A Study To Evaluate The Mechanism Of Action Of CP-690,550 In Patients With Rheumatoid Arthritis

• ClinicalTrials.gov Identifier: NCT00976599
• Recruitment Status: Completed
• First Posted: September 14, 2009
• Results First Posted: January 9, 2013
• Last Update Posted: January 9, 2013
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Basic Science
• Condition: Rheumatoid Arthritis
• Interventions: Drug: CP-690,550 + methotrexate; Drug: Placebo + Methotrexate
• Enrollment: 29

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description	CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Period Title: Overall Study
Started	15	14
Completed	15	14
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		CP-690,550	Placebo	Total
Arm/Group Description		CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Total of all reporting groups
Overall Number of Baseline Participants		15	14	29
Baseline Analysis Population Description		[Not Specified]
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	15 participants	14 participants	29 participants
		53.5 (9.2)	53.1 (14.3)	53.3 (11.7)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	14 participants	29 participants
	Female	14 93.3%	12 85.7%	26 89.7%
	Male	1 6.7%	2 14.3%	3 10.3%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Description	Synovial tissue biopsy were performed and assayed for mRNA gene expression by quantitative polymerized chain reaction (PCR) using standard curve method. Standard curve generated by linear regression using log threshold cycle versus log (cell number). Interleukin-1beta (IL-1beta), IL-6, matrix metalloproteinase-3 (MMP3), cluster of differentiation 19 (CD19), cluster of differentiation 3 epsilon (CD3E), Janus kinase 1 (JAK1), JAK2, JAK3, signal transducers, activators of transcription (STAT1), interferon stimulated gene 15 (ISG15), C-X-C motif chemokine 10 (CXCL10), chemokine (C-C motif) ligand2 (CCL2), phospho-STAT1 (pSTAT1), pSTAT3, tumor necrosis factor alpha (TNFalpha), receptor activator of nuclear factor kappa-B ligand (RANKL) and osteoprotegerin (OPG) presented as control gene normalized expression (relative expression) within synovial tissue.
Time Frame	Day -7 (Baseline), Day 28

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) included all randomized participants who received at least 1 dose of the study medication. Analyses of tumor necrosis factor alpha(TNFα), receptor activator of nuclear factor kappa-B ligand(RANKL), osteoprotegerin(OPG) were not performed due to insufficient samples and lack of appropriate method to process/analyze samples.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: relative expression unit (REU)
Baseline: IL-1beta mRNA	-2.73 (0.77)	-2.83 (0.80)
Baseline: IL-6 mRNA	-3.72 (0.67)	-3.96 (0.55)
Baseline: MMP3 mRNA	-2.01 (1.39)	-2.52 (1.64)
Baseline: CD19 mRNA	-2.98 (1.25)	-3.46 (1.34)
Baseline: CD3E mRNA	-1.58 (0.71)	-1.75 (0.58)
Baseline: JAK1 mRNA	0.30 (0.24)	0.31 (0.29)
Baseline: JAK2 mRNA	0.17 (0.26)	0.15 (0.25)
Baseline: JAK3 mRNA	-0.77 (0.40)	-0.88 (0.52)
Baseline: STAT1 mRNA	-0.43 (0.29)	-0.46 (0.33)
Baseline: ISG15 mRNA	-1.26 (0.23)	-1.33 (0.27)
Baseline: CXCL10 mRNA	-1.21 (0.85)	-1.24 (0.81)
Baseline: CCL2 mRNA	-1.70 (0.29)	-1.73 (0.39)
Baseline: pSTAT1 protein	0.18 (0.33)	0.27 (0.39)
Baseline: pSTAT3 protein	0.77 (0.29)	0.79 (0.30)
Change at Day 28: IL-1beta mRNA	-0.01 (0.88)	0.09 (0.43)
Change at Day 28: IL-6 mRNA	-0.25 (0.86)	-0.08 (0.45)
Change at Day 28: MMP3 mRNA	-0.80 (0.92)	-0.03 (1.23)
Change at Day 28: CD19 mRNA	0.06 (0.85)	-0.31 (0.72)
Change at Day 28: CD3E mRNA	-0.07 (0.53)	-0.12 (0.44)
Change at Day 28: JAK1 mRNA	0.04 (0.36)	-0.10 (0.36)
Change at Day 28: JAK2 mRNA	-0.07 (0.40)	-0.10 (0.29)
Change at Day 28: JAK3 mRNA	-0.05 (0.35)	-0.13 (0.52)
Change at Day 28: STAT1 mRNA	-0.15 (0.46)	0.01 (0.35)
Change at Day 28: ISG15 mRNA	-0.16 (0.40)	0.11 (0.34)
Change at Day 28: CXCL10 mRNA	-0.49 (0.75)	0.15 (0.61)
Change at Day 28: CCL2 mRNA	-0.20 (0.30)	-0.02 (0.28)
Change at Day 28: pSTAT1 protein	-0.20 (0.44)	-0.10 (0.36)
Change at Day 28: pSTAT3 protein	-0.10 (0.42)	-0.10 (0.18)

2. Primary Outcome

Title	Change From Baseline in Protein Expression of Tumor Necrosis Factor Alpha (TNFalpha), Interleukin-6 (IL-6), Interleukin-17a (IL-17a) and Interleukin-10 (IL-10) at Day 28
Description	Synovial tissue biopsy was to be performed and assayed for protein expression by quantitative PCR using standard curve method. Standard curve was to be generated by linear regression using log threshold cycle versus log (cell number). TNFalpha, IL-6, IL-17 and IL-10 data were to be presented as control normalized expression (relative expression) within synovial tissue.
Time Frame	Baseline (Day -7), Day 28

Outcome Measure Data

Analysis Population Description

Analyses of TNFalpha, IL-6, IL-17 and IL-10 were not performed due to insufficient samples and lack of appropriate method to process/analyze the samples.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

3. Primary Outcome

Title	Change From Baseline in Percentage of Area Stained For CD3+ and CD68+ Surface Markers of Inflammatory Cells of the Synovial Tissue at Day 28
Description	The intensity of CD3 and CD68 cell infiltration was expressed as the percentage area of the tissue section occupied by positively stained cells. Surface marker CD68 macrophages and CD3 thymus cells (T cells) in the inflammatory cells of synovial tissue were detected by immunohistochemical staining.
Time Frame	Baseline (Day -7), Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	12	12
Mean (Standard Deviation); Unit of Measure: percentage area stained
Baseline: CD3+ Cells (n=12, 12)	7.33 (6.12)	7.92 (7.49)
Baseline: CD68+ Cells (n=12, 13)	31.83 (20.59)	32.85 (26.05)
Change at Day 28: CD3+ Cells (n=10, 8)	1.50 (3.95)	0.13 (7.38)
Change at Day 28: CD68+ Cells (n=12, 11)	1.67 (19.86)	0.82 (18.37)

4. Primary Outcome

Title	Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7)
Description	Blood levels were utilized for expression analysis (mRNA) of following genes that reflect immune function: CD19, CD3 epsilon (CD3E), STAT1, STAT3, ISG15, CXCL10. mRNA gene expression in blood were assayed by quantitative PCR using standard curve method. Standard curve generated by linear regression using log threshold cycle versus log (cell number). Data were presented as control gene normalized expression (relative expression) within blood.
Time Frame	Baseline (Day -7)

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	14
Mean (Standard Deviation); Unit of Measure: REU
CD19 mRNA	0.11 (0.28)	0.29 (0.25)
CD3E mRNA	0.41 (0.44)	0.40 (0.38)
STAT1 mRNA	0.06 (0.25)	0.02 (0.13)
STAT3 mRNA	0.61 (0.13)	0.64 (0.08)
ISG15 mRNA	-0.65 (0.45)	-0.56 (0.47)
CXCL10 mRNA	-1.58 (0.33)	-1.65 (0.19)

5. Primary Outcome

Title	Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28
Description	Blood levels were utilized for expression analysis (mRNA) of following genes that reflect immune function: CD19, CD3E, STAT1, STAT3, ISG15, CXCL10. mRNA gene expression in blood were assayed by quantitative PCR using standard curve method. Standard curve generated by linear regression using log threshold cycle versus log (cell number). Data were presented as control gene normalized expression (relative expression) within blood.
Time Frame	Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	14
Mean (Standard Deviation); Unit of Measure: REU
CD19 mRNA	0.35 (0.24)	0.30 (0.25)
CD3E mRNA	0.49 (0.34)	0.40 (0.32)
STAT1 mRNA	-0.01 (0.28)	0.04 (0.21)
STAT3 mRNA	0.60 (0.13)	0.59 (0.13)
ISG15 mRNA	-0.93 (0.20)	-0.48 (0.51)
CXCL10 mRNA	-1.64 (0.22)	-1.59 (0.28)

6. Primary Outcome

Title	Blood Cytokine Level at Pre-dose on Day 1
Description	Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, active 70 kDa (p70) form of IL-12(IL-12p70), interferon gamma (IFNgamma) - induced protein 10 (IP-10), TNFalpha, granulocyte macrophage colony-stimulating factor (GM-CSF), macrophage inflammatory protein 1 alpha (MIP1a), monocyte chemotactic protein 1 (MCP1), soluble vascular endothelial growth factor (sVEGF), soluble vascular cell adhesion molecule 1 (sVCAM-1), soluble intercellular adhesion molecule 1 (sICAM-1), granulocyte colony-stimulating factor (G-CSF) was measured by immunoassay and the levels were expresses as picogram per milliliter (pg/mL).
Time Frame	Pre-dose on Day 1

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: pg/mL
IL-1alpha	0.75 (0.68)	0.67 (0.68)
IL-1beta	0.42 (0.39)	0.41 (0.41)
IL-4	0.29 (0.29)	0.17 (0.16)
IL-6	0.97 (0.67)	0.77 (0.45)
IL-7	0.89 (0.32)	0.74 (0.23)
IL-8	1.17 (0.24)	1.19 (0.27)
IL-10	0.25 (0.24)	0.33 (0.37)
IL-12p70	0.31 (0.29)	0.35 (0.44)
IL-17A	0.49 (0.48)	0.44 (0.37)
IL-21	1.56 (1.10)	1.47 (1.04)
IP-10	2.22 (0.23)	2.23 (0.30)
TNFalpha	0.45 (0.43)	0.44 (0.51)
IFNgamma	0.15 (0.16)	0.11 (0.07)
G-CSF	0.57 (0.47)	0.60 (0.34)
GM-CSF	0.48 (0.48)	0.36 (0.46)
MCP1	2.14 (0.26)	2.09 (0.32)
MIP1a	0.85 (0.45)	0.90 (0.32)
sVEGF	1.96 (0.44)	1.87 (0.28)
sVCAM-1	4.95 (0.17)	5.07 (0.17)
sICAM-1	4.65 (0.12)	4.76 (0.17)

7. Primary Outcome

Title	Blood Cytokine Level at 1 Hour Post-dose on Day 1
Description	Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.
Time Frame	1 hour post-dose on Day 1

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: pg/mL
IL-1alpha	0.76 (0.68)	0.73 (0.68)
IL-1beta	0.43 (0.42)	0.40 (0.43)
IL-4	0.29 (0.28)	0.15 (0.13)
IL-6	0.90 (0.52)	0.78 (0.43)
IL-7	0.86 (0.36)	0.72 (0.26)
IL-8	1.12 (0.31)	1.15 (0.23)
IL-10	0.23 (0.22)	0.31 (0.35)
IL-12p70	0.36 (0.31)	0.34 (0.43)
IL-17A	0.58 (0.46)	0.42 (0.36)
IL-21	1.45 (1.16)	1.45 (1.07)
IP-10	2.17 (0.25)	2.22 (0.31)
TNFalpha	0.41 (0.46)	0.44 (0.52)
IFNgamma	0.12 (0.07)	0.10 (0.00)
G-CSF	0.56 (0.47)	0.62 (0.36)
GM-CSF	0.49 (0.49)	0.39 (0.49)
MCP1	2.09 (0.26)	2.03 (0.33)
MIP1a	0.83 (0.47)	0.89 (0.33)
sVEGF	1.98 (0.42)	1.87 (0.27)
sVCAM-1	4.94 (0.15)	5.06 (0.17)
sICAM-1	4.64 (0.13)	4.76 (0.18)

8. Primary Outcome

Title	Blood Cytokine Level at 4 Hours Post-dose on Day 1
Description	Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.
Time Frame	4 hours post-dose on Day 1

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	13
Mean (Standard Deviation); Unit of Measure: pg/mL
IL-1alpha	0.77 (0.69)	0.65 (0.70)
IL-1beta	0.43 (0.46)	0.41 (0.42)
IL-4	0.28 (0.28)	0.18 (0.17)
IL-6	0.74 (0.41)	0.72 (0.39)
IL-7	0.82 (0.39)	0.73 (0.28)
IL-8	1.18 (0.22)	1.15 (0.25)
IL-10	0.19 (0.20)	0.30 (0.35)
IL-12p70	0.35 (0.29)	0.38 (0.43)
IL-17A	0.53 (0.47)	0.39 (0.40)
IL-21	1.60 (1.09)	1.36 (1.07)
IP-10	2.10 (0.22)	2.20 (0.33)
TNFalpha	0.41 (0.47)	0.45 (0.51)
IFNgamma	0.17 (0.13)	0.12 (0.07)
G-CSF	0.55 (0.47)	0.62 (0.41)
GM-CSF	0.50 (0.48)	0.38 (0.48)
MCP1	1.98 (0.29)	2.07 (0.34)
MIP1a	0.81 (0.47)	0.86 (0.33)
sVEGF	1.93 (0.42)	1.85 (0.28)
sVCAM-1	4.96 (0.15)	5.03 (0.21)
sICAM-1	4.66 (0.12)	4.74 (0.20)

9. Primary Outcome

Title	Blood Cytokine Level at Pre-dose on Day 10
Description	Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.
Time Frame	Pre-dose on Day 10

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: pg/mL
IL-1alpha	0.74 (0.66)	0.69 (0.68)
IL-1beta	0.36 (0.46)	0.42 (0.43)
IL-4	0.28 (0.28)	0.19 (0.18)
IL-6	0.68 (0.55)	0.78 (0.45)
IL-7	0.83 (0.31)	0.61 (0.38)
IL-8	1.15 (0.29)	1.21 (0.29)
IL-10	0.21 (0.23)	0.32 (0.35)
IL-12p70	0.34 (0.32)	0.34 (0.43)
IL-17A	0.50 (0.48)	0.41 (0.36)
IL-21	1.62 (1.02)	1.63 (0.86)
IP-10	2.01 (0.25)	2.18 (0.33)
TNFalpha	0.48 (0.49)	0.48 (0.50)
IFNgamma	0.11 (0.05)	0.11 (0.03)
G-CSF	0.60 (0.43)	0.60 (0.31)
GM-CSF	0.48 (0.46)	0.37 (0.48)
MCP1	2.17 (0.34)	2.09 (0.38)
MIP1a	0.83 (0.52)	0.89 (0.35)
sVEGF	1.93 (0.44)	1.90 (0.28)
sVCAM-1	4.90 (0.16)	5.03 (0.16)
sICAM-1	4.63 (0.11)	4.74 (0.20)

10. Primary Outcome

Title	Blood Cytokine Level at Pre-dose on Day 28
Description	Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.
Time Frame	Pre-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: pg/mL
IL-1alpha	0.69 (0.71)	0.68 (0.68)
IL-1beta	0.41 (0.45)	0.39 (0.39)
IL-4	0.24 (0.25)	0.15 (0.15)
IL-6	0.64 (0.42)	0.78 (0.32)
IL-7	0.75 (0.34)	0.53 (0.30)
IL-8	1.19 (0.36)	1.14 (0.32)
IL-10	0.18 (0.17)	0.32 (0.31)
IL-12p70	0.27 (0.26)	0.35 (0.43)
IL-17A	0.49 (0.47)	0.37 (0.37)
IL-21	1.47 (1.08)	1.53 (0.99)
IP-10	2.01 (0.19)	2.24 (0.40)
TNFalpha	0.46 (0.49)	0.43 (0.48)
IFNgamma	0.11 (0.03)	0.10 (0.00)
G-CSF	0.65 (0.39)	0.66 (0.34)
GM-CSF	0.48 (0.48)	0.35 (0.45)
MCP1	2.21 (0.35)	2.09 (0.40)
MIP1a	0.84 (0.44)	0.83 (0.34)
sVEGF	1.89 (0.41)	1.83 (0.27)
sVCAM-1	4.89 (0.14)	5.01 (0.19)
sICAM-1	4.61 (0.09)	4.70 (0.21)

11. Primary Outcome

Title	Blood Cytokine Level at 1 Hour Post-dose on Day 28
Description	Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.
Time Frame	1 Hour Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: pg/mL
IL-1alpha	0.69 (0.68)	0.69 (0.67)
IL-1beta	0.40 (0.41)	0.39 (0.38)
IL-4	0.25 (0.25)	0.15 (0.14)
IL-6	0.67 (0.52)	0.77 (0.39)
IL-7	0.69 (0.38)	0.61 (0.33)
IL-8	1.10 (0.23)	1.12 (0.33)
IL-10	0.18 (0.16)	0.33 (0.33)
IL-12p70	0.33 (0.28)	0.36 (0.44)
IL-17A	0.44 (0.45)	0.36 (0.34)
IL-21	1.46 (1.06)	1.52 (0.99)
IP-10	2.00 (0.21)	2.23 (0.39)
TNFalpha	0.39 (0.46)	0.43 (0.48)
IFNgamma	0.12 (0.06)	0.11 (0.04)
G-CSF	0.63 (0.39)	0.66 (0.29)
GM-CSF	0.47 (0.47)	0.36 (0.45)
MCP1	2.23 (0.30)	2.06 (0.35)
MIP1a	0.81 (0.45)	0.83 (0.33)
sVEGF	1.85 (0.38)	1.81 (0.26)
sVCAM-1	4.85 (0.15)	5.04 (0.17)
sICAM-1	4.58 (0.10)	4.73 (0.23)

12. Primary Outcome

Title	Blood Cytokine Level at 4 Hours Post-dose on Day 28
Description	Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.
Time Frame	4 Hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	13	13
Mean (Standard Deviation); Unit of Measure: pg/mL
IL-1alpha	0.67 (0.69)	0.75 (0.66)
IL-1beta	0.27 (0.32)	0.33 (0.39)
IL-4	0.22 (0.27)	0.14 (0.11)
IL-6	0.56 (0.30)	0.69 (0.29)
IL-7	0.66 (0.45)	0.56 (0.36)
IL-8	1.07 (0.21)	1.07 (0.25)
IL-10	0.16 (0.13)	0.28 (0.32)
IL-12p70	0.26 (0.27)	0.31 (0.44)
IL-17A	0.37 (0.44)	0.34 (0.37)
IL-21	1.51 (1.05)	1.68 (0.92)
IP-10	1.89 (0.21)	2.13 (0.36)
TNFalpha	0.38 (0.42)	0.38 (0.49)
IFNgamma	0.12 (0.07)	0.11 (0.04)
G-CSF	0.57 (0.43)	0.72 (0.26)
GM-CSF	0.49 (0.47)	0.38 (0.46)
MCP1	2.09 (0.23)	1.99 (0.38)
MIP1a	0.71 (0.48)	0.80 (0.31)
sVEGF	1.80 (0.36)	1.84 (0.28)
sVCAM-1	4.91 (0.15)	5.00 (0.14)
sICAM-1	4.61 (0.09)	4.71 (0.22)

13. Primary Outcome

Title	Blood Cytokine Level at 8 Hours Post-dose on Day 28
Description	Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.
Time Frame	8 Hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	12
Mean (Standard Deviation); Unit of Measure: pg/mL
IL-1alpha	0.76 (0.68)	0.63 (0.69)
IL-1beta	0.29 (0.35)	0.34 (0.39)
IL-4	0.23 (0.27)	0.14 (0.12)
IL-6	0.71 (0.39)	0.79 (0.34)
IL-7	0.67 (0.40)	0.66 (0.31)
IL-8	1.10 (0.21)	1.17 (0.26)
IL-10	0.15 (0.11)	0.29 (0.30)
IL-12p70	0.28 (0.28)	0.33 (0.42)
IL-17A	0.44 (0.42)	0.29 (0.36)
IL-21	1.58 (1.04)	1.30 (1.13)
IP-10	1.85 (0.22)	2.14 (0.35)
TNFalpha	0.36 (0.43)	0.35 (0.48)
IFNgamma	0.10 (0.00)	0.12 (0.07)
G-CSF	0.65 (0.37)	0.83 (0.28)
GM-CSF	0.48 (0.45)	0.38 (0.46)
MCP1	2.11 (0.31)	2.02 (0.40)
MIP1a	0.71 (0.45)	0.71 (0.35)
sVEGF	1.71 (0.36)	1.82 (0.25)
sVCAM-1	4.87 (0.16)	5.05 (0.15)
sICAM-1	4.59 (0.09)	4.74 (0.24)

14. Primary Outcome

Title	Blood Cytokine Level at 24 Hours Post-dose on Day 28
Description	Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.
Time Frame	24 Hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: pg/mL
IL-1alpha	0.73 (0.66)	0.66 (0.64)
IL-1beta	0.38 (0.41)	0.38 (0.41)
IL-4	0.26 (0.27)	0.15 (0.15)
IL-6	0.93 (0.42)	0.99 (0.47)
IL-7	0.79 (0.35)	0.64 (0.31)
IL-8	1.21 (0.32)	1.18 (0.29)
IL-10	0.22 (0.17)	0.30 (0.33)
IL-12p70	0.25 (0.25)	0.37 (0.44)
IL-17A	0.44 (0.44)	0.32 (0.32)
IL-21	1.54 (0.98)	1.64 (0.87)
IP-10	2.02 (0.31)	2.27 (0.39)
TNFalpha	0.42 (0.47)	0.42 (0.51)
IFNgamma	0.16 (0.19)	0.10 (0.00)
G-CSF	0.67 (0.39)	0.71 (0.28)
GM-CSF	0.46 (0.46)	0.31 (0.44)
MCP1	2.33 (0.24)	2.10 (0.35)
MIP1a	0.86 (0.49)	0.88 (0.28)
sVEGF	1.89 (0.41)	1.84 (0.23)
sVCAM-1	4.88 (0.14)	5.06 (0.17)
sICAM-1	4.58 (0.10)	4.74 (0.21)

15. Primary Outcome

Title	Blood Cytokine Level at Pre-dose on Day 35 or Early Termination
Description	Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.
Time Frame	Pre-dose on Day 35 or Early Termination

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: pg/mL
IL-1alpha	0.70 (0.68)	0.66 (0.66)
IL-1beta	0.43 (0.43)	0.38 (0.41)
IL-4	0.29 (0.31)	0.14 (0.13)
IL-6	0.81 (0.46)	0.66 (0.44)
IL-7	0.85 (0.31)	0.52 (0.35)
IL-8	1.08 (0.26)	1.04 (0.23)
IL-10	0.22 (0.17)	0.34 (0.37)
IL-12p70	0.32 (0.26)	0.33 (0.45)
IL-17A	0.43 (0.48)	0.36 (0.35)
IL-21	1.41 (1.04)	1.58 (0.99)
IP-10	2.20 (0.27)	2.28 (0.38)
TNFalpha	0.46 (0.48)	0.43 (0.51)
IFNgamma	0.17 (0.22)	0.10 (0.00)
G-CSF	0.57 (0.55)	0.58 (0.28)
GM-CSF	0.45 (0.46)	0.35 (0.42)
MCP1	2.17 (0.26)	2.07 (0.35)
MIP1a	0.82 (0.50)	0.85 (0.31)
sVEGF	1.92 (0.42)	1.88 (0.29)
sVCAM-1	4.97 (0.13)	5.05 (0.16)
sICAM-1	4.65 (0.12)	4.76 (0.15)

16. Primary Outcome

Title	Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
Description	Blood samples were collected for fluorescence-activated cell sorting [FACS] analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, Bone-marrow cells (B cells) and natural killer (NK) cells were analyzed using fluorescent-labeled antibodies against clusters of differentiation (CD) markers.
Time Frame	Pre-dose on Day 1

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	11	12
Mean (Standard Deviation); Unit of Measure: cells per microliter (cells/mcL)
B Cells (CD19)	214.09 (134.72)	389.17 (190.27)
Total T Cells (CD3)	1516.27 (567.38)	1579.00 (628.89)
CD8 T Cells (CD3 CD8)	402.73 (205.74)	376.67 (189.14)
CD4 T Cells (CD3 CD4)	1114.82 (415.59)	1199.17 (496.66)
NK Cells (CD16 CD56)	276.45 (134.62)	190.67 (121.20)
Immature B Cells	10.27 (11.23)	8.83 (5.65)
Naive Cells	165.64 (113.99)	273.67 (178.51)
Marginal B Cells	17.55 (7.62)	81.50 (168.29)
Memory B Cells	20.45 (12.36)	25.00 (14.83)
Central Memory CD4 Cells	627.45 (306.86)	673.33 (291.75)
Effector Memory CD4 Cells	130.09 (138.98)	93.92 (97.30)
Naive CD4 Cells	311.09 (245.67)	420.92 (294.76)
Terminally Differentiated(Diff) EffectorCD4 Cells	45.82 (83.60)	10.25 (15.15)
Central Memory CD8 Cells	117.73 (102.47)	136.58 (77.79)
Effector Memory CD8 Cells	38.55 (29.88)	68.25 (88.65)
Naive CD8 Cells	111.91 (81.86)	113.08 (50.56)
Terminally Diff Effector Memory CD8 Cells	134.36 (140.97)	58.83 (52.87)
CD4 T-Cells	81.91 (34.76)	81.92 (42.95)
CD56 Bright NK-Cells	9.27 (3.85)	7.00 (4.13)
CD56 Dim NK-Cell	209.09 (124.61)	143.83 (103.97)
CD56 Null NK-Cells	57.82 (61.05)	39.58 (27.28)
CD56 Dim Null NK-Cells	266.73 (132.17)	183.42 (118.39)

17. Primary Outcome

Title	Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
Description	Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.
Time Frame	1 Hour Post-dose on Day 1

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	13
Mean (Standard Deviation); Unit of Measure: cells/mcL
B Cells (CD19)	207.07 (128.57)	312.69 (216.36)
Total T Cells (CD3)	1533.53 (631.42)	1596.54 (754.87)
CD8 T Cells (CD3 CD8)	431.07 (229.21)	372.38 (157.96)
CD4 T Cells (CD3 CD4)	1102.60 (450.53)	1208.08 (651.25)
NK Cells (CD16 CD56)	422.87 (182.11)	179.15 (107.03)
Immature B Cells	8.40 (9.63)	8.92 (7.49)
Naive Cells	166.60 (111.95)	222.75 (185.92)
Marginal B Cells	16.20 (6.65)	78.17 (151.67)
Memory B Cells	16.07 (8.04)	25.75 (17.78)
Central Memory CD4 Cells	640.07 (314.78)	706.42 (360.34)
Effector Memory CD4 Cells	121.07 (127.98)	61.83 (45.05)
Naive CD4 Cells	298.47 (197.32)	459.75 (382.27)
Terminally Diff Effector CD4 Cells	42.93 (87.65)	4.50 (6.78)
Central Memory CD8 Cells	134.40 (102.91)	141.75 (87.65)
Effector Memory CD8 Cells	49.00 (37.44)	46.58 (64.47)
Naive CD8 Cells	114.20 (50.74)	137.33 (69.67)
Terminally Diff Effector Memory CD8 Cells	133.53 (168.92)	39.58 (36.34)
CD4 T-Cells	76.13 (39.65)	91.92 (55.68)
CD56 Bright NK-Cells	10.00 (4.75)	7.23 (4.38)
CD56 Dim NK-Cell	358.33 (171.65)	136.92 (97.23)
CD56 Null NK-Cells	54.40 (44.65)	34.77 (23.81)
CD56 Dim Null NK-Cells	412.60 (180.18)	171.62 (104.39)

18. Primary Outcome

Title	Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
Description	Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.
Time Frame	4 Hours Post-dose on Day 1

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	12
Mean (Standard Deviation); Unit of Measure: cells/mcL
B Cells (CD19)	222.79 (154.52)	380.33 (220.41)
Total T Cells (CD3)	1841.07 (880.14)	1710.42 (959.80)
CD8 T Cells (CD3 CD8)	505.64 (298.97)	393.00 (205.06)
CD4 T Cells (CD3 CD4)	1338.79 (633.15)	1312.92 (834.04)
NK Cells (CD16 CD56)	428.50 (207.39)	201.83 (192.98)
Immature B Cells	8.29 (10.41)	10.92 (10.09)
Naive Cells	177.50 (129.90)	265.00 (209.57)
Marginal B Cells	19.86 (12.60)	74.83 (129.24)
Memory B Cells	17.07 (10.98)	29.17 (23.94)
Central Memory CD4 Cells	785.43 (388.64)	720.50 (383.62)
Effector Memory CD4 Cells	155.71 (165.49)	93.42 (129.36)
Naive CD4 Cells	352.43 (307.49)	488.75 (499.88)
Terminally Diff Effector CD4 Cells	45.57 (103.39)	10.42 (18.37)
Central Memory CD8 Cells	159.21 (119.89)	140.42 (90.69)
Effector Memory CD8 Cells	64.07 (52.87)	61.33 (104.75)
Naive CD8 Cells	127.71 (54.79)	142.42 (69.46)
Terminally Diff Effector Memory CD8 Cells	154.43 (201.13)	48.67 (58.85)
CD4 T-Cells	86.36 (42.89)	97.83 (78.84)
CD56 Bright NK-Cells	11.21 (6.05)	7.17 (3.95)
CD56 Dim NK-Cell	364.57 (191.50)	157.17 (158.85)
CD56 Null NK-Cells	52.57 (48.32)	37.33 (37.57)
CD56 Dim Null NK-Cells	417.00 (204.21)	194.50 (191.68)

19. Primary Outcome

Title	Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
Description	Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.
Time Frame	Pre-dose on Day 10

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	13
Mean (Standard Deviation); Unit of Measure: cells/mcL
B Cells (CD19)	290.50 (144.94)	310.92 (154.13)
Total T Cells (CD3)	1732.29 (581.98)	1477.08 (696.45)
CD8 T Cells (CD3 CD8)	413.64 (169.81)	384.15 (216.57)
CD4 T Cells (CD3 CD4)	1314.64 (475.64)	1084.62 (547.23)
NK Cells (CD16 CD56)	258.79 (177.98)	205.38 (138.20)
Immature B Cells	11.21 (9.96)	8.85 (7.99)
Naive Cells	218.57 (121.71)	211.38 (133.45)
Marginal B Cells	32.29 (20.28)	69.23 (135.70)
Memory B Cells	28.50 (14.53)	21.31 (13.01)
Central Memory CD4 Cells	696.21 (294.16)	603.54 (300.56)
Effector Memory CD4 Cells	130.86 (139.79)	78.92 (102.26)
Naive CD4 Cells	453.86 (314.82)	393.08 (296.88)
Terminally Diff Effector CD4 Cells	33.43 (52.47)	9.31 (18.40)
Central Memory CD8 Cells	126.71 (95.74)	132.46 (76.09)
Effector Memory CD8 Cells	37.57 (27.11)	69.38 (104.84)
Naive CD8 Cells	136.93 (66.75)	122.54 (91.92)
Terminally Diff Effector Memory CD8 Cells	112.50 (114.14)	59.77 (70.15)
CD4 T-Cells	93.64 (57.44)	79.69 (43.04)
CD56 Bright NK-Cells	5.07 (2.37)	8.23 (4.80)
CD56 Dim NK-Cell	207.50 (162.82)	149.54 (115.63)
CD56 Null NK-Cells	46.29 (52.45)	47.46 (35.83)
CD56 Dim Null NK-Cells	253.64 (176.82)	196.92 (136.36)

20. Primary Outcome

Title	Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
Description	Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.
Time Frame	Pre-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	13	12
Mean (Standard Deviation); Unit of Measure: cells/mcL
B Cells (CD19)	399.62 (208.61)	392.25 (235.63)
Total T Cells(CD3)	1730.38 (730.18)	1451.92 (622.86)
CD8 T Cells (CD3 CD8)	363.85 (143.45)	346.58 (206.22)
CD4 T Cells (CD3 CD4)	1352.46 (618.78)	1102.08 (454.72)
NK Cells (CD16 CD56)	184.92 (103.73)	180.33 (123.31)
Immature B Cells	13.85 (8.99)	11.25 (11.86)
Naive Cells	304.77 (177.06)	280.50 (212.30)
Marginal B Cells	44.31 (36.38)	73.75 (159.25)
Memory B Cells	36.69 (18.14)	26.50 (19.50)
Central Memory CD4 Cells	736.00 (272.68)	623.67 (259.72)
Effector Memory CD4 Cells	118.54 (91.20)	90.00 (98.80)
Naive CD4 Cells	475.23 (421.51)	378.50 (193.71)
Terminally Diff Effector CD4 Cells	22.69 (28.46)	9.50 (14.13)
Central Memory CD8 Cells	120.69 (65.03)	120.50 (68.09)
Effector Memory CD8 Cells	32.92 (25.69)	55.50 (67.08)
Naive CD8 Cells	131.38 (85.53)	121.75 (86.96)
Terminally Diff Effector Memory CD8 Cells	78.46 (81.53)	49.00 (61.65)
CD4 T-Cells	84.38 (54.71)	75.08 (43.97)
CD56 Bright NK-Cells	4.15 (2.03)	7.17 (4.41)
CD56 Dim NK-Cell	127.15 (78.63)	134.25 (103.99)
CD56 Null NK-Cells	53.77 (51.21)	38.83 (35.54)
CD56 Dim Null NK-Cells	180.77 (103.02)	173.17 (119.76)

21. Primary Outcome

Title	Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
Description	Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.
Time Frame	1 Hour Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	14
Mean (Standard Deviation); Unit of Measure: cells/mcL
B Cells (CD19)	343.21 (159.97)	329.00 (202.97)
Total T Cells(CD3)	1705.57 (621.55)	1630.64 (816.41)
CD8 T Cells (CD3 CD8)	409.71 (158.79)	482.07 (388.11)
CD4 T Cells (CD3 CD4)	1281.00 (491.92)	1145.50 (522.79)
NK Cells (CD16 CD56)	309.43 (112.95)	339.50 (426.91)
Immature B Cells	12.43 (7.84)	9.14 (9.04)
Naive Cells	261.57 (140.28)	233.86 (171.68)
Marginal B Cells	36.43 (20.14)	63.00 (141.24)
Memory B Cells	32.57 (15.27)	23.07 (17.84)
Central Memory CD4 Cells	723.43 (253.15)	614.50 (219.76)
Effector Memory CD4 Cells	117.21 (99.96)	143.14 (237.16)
Naive CD4 Cells	418.93 (321.41)	370.43 (199.66)
Terminally Diff Effector CD4 Cells	21.07 (31.32)	17.43 (36.50)
Central Memory CD8 Cells	141.50 (82.12)	128.14 (70.76)
Effector Memory CD8 Cells	36.07 (23.82)	114.79 (187.14)
Naive CD8 Cells	135.29 (83.65)	140.07 (101.82)
Terminally Diff Effector Memory CD8 Cells	97.21 (109.27)	98.93 (154.16)
CD4 T-Cells	88.50 (51.93)	78.64 (41.50)
CD56 Bright NK-Cells	4.71 (2.43)	8.14 (5.53)
CD56 Dim NK-Cell	258.43 (111.98)	284.14 (394.73)
CD56 Null NK-Cells	46.29 (25.38)	46.93 (52.57)
CD56 Dim Null NK-Cells	304.64 (112.88)	331.14 (422.93)

22. Primary Outcome

Title	Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
Description	Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.
Time Frame	4 Hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	11	12
Mean (Standard Deviation); Unit of Measure: cells/mcL
B Cells (CD19)	336.45 (194.70)	347.67 (233.30)
Total T Cells(CD3)	1483.00 (495.98)	1445.83 (712.35)
CD8 T Cells (CD3 CD8)	355.27 (111.71)	346.00 (209.68)
CD4 T Cells (CD3 CD4)	1122.91 (419.02)	1095.00 (565.70)
NK Cells (CD16 CD56)	188.36 (59.25)	200.75 (191.26)
Immature B Cells	10.73 (8.33)	10.33 (10.82)
Naive Cells	256.91 (156.81)	247.17 (207.69)
Marginal B Cells	38.73 (38.69)	67.17 (129.67)
Memory B Cells	29.91 (17.27)	23.17 (19.64)
Central Memory CD4 Cells	675.55 (270.78)	631.50 (260.76)
Effector Memory CD4 Cells	110.09 (69.34)	85.92 (134.06)
Naive CD4 Cells	312.00 (237.45)	369.50 (314.06)
Terminally Diff Effector CD4 Cells	24.91 (30.27)	8.17 (20.56)
Central Memory CD8 Cells	118.09 (78.61)	112.83 (60.76)
Effector Memory CD8 Cells	37.09 (27.50)	60.17 (91.98)
Naive CD8 Cells	126.00 (90.18)	133.17 (98.02)
Terminally Diff Effector Memory CD8 Cells	73.91 (58.79)	40.00 (75.37)
CD4 T-Cells	64.09 (33.05)	65.36 (36.70)
CD56 Bright NK-Cells	4.55 (2.42)	6.83 (4.71)
CD56 Dim NK-Cell	143.55 (49.57)	163.50 (158.10)
CD56 Null NK-Cells	40.36 (25.74)	30.50 (35.48)
CD56 Dim Null NK-Cells	183.64 (58.53)	193.92 (188.21)

23. Primary Outcome

Title	Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
Description	Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.
Time Frame	8 Hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	12	11
Mean (Standard Deviation); Unit of Measure: cells/mcL
B Cells (CD19)	382.33 (204.55)	318.27 (253.87)
Total T Cells(CD3)	1557.58 (601.36)	1616.00 (934.75)
CD8 T Cells (CD3 CD8)	348.33 (135.33)	420.18 (226.60)
CD4 T Cells (CD3 CD4)	1203.67 (491.02)	1186.73 (788.19)
NK Cells (CD16 CD56)	174.58 (82.07)	217.91 (148.22)
Immature B Cells	11.25 (7.10)	7.30 (8.08)
Naive Cells	291.33 (165.84)	243.10 (220.30)
Marginal B Cells	46.50 (38.57)	76.60 (142.34)
Memory B Cells	33.00 (20.82)	22.70 (19.96)
Central Memory CD4 Cells	726.75 (293.12)	725.00 (424.16)
Effector Memory CD4 Cells	119.17 (87.92)	85.64 (127.90)
Naive CD4 Cells	338.17 (270.26)	367.73 (378.39)
Terminally Diff Effector CD4 Cells	19.83 (21.41)	8.27 (18.79)
Central Memory CD8 Cells	115.92 (51.47)	149.27 (86.30)
Effector Memory CD8 Cells	35.33 (25.27)	85.09 (110.75)
Naive CD8 Cells	133.25 (95.54)	133.64 (111.11)
Terminally Diff Effector Memory CD8 Cells	64.08 (56.47)	52.27 (72.48)
CD4 T-Cells	79.00 (53.92)	89.50 (72.98)
CD56 Bright NK-Cells	3.36 (1.80)	7.27 (4.29)
CD56 Dim NK-Cell	117.18 (59.33)	164.36 (125.72)
CD56 Null NK-Cells	41.91 (29.36)	46.27 (38.40)
CD56 Dim Null NK-Cells	158.91 (74.78)	210.64 (145.85)

24. Primary Outcome

Title	Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
Description	Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.
Time Frame	24 Hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	12	12
Mean (Standard Deviation); Unit of Measure: cells/mcL
B Cells (CD19)	276.00 (167.25)	300.92 (191.57)
Total T Cells(CD3)	1044.08 (505.60)	1619.33 (913.77)
CD8 T Cells (CD3 CD8)	239.92 (113.32)	382.75 (200.38)
CD4 T Cells (CD3 CD4)	799.50 (408.07)	1223.17 (779.67)
NK Cells (CD16 CD56)	92.92 (52.30)	196.67 (152.83)
Immature B Cells	10.00 (4.20)	9.75 (9.52)
Naive Cells	215.83 (146.07)	245.33 (173.16)
Marginal B Cells	25.58 (18.78)	24.08 (27.05)
Memory B Cells	24.83 (11.10)	21.75 (16.10)
Central Memory CD4 Cells	431.92 (186.89)	626.00 (339.12)
Effector Memory CD4 Cells	59.58 (41.84)	79.50 (119.68)
Naive CD4 Cells	297.17 (287.44)	508.83 (483.29)
Terminally Diff Effector CD4 Cells	11.00 (18.39)	9.00 (18.01)
Central Memory CD8 Cells	85.50 (72.10)	133.33 (83.39)
Effector Memory CD8 Cells	16.75 (8.58)	59.17 (93.93)
Naive CD8 Cells	89.25 (62.57)	142.08 (131.13)
Terminally Diff Effector Memory CD8 Cells	48.42 (55.68)	48.17 (60.46)
CD4 T Cells	61.67 (41.32)	92.58 (59.44)
CD56 Bright NK-Cells	1.83 (1.11)	8.50 (4.76)
CD56 Dim NK-Cell	65.42 (47.76)	158.17 (137.82)
CD56 Null NK-Cells	25.50 (12.72)	30.08 (26.57)
CD56 Dim Null NK-Cells	91.08 (51.61)	187.92 (149.63)

25. Primary Outcome

Title	Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
Description	Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.
Time Frame	Pre-dose on Day 35 or Early Termination

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	12
Mean (Standard Deviation); Unit of Measure: cells/mcL
B Cells (CD19)	173.86 (95.29)	344.17 (211.00)
Total T Cells (CD3)	1044.07 (529.37)	1411.75 (474.97)
CD8 T Cells (CD3+CD8)	253.64 (190.57)	364.92 (202.70)
CD4 T Cells (CD3 CD4)	781.57 (350.40)	1046.00 (328.08)
NK Cells (CD16 CD56)	162.21 (116.20)	179.67 (142.64)
Immature B Cells	5.57 (3.59)	11.17 (9.99)
Naive Cells	136.43 (80.37)	252.92 (206.67)
Marginal B Cells	15.50 (8.72)	57.58 (102.20)
Memory B Cells	16.36 (12.73)	22.50 (13.93)
Central Memory CD4 Cells	416.93 (167.72)	605.00 (222.14)
Effector Memory CD4 Cells	56.29 (51.24)	97.25 (103.24)
Naive CD4 Cells	290.36 (244.79)	333.83 (132.59)
Terminally Diff Effector CD4 Cells	18.00 (24.88)	9.75 (16.44)
Central Memory CD8 Cells	73.71 (58.46)	109.42 (49.90)
Effector Memory CD8 Cells	17.93 (13.74)	70.58 (99.36)
Naive CD8 Cells	101.79 (126.51)	133.75 (97.93)
Terminally Diff Effector Memory CD8 Cells	60.07 (67.10)	51.08 (61.27)
CD4 T Cells	66.64 (40.58)	73.50 (39.02)
CD56 Bright NK-Cells	3.62 (2.60)	6.33 (3.52)
CD56 Dim NK-Cell	99.00 (89.92)	141.17 (130.25)
CD56 Null NK-Cells	66.23 (72.59)	32.25 (19.30)
CD56 Dim Null NK-Cells	165.15 (115.88)	173.25 (141.06)

26. Primary Outcome

Title	Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 1
Description	Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific Enzyme-Linked Immunosorbent Assay [ELISA] method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples).
Time Frame	Pre-dose on Day 1

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: nanogram per milliliter (ng/mL)
MMP3	38.31 (32.24)	24.52 (12.65)
Osteocalcin	19.54 (8.23)	18.54 (12.31)
Osteopontin	108.40 (42.59)	98.11 (37.04)

27. Primary Outcome

Title	Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 1
Description	Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.
Time Frame	1 Hour Post-dose on Day 1

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: ng/mL
MMP3	37.30 (32.40)	22.42 (12.06)
Osteocalcin	18.90 (8.12)	18.01 (11.38)
Osteopontin	101.10 (40.23)	94.37 (39.02)

28. Primary Outcome

Title	Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 1
Description	Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.
Time Frame	4 Hours Post-dose on Day 1

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: ng/mL
MMP3	36.98 (30.72)	22.09 (12.08)
Osteocalcin	18.17 (7.30)	19.01 (13.17)
Osteopontin	99.82 (36.77)	95.23 (38.37)

29. Primary Outcome

Title	Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 10
Description	Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.
Time Frame	Pre-dose on Day 10

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: ng/mL
MMP3	32.10 (26.89)	21.05 (12.28)
Osteocalcin	21.35 (8.87)	18.60 (11.28)
Osteopontin	91.13 (29.16)	91.12 (34.13)

30. Primary Outcome

Title	Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 28
Description	Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.
Time Frame	Pre-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: ng/mL
MMP3	25.18 (22.33)	19.26 (11.64)
Osteocalcin	22.05 (9.28)	16.51 (9.06)
Osteopontin	78.23 (17.23)	79.93 (18.63)

31. Primary Outcome

Title	Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 28
Description	Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.
Time Frame	1 Hour Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: ng/mL
MMP3	21.59 (19.30)	18.86 (11.73)
Osteocalcin	21.45 (9.65)	17.37 (8.85)
Osteopontin	78.60 (19.24)	86.66 (29.65)

32. Primary Outcome

Title	Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 28
Description	Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.
Time Frame	4 Hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	13	13
Mean (Standard Deviation); Unit of Measure: ng/mL
MMP3	19.71 (17.65)	16.67 (10.70)
Osteocalcin	21.09 (8.26)	15.45 (7.22)
Osteopontin	71.52 (24.92)	86.56 (33.00)

33. Primary Outcome

Title	Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 8 Hours Post-dose on Day 28
Description	Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.
Time Frame	8 Hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	12
Mean (Standard Deviation); Unit of Measure: ng/mL
MMP3	17.94 (14.38)	16.68 (11.75)
Osteocalcin	20.93 (6.37)	16.67 (8.63)
Osteopontin	75.32 (21.32)	89.84 (33.02)

34. Primary Outcome

Title	Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 24 Hours Post-dose on Day 28
Description	Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.
Time Frame	24 Hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	14
Mean (Standard Deviation); Unit of Measure: ng/mL
MMP3	24.48 (20.82)	26.20 (15.56)
Osteocalcin	20.96 (9.45)	17.49 (9.57)
Osteopontin	82.60 (22.28)	95.51 (28.50)

35. Primary Outcome

Title	Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 35 or Early Termination
Description	Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.
Time Frame	Pre-dose on Day 35 or Early Termination

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: ng/mL
MMP3	28.98 (21.36)	28.72 (24.48)
Osteocalcin	21.79 (9.38)	16.60 (10.48)
Osteopontin	95.93 (29.73)	86.48 (29.69)

36. Primary Outcome

Title	Parathyroid Hormone (PTH) Level at Pre-dose on Day 1
Description	Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Time Frame	Pre-dose on Day 1

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: pg/mL
	38.40 (17.44)	33.32 (5.80)

37. Primary Outcome

Title	Parathyroid Hormone (PTH) Level at 1 Hour Post-dose on Day 1
Description	Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Time Frame	1 Hour Post-dose on Day 1

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	13
Mean (Standard Deviation); Unit of Measure: pg/mL
	33.89 (13.44)	31.48 (8.77)

38. Primary Outcome

Title	Parathyroid Hormone (PTH) Level at 4 Hours Post-dose on Day 1
Description	Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Time Frame	4 Hours Post-dose on Day 1

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	13
Mean (Standard Deviation); Unit of Measure: pg/mL
	32.97 (13.31)	33.35 (7.12)

39. Primary Outcome

Title	Parathyroid Hormone (PTH) Level at Pre-dose on Day 10
Description	Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Time Frame	Pre-dose on Day 10

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	13
Mean (Standard Deviation); Unit of Measure: pg/mL
	34.93 (11.76)	31.48 (8.37)

40. Primary Outcome

Title	Parathyroid Hormone (PTH) Level at Pre-dose on Day 28
Description	Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Time Frame	Pre-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	14
Mean (Standard Deviation); Unit of Measure: pg/mL
	38.46 (12.64)	33.39 (8.94)

41. Primary Outcome

Title	Parathyroid Hormone (PTH) Level at 1 Hour Post-dose on Day 28
Description	Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Time Frame	1 Hour Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: pg/mL
	37.97 (14.05)	33.93 (7.51)

42. Primary Outcome

Title	Parathyroid Hormone (PTH) Level at 4 Hours Post-dose on Day 28
Description	Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Time Frame	4 Hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	13	13
Mean (Standard Deviation); Unit of Measure: pg/mL
	38.70 (13.25)	36.65 (12.54)

43. Primary Outcome

Title	Parathyroid Hormone (PTH) Level at 8 Hours Post-dose on Day 28
Description	Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Time Frame	8 Hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	11
Mean (Standard Deviation); Unit of Measure: pg/mL
	37.76 (15.90)	37.82 (18.84)

44. Primary Outcome

Title	Parathyroid Hormone (PTH) Level at 24 Hours Post-dose on Day 28
Description	Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Time Frame	24 Hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	13	12
Mean (Standard Deviation); Unit of Measure: pg/mL
	35.91 (19.94)	36.08 (10.17)

45. Primary Outcome

Title	Parathyroid Hormone (PTH) Level at Pre-dose on Day 35 or Early Termination
Description	Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Time Frame	Pre-dose on Day 35 or Early Termination

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: pg/mL
	37.30 (14.86)	34.59 (10.40)

46. Primary Outcome

Title	Osteoprotegerin (OPG) Level at Pre-dose on Day 1
Description	Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Time Frame	Pre-dose on Day 1

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: picomole per liter (pmol/L)
	5.99 (2.04)	6.21 (1.91)

47. Primary Outcome

Title	Osteoprotegerin (OPG) Level at 1 Hour Post-dose on Day 1
Description	Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Time Frame	1 Hour Post-dose on Day 1

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: pmol/L
	6.13 (1.99)	5.72 (2.16)

48. Primary Outcome

Title	Osteoprotegerin (OPG) Level at 4 Hours Post-dose on Day 1
Description	Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Time Frame	4 Hours Post-dose on Day 1

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	13
Mean (Standard Deviation); Unit of Measure: picomole per liter (pmol/L)
	5.50 (1.53)	5.35 (1.86)

49. Primary Outcome

Title	Osteoprotegerin (OPG) Level at Pre-dose on Day 10
Description	Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Time Frame	Pre-dose on Day 10

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	14
Mean (Standard Deviation); Unit of Measure: pmol/L
	6.02 (1.88)	5.82 (2.22)

50. Primary Outcome

Title	Osteoprotegerin (OPG) Level at Pre-dose on Day 28
Description	Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Time Frame	Pre-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: pmol/L
	5.53 (1.79)	5.64 (2.48)

51. Primary Outcome

Title	Osteoprotegerin (OPG) Level at 1 Hour Post-dose on Day 28
Description	Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Time Frame	1 Hour Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: pmol/L
	5.72 (1.86)	5.56 (2.14)

52. Primary Outcome

Title	Osteoprotegerin (OPG) Level at 4 Hours Post-dose on Day 28
Description	Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Time Frame	4 Hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	13	13
Mean (Standard Deviation); Unit of Measure: pmol/L
	5.18 (1.55)	5.69 (2.13)

53. Primary Outcome

Title	Osteoprotegerin (OPG) Level at 8 Hours Post-dose on Day 28
Description	Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Time Frame	8 Hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	12
Mean (Standard Deviation); Unit of Measure: pmol/L
	4.64 (1.28)	5.64 (2.39)

54. Primary Outcome

Title	Osteoprotegerin (OPG) Level at 24 Hours Post-dose on Day 28
Description	Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Time Frame	24 Hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	14
Mean (Standard Deviation); Unit of Measure: pmol/L
	7.22 (2.74)	6.20 (2.07)

55. Primary Outcome

Title	Osteoprotegerin(OPG) Level at Pre-dose on Day 35 or Early Termination
Description	Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Time Frame	Pre-dose on Day 35 or Early Termination

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: pmol/L
	6.31 (1.70)	5.65 (2.01)

56. Primary Outcome

Title	Plasma Level of Matrix Metallopeptidase (MMP13)
Description	[Not Specified]
Time Frame	Pre-dose on Day 1, 10, 28 and 35 or Early Termination; 1, 4 hours Post-dose on Day 1, 28; 8, 24 hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

Analyses of MMP13 was not performed as valid assay for MMP13 was not available.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

57. Primary Outcome

Title	Plasma Level of Interleukin-34 (IL-34) and Interleukin-18 (IL-18)
Description	[Not Specified]
Time Frame	Pre-dose on Day 1, 10, 28 and 35 or Early Termination; 1, 4 hours Post-dose on Day 1, 28; 8, 24 hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

Analyses of IL-34 and IL-18 were not performed as a valid assay was not available.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

58. Primary Outcome

Title	Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 1
Description	Serum samples were analyzed for SAA concentrations using meso scale discovery (MSD) single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific Electro ChemiLuminescent ImmunoAssay (ECLIA).
Time Frame	Pre-dose on Day 1

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	14
Mean (Standard Deviation); Unit of Measure: ng/mL
SAA (n=14, 14)	26383.03 (43196.37)	23427.00 (43431.26)
CTX-1 (n=14, 12)	0.43 (0.26)	0.37 (0.27)

59. Primary Outcome

Title	Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 1
Description	Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.
Time Frame	1 Hour Post-dose on Day 1

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	14
Mean (Standard Deviation); Unit of Measure: ng/mL
SAA	25716.93 (42986.70)	23308.57 (41911.51)
CTX-1	0.36 (0.25)	0.32 (0.22)

60. Primary Outcome

Title	Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 1
Description	Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.
Time Frame	4 Hours Post-dose on Day 1

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	13
Mean (Standard Deviation); Unit of Measure: ng/mL
SAA	26460.26 (46059.64)	27297.36 (52346.36)
CTX-1	0.25 (0.12)	0.25 (0.19)

61. Primary Outcome

Title	Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 10
Description	Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.
Time Frame	Pre-dose on Day 10

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	13
Mean (Standard Deviation); Unit of Measure: ng/mL
SAA	5968.89 (5509.18)	31666.50 (92833.52)
CTX-1	0.34 (0.16)	0.35 (0.22)

62. Primary Outcome

Title	Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 28
Description	Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.
Time Frame	Pre-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: ng/mL
SAA	4094.94 (2527.72)	14818.88 (18346.19)
CTX-1	0.36 (0.19)	0.35 (0.19)

63. Primary Outcome

Title	Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 28
Description	Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.
Time Frame	1 Hour Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	14
Mean (Standard Deviation); Unit of Measure: ng/mL
SAA	3921.49 (2291.33)	18976.74 (29228.65)
CTX-1	0.32 (0.16)	0.35 (0.25)

64. Primary Outcome

Title	Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 28
Description	Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.
Time Frame	4 Hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	13	13
Mean (Standard Deviation); Unit of Measure: ng/mL
SAA	4042.21 (2974.03)	20123.97 (31463.56)
CTX-1	0.29 (0.17)	0.20 (0.12)

65. Primary Outcome

Title	Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 8 Hours Post-dose on Day 28
Description	Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.
Time Frame	8 Hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	12
Mean (Standard Deviation); Unit of Measure: ng/mL
SAA (n=14, 12)	4113.05 (2939.86)	15403.08 (24616.14)
CTX-1 (n=12, 12)	0.28 (0.17)	0.31 (0.21)

66. Primary Outcome

Title	Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 24 Hours Post-dose on Day 28
Description	Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.
Time Frame	24 Hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	13	14
Mean (Standard Deviation); Unit of Measure: ng/mL
SAA	6643.14 (6504.55)	14627.28 (16685.62)
CTX-1	0.28 (0.16)	0.28 (0.13)

67. Primary Outcome

Title	Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 35 or Early Termination
Description	Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.
Time Frame	Pre-dose on Day 35 or Early Termination

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: ng/mL
SAA	22174.19 (25387.79)	33853.61 (88542.43)
CTX-1	0.27 (0.15)	0.34 (0.16)

68. Primary Outcome

Title	Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 1
Description	Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.
Time Frame	Pre-dose on Day 1

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	13
Mean (Standard Deviation); Unit of Measure: pg/mL
IL-1ra	545.71 (279.48)	449.38 (163.85)
IL-15	8.00 (0.00)	8.00 (0.00)

69. Primary Outcome

Title	Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 1
Description	Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.
Time Frame	1 Hour Post-dose on Day 1

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	14
Mean (Standard Deviation); Unit of Measure: pg/mL
IL-1ra	565.43 (262.73)	479.93 (167.61)
IL-15	8.00 (0.00)	8.00 (0.00)

70. Primary Outcome

Title	Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 1
Description	Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.
Time Frame	4 Hours Post-dose on Day 1

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	13
Mean (Standard Deviation); Unit of Measure: pg/mL
IL-1ra	518.29 (297.33)	477.25 (142.17)
IL-15	8.00 (0.00)	8.00 (0.00)

71. Primary Outcome

Title	Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 10
Description	Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.
Time Frame	Pre-dose on Day 10

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	13
Mean (Standard Deviation); Unit of Measure: pg/mL
IL-1ra	487.00 (265.16)	465.00 (176.17)
IL-15	8.00 (0.00)	8.00 (0.00)

72. Primary Outcome

Title	Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 28
Description	Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.
Time Frame	Pre-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	13
Mean (Standard Deviation); Unit of Measure: pg/mL
IL-1ra	437.73 (171.93)	617.38 (624.81)
IL-15	8.00 (0.00)	8.00 (0.00)

73. Primary Outcome

Title	Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 28
Description	Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.
Time Frame	1 Hour Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	13
Mean (Standard Deviation); Unit of Measure: pg/mL
IL-1ra	421.00 (196.57)	501.31 (337.85)
IL-15	8.00 (0.00)	8.00 (0.00)

74. Primary Outcome

Title	Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 28
Description	Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.
Time Frame	4 Hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	13	13
Mean (Standard Deviation); Unit of Measure: pg/mL
IL-1ra (n= 13, 13)	388.15 (147.27)	552.85 (415.32)
IL-15 (n=11, 12)	8.00 (0.00)	8.00 (0.00)

75. Primary Outcome

Title	Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 8 Hours Post-dose on Day 28
Description	Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.
Time Frame	8 Hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	12	12
Mean (Standard Deviation); Unit of Measure: pg/mL
IL-1ra (n=12, 12)	399.08 (157.84)	414.67 (152.99)
IL-15 (n=12, 10)	8.00 (0.00)	8.00 (0.00)

76. Primary Outcome

Title	Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 24 Hours Post-dose on Day 28
Description	Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.
Time Frame	24 Hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	13	14
Mean (Standard Deviation); Unit of Measure: pg/mL
IL-1ra	500.38 (187.55)	462.57 (175.80)
IL-15	8.26 (0.94)	8.00 (0.00)

77. Primary Outcome

Title	Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 35 or Early Termination
Description	Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.
Time Frame	Pre-dose on Day 35 or Early Termination

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: pg/mL
IL-1ra	520.87 (282.88)	486.57 (317.27)
IL-15	8.00 (0.00)	8.00 (0.00)

78. Primary Outcome

Title	Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 1
Description	Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as nanogram per millimoles of creatinine (ng/mmol Cr).
Time Frame	Pre-dose on Day 1

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	13	13
Mean (Standard Deviation); Unit of Measure: ng/mmol Cr
	454.74 (216.74)	345.87 (259.83)

79. Primary Outcome

Title	Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 10
Description	Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.
Time Frame	Pre-dose on Day 10

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	13
Mean (Standard Deviation); Unit of Measure: ng/mmol Cr
	318.10 (208.07)	423.76 (389.15)

80. Primary Outcome

Title	Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 28
Description	Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.
Time Frame	Pre-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: ng/mmol Cr
	320.42 (192.31)	409.89 (338.67)

81. Primary Outcome

Title	Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at 24 Hours Post-dose on Day 28
Description	Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.
Time Frame	24 Hours Post-dose on Day 28

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	13
Mean (Standard Deviation); Unit of Measure: ng/mmol Cr
	267.86 (159.63)	284.87 (202.92)

82. Primary Outcome

Title	Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 35 or Early Termination
Description	Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.
Time Frame	Pre-dose on Day 35 or Early Termination

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	14	14
Mean (Standard Deviation); Unit of Measure: ng/mmol Cr
	278.55 (198.90)	340.83 (379.42)

83. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 20% Response
Description	ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Time Frame	Day 28, 35 or Early Termination

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Measure Type: Number; Unit of Measure: percentage of participants
Day 28	60.0	0.0
Day 35 or Early Termination	33.3	0.0

84. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Description	ACR50 response: >=50% improvement in TJC; >= 50% improvement in SJC; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame	Day 28, 35 or Early Termination

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Measure Type: Number; Unit of Measure: percentage of participants
Day 28	40.0	0.0
Day 35 or Early Termination	13.3	0.0

85. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Description	ACR70 response: >=70% improvement in TJC; >= 70% improvement in SJC; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame	Day 28, 35 or Early Termination

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Measure Type: Number; Unit of Measure: percentage of participants
Day 28	6.7	0.0
Day 35 or Early Termination	6.7	0.0

86. Secondary Outcome

Title	Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Description	DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP) (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6 implied remission.
Time Frame	Day -7, 1 (Baseline), 28, 35 or Early Termination

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: units on a scale
Day -7	5.58 (0.87)	5.06 (1.16)
Day 1 (Baseline)	5.57 (0.78)	5.22 (0.96)
Day 28	4.06 (0.97)	4.91 (0.92)
Day 35 or Early Termination	4.91 (1.10)	4.79 (1.10)

87. Secondary Outcome

Title	Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 28 and 35
Description	DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP (mg/mL). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame	Day 1 (Baseline), 28, 35 or Early Termination

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: units on a scale
Day 28	-1.51 (0.97)	-0.31 (0.49)
Day 35 or Early Termination	-0.66 (0.96)	-0.43 (0.40)

88. Secondary Outcome

Title	Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6
Description	DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP (mg/mL). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame	Day -7, 1 (Baseline), 28, 35 or Early Termination

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Measure Type: Number; Unit of Measure: percentage of participants
Day -7: DAS28-3 (CRP) <=3.2	0.0	7.1
Day -7: DAS28-3 (CRP) <2.6	0.0	0.0
Day 1 (Baseline): DAS28-3 (CRP) <=3.2	0.0	0.0
Day 1 (Baseline): DAS28-3 (CRP) <2.6	0.0	0.0
Day 28: DAS28-3 (CRP) <=3.2	20.0	14.3
Day 28: DAS28-3 (CRP) <2.6	0.0	0.0
Day 35 or Early Termination: DAS28-3 (CRP) <=3.2	6.7	7.1
Day 35 or Early Termination: DAS28-3 (CRP) <2.6	0.0	0.0

89. Secondary Outcome

Title	Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
Description	DAS28-4 (ESR) was calculated from the number of SJC, TJC using the 28 joints count, ESR (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity, > 3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame	Day -7, 1 (Baseline), 28, 35 or Early Termination

Outcome Measure Data

Analysis Population Description

FAS included all randomized participants who received at least 1 dose of the study medication.

Arm/Group Title	CP-690,550	Placebo
Arm/Group Description:	CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.	Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
Overall Number of Participants Analyzed	15	14
Mean (Standard Deviation); Unit of Measure: units on a scale
Day -7	6.60 (0.98)	6.17 (1.12)
Day 1 (Baseline)	6.55 (0.98)	6.32 (1.01)
Day 28	4.90 (1.11)	6.03 (0.98)
Day 35 or Early Termination	5.83 (1.23)	6.00 (1.01)

90. Secondary Outcome

Title	Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Day 28 and 35
Description	DAS28-4 (ESR) was calculated from the number of SJC, TJC using the 28 joints count, ESR [mm/hour] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity, > 3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.