107490% CI: [-6.24, 46.16]Barnard-Exact test
Comparison: Day 14p-value: 0.23490% CI: [-10.08, 43.7]Barnard-Exact test
Comparison: Day 14p-value: 0.044290% CI: [0.91, 53.07]Barnard-Exact test
Comparison: Day 14p-value: 0.381390% CI: [-19.82, 32.92]Barnard-Exact test
Secondary
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 7 and 14
ACR50 responder: participants who achieved at =50% improvement in tender and swollen 28-joints count, and \>=50% improvement in at least 3 of the following 5 measures: 1) participant's assessment of arthritis pain (participant's self-assessed severity of arthritis pain, score range from 0\[no pain\] to 100\[most severe pain\], higher scores=more pain), 2) PGA of arthritis (participant's assessed overall arthritis activity, score range from 0\[no arthritis\] to 100\[extreme arthritis\], higher scores=higher degree of arthritis), 3) PhGA of arthritis (physician rated severity of participants overall arthritis activity, score range from 0\[no arthritis\] to 100\[extreme arthritis\], higher scores=higher degree of arthritis), 4) HAQ-DI (assessment of functional disability, score range from 0\[no difficulty\] to 3\[extreme difficulty\], higher scores=more functional limitation) and 5) CRP (assessment of inflammation, normal range of CRP is \<10 mg/L, decrease in the level of CRP=reduction in inflammation).
Time frame: Day 7, 14
Population: FAS included all randomized participants who received at least 1 dose of the randomized investigational drug. Here, 'n' signifies those participants who were evaluable at specified time points, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04171327 10 mg + Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 7 and 14 | Day 7 | 9.52 percentage of participants |
| PF-04171327 10 mg + Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 7 and 14 | Day 14 | 22.22 percentage of participants |
| PF-04171327 25 mg + Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 7 and 14 | Day 14 | 47.62 percentage of participants |
| PF-04171327 25 mg + Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 7 and 14 | Day 7 | 19.05 percentage of participants |
| Prednisone 5 mg + Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 7 and 14 | Day 7 | 0.00 percentage of participants |
| Prednisone 5 mg + Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 7 and 14 | Day 14 | 20.00 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 7 and 14 | Day 7 | 0.00 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 7 and 14 | Day 14 | 14.29 percentage of participants |
Comparison: Day 7p-value: 0.101790% CI: [-3.9, 27.09]Barnard exact test
Comparison: Day 7p-value: 0.021890% CI: [4.49, 38.44]Barnard exact test
Comparison: Day 7p-value: 0.108290% CI: [-3.71, 27.06]Barnard exact test
Comparison: Day 7p-value: 0.016690% CI: [4.81, 38.44]Barnard exact test
Comparison: Day 14p-value: 0.477690% CI: [-21.61, 25.87]Barnard exact test
Comparison: Day 14p-value: 0.034790% CI: [2.53, 50.78]Barnard exact test
Comparison: Day 14p-value: 0.334390% CI: [-13.71, 31.59]Barnard exact test
Comparison: Day 14p-value: 0.011790% CI: [8.35, 55]Barnard exact test
Comparison: Day 14p-value: 0.37290% CI: [-15.86, 27.04]Barnard exact test
Secondary
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Day 7 and 14
ACR70 responder: participants who achieved at =70% improvement in tender and swollen 28-joints count, and \>=70% improvement in at least 3 of the following 5 measures: 1) participant's assessment of arthritis pain (participant's self-assessed severity of arthritis pain, score range from 0\[no pain\] to 100\[most severe pain\], higher scores=more pain), 2) PGA of arthritis (participant's assessed overall arthritis activity, score range from 0\[no arthritis\] to 100\[extreme arthritis\], higher scores=higher degree of arthritis), 3) PhGA of arthritis (physician rated severity of participants overall arthritis activity, score range from 0\[no arthritis\] to 100\[extreme arthritis\], higher scores=higher degree of arthritis), 4) HAQ-DI (assessment of functional disability, score range from 0\[no difficulty\] to 3\[extreme difficulty\], higher scores=more functional limitation) and 5) CRP (assessment of inflammation, normal range of CRP is \<10 mg/L, decrease in the level of CRP=reduction in inflammation).
Time frame: Day 7, 14
Population: FAS included all randomized participants who received at least 1 dose of the randomized investigational drug. Here, 'n' signifies those participants who were evaluable at specified time points, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04171327 10 mg + Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Day 7 and 14 | Day 7 | 4.76 percentage of participants |
| PF-04171327 10 mg + Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Day 7 and 14 | Day 14 | 0.00 percentage of participants |
| PF-04171327 25 mg + Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Day 7 and 14 | Day 14 | 14.29 percentage of participants |
| PF-04171327 25 mg + Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Day 7 and 14 | Day 7 | 4.76 percentage of participants |
| Prednisone 5 mg + Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Day 7 and 14 | Day 7 | 0.00 percentage of participants |
| Prednisone 5 mg + Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Day 7 and 14 | Day 14 | 0.00 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Day 7 and 14 | Day 7 | 0.00 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Day 7 and 14 | Day 14 | 0.00 percentage of participants |
Comparison: Day 7p-value: 0.26390% CI: [-8.61, 20.67]Barnard exact test
Comparison: Day 7p-value: 0.26390% CI: [-8.61, 20.67]Barnard exact test
Comparison: Day 7p-value: 0.253990% CI: [-7.51, 20.67]Barnard exact test
Comparison: Day 7p-value: 0.253990% CI: [-7.51, 20.67]Barnard exact test
Comparison: Day 14p-value: 0.047790% CI: [0.23, 32.92]Barnard exact test
Comparison: Day 14p-value: 0.044290% CI: [0.65, 32.92]Barnard exact test
Secondary
Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14
Plasma concentration of PF-00251802 versus time summary, a metabolite of PF-04171327 was reported in this outcome measure.
Time frame: 0, 1, 2, 3 and 4 hours post-dose on Day 7, 14
Population: Analysis set included all randomized participants who received at least 1 dose of PF-04171327. Here, 'Number of Participants analyzed' signifies those participants who were evaluable for this outcome measure. Here, 'n' signifies those participants who were evaluable at specified time points, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 10 mg + Placebo | Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14 | Day 7 (0 hour) | 53.07 nanogram per milliliter (ng/mL) | Standard Deviation 21.48 |
| PF-04171327 10 mg + Placebo | Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14 | Day 7 (1 hour) | 90.28 nanogram per milliliter (ng/mL) | Standard Deviation 50.25 |
| PF-04171327 10 mg + Placebo | Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14 | Day 7 (2 hour) | 118.1 nanogram per milliliter (ng/mL) | Standard Deviation 40.314 |
| PF-04171327 10 mg + Placebo | Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14 | Day 7 (3 hour) | 116.3 nanogram per milliliter (ng/mL) | Standard Deviation 42.988 |
| PF-04171327 10 mg + Placebo | Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14 | Day 7 (4 hour) | 107.5 nanogram per milliliter (ng/mL) | Standard Deviation 27.303 |
| PF-04171327 10 mg + Placebo | Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14 | Day 14 (0 hour) | 53.94 nanogram per milliliter (ng/mL) | Standard Deviation 25.382 |
| PF-04171327 10 mg + Placebo | Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14 | Day 14 (1 hour) | 115.7 nanogram per milliliter (ng/mL) | Standard Deviation 64.846 |
| PF-04171327 10 mg + Placebo | Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14 | Day 14 (2 hour) | 133.9 nanogram per milliliter (ng/mL) | Standard Deviation 50.294 |
| PF-04171327 10 mg + Placebo | Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14 | Day 14 (3 hour) | 123.7 nanogram per milliliter (ng/mL) | Standard Deviation 36.72 |
| PF-04171327 10 mg + Placebo | Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14 | Day 14 (4 hour) | 106.3 nanogram per milliliter (ng/mL) | Standard Deviation 28.542 |
| PF-04171327 25 mg + Placebo | Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14 | Day 14 (2 hour) | 284.9 nanogram per milliliter (ng/mL) | Standard Deviation 117.38 |
| PF-04171327 25 mg + Placebo | Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14 | Day 7 (0 hour) | 136.8 nanogram per milliliter (ng/mL) | Standard Deviation 82.246 |
| PF-04171327 25 mg + Placebo | Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14 | Day 14 (0 hour) | 136.3 nanogram per milliliter (ng/mL) | Standard Deviation 53.159 |
| PF-04171327 25 mg + Placebo | Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14 | Day 7 (1 hour) | 257.9 nanogram per milliliter (ng/mL) | Standard Deviation 93.716 |
| PF-04171327 25 mg + Placebo | Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14 | Day 14 (4 hour) | 243.3 nanogram per milliliter (ng/mL) | Standard Deviation 90.962 |
| PF-04171327 25 mg + Placebo | Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14 | Day 7 (2 hour) | 281.3 nanogram per milliliter (ng/mL) | Standard Deviation 73.866 |
| PF-04171327 25 mg + Placebo | Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14 | Day 14 (1 hour) | 216.4 nanogram per milliliter (ng/mL) | Standard Deviation 102.88 |
| PF-04171327 25 mg + Placebo | Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14 | Day 7 (3 hour) | 230.7 nanogram per milliliter (ng/mL) | Standard Deviation 82.895 |
| PF-04171327 25 mg + Placebo | Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14 | Day 14 (3 hour) | 296.6 nanogram per milliliter (ng/mL) | Standard Deviation 119.76 |
| PF-04171327 25 mg + Placebo | Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14 | Day 7 (4 hour) | 220.6 nanogram per milliliter (ng/mL) | Standard Deviation 53.416 |
Secondary
Ratio of Apparent Oral Clearance on Day 1 to Day 14 of Methotrexate
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Methotrexate was used as a background therapy by participants.
Time frame: Pre-dose (0 hour), 1, 2, 3 and 4 hours post-dose
Population: Analysis set included all randomized participants who received at least 1 dose of the randomized investigational drug. Here, 'Number of Participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04171327 10 mg + Placebo | Ratio of Apparent Oral Clearance on Day 1 to Day 14 of Methotrexate | 1.24 ratio | Standard Error 0.12 |
| PF-04171327 25 mg + Placebo | Ratio of Apparent Oral Clearance on Day 1 to Day 14 of Methotrexate | 0.98 ratio | Standard Error 0.05 |
| Prednisone 5 mg + Placebo | Ratio of Apparent Oral Clearance on Day 1 to Day 14 of Methotrexate | 1.14 ratio | Standard Error 0.1 |
| Placebo | Ratio of Apparent Oral Clearance on Day 1 to Day 14 of Methotrexate | 0.93 ratio | Standard Error 0.07 |