Trial Outcomes & Findings for A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis (NCT NCT00938587)

Last Updated: 2023-11-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

86 participants

Primary outcome timeframe

Baseline, Day 14

Results posted on

2023-11-22

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.
Overall Study STARTED	21	22	21	22
Overall Study COMPLETED	18	21	20	20
Overall Study NOT COMPLETED	3	1	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.
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

A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-04171327 10 mg + Placebo n=21 Participants 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.	PF-04171327 25 mg + Placebo n=22 Participants 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.	Prednisone 5 mg + Placebo n=21 Participants 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.	Placebo n=22 Participants 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.	Total n=86 Participants Total of all reporting groups
Age, Continuous	56.5 years STANDARD_DEVIATION 12.2 • n=5 Participants	55.6 years STANDARD_DEVIATION 11.4 • n=7 Participants	56.0 years STANDARD_DEVIATION 8.4 • n=5 Participants	53.8 years STANDARD_DEVIATION 11.9 • n=4 Participants	55.5 years STANDARD_DEVIATION 10.9 • n=21 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	12 Participants n=7 Participants	15 Participants n=5 Participants	20 Participants n=4 Participants	61 Participants n=21 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	25 Participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants 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.	PF-04171327 10 mg + Placebo n=21 Participants 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.	PF-04171327 25 mg + Placebo n=22 Participants 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.	Prednisone 5 mg + Placebo n=21 Participants 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.
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 0.810	6.04 units on a scale Standard Deviation 0.869	6.14 units on a scale Standard Deviation 0.755	5.92 units on a scale Standard Deviation 0.658
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 0.970	-1.79 units on a scale Standard Deviation 0.916	-2.22 units on a scale Standard Deviation 1.307	-1.15 units on a scale Standard Deviation 0.935

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants 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.	PF-04171327 10 mg + Placebo n=21 Participants 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.	PF-04171327 25 mg + Placebo n=22 Participants 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.	Prednisone 5 mg + Placebo n=21 Participants 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.
Change From Baseline in Tender Joints Count at Day 7, 14, 42 Baseline	17.09 tender joints Standard Deviation 6.023	17.10 tender joints Standard Deviation 6.670	16.86 tender joints Standard Deviation 5.375	15.05 tender joints Standard Deviation 4.489
Change From Baseline in Tender Joints Count at Day 7, 14, 42 Change at Day 7	-4.18 tender joints Standard Deviation 4.584	-5.14 tender joints Standard Deviation 6.807	-5.95 tender joints Standard Deviation 5.617	-3.05 tender joints Standard Deviation 4.117
Change From Baseline in Tender Joints Count at Day 7, 14, 42 Change at Day 14	-5.67 tender joints Standard Deviation 6.807	-7.22 tender joints Standard Deviation 6.367	-8.14 tender joints Standard Deviation 6.755	-4.15 tender joints Standard Deviation 7.569
Change From Baseline in Tender Joints Count at Day 7, 14, 42 Change at Day 42	-6.81 tender joints Standard Deviation 5.733	-5.21 tender joints Standard Deviation 6.188	-6.52 tender joints Standard Deviation 6.743	-5.10 tender joints Standard Deviation 6.703

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants 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.	PF-04171327 10 mg + Placebo n=21 Participants 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.	PF-04171327 25 mg + Placebo n=22 Participants 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.	Prednisone 5 mg + Placebo n=21 Participants 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.
Change From Baseline in Swollen Joints Count at Day 7, 14 and 42 Baseline	11.64 swollen joints Standard Deviation 4.065	11.95 swollen joints Standard Deviation 4.717	11.73 swollen joints Standard Deviation 4.038	10.67 swollen joints Standard Deviation 3.554
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	-3.19 swollen joints Standard Deviation 3.544	-5.19 swollen joints Standard Deviation 4.045	-2.90 swollen joints Standard Deviation 3.048
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	-5.50 swollen joints Standard Deviation 3.777	-6.71 swollen joints Standard Deviation 4.256	-4.85 swollen joints Standard Deviation 3.133
Change From Baseline in Swollen Joints Count at Day 7, 14 and 42 Change at Day 42	-4.71 swollen joints Standard Deviation 4.900	-3.26 swollen joints Standard Deviation 3.679	-4.81 swollen joints Standard Deviation 4.167	-6.15 swollen joints Standard Deviation 3.787

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants 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.	PF-04171327 10 mg + Placebo n=21 Participants 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.	PF-04171327 25 mg + Placebo n=22 Participants 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.	Prednisone 5 mg + Placebo n=21 Participants 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.
Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42 Baseline	16.97 mg/L Standard Deviation 19.580	20.24 mg/L Standard Deviation 16.431	30.15 mg/L Standard Deviation 35.396	20.02 mg/L Standard Deviation 14.022
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	-13.78 mg/L Standard Deviation 18.208	-23.60 mg/L Standard Deviation 32.808	-4.64 mg/L Standard Deviation 18.487
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	-18.13 mg/L Standard Deviation 17.519	-24.12 mg/L Standard Deviation 33.273	-7.63 mg/L Standard Deviation 16.876
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	3.14 mg/L Standard Deviation 28.198	-13.09 mg/L Standard Deviation 27.448	-8.02 mg/L Standard Deviation 13.850

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants 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.	PF-04171327 10 mg + Placebo n=21 Participants 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.	PF-04171327 25 mg + Placebo n=22 Participants 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.	Prednisone 5 mg + Placebo n=21 Participants 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.
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	1.76 units on a scale Standard Deviation 0.831	1.41 units on a scale Standard Deviation 0.796	1.62 units on a scale Standard Deviation 0.498
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	-0.24 units on a scale Standard Deviation 0.700	-0.24 units on a scale Standard Deviation 0.700	-0.24 units on a scale Standard Deviation 0.436
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	-0.58 units on a scale Standard Deviation 1.017	-0.43 units on a scale Standard Deviation 0.870	-0.25 units on a scale Standard Deviation 0.550

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants 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.	PF-04171327 10 mg + Placebo n=21 Participants 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.	PF-04171327 25 mg + Placebo n=22 Participants 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.	Prednisone 5 mg + Placebo n=21 Participants 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.
Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14 Baseline	66.65 mm Standard Deviation 15.368	62.45 mm Standard Deviation 25.586	60.49 mm Standard Deviation 21.123	63.17 mm Standard Deviation 15.551
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	-12.03 mm Standard Deviation 23.584	-16.95 mm Standard Deviation 25.056	-8.67 mm Standard Deviation 18.343
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	-25.83 mm Standard Deviation 31.899	-27.29 mm Standard Deviation 25.823	-21.47 mm Standard Deviation 23.627

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants 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.	PF-04171327 10 mg + Placebo n=21 Participants 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.	PF-04171327 25 mg + Placebo n=22 Participants 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.	Prednisone 5 mg + Placebo n=21 Participants 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.
Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Day 7 and 14 Baseline	65.26 mm Standard Deviation 18.426	60.71 mm Standard Deviation 24.265	63.55 mm Standard Deviation 20.589	65.89 mm Standard Deviation 14.957
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	-16.05 mm Standard Deviation 21.800	-18.75 mm Standard Deviation 25.933	-11.87 mm Standard Deviation 17.036
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	-22.63 mm Standard Deviation 30.656	-27.97 mm Standard Deviation 26.894	-22.43 mm Standard Deviation 22.303

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants 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.	PF-04171327 10 mg + Placebo n=21 Participants 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.	PF-04171327 25 mg + Placebo n=22 Participants 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.	Prednisone 5 mg + Placebo n=21 Participants 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.
Change From Baseline in Physician Global Assessment (PhGA) of Arthritis at Day 7 and 14 Baseline	59.87 mm Standard Deviation 15.194	58.10 mm Standard Deviation 19.917	62.27 mm Standard Deviation 13.016	57.86 mm Standard Deviation 13.309
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	-13.38 mm Standard Deviation 22.295	-20.42 mm Standard Deviation 16.487	-9.71 mm Standard Deviation 13.723
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	-22.16 mm Standard Deviation 23.176	-32.19 mm Standard Deviation 19.473	-20.90 mm Standard Deviation 18.671

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants 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.	PF-04171327 10 mg + Placebo n=21 Participants 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.	PF-04171327 25 mg + Placebo n=22 Participants 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.	Prednisone 5 mg + Placebo n=21 Participants 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.
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	29.92 units on a scale Standard Deviation 9.624	30.69 units on a scale Standard Deviation 8.305	29.14 units on a scale Standard Deviation 7.187
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	4.52 units on a scale Standard Deviation 9.142	4.58 units on a scale Standard Deviation 6.660	4.71 units on a scale Standard Deviation 6.543
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	35.72 units on a scale Standard Deviation 9.452	35.69 units on a scale Standard Deviation 8.680	33.10 units on a scale Standard Deviation 7.288
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	4.27 units on a scale Standard Deviation 12.182	7.27 units on a scale Standard Deviation 9.378	5.01 units on a scale Standard Deviation 6.789
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	31.41 units on a scale Standard Deviation 7.473	32.88 units on a scale Standard Deviation 6.234	31.35 units on a scale Standard Deviation 4.159
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	11.25 units on a scale Standard Deviation 11.394	11.60 units on a scale Standard Deviation 7.609	7.73 units on a scale Standard Deviation 6.435
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	30.91 units on a scale Standard Deviation 9.564	37.33 units on a scale Standard Deviation 11.005	35.36 units on a scale Standard Deviation 8.423
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 6.740	4.40 units on a scale Standard Deviation 6.604	3.96 units on a scale Standard Deviation 5.853	3.31 units on a scale Standard Deviation 5.652
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	38.98 units on a scale Standard Deviation 10.166	42.43 units on a scale Standard Deviation 9.891	39.70 units on a scale Standard Deviation 8.671
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	7.88 units on a scale Standard Deviation 11.603	7.70 units on a scale Standard Deviation 7.183	4.79 units on a scale Standard Deviation 7.229
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	39.50 units on a scale Standard Deviation 10.384	39.05 units on a scale Standard Deviation 12.411	34.89 units on a scale Standard Deviation 9.468
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	4.25 units on a scale Standard Deviation 10.988	7.68 units on a scale Standard Deviation 9.090	5.65 units on a scale Standard Deviation 5.647
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	36.39 units on a scale Standard Deviation 13.164	37.95 units on a scale Standard Deviation 12.978	35.49 units on a scale Standard Deviation 12.287
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	5.18 units on a scale Standard Deviation 15.873	6.31 units on a scale Standard Deviation 12.051	2.65 units on a scale Standard Deviation 12.888
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	37.71 units on a scale Standard Deviation 14.742	42.40 units on a scale Standard Deviation 11.681	37.97 units on a scale Standard Deviation 11.807
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	7.00 units on a scale Standard Deviation 15.072	4.62 units on a scale Standard Deviation 9.368	5.13 units on a scale Standard Deviation 8.540
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	30.89 units on a scale Standard Deviation 7.342	32.05 units on a scale Standard Deviation 6.627	30.91 units on a scale Standard Deviation 5.185
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	5.74 units on a scale Standard Deviation 6.611	7.10 units on a scale Standard Deviation 4.351	5.49 units on a scale Standard Deviation 5.219
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	41.19 units on a scale Standard Deviation 14.648	44.42 units on a scale Standard Deviation 13.036	40.30 units on a scale Standard Deviation 12.464
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	5.91 units on a scale Standard Deviation 14.065	5.72 units on a scale Standard Deviation 9.743	3.78 units on a scale Standard Deviation 8.358

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants 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.	PF-04171327 10 mg + Placebo n=21 Participants 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.	PF-04171327 25 mg + Placebo n=22 Participants 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.	Prednisone 5 mg + Placebo n=21 Participants 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.
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	-0.81 units on a scale Standard Deviation 1.007	-1.26 units on a scale Standard Deviation 1.199	-1.17 units on a scale Standard Deviation 0.949
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	5.80 units on a scale Standard Deviation 0.731	5.87 units on a scale Standard Deviation 0.674	5.59 units on a scale Standard Deviation 0.666
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	-1.07 units on a scale Standard Deviation 0.800	-1.51 units on a scale Standard Deviation 0.845	-0.55 units on a scale Standard Deviation 0.632
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	-1.57 units on a scale Standard Deviation 0.749	-2.01 units on a scale Standard Deviation 1.178	-0.92 units on a scale Standard Deviation 0.994

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants 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.	PF-04171327 10 mg + Placebo n=20 Participants 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.	PF-04171327 25 mg + Placebo n=21 Participants 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.	Prednisone 5 mg + Placebo n=21 Participants 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.
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	-1.21 units on a scale Standard Deviation 0.889	-1.63 units on a scale Standard Deviation 1.034	-0.67 units on a scale Standard Deviation 0.639

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants 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.	PF-04171327 10 mg + Placebo n=21 Participants 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.	PF-04171327 25 mg + Placebo n=22 Participants 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.	Prednisone 5 mg + Placebo n=21 Participants 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.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Day 7 and 14 Day 7	27.27 percentage of participants	28.57 percentage of participants	52.38 percentage of participants	14.29 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Day 7 and 14 Day 14	38.10 percentage of participants	55.56 percentage of participants	66.67 percentage of participants	45.00 percentage of participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants 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.	PF-04171327 10 mg + Placebo n=21 Participants 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.	PF-04171327 25 mg + Placebo n=22 Participants 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.	Prednisone 5 mg + Placebo n=21 Participants 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.
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 7 and 14 Day 7	0.00 percentage of participants	9.52 percentage of participants	19.05 percentage of participants	0.00 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 7 and 14 Day 14	14.29 percentage of participants	22.22 percentage of participants	47.62 percentage of participants	20.00 percentage of participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants 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.	PF-04171327 10 mg + Placebo n=21 Participants 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.	PF-04171327 25 mg + Placebo n=22 Participants 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.	Prednisone 5 mg + Placebo n=21 Participants 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.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Day 7 and 14 Day 7	0.00 percentage of participants	4.76 percentage of participants	4.76 percentage of participants	0.00 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Day 7 and 14 Day 14	0.00 percentage of participants	0.00 percentage of participants	14.29 percentage of participants	0.00 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Day 45

Population: Safety analysis set included all randomized participants who received at least 1 dose of the randomized investigational drug.

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.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants 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.	PF-04171327 10 mg + Placebo n=21 Participants 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.	PF-04171327 25 mg + Placebo n=22 Participants 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.	Prednisone 5 mg + Placebo n=21 Participants 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.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AE	12 participants	8 participants	3 participants	4 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAE	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline up to Day 45

Population: Safety analysis set included all randomized participants who received at least 1 dose of the randomized investigational drug.

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.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants 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.	PF-04171327 10 mg + Placebo n=21 Participants 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.	PF-04171327 25 mg + Placebo n=22 Participants 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.	Prednisone 5 mg + Placebo n=21 Participants 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.
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants 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.	PF-04171327 10 mg + Placebo n=21 Participants 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.	PF-04171327 25 mg + Placebo n=22 Participants 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.	Prednisone 5 mg + Placebo n=21 Participants 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.
Change From Baseline in Body Weight at Day 7 and 14 Change at Day 7	-0.05 kilogram Standard Deviation 0.858	0.12 kilogram Standard Deviation 0.733	-0.04 kilogram Standard Deviation 1.256	-0.02 kilogram Standard Deviation 1.036
Change From Baseline in Body Weight at Day 7 and 14 Baseline	75.0 kilogram Standard Deviation 17.2	83.7 kilogram Standard Deviation 17.0	74.1 kilogram Standard Deviation 16.1	78.4 kilogram Standard Deviation 15.4
Change From Baseline in Body Weight at Day 7 and 14 Change at Day 14	-0.04 kilogram Standard Deviation 0.903	0.35 kilogram Standard Deviation 1.064	0.20 kilogram Standard Deviation 1.158	0.18 kilogram Standard Deviation 1.467

SECONDARY outcome

Timeframe: Baseline up to Day 45

Population: Safety analysis set included all randomized participants who received at least 1 dose of the randomized investigational drug.

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.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants 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.	PF-04171327 10 mg + Placebo n=21 Participants 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.	PF-04171327 25 mg + Placebo n=22 Participants 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.	Prednisone 5 mg + Placebo n=21 Participants 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.
Number of Participants With Clinically Significant Vital Signs Abnormalities	0 participants 7.54	0 participants 6.55	0 participants 7.78	0 participants 7.30

SECONDARY outcome

Timeframe: Baseline up to Day 45

Population: Safety analysis set included all randomized participants who received at least 1 dose of the randomized investigational drug.

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.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants 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.	PF-04171327 10 mg + Placebo n=21 Participants 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.	PF-04171327 25 mg + Placebo n=22 Participants 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.	Prednisone 5 mg + Placebo n=21 Participants 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.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 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.

Plasma concentration of PF-00251802 versus time summary, a metabolite of PF-04171327 was reported in this outcome measure.

Outcome measures

Outcome measures
Measure	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.	PF-04171327 10 mg + Placebo n=19 Participants 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.	PF-04171327 25 mg + Placebo n=20 Participants 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.	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.
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 21.480	136.8 nanogram per milliliter (ng/mL) Standard Deviation 82.246	—
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 50.250	257.9 nanogram per milliliter (ng/mL) Standard Deviation 93.716	—
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	281.3 nanogram per milliliter (ng/mL) Standard Deviation 73.866	—
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	230.7 nanogram per milliliter (ng/mL) Standard Deviation 82.895	—
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	220.6 nanogram per milliliter (ng/mL) Standard Deviation 53.416	—
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	136.3 nanogram per milliliter (ng/mL) Standard Deviation 53.159	—
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	216.4 nanogram per milliliter (ng/mL) Standard Deviation 102.88	—
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	284.9 nanogram per milliliter (ng/mL) Standard Deviation 117.38	—
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 36.720	296.6 nanogram per milliliter (ng/mL) Standard Deviation 119.76	—
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	243.3 nanogram per milliliter (ng/mL) Standard Deviation 90.962	—

SECONDARY outcome

Timeframe: 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.

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.