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

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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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CP-690,550 Placebo
Hide 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
Arm/Group Title CP-690,550 Placebo Total
Hide 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
Hide 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%
1.Primary Outcome
Title Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Time Frame Pre-dose on Day 1
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Time Frame Pre-dose on Day 10
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Time Frame Pre-dose on Day 28
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Time Frame Pre-dose on Day 1
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Time Frame Pre-dose on Day 10
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Time Frame Pre-dose on Day 28
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses of MMP13 was not performed as valid assay for MMP13 was not available.
Arm/Group Title CP-690,550 Placebo
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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