Rheumatoid Arthritis
Conditions
Brief summary
To explore the effect of CP-690,550 on blood and synovial markers in subjects with rheumatoid arthritis. To evaluate the safety, tolerability and efficacy of CP-690,550.
Interventions
DRUGCP-690,550 + methotrexate
CP-690,550 dose is 10 mg twice daily, oral tablets, for 4 weeks Methotrexate dose is ≥ 7.5 mg / week and ≤ 25 mg / week
Methotrexate dose is ≥ 7.5 mg / week and ≤ 25 mg / week
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must have a diagnosis of rheumatoid arthritis based on the American College of Rheumatology Association * The subject has active disease at both Screening and Baseline, as defined: * ≥4 joints tender or painful on motion, AND * ≥4 joints swollen; * The subject must have at least one knee, one elbow, one wrist or two metacarpophalangeal joints with active synovitis suitable for biopsy by the shaver technique
Exclusion criteria
* No arthroscopy should have been performed in the past 3 months in the same joint that is to be biopsied in this study. * No intra-articular steroids should have been injected in the joint to be biopsied in this study in the previous 3 months. * Subjects with evidence of hematopoietic disorders or evidence of hemoglobin levels \< 9.0 gm/dL or hematocrit \< 30 % at screening visit or within the 3 months prior to baseline synovial biopsy. * An absolute white blood cell (WBC) count of \< 3.0 x 109/L (\<3000/mm3) or absolute neutrophil count of \<1.2 X 109/L (\<1200/mm3) at screening visit or within the 3 months prior to baseline synovial biopsy. * Thrombocytopenia, as defined by a platelet count \<100 x 109/L (\< 100,000/mm3) at screening visit or within the 3 months prior to baseline synovial biopsy. * Estimated GFR less than 40 ml/min based on Cockcroft Gault calculation .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 35 or Early Termination | Pre-dose on Day 35 or Early Termination | Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr. |
| Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 28 | Pre-dose on Day 28 | Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method. |
| Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 28 | 1 Hour Post-dose on Day 28 | Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method. |
| Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 28 | 4 Hours Post-dose on Day 28 | Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method. |
| Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 8 Hours Post-dose on Day 28 | 8 Hours Post-dose on Day 28 | Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method. |
| Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 24 Hours Post-dose on Day 28 | 24 Hours Post-dose on Day 28 | Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method. |
| Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 35 or Early Termination | Pre-dose on Day 35 or Early Termination | Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method. |
| Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 1 | Pre-dose on Day 1 | 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). |
| Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 10 | Pre-dose on Day 10 | Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr. |
| Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 28 | Pre-dose on Day 28 | Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr. |
| Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Day -7 (Baseline), Day 28 | 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. |
| 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 | Baseline (Day -7), Day 28 | 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. |
| Change From Baseline in Percentage of Area Stained For CD3+ and CD68+ Surface Markers of Inflammatory Cells of the Synovial Tissue at Day 28 | Baseline (Day -7), Day 28 | 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. |
| Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7) | Baseline (Day -7) | 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. |
| Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28 | Day 28 | 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. |
| Blood Cytokine Level at Pre-dose on Day 1 | Pre-dose on Day 1 | 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). |
| Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | 4 Hours Post-dose on Day 1 | 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. |
| Blood Cytokine Level at 1 Hour Post-dose on Day 1 | 1 hour post-dose on Day 1 | 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. |
| Blood Cytokine Level at 4 Hours Post-dose on Day 1 | 4 hours post-dose on Day 1 | 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. |
| Blood Cytokine Level at Pre-dose on Day 10 | Pre-dose on Day 10 | 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. |
| Blood Cytokine Level at Pre-dose on Day 28 | Pre-dose on Day 28 | 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. |
| Blood Cytokine Level at 1 Hour Post-dose on Day 28 | 1 Hour Post-dose on Day 28 | 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. |
| Blood Cytokine Level at 4 Hours Post-dose on Day 28 | 4 Hours Post-dose on Day 28 | 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. |
| Blood Cytokine Level at 8 Hours Post-dose on Day 28 | 8 Hours Post-dose on Day 28 | 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. |
| Blood Cytokine Level at 24 Hours Post-dose on Day 28 | 24 Hours Post-dose on Day 28 | 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. |
| Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | Pre-dose on Day 35 or Early Termination | 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. |
| Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Pre-dose on Day 1 | 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. |
| Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | 1 Hour Post-dose on Day 1 | 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. |
| Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Pre-dose on Day 10 | 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. |
| Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Pre-dose on Day 28 | 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. |
| Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | 1 Hour Post-dose on Day 28 | 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. |
| Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | 4 Hours Post-dose on Day 28 | 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. |
| Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | 8 Hours Post-dose on Day 28 | 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. |
| Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | 24 Hours Post-dose on Day 28 | 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. |
| Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Pre-dose on Day 35 or Early Termination | 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. |
| Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 1 | Pre-dose on Day 1 | 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). |
| Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 1 | 1 Hour Post-dose on Day 1 | 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. |
| Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 1 | 4 Hours Post-dose on Day 1 | 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. |
| Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 10 | Pre-dose on Day 10 | 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. |
| Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 28 | Pre-dose on Day 28 | 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. |
| Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 28 | 1 Hour Post-dose on Day 28 | 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. |
| Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 28 | 4 Hours Post-dose on Day 28 | 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. |
| Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 8 Hours Post-dose on Day 28 | 8 Hours Post-dose on Day 28 | 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. |
| Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at 24 Hours Post-dose on Day 28 | 24 Hours Post-dose on Day 28 | Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr. |
| Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 24 Hours Post-dose on Day 28 | 24 Hours Post-dose on Day 28 | 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. |
| Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 35 or Early Termination | Pre-dose on Day 35 or Early Termination | 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. |
| Parathyroid Hormone (PTH) Level at Pre-dose on Day 1 | Pre-dose on Day 1 | Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method. |
| Parathyroid Hormone (PTH) Level at 1 Hour Post-dose on Day 1 | 1 Hour Post-dose on Day 1 | Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method. |
| Parathyroid Hormone (PTH) Level at 4 Hours Post-dose on Day 1 | 4 Hours Post-dose on Day 1 | Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method. |
| Parathyroid Hormone (PTH) Level at Pre-dose on Day 10 | Pre-dose on Day 10 | Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method. |
| Parathyroid Hormone (PTH) Level at Pre-dose on Day 28 | Pre-dose on Day 28 | Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method. |
| Parathyroid Hormone (PTH) Level at 1 Hour Post-dose on Day 28 | 1 Hour Post-dose on Day 28 | Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method. |
| Parathyroid Hormone (PTH) Level at 4 Hours Post-dose on Day 28 | 4 Hours Post-dose on Day 28 | Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method. |
| Parathyroid Hormone (PTH) Level at 8 Hours Post-dose on Day 28 | 8 Hours Post-dose on Day 28 | Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method. |
| Parathyroid Hormone (PTH) Level at 24 Hours Post-dose on Day 28 | 24 Hours Post-dose on Day 28 | Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method. |
| Parathyroid Hormone (PTH) Level at Pre-dose on Day 35 or Early Termination | Pre-dose on Day 35 or Early Termination | Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method. |
| Osteoprotegerin (OPG) Level at Pre-dose on Day 1 | Pre-dose on Day 1 | Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method. |
| Osteoprotegerin (OPG) Level at 1 Hour Post-dose on Day 1 | 1 Hour Post-dose on Day 1 | Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method. |
| Osteoprotegerin (OPG) Level at 4 Hours Post-dose on Day 1 | 4 Hours Post-dose on Day 1 | Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method. |
| Osteoprotegerin (OPG) Level at Pre-dose on Day 10 | Pre-dose on Day 10 | Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method. |
| Osteoprotegerin (OPG) Level at Pre-dose on Day 28 | Pre-dose on Day 28 | Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method. |
| Osteoprotegerin (OPG) Level at 1 Hour Post-dose on Day 28 | 1 Hour Post-dose on Day 28 | Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method. |
| Osteoprotegerin (OPG) Level at 4 Hours Post-dose on Day 28 | 4 Hours Post-dose on Day 28 | Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method. |
| Osteoprotegerin (OPG) Level at 8 Hours Post-dose on Day 28 | 8 Hours Post-dose on Day 28 | Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method. |
| Osteoprotegerin (OPG) Level at 24 Hours Post-dose on Day 28 | 24 Hours Post-dose on Day 28 | Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method. |
| Osteoprotegerin(OPG) Level at Pre-dose on Day 35 or Early Termination | Pre-dose on Day 35 or Early Termination | Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method. |
| Plasma Level of Matrix Metallopeptidase (MMP13) | 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 | — |
| Plasma Level of Interleukin-34 (IL-34) and Interleukin-18 (IL-18) | 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 | — |
| Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 1 | Pre-dose on Day 1 | 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). |
| Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 1 | 1 Hour Post-dose on Day 1 | 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. |
| Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 1 | 4 Hours Post-dose on Day 1 | 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. |
| Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 10 | Pre-dose on Day 10 | 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. |
| Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 28 | Pre-dose on Day 28 | 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. |
| Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 28 | 1 Hour Post-dose on Day 28 | 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. |
| Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 28 | 4 Hours Post-dose on Day 28 | 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. |
| Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 8 Hours Post-dose on Day 28 | 8 Hours Post-dose on Day 28 | 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. |
| Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 24 Hours Post-dose on Day 28 | 24 Hours Post-dose on Day 28 | 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. |
| Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 35 or Early Termination | Pre-dose on Day 35 or Early Termination | 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. |
| Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 1 | Pre-dose on Day 1 | Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method. |
| Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 1 | 1 Hour Post-dose on Day 1 | Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method. |
| Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 1 | 4 Hours Post-dose on Day 1 | Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method. |
| Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 10 | Pre-dose on Day 10 | Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Day 28, 35 or Early Termination | ACR50 response: \>=50% improvement in TJC; \>= 50% improvement in SJC; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. |
| Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Day 28, 35 or Early Termination | ACR70 response: \>=70% improvement in TJC; \>= 70% improvement in SJC; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. |
| Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Day -7, 1 (Baseline), 28, 35 or Early Termination | DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP) (milligram per liter \[mg/L\]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (\<=) 3.2 implied low disease activity, greater than (\>) 3.2 to 5.1 implied moderate to high disease activity and less than (\<) 2.6 implied remission. |
| Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 28 and 35 | Day 1 (Baseline), 28, 35 or Early Termination | DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP (mg/mL). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \<= 3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6 | Day -7, 1 (Baseline), 28, 35 or Early Termination | DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP (mg/mL). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \<= 3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Day -7, 1 (Baseline), 28, 35 or Early Termination | DAS28-4 (ESR) was calculated from the number of SJC, TJC using the 28 joints count, ESR (millimeters per hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity, \> 3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Day 28 and 35 | Day 1 (Baseline), 28, 35 or Early Termination | DAS28-4 (ESR) was calculated from the number of SJC, TJC using the 28 joints count, ESR \[mm/hour\] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity, \> 3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6 | Day -7, 1 (Baseline), 28, 35 or Early Termination | DAS28-4 (ESR) was calculated from the number of SJC, TJC using the 28 joints count, ESR \[mm/hour\] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity, \> 3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Percentage of Participants Achieving American College of Rheumatology 20% Response | Day 28, 35 or Early Termination | ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CP-690,550 CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | 15 |
| Placebo Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | 14 |
| Total | 29 |
Baseline characteristics
| Characteristic | CP-690,550 | Placebo | Total |
|---|---|---|---|
| Age Continuous | 53.5 years STANDARD_DEVIATION 9.2 | 53.1 years STANDARD_DEVIATION 14.3 | 53.3 years STANDARD_DEVIATION 11.7 |
| Sex: Female, Male Female | 14 Participants | 12 Participants | 26 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 15 | 10 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 14 |
Outcome results
Primary
Blood Cytokine Level at 1 Hour Post-dose on Day 1
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
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IL-4 | 0.29 pg/mL | Standard Deviation 0.28 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IP-10 | 2.17 pg/mL | Standard Deviation 0.25 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IL-8 | 1.12 pg/mL | Standard Deviation 0.31 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | TNFalpha | 0.41 pg/mL | Standard Deviation 0.46 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IL-1beta | 0.43 pg/mL | Standard Deviation 0.42 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IFNgamma | 0.12 pg/mL | Standard Deviation 0.07 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IL-10 | 0.23 pg/mL | Standard Deviation 0.22 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | G-CSF | 0.56 pg/mL | Standard Deviation 0.47 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IL-6 | 0.90 pg/mL | Standard Deviation 0.52 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | GM-CSF | 0.49 pg/mL | Standard Deviation 0.49 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IL-12p70 | 0.36 pg/mL | Standard Deviation 0.31 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | MCP1 | 2.09 pg/mL | Standard Deviation 0.26 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IL-1alpha | 0.76 pg/mL | Standard Deviation 0.68 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IL-17A | 0.58 pg/mL | Standard Deviation 0.46 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | sVEGF | 1.98 pg/mL | Standard Deviation 0.42 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IL-7 | 0.86 pg/mL | Standard Deviation 0.36 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | sVCAM-1 | 4.94 pg/mL | Standard Deviation 0.15 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IL-21 | 1.45 pg/mL | Standard Deviation 1.16 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | sICAM-1 | 4.64 pg/mL | Standard Deviation 0.13 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | MIP1a | 0.83 pg/mL | Standard Deviation 0.47 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | sICAM-1 | 4.76 pg/mL | Standard Deviation 0.18 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IL-1alpha | 0.73 pg/mL | Standard Deviation 0.68 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IL-1beta | 0.40 pg/mL | Standard Deviation 0.43 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IL-4 | 0.15 pg/mL | Standard Deviation 0.13 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IL-6 | 0.78 pg/mL | Standard Deviation 0.43 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IL-7 | 0.72 pg/mL | Standard Deviation 0.26 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IL-8 | 1.15 pg/mL | Standard Deviation 0.23 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IL-10 | 0.31 pg/mL | Standard Deviation 0.35 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IL-12p70 | 0.34 pg/mL | Standard Deviation 0.43 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IL-17A | 0.42 pg/mL | Standard Deviation 0.36 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IL-21 | 1.45 pg/mL | Standard Deviation 1.07 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IP-10 | 2.22 pg/mL | Standard Deviation 0.31 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | TNFalpha | 0.44 pg/mL | Standard Deviation 0.52 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | IFNgamma | 0.10 pg/mL | Standard Deviation 0 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | G-CSF | 0.62 pg/mL | Standard Deviation 0.36 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | GM-CSF | 0.39 pg/mL | Standard Deviation 0.49 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | MCP1 | 2.03 pg/mL | Standard Deviation 0.33 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | MIP1a | 0.89 pg/mL | Standard Deviation 0.33 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | sVEGF | 1.87 pg/mL | Standard Deviation 0.27 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 1 | sVCAM-1 | 5.06 pg/mL | Standard Deviation 0.17 |
Primary
Blood Cytokine Level at 1 Hour Post-dose on Day 28
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
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IL-1alpha | 0.69 pg/mL | Standard Deviation 0.68 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IL-1beta | 0.40 pg/mL | Standard Deviation 0.41 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IL-4 | 0.25 pg/mL | Standard Deviation 0.25 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IL-6 | 0.67 pg/mL | Standard Deviation 0.52 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IL-7 | 0.69 pg/mL | Standard Deviation 0.38 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IL-8 | 1.10 pg/mL | Standard Deviation 0.23 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IL-10 | 0.18 pg/mL | Standard Deviation 0.16 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IL-12p70 | 0.33 pg/mL | Standard Deviation 0.28 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IL-17A | 0.44 pg/mL | Standard Deviation 0.45 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IL-21 | 1.46 pg/mL | Standard Deviation 1.06 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IP-10 | 2.00 pg/mL | Standard Deviation 0.21 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | TNFalpha | 0.39 pg/mL | Standard Deviation 0.46 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IFNgamma | 0.12 pg/mL | Standard Deviation 0.06 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | G-CSF | 0.63 pg/mL | Standard Deviation 0.39 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | GM-CSF | 0.47 pg/mL | Standard Deviation 0.47 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | MCP1 | 2.23 pg/mL | Standard Deviation 0.3 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | MIP1a | 0.81 pg/mL | Standard Deviation 0.45 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | sVEGF | 1.85 pg/mL | Standard Deviation 0.38 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | sVCAM-1 | 4.85 pg/mL | Standard Deviation 0.15 |
| CP-690,550 | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | sICAM-1 | 4.58 pg/mL | Standard Deviation 0.1 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | sVEGF | 1.81 pg/mL | Standard Deviation 0.26 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IL-1alpha | 0.69 pg/mL | Standard Deviation 0.67 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IP-10 | 2.23 pg/mL | Standard Deviation 0.39 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IL-1beta | 0.39 pg/mL | Standard Deviation 0.38 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | MCP1 | 2.06 pg/mL | Standard Deviation 0.35 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IL-4 | 0.15 pg/mL | Standard Deviation 0.14 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | TNFalpha | 0.43 pg/mL | Standard Deviation 0.48 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IL-6 | 0.77 pg/mL | Standard Deviation 0.39 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | sICAM-1 | 4.73 pg/mL | Standard Deviation 0.23 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IL-7 | 0.61 pg/mL | Standard Deviation 0.33 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IFNgamma | 0.11 pg/mL | Standard Deviation 0.04 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IL-8 | 1.12 pg/mL | Standard Deviation 0.33 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | MIP1a | 0.83 pg/mL | Standard Deviation 0.33 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IL-10 | 0.33 pg/mL | Standard Deviation 0.33 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | G-CSF | 0.66 pg/mL | Standard Deviation 0.29 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IL-12p70 | 0.36 pg/mL | Standard Deviation 0.44 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | sVCAM-1 | 5.04 pg/mL | Standard Deviation 0.17 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IL-17A | 0.36 pg/mL | Standard Deviation 0.34 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | GM-CSF | 0.36 pg/mL | Standard Deviation 0.45 |
| Placebo | Blood Cytokine Level at 1 Hour Post-dose on Day 28 | IL-21 | 1.52 pg/mL | Standard Deviation 0.99 |
Primary
Blood Cytokine Level at 24 Hours Post-dose on Day 28
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
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IL-1alpha | 0.73 pg/mL | Standard Deviation 0.66 |
| CP-690,550 | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IL-1beta | 0.38 pg/mL | Standard Deviation 0.41 |
| CP-690,550 | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IL-4 | 0.26 pg/mL | Standard Deviation 0.27 |
| CP-690,550 | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IL-6 | 0.93 pg/mL | Standard Deviation 0.42 |
| CP-690,550 | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IL-7 | 0.79 pg/mL | Standard Deviation 0.35 |
| CP-690,550 | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IL-8 | 1.21 pg/mL | Standard Deviation 0.32 |
| CP-690,550 | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IL-10 | 0.22 pg/mL | Standard Deviation 0.17 |
| CP-690,550 | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IL-12p70 | 0.25 pg/mL | Standard Deviation 0.25 |
| CP-690,550 | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IL-17A | 0.44 pg/mL | Standard Deviation 0.44 |
| CP-690,550 | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IL-21 | 1.54 pg/mL | Standard Deviation 0.98 |
| CP-690,550 | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IP-10 | 2.02 pg/mL | Standard Deviation 0.31 |
| CP-690,550 | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | TNFalpha | 0.42 pg/mL | Standard Deviation 0.47 |
| CP-690,550 | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IFNgamma | 0.16 pg/mL | Standard Deviation 0.19 |
| CP-690,550 | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | G-CSF | 0.67 pg/mL | Standard Deviation 0.39 |
| CP-690,550 | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | GM-CSF | 0.46 pg/mL | Standard Deviation 0.46 |
| CP-690,550 | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | MCP1 | 2.33 pg/mL | Standard Deviation 0.24 |
| CP-690,550 | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | MIP1a | 0.86 pg/mL | Standard Deviation 0.49 |
| CP-690,550 | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | sVEGF | 1.89 pg/mL | Standard Deviation 0.41 |
| CP-690,550 | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | sVCAM-1 | 4.88 pg/mL | Standard Deviation 0.14 |
| CP-690,550 | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | sICAM-1 | 4.58 pg/mL | Standard Deviation 0.1 |
| Placebo | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | sVEGF | 1.84 pg/mL | Standard Deviation 0.23 |
| Placebo | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IL-1alpha | 0.66 pg/mL | Standard Deviation 0.64 |
| Placebo | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IP-10 | 2.27 pg/mL | Standard Deviation 0.39 |
| Placebo | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IL-1beta | 0.38 pg/mL | Standard Deviation 0.41 |
| Placebo | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | MCP1 | 2.10 pg/mL | Standard Deviation 0.35 |
| Placebo | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IL-4 | 0.15 pg/mL | Standard Deviation 0.15 |
| Placebo | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | TNFalpha | 0.42 pg/mL | Standard Deviation 0.51 |
| Placebo | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IL-6 | 0.99 pg/mL | Standard Deviation 0.47 |
| Placebo | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | sICAM-1 | 4.74 pg/mL | Standard Deviation 0.21 |
| Placebo | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IL-7 | 0.64 pg/mL | Standard Deviation 0.31 |
| Placebo | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IFNgamma | 0.10 pg/mL | Standard Deviation 0 |
| Placebo | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IL-8 | 1.18 pg/mL | Standard Deviation 0.29 |
| Placebo | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | MIP1a | 0.88 pg/mL | Standard Deviation 0.28 |
| Placebo | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IL-10 | 0.30 pg/mL | Standard Deviation 0.33 |
| Placebo | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | G-CSF | 0.71 pg/mL | Standard Deviation 0.28 |
| Placebo | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IL-12p70 | 0.37 pg/mL | Standard Deviation 0.44 |
| Placebo | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | sVCAM-1 | 5.06 pg/mL | Standard Deviation 0.17 |
| Placebo | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IL-17A | 0.32 pg/mL | Standard Deviation 0.32 |
| Placebo | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | GM-CSF | 0.31 pg/mL | Standard Deviation 0.44 |
| Placebo | Blood Cytokine Level at 24 Hours Post-dose on Day 28 | IL-21 | 1.64 pg/mL | Standard Deviation 0.87 |
Primary
Blood Cytokine Level at 4 Hours Post-dose on Day 1
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IL-1alpha | 0.77 pg/mL | Standard Deviation 0.69 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IL-1beta | 0.43 pg/mL | Standard Deviation 0.46 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IL-4 | 0.28 pg/mL | Standard Deviation 0.28 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IL-6 | 0.74 pg/mL | Standard Deviation 0.41 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IL-7 | 0.82 pg/mL | Standard Deviation 0.39 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IL-8 | 1.18 pg/mL | Standard Deviation 0.22 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IL-10 | 0.19 pg/mL | Standard Deviation 0.2 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IL-12p70 | 0.35 pg/mL | Standard Deviation 0.29 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IL-17A | 0.53 pg/mL | Standard Deviation 0.47 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IL-21 | 1.60 pg/mL | Standard Deviation 1.09 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IP-10 | 2.10 pg/mL | Standard Deviation 0.22 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | TNFalpha | 0.41 pg/mL | Standard Deviation 0.47 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IFNgamma | 0.17 pg/mL | Standard Deviation 0.13 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | G-CSF | 0.55 pg/mL | Standard Deviation 0.47 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | GM-CSF | 0.50 pg/mL | Standard Deviation 0.48 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | MCP1 | 1.98 pg/mL | Standard Deviation 0.29 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | MIP1a | 0.81 pg/mL | Standard Deviation 0.47 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | sVEGF | 1.93 pg/mL | Standard Deviation 0.42 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | sVCAM-1 | 4.96 pg/mL | Standard Deviation 0.15 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | sICAM-1 | 4.66 pg/mL | Standard Deviation 0.12 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | sVEGF | 1.85 pg/mL | Standard Deviation 0.28 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IL-1alpha | 0.65 pg/mL | Standard Deviation 0.7 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IP-10 | 2.20 pg/mL | Standard Deviation 0.33 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IL-1beta | 0.41 pg/mL | Standard Deviation 0.42 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | MCP1 | 2.07 pg/mL | Standard Deviation 0.34 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IL-4 | 0.18 pg/mL | Standard Deviation 0.17 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | TNFalpha | 0.45 pg/mL | Standard Deviation 0.51 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IL-6 | 0.72 pg/mL | Standard Deviation 0.39 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | sICAM-1 | 4.74 pg/mL | Standard Deviation 0.2 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IL-7 | 0.73 pg/mL | Standard Deviation 0.28 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IFNgamma | 0.12 pg/mL | Standard Deviation 0.07 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IL-8 | 1.15 pg/mL | Standard Deviation 0.25 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | MIP1a | 0.86 pg/mL | Standard Deviation 0.33 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IL-10 | 0.30 pg/mL | Standard Deviation 0.35 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | G-CSF | 0.62 pg/mL | Standard Deviation 0.41 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IL-12p70 | 0.38 pg/mL | Standard Deviation 0.43 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | sVCAM-1 | 5.03 pg/mL | Standard Deviation 0.21 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IL-17A | 0.39 pg/mL | Standard Deviation 0.4 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | GM-CSF | 0.38 pg/mL | Standard Deviation 0.48 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 1 | IL-21 | 1.36 pg/mL | Standard Deviation 1.07 |
Primary
Blood Cytokine Level at 4 Hours Post-dose on Day 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IL-1alpha | 0.67 pg/mL | Standard Deviation 0.69 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IL-1beta | 0.27 pg/mL | Standard Deviation 0.32 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IL-4 | 0.22 pg/mL | Standard Deviation 0.27 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IL-6 | 0.56 pg/mL | Standard Deviation 0.3 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IL-7 | 0.66 pg/mL | Standard Deviation 0.45 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IL-8 | 1.07 pg/mL | Standard Deviation 0.21 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IL-10 | 0.16 pg/mL | Standard Deviation 0.13 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IL-12p70 | 0.26 pg/mL | Standard Deviation 0.27 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IL-17A | 0.37 pg/mL | Standard Deviation 0.44 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IL-21 | 1.51 pg/mL | Standard Deviation 1.05 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IP-10 | 1.89 pg/mL | Standard Deviation 0.21 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | TNFalpha | 0.38 pg/mL | Standard Deviation 0.42 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IFNgamma | 0.12 pg/mL | Standard Deviation 0.07 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | G-CSF | 0.57 pg/mL | Standard Deviation 0.43 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | GM-CSF | 0.49 pg/mL | Standard Deviation 0.47 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | MCP1 | 2.09 pg/mL | Standard Deviation 0.23 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | MIP1a | 0.71 pg/mL | Standard Deviation 0.48 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | sVEGF | 1.80 pg/mL | Standard Deviation 0.36 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | sVCAM-1 | 4.91 pg/mL | Standard Deviation 0.15 |
| CP-690,550 | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | sICAM-1 | 4.61 pg/mL | Standard Deviation 0.09 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | sVEGF | 1.84 pg/mL | Standard Deviation 0.28 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IL-1alpha | 0.75 pg/mL | Standard Deviation 0.66 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IP-10 | 2.13 pg/mL | Standard Deviation 0.36 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IL-1beta | 0.33 pg/mL | Standard Deviation 0.39 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | MCP1 | 1.99 pg/mL | Standard Deviation 0.38 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IL-4 | 0.14 pg/mL | Standard Deviation 0.11 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | TNFalpha | 0.38 pg/mL | Standard Deviation 0.49 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IL-6 | 0.69 pg/mL | Standard Deviation 0.29 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | sICAM-1 | 4.71 pg/mL | Standard Deviation 0.22 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IL-7 | 0.56 pg/mL | Standard Deviation 0.36 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IFNgamma | 0.11 pg/mL | Standard Deviation 0.04 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IL-8 | 1.07 pg/mL | Standard Deviation 0.25 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | MIP1a | 0.80 pg/mL | Standard Deviation 0.31 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IL-10 | 0.28 pg/mL | Standard Deviation 0.32 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | G-CSF | 0.72 pg/mL | Standard Deviation 0.26 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IL-12p70 | 0.31 pg/mL | Standard Deviation 0.44 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | sVCAM-1 | 5.00 pg/mL | Standard Deviation 0.14 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IL-17A | 0.34 pg/mL | Standard Deviation 0.37 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | GM-CSF | 0.38 pg/mL | Standard Deviation 0.46 |
| Placebo | Blood Cytokine Level at 4 Hours Post-dose on Day 28 | IL-21 | 1.68 pg/mL | Standard Deviation 0.92 |
Primary
Blood Cytokine Level at 8 Hours Post-dose on Day 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IL-1alpha | 0.76 pg/mL | Standard Deviation 0.68 |
| CP-690,550 | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IL-1beta | 0.29 pg/mL | Standard Deviation 0.35 |
| CP-690,550 | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IL-4 | 0.23 pg/mL | Standard Deviation 0.27 |
| CP-690,550 | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IL-6 | 0.71 pg/mL | Standard Deviation 0.39 |
| CP-690,550 | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IL-7 | 0.67 pg/mL | Standard Deviation 0.4 |
| CP-690,550 | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IL-8 | 1.10 pg/mL | Standard Deviation 0.21 |
| CP-690,550 | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IL-10 | 0.15 pg/mL | Standard Deviation 0.11 |
| CP-690,550 | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IL-12p70 | 0.28 pg/mL | Standard Deviation 0.28 |
| CP-690,550 | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IL-17A | 0.44 pg/mL | Standard Deviation 0.42 |
| CP-690,550 | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IL-21 | 1.58 pg/mL | Standard Deviation 1.04 |
| CP-690,550 | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IP-10 | 1.85 pg/mL | Standard Deviation 0.22 |
| CP-690,550 | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | TNFalpha | 0.36 pg/mL | Standard Deviation 0.43 |
| CP-690,550 | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IFNgamma | 0.10 pg/mL | Standard Deviation 0 |
| CP-690,550 | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | G-CSF | 0.65 pg/mL | Standard Deviation 0.37 |
| CP-690,550 | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | GM-CSF | 0.48 pg/mL | Standard Deviation 0.45 |
| CP-690,550 | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | MCP1 | 2.11 pg/mL | Standard Deviation 0.31 |
| CP-690,550 | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | MIP1a | 0.71 pg/mL | Standard Deviation 0.45 |
| CP-690,550 | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | sVEGF | 1.71 pg/mL | Standard Deviation 0.36 |
| CP-690,550 | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | sVCAM-1 | 4.87 pg/mL | Standard Deviation 0.16 |
| CP-690,550 | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | sICAM-1 | 4.59 pg/mL | Standard Deviation 0.09 |
| Placebo | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | sVEGF | 1.82 pg/mL | Standard Deviation 0.25 |
| Placebo | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IL-1alpha | 0.63 pg/mL | Standard Deviation 0.69 |
| Placebo | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IP-10 | 2.14 pg/mL | Standard Deviation 0.35 |
| Placebo | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IL-1beta | 0.34 pg/mL | Standard Deviation 0.39 |
| Placebo | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | MCP1 | 2.02 pg/mL | Standard Deviation 0.4 |
| Placebo | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IL-4 | 0.14 pg/mL | Standard Deviation 0.12 |
| Placebo | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | TNFalpha | 0.35 pg/mL | Standard Deviation 0.48 |
| Placebo | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IL-6 | 0.79 pg/mL | Standard Deviation 0.34 |
| Placebo | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | sICAM-1 | 4.74 pg/mL | Standard Deviation 0.24 |
| Placebo | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IL-7 | 0.66 pg/mL | Standard Deviation 0.31 |
| Placebo | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IFNgamma | 0.12 pg/mL | Standard Deviation 0.07 |
| Placebo | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IL-8 | 1.17 pg/mL | Standard Deviation 0.26 |
| Placebo | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | MIP1a | 0.71 pg/mL | Standard Deviation 0.35 |
| Placebo | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IL-10 | 0.29 pg/mL | Standard Deviation 0.3 |
| Placebo | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | G-CSF | 0.83 pg/mL | Standard Deviation 0.28 |
| Placebo | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IL-12p70 | 0.33 pg/mL | Standard Deviation 0.42 |
| Placebo | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | sVCAM-1 | 5.05 pg/mL | Standard Deviation 0.15 |
| Placebo | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IL-17A | 0.29 pg/mL | Standard Deviation 0.36 |
| Placebo | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | GM-CSF | 0.38 pg/mL | Standard Deviation 0.46 |
| Placebo | Blood Cytokine Level at 8 Hours Post-dose on Day 28 | IL-21 | 1.30 pg/mL | Standard Deviation 1.13 |
Primary
Blood Cytokine Level at Pre-dose on Day 1
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
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 1 | IL-1alpha | 0.75 pg/mL | Standard Deviation 0.68 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 1 | IL-1beta | 0.42 pg/mL | Standard Deviation 0.39 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 1 | IL-4 | 0.29 pg/mL | Standard Deviation 0.29 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 1 | IL-6 | 0.97 pg/mL | Standard Deviation 0.67 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 1 | IL-7 | 0.89 pg/mL | Standard Deviation 0.32 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 1 | IL-8 | 1.17 pg/mL | Standard Deviation 0.24 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 1 | IL-10 | 0.25 pg/mL | Standard Deviation 0.24 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 1 | IL-12p70 | 0.31 pg/mL | Standard Deviation 0.29 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 1 | IL-17A | 0.49 pg/mL | Standard Deviation 0.48 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 1 | IL-21 | 1.56 pg/mL | Standard Deviation 1.1 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 1 | IP-10 | 2.22 pg/mL | Standard Deviation 0.23 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 1 | TNFalpha | 0.45 pg/mL | Standard Deviation 0.43 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 1 | IFNgamma | 0.15 pg/mL | Standard Deviation 0.16 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 1 | G-CSF | 0.57 pg/mL | Standard Deviation 0.47 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 1 | GM-CSF | 0.48 pg/mL | Standard Deviation 0.48 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 1 | MCP1 | 2.14 pg/mL | Standard Deviation 0.26 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 1 | MIP1a | 0.85 pg/mL | Standard Deviation 0.45 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 1 | sVEGF | 1.96 pg/mL | Standard Deviation 0.44 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 1 | sVCAM-1 | 4.95 pg/mL | Standard Deviation 0.17 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 1 | sICAM-1 | 4.65 pg/mL | Standard Deviation 0.12 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 1 | sVEGF | 1.87 pg/mL | Standard Deviation 0.28 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 1 | IL-1alpha | 0.67 pg/mL | Standard Deviation 0.68 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 1 | IP-10 | 2.23 pg/mL | Standard Deviation 0.3 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 1 | IL-1beta | 0.41 pg/mL | Standard Deviation 0.41 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 1 | MCP1 | 2.09 pg/mL | Standard Deviation 0.32 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 1 | IL-4 | 0.17 pg/mL | Standard Deviation 0.16 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 1 | TNFalpha | 0.44 pg/mL | Standard Deviation 0.51 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 1 | IL-6 | 0.77 pg/mL | Standard Deviation 0.45 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 1 | sICAM-1 | 4.76 pg/mL | Standard Deviation 0.17 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 1 | IL-7 | 0.74 pg/mL | Standard Deviation 0.23 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 1 | IFNgamma | 0.11 pg/mL | Standard Deviation 0.07 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 1 | IL-8 | 1.19 pg/mL | Standard Deviation 0.27 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 1 | MIP1a | 0.90 pg/mL | Standard Deviation 0.32 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 1 | IL-10 | 0.33 pg/mL | Standard Deviation 0.37 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 1 | G-CSF | 0.60 pg/mL | Standard Deviation 0.34 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 1 | IL-12p70 | 0.35 pg/mL | Standard Deviation 0.44 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 1 | sVCAM-1 | 5.07 pg/mL | Standard Deviation 0.17 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 1 | IL-17A | 0.44 pg/mL | Standard Deviation 0.37 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 1 | GM-CSF | 0.36 pg/mL | Standard Deviation 0.46 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 1 | IL-21 | 1.47 pg/mL | Standard Deviation 1.04 |
Primary
Blood Cytokine Level at Pre-dose on Day 10
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
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 10 | IL-1alpha | 0.74 pg/mL | Standard Deviation 0.66 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 10 | IL-1beta | 0.36 pg/mL | Standard Deviation 0.46 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 10 | IL-4 | 0.28 pg/mL | Standard Deviation 0.28 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 10 | IL-6 | 0.68 pg/mL | Standard Deviation 0.55 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 10 | IL-7 | 0.83 pg/mL | Standard Deviation 0.31 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 10 | IL-8 | 1.15 pg/mL | Standard Deviation 0.29 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 10 | IL-10 | 0.21 pg/mL | Standard Deviation 0.23 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 10 | IL-12p70 | 0.34 pg/mL | Standard Deviation 0.32 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 10 | IL-17A | 0.50 pg/mL | Standard Deviation 0.48 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 10 | IL-21 | 1.62 pg/mL | Standard Deviation 1.02 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 10 | IP-10 | 2.01 pg/mL | Standard Deviation 0.25 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 10 | TNFalpha | 0.48 pg/mL | Standard Deviation 0.49 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 10 | IFNgamma | 0.11 pg/mL | Standard Deviation 0.05 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 10 | G-CSF | 0.60 pg/mL | Standard Deviation 0.43 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 10 | GM-CSF | 0.48 pg/mL | Standard Deviation 0.46 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 10 | MCP1 | 2.17 pg/mL | Standard Deviation 0.34 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 10 | MIP1a | 0.83 pg/mL | Standard Deviation 0.52 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 10 | sVEGF | 1.93 pg/mL | Standard Deviation 0.44 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 10 | sVCAM-1 | 4.90 pg/mL | Standard Deviation 0.16 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 10 | sICAM-1 | 4.63 pg/mL | Standard Deviation 0.11 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 10 | sVEGF | 1.90 pg/mL | Standard Deviation 0.28 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 10 | IL-1alpha | 0.69 pg/mL | Standard Deviation 0.68 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 10 | IP-10 | 2.18 pg/mL | Standard Deviation 0.33 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 10 | IL-1beta | 0.42 pg/mL | Standard Deviation 0.43 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 10 | MCP1 | 2.09 pg/mL | Standard Deviation 0.38 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 10 | IL-4 | 0.19 pg/mL | Standard Deviation 0.18 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 10 | TNFalpha | 0.48 pg/mL | Standard Deviation 0.5 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 10 | IL-6 | 0.78 pg/mL | Standard Deviation 0.45 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 10 | sICAM-1 | 4.74 pg/mL | Standard Deviation 0.2 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 10 | IL-7 | 0.61 pg/mL | Standard Deviation 0.38 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 10 | IFNgamma | 0.11 pg/mL | Standard Deviation 0.03 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 10 | IL-8 | 1.21 pg/mL | Standard Deviation 0.29 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 10 | MIP1a | 0.89 pg/mL | Standard Deviation 0.35 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 10 | IL-10 | 0.32 pg/mL | Standard Deviation 0.35 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 10 | G-CSF | 0.60 pg/mL | Standard Deviation 0.31 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 10 | IL-12p70 | 0.34 pg/mL | Standard Deviation 0.43 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 10 | sVCAM-1 | 5.03 pg/mL | Standard Deviation 0.16 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 10 | IL-17A | 0.41 pg/mL | Standard Deviation 0.36 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 10 | GM-CSF | 0.37 pg/mL | Standard Deviation 0.48 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 10 | IL-21 | 1.63 pg/mL | Standard Deviation 0.86 |
Primary
Blood Cytokine Level at Pre-dose on Day 28
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
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 28 | IL-1alpha | 0.69 pg/mL | Standard Deviation 0.71 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 28 | IL-1beta | 0.41 pg/mL | Standard Deviation 0.45 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 28 | IL-4 | 0.24 pg/mL | Standard Deviation 0.25 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 28 | IL-6 | 0.64 pg/mL | Standard Deviation 0.42 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 28 | IL-7 | 0.75 pg/mL | Standard Deviation 0.34 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 28 | IL-8 | 1.19 pg/mL | Standard Deviation 0.36 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 28 | IL-10 | 0.18 pg/mL | Standard Deviation 0.17 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 28 | IL-12p70 | 0.27 pg/mL | Standard Deviation 0.26 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 28 | IL-17A | 0.49 pg/mL | Standard Deviation 0.47 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 28 | IL-21 | 1.47 pg/mL | Standard Deviation 1.08 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 28 | IP-10 | 2.01 pg/mL | Standard Deviation 0.19 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 28 | TNFalpha | 0.46 pg/mL | Standard Deviation 0.49 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 28 | IFNgamma | 0.11 pg/mL | Standard Deviation 0.03 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 28 | G-CSF | 0.65 pg/mL | Standard Deviation 0.39 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 28 | GM-CSF | 0.48 pg/mL | Standard Deviation 0.48 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 28 | MCP1 | 2.21 pg/mL | Standard Deviation 0.35 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 28 | MIP1a | 0.84 pg/mL | Standard Deviation 0.44 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 28 | sVEGF | 1.89 pg/mL | Standard Deviation 0.41 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 28 | sVCAM-1 | 4.89 pg/mL | Standard Deviation 0.14 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 28 | sICAM-1 | 4.61 pg/mL | Standard Deviation 0.09 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 28 | sVEGF | 1.83 pg/mL | Standard Deviation 0.27 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 28 | IL-1alpha | 0.68 pg/mL | Standard Deviation 0.68 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 28 | IP-10 | 2.24 pg/mL | Standard Deviation 0.4 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 28 | IL-1beta | 0.39 pg/mL | Standard Deviation 0.39 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 28 | MCP1 | 2.09 pg/mL | Standard Deviation 0.4 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 28 | IL-4 | 0.15 pg/mL | Standard Deviation 0.15 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 28 | TNFalpha | 0.43 pg/mL | Standard Deviation 0.48 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 28 | IL-6 | 0.78 pg/mL | Standard Deviation 0.32 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 28 | sICAM-1 | 4.70 pg/mL | Standard Deviation 0.21 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 28 | IL-7 | 0.53 pg/mL | Standard Deviation 0.3 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 28 | IFNgamma | 0.10 pg/mL | Standard Deviation 0 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 28 | IL-8 | 1.14 pg/mL | Standard Deviation 0.32 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 28 | MIP1a | 0.83 pg/mL | Standard Deviation 0.34 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 28 | IL-10 | 0.32 pg/mL | Standard Deviation 0.31 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 28 | G-CSF | 0.66 pg/mL | Standard Deviation 0.34 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 28 | IL-12p70 | 0.35 pg/mL | Standard Deviation 0.43 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 28 | sVCAM-1 | 5.01 pg/mL | Standard Deviation 0.19 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 28 | IL-17A | 0.37 pg/mL | Standard Deviation 0.37 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 28 | GM-CSF | 0.35 pg/mL | Standard Deviation 0.45 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 28 | IL-21 | 1.53 pg/mL | Standard Deviation 0.99 |
Primary
Blood Cytokine Level at Pre-dose on Day 35 or Early Termination
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
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IL-1alpha | 0.70 pg/mL | Standard Deviation 0.68 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IL-1beta | 0.43 pg/mL | Standard Deviation 0.43 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IL-4 | 0.29 pg/mL | Standard Deviation 0.31 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IL-6 | 0.81 pg/mL | Standard Deviation 0.46 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IL-7 | 0.85 pg/mL | Standard Deviation 0.31 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IL-8 | 1.08 pg/mL | Standard Deviation 0.26 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IL-10 | 0.22 pg/mL | Standard Deviation 0.17 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IL-12p70 | 0.32 pg/mL | Standard Deviation 0.26 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IL-17A | 0.43 pg/mL | Standard Deviation 0.48 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IL-21 | 1.41 pg/mL | Standard Deviation 1.04 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IP-10 | 2.20 pg/mL | Standard Deviation 0.27 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | TNFalpha | 0.46 pg/mL | Standard Deviation 0.48 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IFNgamma | 0.17 pg/mL | Standard Deviation 0.22 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | G-CSF | 0.57 pg/mL | Standard Deviation 0.55 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | GM-CSF | 0.45 pg/mL | Standard Deviation 0.46 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | MCP1 | 2.17 pg/mL | Standard Deviation 0.26 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | MIP1a | 0.82 pg/mL | Standard Deviation 0.5 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | sVEGF | 1.92 pg/mL | Standard Deviation 0.42 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | sVCAM-1 | 4.97 pg/mL | Standard Deviation 0.13 |
| CP-690,550 | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | sICAM-1 | 4.65 pg/mL | Standard Deviation 0.12 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | sVEGF | 1.88 pg/mL | Standard Deviation 0.29 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IL-1alpha | 0.66 pg/mL | Standard Deviation 0.66 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IP-10 | 2.28 pg/mL | Standard Deviation 0.38 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IL-1beta | 0.38 pg/mL | Standard Deviation 0.41 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | MCP1 | 2.07 pg/mL | Standard Deviation 0.35 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IL-4 | 0.14 pg/mL | Standard Deviation 0.13 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | TNFalpha | 0.43 pg/mL | Standard Deviation 0.51 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IL-6 | 0.66 pg/mL | Standard Deviation 0.44 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | sICAM-1 | 4.76 pg/mL | Standard Deviation 0.15 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IL-7 | 0.52 pg/mL | Standard Deviation 0.35 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IFNgamma | 0.10 pg/mL | Standard Deviation 0 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IL-8 | 1.04 pg/mL | Standard Deviation 0.23 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | MIP1a | 0.85 pg/mL | Standard Deviation 0.31 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IL-10 | 0.34 pg/mL | Standard Deviation 0.37 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | G-CSF | 0.58 pg/mL | Standard Deviation 0.28 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IL-12p70 | 0.33 pg/mL | Standard Deviation 0.45 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | sVCAM-1 | 5.05 pg/mL | Standard Deviation 0.16 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IL-17A | 0.36 pg/mL | Standard Deviation 0.35 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | GM-CSF | 0.35 pg/mL | Standard Deviation 0.42 |
| Placebo | Blood Cytokine Level at Pre-dose on Day 35 or Early Termination | IL-21 | 1.58 pg/mL | Standard Deviation 0.99 |
Primary
Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7)
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)
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7) | CD19 mRNA | 0.11 REU | Standard Deviation 0.28 |
| CP-690,550 | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7) | CD3E mRNA | 0.41 REU | Standard Deviation 0.44 |
| CP-690,550 | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7) | STAT1 mRNA | 0.06 REU | Standard Deviation 0.25 |
| CP-690,550 | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7) | STAT3 mRNA | 0.61 REU | Standard Deviation 0.13 |
| CP-690,550 | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7) | ISG15 mRNA | -0.65 REU | Standard Deviation 0.45 |
| CP-690,550 | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7) | CXCL10 mRNA | -1.58 REU | Standard Deviation 0.33 |
| Placebo | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7) | ISG15 mRNA | -0.56 REU | Standard Deviation 0.47 |
| Placebo | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7) | CD19 mRNA | 0.29 REU | Standard Deviation 0.25 |
| Placebo | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7) | STAT3 mRNA | 0.64 REU | Standard Deviation 0.08 |
| Placebo | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7) | CD3E mRNA | 0.40 REU | Standard Deviation 0.38 |
| Placebo | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7) | CXCL10 mRNA | -1.65 REU | Standard Deviation 0.19 |
| Placebo | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7) | STAT1 mRNA | 0.02 REU | Standard Deviation 0.13 |
Primary
Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28 | STAT3 mRNA | 0.60 REU | Standard Deviation 0.13 |
| CP-690,550 | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28 | CD3E mRNA | 0.49 REU | Standard Deviation 0.34 |
| CP-690,550 | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28 | ISG15 mRNA | -0.93 REU | Standard Deviation 0.2 |
| CP-690,550 | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28 | STAT1 mRNA | -0.01 REU | Standard Deviation 0.28 |
| CP-690,550 | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28 | CXCL10 mRNA | -1.64 REU | Standard Deviation 0.22 |
| CP-690,550 | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28 | CD19 mRNA | 0.35 REU | Standard Deviation 0.24 |
| Placebo | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28 | CXCL10 mRNA | -1.59 REU | Standard Deviation 0.28 |
| Placebo | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28 | CD19 mRNA | 0.30 REU | Standard Deviation 0.25 |
| Placebo | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28 | STAT1 mRNA | 0.04 REU | Standard Deviation 0.21 |
| Placebo | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28 | STAT3 mRNA | 0.59 REU | Standard Deviation 0.13 |
| Placebo | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28 | ISG15 mRNA | -0.48 REU | Standard Deviation 0.51 |
| Placebo | Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28 | CD3E mRNA | 0.40 REU | Standard Deviation 0.32 |
Primary
Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Naive CD4 Cells | 290.36 cells/mcL | Standard Deviation 244.79 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Naive Cells | 136.43 cells/mcL | Standard Deviation 80.37 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Terminally Diff Effector CD4 Cells | 18.00 cells/mcL | Standard Deviation 24.88 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | CD8 T Cells (CD3+CD8) | 253.64 cells/mcL | Standard Deviation 190.57 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Central Memory CD8 Cells | 73.71 cells/mcL | Standard Deviation 58.46 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Marginal B Cells | 15.50 cells/mcL | Standard Deviation 8.72 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Effector Memory CD8 Cells | 17.93 cells/mcL | Standard Deviation 13.74 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | NK Cells (CD16 CD56) | 162.21 cells/mcL | Standard Deviation 116.2 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Naive CD8 Cells | 101.79 cells/mcL | Standard Deviation 126.51 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Memory B Cells | 16.36 cells/mcL | Standard Deviation 12.73 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Terminally Diff Effector Memory CD8 Cells | 60.07 cells/mcL | Standard Deviation 67.1 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Total T Cells (CD3) | 1044.07 cells/mcL | Standard Deviation 529.37 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | CD4 T Cells | 66.64 cells/mcL | Standard Deviation 40.58 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Central Memory CD4 Cells | 416.93 cells/mcL | Standard Deviation 167.72 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | CD56 Bright NK-Cells | 3.62 cells/mcL | Standard Deviation 2.6 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Immature B Cells | 5.57 cells/mcL | Standard Deviation 3.59 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | CD56 Dim NK-Cell | 99.00 cells/mcL | Standard Deviation 89.92 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Effector Memory CD4 Cells | 56.29 cells/mcL | Standard Deviation 51.24 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | CD56 Null NK-Cells | 66.23 cells/mcL | Standard Deviation 72.59 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | CD4 T Cells (CD3 CD4) | 781.57 cells/mcL | Standard Deviation 350.4 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | CD56 Dim Null NK-Cells | 165.15 cells/mcL | Standard Deviation 115.88 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | B Cells (CD19) | 173.86 cells/mcL | Standard Deviation 95.29 |
| Placebo | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | CD56 Dim Null NK-Cells | 173.25 cells/mcL | Standard Deviation 141.06 |
| Placebo | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | B Cells (CD19) | 344.17 cells/mcL | Standard Deviation 211 |
| Placebo | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Total T Cells (CD3) | 1411.75 cells/mcL | Standard Deviation 474.97 |
| Placebo | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | CD8 T Cells (CD3+CD8) | 364.92 cells/mcL | Standard Deviation 202.7 |
| Placebo | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | CD4 T Cells (CD3 CD4) | 1046.00 cells/mcL | Standard Deviation 328.08 |
| Placebo | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | NK Cells (CD16 CD56) | 179.67 cells/mcL | Standard Deviation 142.64 |
| Placebo | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Immature B Cells | 11.17 cells/mcL | Standard Deviation 9.99 |
| Placebo | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Naive Cells | 252.92 cells/mcL | Standard Deviation 206.67 |
| Placebo | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Marginal B Cells | 57.58 cells/mcL | Standard Deviation 102.2 |
| Placebo | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Memory B Cells | 22.50 cells/mcL | Standard Deviation 13.93 |
| Placebo | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Central Memory CD4 Cells | 605.00 cells/mcL | Standard Deviation 222.14 |
| Placebo | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Effector Memory CD4 Cells | 97.25 cells/mcL | Standard Deviation 103.24 |
| Placebo | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Naive CD4 Cells | 333.83 cells/mcL | Standard Deviation 132.59 |
| Placebo | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Terminally Diff Effector CD4 Cells | 9.75 cells/mcL | Standard Deviation 16.44 |
| Placebo | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Central Memory CD8 Cells | 109.42 cells/mcL | Standard Deviation 49.9 |
| Placebo | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Effector Memory CD8 Cells | 70.58 cells/mcL | Standard Deviation 99.36 |
| Placebo | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Naive CD8 Cells | 133.75 cells/mcL | Standard Deviation 97.93 |
| Placebo | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | Terminally Diff Effector Memory CD8 Cells | 51.08 cells/mcL | Standard Deviation 61.27 |
| Placebo | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | CD4 T Cells | 73.50 cells/mcL | Standard Deviation 39.02 |
| Placebo | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | CD56 Bright NK-Cells | 6.33 cells/mcL | Standard Deviation 3.52 |
| Placebo | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | CD56 Dim NK-Cell | 141.17 cells/mcL | Standard Deviation 130.25 |
| Placebo | Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination | CD56 Null NK-Cells | 32.25 cells/mcL | Standard Deviation 19.3 |
Primary
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Naive CD4 Cells | 298.47 cells/mcL | Standard Deviation 197.32 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Naive Cells | 166.60 cells/mcL | Standard Deviation 111.95 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Terminally Diff Effector CD4 Cells | 42.93 cells/mcL | Standard Deviation 87.65 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | CD8 T Cells (CD3 CD8) | 431.07 cells/mcL | Standard Deviation 229.21 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Central Memory CD8 Cells | 134.40 cells/mcL | Standard Deviation 102.91 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Marginal B Cells | 16.20 cells/mcL | Standard Deviation 6.65 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Effector Memory CD8 Cells | 49.00 cells/mcL | Standard Deviation 37.44 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | NK Cells (CD16 CD56) | 422.87 cells/mcL | Standard Deviation 182.11 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Naive CD8 Cells | 114.20 cells/mcL | Standard Deviation 50.74 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Memory B Cells | 16.07 cells/mcL | Standard Deviation 8.04 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Terminally Diff Effector Memory CD8 Cells | 133.53 cells/mcL | Standard Deviation 168.92 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Total T Cells (CD3) | 1533.53 cells/mcL | Standard Deviation 631.42 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | CD4 T-Cells | 76.13 cells/mcL | Standard Deviation 39.65 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Central Memory CD4 Cells | 640.07 cells/mcL | Standard Deviation 314.78 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | CD56 Bright NK-Cells | 10.00 cells/mcL | Standard Deviation 4.75 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Immature B Cells | 8.40 cells/mcL | Standard Deviation 9.63 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | CD56 Dim NK-Cell | 358.33 cells/mcL | Standard Deviation 171.65 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Effector Memory CD4 Cells | 121.07 cells/mcL | Standard Deviation 127.98 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | CD56 Null NK-Cells | 54.40 cells/mcL | Standard Deviation 44.65 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | CD4 T Cells (CD3 CD4) | 1102.60 cells/mcL | Standard Deviation 450.53 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | CD56 Dim Null NK-Cells | 412.60 cells/mcL | Standard Deviation 180.18 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | B Cells (CD19) | 207.07 cells/mcL | Standard Deviation 128.57 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | CD56 Dim Null NK-Cells | 171.62 cells/mcL | Standard Deviation 104.39 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | B Cells (CD19) | 312.69 cells/mcL | Standard Deviation 216.36 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Total T Cells (CD3) | 1596.54 cells/mcL | Standard Deviation 754.87 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | CD8 T Cells (CD3 CD8) | 372.38 cells/mcL | Standard Deviation 157.96 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | CD4 T Cells (CD3 CD4) | 1208.08 cells/mcL | Standard Deviation 651.25 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | NK Cells (CD16 CD56) | 179.15 cells/mcL | Standard Deviation 107.03 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Immature B Cells | 8.92 cells/mcL | Standard Deviation 7.49 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Naive Cells | 222.75 cells/mcL | Standard Deviation 185.92 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Marginal B Cells | 78.17 cells/mcL | Standard Deviation 151.67 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Memory B Cells | 25.75 cells/mcL | Standard Deviation 17.78 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Central Memory CD4 Cells | 706.42 cells/mcL | Standard Deviation 360.34 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Effector Memory CD4 Cells | 61.83 cells/mcL | Standard Deviation 45.05 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Naive CD4 Cells | 459.75 cells/mcL | Standard Deviation 382.27 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Terminally Diff Effector CD4 Cells | 4.50 cells/mcL | Standard Deviation 6.78 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Central Memory CD8 Cells | 141.75 cells/mcL | Standard Deviation 87.65 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Effector Memory CD8 Cells | 46.58 cells/mcL | Standard Deviation 64.47 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Naive CD8 Cells | 137.33 cells/mcL | Standard Deviation 69.67 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | Terminally Diff Effector Memory CD8 Cells | 39.58 cells/mcL | Standard Deviation 36.34 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | CD4 T-Cells | 91.92 cells/mcL | Standard Deviation 55.68 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | CD56 Bright NK-Cells | 7.23 cells/mcL | Standard Deviation 4.38 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | CD56 Dim NK-Cell | 136.92 cells/mcL | Standard Deviation 97.23 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 | CD56 Null NK-Cells | 34.77 cells/mcL | Standard Deviation 23.81 |
Primary
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Naive CD4 Cells | 418.93 cells/mcL | Standard Deviation 321.41 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Naive Cells | 261.57 cells/mcL | Standard Deviation 140.28 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Terminally Diff Effector CD4 Cells | 21.07 cells/mcL | Standard Deviation 31.32 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | CD8 T Cells (CD3 CD8) | 409.71 cells/mcL | Standard Deviation 158.79 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Central Memory CD8 Cells | 141.50 cells/mcL | Standard Deviation 82.12 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Marginal B Cells | 36.43 cells/mcL | Standard Deviation 20.14 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Effector Memory CD8 Cells | 36.07 cells/mcL | Standard Deviation 23.82 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | NK Cells (CD16 CD56) | 309.43 cells/mcL | Standard Deviation 112.95 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Naive CD8 Cells | 135.29 cells/mcL | Standard Deviation 83.65 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Memory B Cells | 32.57 cells/mcL | Standard Deviation 15.27 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Terminally Diff Effector Memory CD8 Cells | 97.21 cells/mcL | Standard Deviation 109.27 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Total T Cells(CD3) | 1705.57 cells/mcL | Standard Deviation 621.55 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | CD4 T-Cells | 88.50 cells/mcL | Standard Deviation 51.93 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Central Memory CD4 Cells | 723.43 cells/mcL | Standard Deviation 253.15 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | CD56 Bright NK-Cells | 4.71 cells/mcL | Standard Deviation 2.43 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Immature B Cells | 12.43 cells/mcL | Standard Deviation 7.84 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | CD56 Dim NK-Cell | 258.43 cells/mcL | Standard Deviation 111.98 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Effector Memory CD4 Cells | 117.21 cells/mcL | Standard Deviation 99.96 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | CD56 Null NK-Cells | 46.29 cells/mcL | Standard Deviation 25.38 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | CD4 T Cells (CD3 CD4) | 1281.00 cells/mcL | Standard Deviation 491.92 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | CD56 Dim Null NK-Cells | 304.64 cells/mcL | Standard Deviation 112.88 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | B Cells (CD19) | 343.21 cells/mcL | Standard Deviation 159.97 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | CD56 Dim Null NK-Cells | 331.14 cells/mcL | Standard Deviation 422.93 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | B Cells (CD19) | 329.00 cells/mcL | Standard Deviation 202.97 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Total T Cells(CD3) | 1630.64 cells/mcL | Standard Deviation 816.41 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | CD8 T Cells (CD3 CD8) | 482.07 cells/mcL | Standard Deviation 388.11 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | CD4 T Cells (CD3 CD4) | 1145.50 cells/mcL | Standard Deviation 522.79 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | NK Cells (CD16 CD56) | 339.50 cells/mcL | Standard Deviation 426.91 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Immature B Cells | 9.14 cells/mcL | Standard Deviation 9.04 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Naive Cells | 233.86 cells/mcL | Standard Deviation 171.68 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Marginal B Cells | 63.00 cells/mcL | Standard Deviation 141.24 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Memory B Cells | 23.07 cells/mcL | Standard Deviation 17.84 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Central Memory CD4 Cells | 614.50 cells/mcL | Standard Deviation 219.76 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Effector Memory CD4 Cells | 143.14 cells/mcL | Standard Deviation 237.16 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Naive CD4 Cells | 370.43 cells/mcL | Standard Deviation 199.66 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Terminally Diff Effector CD4 Cells | 17.43 cells/mcL | Standard Deviation 36.5 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Central Memory CD8 Cells | 128.14 cells/mcL | Standard Deviation 70.76 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Effector Memory CD8 Cells | 114.79 cells/mcL | Standard Deviation 187.14 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Naive CD8 Cells | 140.07 cells/mcL | Standard Deviation 101.82 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | Terminally Diff Effector Memory CD8 Cells | 98.93 cells/mcL | Standard Deviation 154.16 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | CD4 T-Cells | 78.64 cells/mcL | Standard Deviation 41.5 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | CD56 Bright NK-Cells | 8.14 cells/mcL | Standard Deviation 5.53 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | CD56 Dim NK-Cell | 284.14 cells/mcL | Standard Deviation 394.73 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 | CD56 Null NK-Cells | 46.93 cells/mcL | Standard Deviation 52.57 |
Primary
Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Terminally Diff Effector Memory CD8 Cells | 48.42 cells/mcL | Standard Deviation 55.68 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | B Cells (CD19) | 276.00 cells/mcL | Standard Deviation 167.25 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Total T Cells(CD3) | 1044.08 cells/mcL | Standard Deviation 505.6 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | CD8 T Cells (CD3 CD8) | 239.92 cells/mcL | Standard Deviation 113.32 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | CD4 T Cells (CD3 CD4) | 799.50 cells/mcL | Standard Deviation 408.07 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | NK Cells (CD16 CD56) | 92.92 cells/mcL | Standard Deviation 52.3 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Immature B Cells | 10.00 cells/mcL | Standard Deviation 4.2 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Naive Cells | 215.83 cells/mcL | Standard Deviation 146.07 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Marginal B Cells | 25.58 cells/mcL | Standard Deviation 18.78 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Memory B Cells | 24.83 cells/mcL | Standard Deviation 11.1 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Central Memory CD4 Cells | 431.92 cells/mcL | Standard Deviation 186.89 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Effector Memory CD4 Cells | 59.58 cells/mcL | Standard Deviation 41.84 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Naive CD4 Cells | 297.17 cells/mcL | Standard Deviation 287.44 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Terminally Diff Effector CD4 Cells | 11.00 cells/mcL | Standard Deviation 18.39 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Central Memory CD8 Cells | 85.50 cells/mcL | Standard Deviation 72.1 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Effector Memory CD8 Cells | 16.75 cells/mcL | Standard Deviation 8.58 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Naive CD8 Cells | 89.25 cells/mcL | Standard Deviation 62.57 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | CD4 T Cells | 61.67 cells/mcL | Standard Deviation 41.32 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | CD56 Bright NK-Cells | 1.83 cells/mcL | Standard Deviation 1.11 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | CD56 Dim NK-Cell | 65.42 cells/mcL | Standard Deviation 47.76 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | CD56 Null NK-Cells | 25.50 cells/mcL | Standard Deviation 12.72 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | CD56 Dim Null NK-Cells | 91.08 cells/mcL | Standard Deviation 51.61 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Effector Memory CD4 Cells | 79.50 cells/mcL | Standard Deviation 119.68 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | CD56 Dim NK-Cell | 158.17 cells/mcL | Standard Deviation 137.82 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | B Cells (CD19) | 300.92 cells/mcL | Standard Deviation 191.57 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Naive CD4 Cells | 508.83 cells/mcL | Standard Deviation 483.29 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Total T Cells(CD3) | 1619.33 cells/mcL | Standard Deviation 913.77 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | CD4 T Cells | 92.58 cells/mcL | Standard Deviation 59.44 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | CD8 T Cells (CD3 CD8) | 382.75 cells/mcL | Standard Deviation 200.38 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Terminally Diff Effector CD4 Cells | 9.00 cells/mcL | Standard Deviation 18.01 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | CD4 T Cells (CD3 CD4) | 1223.17 cells/mcL | Standard Deviation 779.67 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | CD56 Dim Null NK-Cells | 187.92 cells/mcL | Standard Deviation 149.63 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | NK Cells (CD16 CD56) | 196.67 cells/mcL | Standard Deviation 152.83 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Central Memory CD8 Cells | 133.33 cells/mcL | Standard Deviation 83.39 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Immature B Cells | 9.75 cells/mcL | Standard Deviation 9.52 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | CD56 Bright NK-Cells | 8.50 cells/mcL | Standard Deviation 4.76 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Naive Cells | 245.33 cells/mcL | Standard Deviation 173.16 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Effector Memory CD8 Cells | 59.17 cells/mcL | Standard Deviation 93.93 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Marginal B Cells | 24.08 cells/mcL | Standard Deviation 27.05 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | CD56 Null NK-Cells | 30.08 cells/mcL | Standard Deviation 26.57 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Memory B Cells | 21.75 cells/mcL | Standard Deviation 16.1 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Naive CD8 Cells | 142.08 cells/mcL | Standard Deviation 131.13 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Central Memory CD4 Cells | 626.00 cells/mcL | Standard Deviation 339.12 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 | Terminally Diff Effector Memory CD8 Cells | 48.17 cells/mcL | Standard Deviation 60.46 |
Primary
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Naive CD4 Cells | 352.43 cells/mcL | Standard Deviation 307.49 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Naive Cells | 177.50 cells/mcL | Standard Deviation 129.9 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Terminally Diff Effector CD4 Cells | 45.57 cells/mcL | Standard Deviation 103.39 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | CD8 T Cells (CD3 CD8) | 505.64 cells/mcL | Standard Deviation 298.97 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Central Memory CD8 Cells | 159.21 cells/mcL | Standard Deviation 119.89 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Marginal B Cells | 19.86 cells/mcL | Standard Deviation 12.6 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Effector Memory CD8 Cells | 64.07 cells/mcL | Standard Deviation 52.87 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | NK Cells (CD16 CD56) | 428.50 cells/mcL | Standard Deviation 207.39 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Naive CD8 Cells | 127.71 cells/mcL | Standard Deviation 54.79 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Memory B Cells | 17.07 cells/mcL | Standard Deviation 10.98 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Terminally Diff Effector Memory CD8 Cells | 154.43 cells/mcL | Standard Deviation 201.13 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Total T Cells (CD3) | 1841.07 cells/mcL | Standard Deviation 880.14 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | CD4 T-Cells | 86.36 cells/mcL | Standard Deviation 42.89 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Central Memory CD4 Cells | 785.43 cells/mcL | Standard Deviation 388.64 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | CD56 Bright NK-Cells | 11.21 cells/mcL | Standard Deviation 6.05 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Immature B Cells | 8.29 cells/mcL | Standard Deviation 10.41 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | CD56 Dim NK-Cell | 364.57 cells/mcL | Standard Deviation 191.5 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Effector Memory CD4 Cells | 155.71 cells/mcL | Standard Deviation 165.49 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | CD56 Null NK-Cells | 52.57 cells/mcL | Standard Deviation 48.32 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | CD4 T Cells (CD3 CD4) | 1338.79 cells/mcL | Standard Deviation 633.15 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | CD56 Dim Null NK-Cells | 417.00 cells/mcL | Standard Deviation 204.21 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | B Cells (CD19) | 222.79 cells/mcL | Standard Deviation 154.52 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | CD56 Dim Null NK-Cells | 194.50 cells/mcL | Standard Deviation 191.68 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | B Cells (CD19) | 380.33 cells/mcL | Standard Deviation 220.41 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Total T Cells (CD3) | 1710.42 cells/mcL | Standard Deviation 959.8 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | CD8 T Cells (CD3 CD8) | 393.00 cells/mcL | Standard Deviation 205.06 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | CD4 T Cells (CD3 CD4) | 1312.92 cells/mcL | Standard Deviation 834.04 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | NK Cells (CD16 CD56) | 201.83 cells/mcL | Standard Deviation 192.98 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Immature B Cells | 10.92 cells/mcL | Standard Deviation 10.09 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Naive Cells | 265.00 cells/mcL | Standard Deviation 209.57 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Marginal B Cells | 74.83 cells/mcL | Standard Deviation 129.24 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Memory B Cells | 29.17 cells/mcL | Standard Deviation 23.94 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Central Memory CD4 Cells | 720.50 cells/mcL | Standard Deviation 383.62 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Effector Memory CD4 Cells | 93.42 cells/mcL | Standard Deviation 129.36 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Naive CD4 Cells | 488.75 cells/mcL | Standard Deviation 499.88 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Terminally Diff Effector CD4 Cells | 10.42 cells/mcL | Standard Deviation 18.37 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Central Memory CD8 Cells | 140.42 cells/mcL | Standard Deviation 90.69 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Effector Memory CD8 Cells | 61.33 cells/mcL | Standard Deviation 104.75 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Naive CD8 Cells | 142.42 cells/mcL | Standard Deviation 69.46 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | Terminally Diff Effector Memory CD8 Cells | 48.67 cells/mcL | Standard Deviation 58.85 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | CD4 T-Cells | 97.83 cells/mcL | Standard Deviation 78.84 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | CD56 Bright NK-Cells | 7.17 cells/mcL | Standard Deviation 3.95 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | CD56 Dim NK-Cell | 157.17 cells/mcL | Standard Deviation 158.85 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 | CD56 Null NK-Cells | 37.33 cells/mcL | Standard Deviation 37.57 |
Primary
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Naive CD4 Cells | 312.00 cells/mcL | Standard Deviation 237.45 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Naive Cells | 256.91 cells/mcL | Standard Deviation 156.81 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Terminally Diff Effector CD4 Cells | 24.91 cells/mcL | Standard Deviation 30.27 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | CD8 T Cells (CD3 CD8) | 355.27 cells/mcL | Standard Deviation 111.71 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Central Memory CD8 Cells | 118.09 cells/mcL | Standard Deviation 78.61 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Marginal B Cells | 38.73 cells/mcL | Standard Deviation 38.69 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Effector Memory CD8 Cells | 37.09 cells/mcL | Standard Deviation 27.5 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | NK Cells (CD16 CD56) | 188.36 cells/mcL | Standard Deviation 59.25 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Naive CD8 Cells | 126.00 cells/mcL | Standard Deviation 90.18 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Memory B Cells | 29.91 cells/mcL | Standard Deviation 17.27 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Terminally Diff Effector Memory CD8 Cells | 73.91 cells/mcL | Standard Deviation 58.79 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Total T Cells(CD3) | 1483.00 cells/mcL | Standard Deviation 495.98 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | CD4 T-Cells | 64.09 cells/mcL | Standard Deviation 33.05 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Central Memory CD4 Cells | 675.55 cells/mcL | Standard Deviation 270.78 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | CD56 Bright NK-Cells | 4.55 cells/mcL | Standard Deviation 2.42 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Immature B Cells | 10.73 cells/mcL | Standard Deviation 8.33 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | CD56 Dim NK-Cell | 143.55 cells/mcL | Standard Deviation 49.57 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Effector Memory CD4 Cells | 110.09 cells/mcL | Standard Deviation 69.34 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | CD56 Null NK-Cells | 40.36 cells/mcL | Standard Deviation 25.74 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | CD4 T Cells (CD3 CD4) | 1122.91 cells/mcL | Standard Deviation 419.02 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | CD56 Dim Null NK-Cells | 183.64 cells/mcL | Standard Deviation 58.53 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | B Cells (CD19) | 336.45 cells/mcL | Standard Deviation 194.7 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | CD56 Dim Null NK-Cells | 193.92 cells/mcL | Standard Deviation 188.21 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | B Cells (CD19) | 347.67 cells/mcL | Standard Deviation 233.3 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Total T Cells(CD3) | 1445.83 cells/mcL | Standard Deviation 712.35 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | CD8 T Cells (CD3 CD8) | 346.00 cells/mcL | Standard Deviation 209.68 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | CD4 T Cells (CD3 CD4) | 1095.00 cells/mcL | Standard Deviation 565.7 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | NK Cells (CD16 CD56) | 200.75 cells/mcL | Standard Deviation 191.26 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Immature B Cells | 10.33 cells/mcL | Standard Deviation 10.82 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Naive Cells | 247.17 cells/mcL | Standard Deviation 207.69 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Marginal B Cells | 67.17 cells/mcL | Standard Deviation 129.67 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Memory B Cells | 23.17 cells/mcL | Standard Deviation 19.64 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Central Memory CD4 Cells | 631.50 cells/mcL | Standard Deviation 260.76 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Effector Memory CD4 Cells | 85.92 cells/mcL | Standard Deviation 134.06 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Naive CD4 Cells | 369.50 cells/mcL | Standard Deviation 314.06 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Terminally Diff Effector CD4 Cells | 8.17 cells/mcL | Standard Deviation 20.56 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Central Memory CD8 Cells | 112.83 cells/mcL | Standard Deviation 60.76 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Effector Memory CD8 Cells | 60.17 cells/mcL | Standard Deviation 91.98 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Naive CD8 Cells | 133.17 cells/mcL | Standard Deviation 98.02 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | Terminally Diff Effector Memory CD8 Cells | 40.00 cells/mcL | Standard Deviation 75.37 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | CD4 T-Cells | 65.36 cells/mcL | Standard Deviation 36.7 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | CD56 Bright NK-Cells | 6.83 cells/mcL | Standard Deviation 4.71 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | CD56 Dim NK-Cell | 163.50 cells/mcL | Standard Deviation 158.1 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 | CD56 Null NK-Cells | 30.50 cells/mcL | Standard Deviation 35.48 |
Primary
Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Naive CD4 Cells | 338.17 cells/mcL | Standard Deviation 270.26 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Naive Cells | 291.33 cells/mcL | Standard Deviation 165.84 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Terminally Diff Effector CD4 Cells | 19.83 cells/mcL | Standard Deviation 21.41 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | CD8 T Cells (CD3 CD8) | 348.33 cells/mcL | Standard Deviation 135.33 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Central Memory CD8 Cells | 115.92 cells/mcL | Standard Deviation 51.47 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Marginal B Cells | 46.50 cells/mcL | Standard Deviation 38.57 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Effector Memory CD8 Cells | 35.33 cells/mcL | Standard Deviation 25.27 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | NK Cells (CD16 CD56) | 174.58 cells/mcL | Standard Deviation 82.07 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Naive CD8 Cells | 133.25 cells/mcL | Standard Deviation 95.54 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Memory B Cells | 33.00 cells/mcL | Standard Deviation 20.82 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Terminally Diff Effector Memory CD8 Cells | 64.08 cells/mcL | Standard Deviation 56.47 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Total T Cells(CD3) | 1557.58 cells/mcL | Standard Deviation 601.36 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | CD4 T-Cells | 79.00 cells/mcL | Standard Deviation 53.92 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Central Memory CD4 Cells | 726.75 cells/mcL | Standard Deviation 293.12 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | CD56 Bright NK-Cells | 3.36 cells/mcL | Standard Deviation 1.8 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Immature B Cells | 11.25 cells/mcL | Standard Deviation 7.1 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | CD56 Dim NK-Cell | 117.18 cells/mcL | Standard Deviation 59.33 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Effector Memory CD4 Cells | 119.17 cells/mcL | Standard Deviation 87.92 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | CD56 Null NK-Cells | 41.91 cells/mcL | Standard Deviation 29.36 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | CD4 T Cells (CD3 CD4) | 1203.67 cells/mcL | Standard Deviation 491.02 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | CD56 Dim Null NK-Cells | 158.91 cells/mcL | Standard Deviation 74.78 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | B Cells (CD19) | 382.33 cells/mcL | Standard Deviation 204.55 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | CD56 Dim Null NK-Cells | 210.64 cells/mcL | Standard Deviation 145.85 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | B Cells (CD19) | 318.27 cells/mcL | Standard Deviation 253.87 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Total T Cells(CD3) | 1616.00 cells/mcL | Standard Deviation 934.75 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | CD8 T Cells (CD3 CD8) | 420.18 cells/mcL | Standard Deviation 226.6 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | CD4 T Cells (CD3 CD4) | 1186.73 cells/mcL | Standard Deviation 788.19 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | NK Cells (CD16 CD56) | 217.91 cells/mcL | Standard Deviation 148.22 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Immature B Cells | 7.30 cells/mcL | Standard Deviation 8.08 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Naive Cells | 243.10 cells/mcL | Standard Deviation 220.3 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Marginal B Cells | 76.60 cells/mcL | Standard Deviation 142.34 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Memory B Cells | 22.70 cells/mcL | Standard Deviation 19.96 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Central Memory CD4 Cells | 725.00 cells/mcL | Standard Deviation 424.16 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Effector Memory CD4 Cells | 85.64 cells/mcL | Standard Deviation 127.9 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Naive CD4 Cells | 367.73 cells/mcL | Standard Deviation 378.39 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Terminally Diff Effector CD4 Cells | 8.27 cells/mcL | Standard Deviation 18.79 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Central Memory CD8 Cells | 149.27 cells/mcL | Standard Deviation 86.3 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Effector Memory CD8 Cells | 85.09 cells/mcL | Standard Deviation 110.75 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Naive CD8 Cells | 133.64 cells/mcL | Standard Deviation 111.11 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | Terminally Diff Effector Memory CD8 Cells | 52.27 cells/mcL | Standard Deviation 72.48 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | CD4 T-Cells | 89.50 cells/mcL | Standard Deviation 72.98 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | CD56 Bright NK-Cells | 7.27 cells/mcL | Standard Deviation 4.29 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | CD56 Dim NK-Cell | 164.36 cells/mcL | Standard Deviation 125.72 |
| Placebo | Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 | CD56 Null NK-Cells | 46.27 cells/mcL | Standard Deviation 38.4 |
Primary
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Naive CD4 Cells | 311.09 cells per microliter (cells/mcL) | Standard Deviation 245.67 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Naive Cells | 165.64 cells per microliter (cells/mcL) | Standard Deviation 113.99 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Terminally Differentiated(Diff) EffectorCD4 Cells | 45.82 cells per microliter (cells/mcL) | Standard Deviation 83.6 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | CD8 T Cells (CD3 CD8) | 402.73 cells per microliter (cells/mcL) | Standard Deviation 205.74 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Central Memory CD8 Cells | 117.73 cells per microliter (cells/mcL) | Standard Deviation 102.47 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Marginal B Cells | 17.55 cells per microliter (cells/mcL) | Standard Deviation 7.62 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Effector Memory CD8 Cells | 38.55 cells per microliter (cells/mcL) | Standard Deviation 29.88 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | NK Cells (CD16 CD56) | 276.45 cells per microliter (cells/mcL) | Standard Deviation 134.62 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Naive CD8 Cells | 111.91 cells per microliter (cells/mcL) | Standard Deviation 81.86 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Memory B Cells | 20.45 cells per microliter (cells/mcL) | Standard Deviation 12.36 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Terminally Diff Effector Memory CD8 Cells | 134.36 cells per microliter (cells/mcL) | Standard Deviation 140.97 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Total T Cells (CD3) | 1516.27 cells per microliter (cells/mcL) | Standard Deviation 567.38 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | CD4 T-Cells | 81.91 cells per microliter (cells/mcL) | Standard Deviation 34.76 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Central Memory CD4 Cells | 627.45 cells per microliter (cells/mcL) | Standard Deviation 306.86 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | CD56 Bright NK-Cells | 9.27 cells per microliter (cells/mcL) | Standard Deviation 3.85 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Immature B Cells | 10.27 cells per microliter (cells/mcL) | Standard Deviation 11.23 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | CD56 Dim NK-Cell | 209.09 cells per microliter (cells/mcL) | Standard Deviation 124.61 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Effector Memory CD4 Cells | 130.09 cells per microliter (cells/mcL) | Standard Deviation 138.98 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | CD56 Null NK-Cells | 57.82 cells per microliter (cells/mcL) | Standard Deviation 61.05 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | CD4 T Cells (CD3 CD4) | 1114.82 cells per microliter (cells/mcL) | Standard Deviation 415.59 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | CD56 Dim Null NK-Cells | 266.73 cells per microliter (cells/mcL) | Standard Deviation 132.17 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | B Cells (CD19) | 214.09 cells per microliter (cells/mcL) | Standard Deviation 134.72 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | CD56 Dim Null NK-Cells | 183.42 cells per microliter (cells/mcL) | Standard Deviation 118.39 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | B Cells (CD19) | 389.17 cells per microliter (cells/mcL) | Standard Deviation 190.27 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Total T Cells (CD3) | 1579.00 cells per microliter (cells/mcL) | Standard Deviation 628.89 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | CD8 T Cells (CD3 CD8) | 376.67 cells per microliter (cells/mcL) | Standard Deviation 189.14 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | CD4 T Cells (CD3 CD4) | 1199.17 cells per microliter (cells/mcL) | Standard Deviation 496.66 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | NK Cells (CD16 CD56) | 190.67 cells per microliter (cells/mcL) | Standard Deviation 121.2 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Immature B Cells | 8.83 cells per microliter (cells/mcL) | Standard Deviation 5.65 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Naive Cells | 273.67 cells per microliter (cells/mcL) | Standard Deviation 178.51 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Marginal B Cells | 81.50 cells per microliter (cells/mcL) | Standard Deviation 168.29 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Memory B Cells | 25.00 cells per microliter (cells/mcL) | Standard Deviation 14.83 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Central Memory CD4 Cells | 673.33 cells per microliter (cells/mcL) | Standard Deviation 291.75 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Effector Memory CD4 Cells | 93.92 cells per microliter (cells/mcL) | Standard Deviation 97.3 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Naive CD4 Cells | 420.92 cells per microliter (cells/mcL) | Standard Deviation 294.76 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Terminally Differentiated(Diff) EffectorCD4 Cells | 10.25 cells per microliter (cells/mcL) | Standard Deviation 15.15 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Central Memory CD8 Cells | 136.58 cells per microliter (cells/mcL) | Standard Deviation 77.79 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Effector Memory CD8 Cells | 68.25 cells per microliter (cells/mcL) | Standard Deviation 88.65 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Naive CD8 Cells | 113.08 cells per microliter (cells/mcL) | Standard Deviation 50.56 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | Terminally Diff Effector Memory CD8 Cells | 58.83 cells per microliter (cells/mcL) | Standard Deviation 52.87 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | CD4 T-Cells | 81.92 cells per microliter (cells/mcL) | Standard Deviation 42.95 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | CD56 Bright NK-Cells | 7.00 cells per microliter (cells/mcL) | Standard Deviation 4.13 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | CD56 Dim NK-Cell | 143.83 cells per microliter (cells/mcL) | Standard Deviation 103.97 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 | CD56 Null NK-Cells | 39.58 cells per microliter (cells/mcL) | Standard Deviation 27.28 |
Primary
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Terminally Diff Effector Memory CD8 Cells | 112.50 cells/mcL | Standard Deviation 114.14 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Total T Cells (CD3) | 1732.29 cells/mcL | Standard Deviation 581.98 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | CD56 Bright NK-Cells | 5.07 cells/mcL | Standard Deviation 2.37 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | CD8 T Cells (CD3 CD8) | 413.64 cells/mcL | Standard Deviation 169.81 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | CD4 T Cells (CD3 CD4) | 1314.64 cells/mcL | Standard Deviation 475.64 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | NK Cells (CD16 CD56) | 258.79 cells/mcL | Standard Deviation 177.98 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Immature B Cells | 11.21 cells/mcL | Standard Deviation 9.96 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Naive Cells | 218.57 cells/mcL | Standard Deviation 121.71 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Marginal B Cells | 32.29 cells/mcL | Standard Deviation 20.28 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Memory B Cells | 28.50 cells/mcL | Standard Deviation 14.53 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Central Memory CD4 Cells | 696.21 cells/mcL | Standard Deviation 294.16 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Effector Memory CD4 Cells | 130.86 cells/mcL | Standard Deviation 139.79 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Naive CD4 Cells | 453.86 cells/mcL | Standard Deviation 314.82 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Terminally Diff Effector CD4 Cells | 33.43 cells/mcL | Standard Deviation 52.47 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Central Memory CD8 Cells | 126.71 cells/mcL | Standard Deviation 95.74 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Effector Memory CD8 Cells | 37.57 cells/mcL | Standard Deviation 27.11 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Naive CD8 Cells | 136.93 cells/mcL | Standard Deviation 66.75 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | B Cells (CD19) | 290.50 cells/mcL | Standard Deviation 144.94 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | CD4 T-Cells | 93.64 cells/mcL | Standard Deviation 57.44 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | CD56 Dim NK-Cell | 207.50 cells/mcL | Standard Deviation 162.82 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | CD56 Null NK-Cells | 46.29 cells/mcL | Standard Deviation 52.45 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | CD56 Dim Null NK-Cells | 253.64 cells/mcL | Standard Deviation 176.82 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Effector Memory CD4 Cells | 78.92 cells/mcL | Standard Deviation 102.26 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | B Cells (CD19) | 310.92 cells/mcL | Standard Deviation 154.13 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Terminally Diff Effector Memory CD8 Cells | 59.77 cells/mcL | Standard Deviation 70.15 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Naive CD4 Cells | 393.08 cells/mcL | Standard Deviation 296.88 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Total T Cells (CD3) | 1477.08 cells/mcL | Standard Deviation 696.45 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | CD56 Dim Null NK-Cells | 196.92 cells/mcL | Standard Deviation 136.36 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | CD8 T Cells (CD3 CD8) | 384.15 cells/mcL | Standard Deviation 216.57 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Terminally Diff Effector CD4 Cells | 9.31 cells/mcL | Standard Deviation 18.4 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | CD4 T Cells (CD3 CD4) | 1084.62 cells/mcL | Standard Deviation 547.23 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | CD4 T-Cells | 79.69 cells/mcL | Standard Deviation 43.04 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | NK Cells (CD16 CD56) | 205.38 cells/mcL | Standard Deviation 138.2 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Central Memory CD8 Cells | 132.46 cells/mcL | Standard Deviation 76.09 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Immature B Cells | 8.85 cells/mcL | Standard Deviation 7.99 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | CD56 Bright NK-Cells | 8.23 cells/mcL | Standard Deviation 4.8 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Naive Cells | 211.38 cells/mcL | Standard Deviation 133.45 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Effector Memory CD8 Cells | 69.38 cells/mcL | Standard Deviation 104.84 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Marginal B Cells | 69.23 cells/mcL | Standard Deviation 135.7 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | CD56 Null NK-Cells | 47.46 cells/mcL | Standard Deviation 35.83 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Memory B Cells | 21.31 cells/mcL | Standard Deviation 13.01 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Naive CD8 Cells | 122.54 cells/mcL | Standard Deviation 91.92 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | Central Memory CD4 Cells | 603.54 cells/mcL | Standard Deviation 300.56 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 | CD56 Dim NK-Cell | 149.54 cells/mcL | Standard Deviation 115.63 |
Primary
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Naive CD4 Cells | 475.23 cells/mcL | Standard Deviation 421.51 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Naive Cells | 304.77 cells/mcL | Standard Deviation 177.06 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Terminally Diff Effector CD4 Cells | 22.69 cells/mcL | Standard Deviation 28.46 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | CD8 T Cells (CD3 CD8) | 363.85 cells/mcL | Standard Deviation 143.45 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Central Memory CD8 Cells | 120.69 cells/mcL | Standard Deviation 65.03 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Marginal B Cells | 44.31 cells/mcL | Standard Deviation 36.38 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Effector Memory CD8 Cells | 32.92 cells/mcL | Standard Deviation 25.69 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | NK Cells (CD16 CD56) | 184.92 cells/mcL | Standard Deviation 103.73 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Naive CD8 Cells | 131.38 cells/mcL | Standard Deviation 85.53 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Memory B Cells | 36.69 cells/mcL | Standard Deviation 18.14 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Terminally Diff Effector Memory CD8 Cells | 78.46 cells/mcL | Standard Deviation 81.53 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Total T Cells(CD3) | 1730.38 cells/mcL | Standard Deviation 730.18 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | CD4 T-Cells | 84.38 cells/mcL | Standard Deviation 54.71 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Central Memory CD4 Cells | 736.00 cells/mcL | Standard Deviation 272.68 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | CD56 Bright NK-Cells | 4.15 cells/mcL | Standard Deviation 2.03 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Immature B Cells | 13.85 cells/mcL | Standard Deviation 8.99 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | CD56 Dim NK-Cell | 127.15 cells/mcL | Standard Deviation 78.63 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Effector Memory CD4 Cells | 118.54 cells/mcL | Standard Deviation 91.2 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | CD56 Null NK-Cells | 53.77 cells/mcL | Standard Deviation 51.21 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | CD4 T Cells (CD3 CD4) | 1352.46 cells/mcL | Standard Deviation 618.78 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | CD56 Dim Null NK-Cells | 180.77 cells/mcL | Standard Deviation 103.02 |
| CP-690,550 | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | B Cells (CD19) | 399.62 cells/mcL | Standard Deviation 208.61 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | CD56 Dim Null NK-Cells | 173.17 cells/mcL | Standard Deviation 119.76 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | B Cells (CD19) | 392.25 cells/mcL | Standard Deviation 235.63 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Total T Cells(CD3) | 1451.92 cells/mcL | Standard Deviation 622.86 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | CD8 T Cells (CD3 CD8) | 346.58 cells/mcL | Standard Deviation 206.22 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | CD4 T Cells (CD3 CD4) | 1102.08 cells/mcL | Standard Deviation 454.72 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | NK Cells (CD16 CD56) | 180.33 cells/mcL | Standard Deviation 123.31 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Immature B Cells | 11.25 cells/mcL | Standard Deviation 11.86 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Naive Cells | 280.50 cells/mcL | Standard Deviation 212.3 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Marginal B Cells | 73.75 cells/mcL | Standard Deviation 159.25 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Memory B Cells | 26.50 cells/mcL | Standard Deviation 19.5 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Central Memory CD4 Cells | 623.67 cells/mcL | Standard Deviation 259.72 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Effector Memory CD4 Cells | 90.00 cells/mcL | Standard Deviation 98.8 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Naive CD4 Cells | 378.50 cells/mcL | Standard Deviation 193.71 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Terminally Diff Effector CD4 Cells | 9.50 cells/mcL | Standard Deviation 14.13 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Central Memory CD8 Cells | 120.50 cells/mcL | Standard Deviation 68.09 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Effector Memory CD8 Cells | 55.50 cells/mcL | Standard Deviation 67.08 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Naive CD8 Cells | 121.75 cells/mcL | Standard Deviation 86.96 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | Terminally Diff Effector Memory CD8 Cells | 49.00 cells/mcL | Standard Deviation 61.65 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | CD4 T-Cells | 75.08 cells/mcL | Standard Deviation 43.97 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | CD56 Bright NK-Cells | 7.17 cells/mcL | Standard Deviation 4.41 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | CD56 Dim NK-Cell | 134.25 cells/mcL | Standard Deviation 103.99 |
| Placebo | Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 | CD56 Null NK-Cells | 38.83 cells/mcL | Standard Deviation 35.54 |
Primary
Change From Baseline in Percentage of Area Stained For CD3+ and CD68+ Surface Markers of Inflammatory Cells of the Synovial Tissue at Day 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Change From Baseline in Percentage of Area Stained For CD3+ and CD68+ Surface Markers of Inflammatory Cells of the Synovial Tissue at Day 28 | Baseline: CD3+ Cells (n=12, 12) | 7.33 percentage area stained | Standard Deviation 6.12 |
| CP-690,550 | Change From Baseline in Percentage of Area Stained For CD3+ and CD68+ Surface Markers of Inflammatory Cells of the Synovial Tissue at Day 28 | Baseline: CD68+ Cells (n=12, 13) | 31.83 percentage area stained | Standard Deviation 20.59 |
| CP-690,550 | Change From Baseline in Percentage of Area Stained For CD3+ and CD68+ Surface Markers of Inflammatory Cells of the Synovial Tissue at Day 28 | Change at Day 28: CD3+ Cells (n=10, 8) | 1.50 percentage area stained | Standard Deviation 3.95 |
| CP-690,550 | Change From Baseline in Percentage of Area Stained For CD3+ and CD68+ Surface Markers of Inflammatory Cells of the Synovial Tissue at Day 28 | Change at Day 28: CD68+ Cells (n=12, 11) | 1.67 percentage area stained | Standard Deviation 19.86 |
| Placebo | Change From Baseline in Percentage of Area Stained For CD3+ and CD68+ Surface Markers of Inflammatory Cells of the Synovial Tissue at Day 28 | Change at Day 28: CD68+ Cells (n=12, 11) | 0.82 percentage area stained | Standard Deviation 18.37 |
| Placebo | Change From Baseline in Percentage of Area Stained For CD3+ and CD68+ Surface Markers of Inflammatory Cells of the Synovial Tissue at Day 28 | Baseline: CD3+ Cells (n=12, 12) | 7.92 percentage area stained | Standard Deviation 7.49 |
| Placebo | Change From Baseline in Percentage of Area Stained For CD3+ and CD68+ Surface Markers of Inflammatory Cells of the Synovial Tissue at Day 28 | Change at Day 28: CD3+ Cells (n=10, 8) | 0.13 percentage area stained | Standard Deviation 7.38 |
| Placebo | Change From Baseline in Percentage of Area Stained For CD3+ and CD68+ Surface Markers of Inflammatory Cells of the Synovial Tissue at Day 28 | Baseline: CD68+ Cells (n=12, 13) | 32.85 percentage area stained | Standard Deviation 26.05 |
Primary
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
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
Population: 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.
Primary
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: IL-1beta mRNA | -0.01 relative expression unit (REU) | Standard Deviation 0.88 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: CD3E mRNA | -1.58 relative expression unit (REU) | Standard Deviation 0.71 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: IL-6 mRNA | -0.25 relative expression unit (REU) | Standard Deviation 0.86 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: STAT1 mRNA | -0.43 relative expression unit (REU) | Standard Deviation 0.29 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: MMP3 mRNA | -0.80 relative expression unit (REU) | Standard Deviation 0.92 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: IL-6 mRNA | -3.72 relative expression unit (REU) | Standard Deviation 0.67 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: CD19 mRNA | 0.06 relative expression unit (REU) | Standard Deviation 0.85 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: ISG15 mRNA | -1.26 relative expression unit (REU) | Standard Deviation 0.23 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: CD3E mRNA | -0.07 relative expression unit (REU) | Standard Deviation 0.53 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: JAK1 mRNA | 0.30 relative expression unit (REU) | Standard Deviation 0.24 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: JAK1 mRNA | 0.04 relative expression unit (REU) | Standard Deviation 0.36 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: CXCL10 mRNA | -1.21 relative expression unit (REU) | Standard Deviation 0.85 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: JAK2 mRNA | -0.07 relative expression unit (REU) | Standard Deviation 0.4 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: CD19 mRNA | -2.98 relative expression unit (REU) | Standard Deviation 1.25 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: JAK3 mRNA | -0.05 relative expression unit (REU) | Standard Deviation 0.35 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: CCL2 mRNA | -1.70 relative expression unit (REU) | Standard Deviation 0.29 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: STAT1 mRNA | -0.15 relative expression unit (REU) | Standard Deviation 0.46 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: JAK2 mRNA | 0.17 relative expression unit (REU) | Standard Deviation 0.26 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: ISG15 mRNA | -0.16 relative expression unit (REU) | Standard Deviation 0.4 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: pSTAT1 protein | 0.18 relative expression unit (REU) | Standard Deviation 0.33 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: CXCL10 mRNA | -0.49 relative expression unit (REU) | Standard Deviation 0.75 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: MMP3 mRNA | -2.01 relative expression unit (REU) | Standard Deviation 1.39 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: CCL2 mRNA | -0.20 relative expression unit (REU) | Standard Deviation 0.3 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: pSTAT3 protein | 0.77 relative expression unit (REU) | Standard Deviation 0.29 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: pSTAT1 protein | -0.20 relative expression unit (REU) | Standard Deviation 0.44 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: JAK3 mRNA | -0.77 relative expression unit (REU) | Standard Deviation 0.4 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: pSTAT3 protein | -0.10 relative expression unit (REU) | Standard Deviation 0.42 |
| CP-690,550 | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: IL-1beta mRNA | -2.73 relative expression unit (REU) | Standard Deviation 0.77 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: pSTAT3 protein | -0.10 relative expression unit (REU) | Standard Deviation 0.18 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: IL-1beta mRNA | -2.83 relative expression unit (REU) | Standard Deviation 0.8 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: IL-6 mRNA | -3.96 relative expression unit (REU) | Standard Deviation 0.55 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: MMP3 mRNA | -2.52 relative expression unit (REU) | Standard Deviation 1.64 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: CD19 mRNA | -3.46 relative expression unit (REU) | Standard Deviation 1.34 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: CD3E mRNA | -1.75 relative expression unit (REU) | Standard Deviation 0.58 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: JAK1 mRNA | 0.31 relative expression unit (REU) | Standard Deviation 0.29 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: JAK2 mRNA | 0.15 relative expression unit (REU) | Standard Deviation 0.25 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: JAK3 mRNA | -0.88 relative expression unit (REU) | Standard Deviation 0.52 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: STAT1 mRNA | -0.46 relative expression unit (REU) | Standard Deviation 0.33 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: ISG15 mRNA | -1.33 relative expression unit (REU) | Standard Deviation 0.27 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: CXCL10 mRNA | -1.24 relative expression unit (REU) | Standard Deviation 0.81 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: CCL2 mRNA | -1.73 relative expression unit (REU) | Standard Deviation 0.39 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: pSTAT1 protein | 0.27 relative expression unit (REU) | Standard Deviation 0.39 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Baseline: pSTAT3 protein | 0.79 relative expression unit (REU) | Standard Deviation 0.3 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: IL-1beta mRNA | 0.09 relative expression unit (REU) | Standard Deviation 0.43 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: IL-6 mRNA | -0.08 relative expression unit (REU) | Standard Deviation 0.45 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: MMP3 mRNA | -0.03 relative expression unit (REU) | Standard Deviation 1.23 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: CD19 mRNA | -0.31 relative expression unit (REU) | Standard Deviation 0.72 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: CD3E mRNA | -0.12 relative expression unit (REU) | Standard Deviation 0.44 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: JAK1 mRNA | -0.10 relative expression unit (REU) | Standard Deviation 0.36 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: JAK2 mRNA | -0.10 relative expression unit (REU) | Standard Deviation 0.29 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: JAK3 mRNA | -0.13 relative expression unit (REU) | Standard Deviation 0.52 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: STAT1 mRNA | 0.01 relative expression unit (REU) | Standard Deviation 0.35 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: ISG15 mRNA | 0.11 relative expression unit (REU) | Standard Deviation 0.34 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: CXCL10 mRNA | 0.15 relative expression unit (REU) | Standard Deviation 0.61 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: CCL2 mRNA | -0.02 relative expression unit (REU) | Standard Deviation 0.28 |
| Placebo | Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 | Change at Day 28: pSTAT1 protein | -0.10 relative expression unit (REU) | Standard Deviation 0.36 |
Primary
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 1
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 1 | IL-1ra | 565.43 pg/mL | Standard Deviation 262.73 |
| CP-690,550 | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 1 | IL-15 | 8.00 pg/mL | Standard Deviation 0 |
| Placebo | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 1 | IL-1ra | 479.93 pg/mL | Standard Deviation 167.61 |
| Placebo | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 1 | IL-15 | 8.00 pg/mL | Standard Deviation 0 |
Primary
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 28 | IL-1ra | 421.00 pg/mL | Standard Deviation 196.57 |
| CP-690,550 | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 28 | IL-15 | 8.00 pg/mL | Standard Deviation 0 |
| Placebo | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 28 | IL-1ra | 501.31 pg/mL | Standard Deviation 337.85 |
| Placebo | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 28 | IL-15 | 8.00 pg/mL | Standard Deviation 0 |
Primary
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 24 Hours Post-dose on Day 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 24 Hours Post-dose on Day 28 | IL-1ra | 500.38 pg/mL | Standard Deviation 187.55 |
| CP-690,550 | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 24 Hours Post-dose on Day 28 | IL-15 | 8.26 pg/mL | Standard Deviation 0.94 |
| Placebo | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 24 Hours Post-dose on Day 28 | IL-1ra | 462.57 pg/mL | Standard Deviation 175.8 |
| Placebo | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 24 Hours Post-dose on Day 28 | IL-15 | 8.00 pg/mL | Standard Deviation 0 |
Primary
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 1
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 1 | IL-1ra | 518.29 pg/mL | Standard Deviation 297.33 |
| CP-690,550 | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 1 | IL-15 | 8.00 pg/mL | Standard Deviation 0 |
| Placebo | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 1 | IL-1ra | 477.25 pg/mL | Standard Deviation 142.17 |
| Placebo | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 1 | IL-15 | 8.00 pg/mL | Standard Deviation 0 |
Primary
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 28 | IL-1ra (n= 13, 13) | 388.15 pg/mL | Standard Deviation 147.27 |
| CP-690,550 | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 28 | IL-15 (n=11, 12) | 8.00 pg/mL | Standard Deviation 0 |
| Placebo | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 28 | IL-1ra (n= 13, 13) | 552.85 pg/mL | Standard Deviation 415.32 |
| Placebo | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 28 | IL-15 (n=11, 12) | 8.00 pg/mL | Standard Deviation 0 |
Primary
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 8 Hours Post-dose on Day 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 8 Hours Post-dose on Day 28 | IL-1ra (n=12, 12) | 399.08 pg/mL | Standard Deviation 157.84 |
| CP-690,550 | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 8 Hours Post-dose on Day 28 | IL-15 (n=12, 10) | 8.00 pg/mL | Standard Deviation 0 |
| Placebo | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 8 Hours Post-dose on Day 28 | IL-1ra (n=12, 12) | 414.67 pg/mL | Standard Deviation 152.99 |
| Placebo | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 8 Hours Post-dose on Day 28 | IL-15 (n=12, 10) | 8.00 pg/mL | Standard Deviation 0 |
Primary
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 1
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 1 | IL-1ra | 545.71 pg/mL | Standard Deviation 279.48 |
| CP-690,550 | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 1 | IL-15 | 8.00 pg/mL | Standard Deviation 0 |
| Placebo | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 1 | IL-1ra | 449.38 pg/mL | Standard Deviation 163.85 |
| Placebo | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 1 | IL-15 | 8.00 pg/mL | Standard Deviation 0 |
Primary
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 10
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 10 | IL-1ra | 487.00 pg/mL | Standard Deviation 265.16 |
| CP-690,550 | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 10 | IL-15 | 8.00 pg/mL | Standard Deviation 0 |
| Placebo | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 10 | IL-1ra | 465.00 pg/mL | Standard Deviation 176.17 |
| Placebo | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 10 | IL-15 | 8.00 pg/mL | Standard Deviation 0 |
Primary
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 28 | IL-1ra | 437.73 pg/mL | Standard Deviation 171.93 |
| CP-690,550 | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 28 | IL-15 | 8.00 pg/mL | Standard Deviation 0 |
| Placebo | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 28 | IL-1ra | 617.38 pg/mL | Standard Deviation 624.81 |
| Placebo | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 28 | IL-15 | 8.00 pg/mL | Standard Deviation 0 |
Primary
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 35 or Early Termination
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
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 35 or Early Termination | IL-1ra | 520.87 pg/mL | Standard Deviation 282.88 |
| CP-690,550 | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 35 or Early Termination | IL-15 | 8.00 pg/mL | Standard Deviation 0 |
| Placebo | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 35 or Early Termination | IL-1ra | 486.57 pg/mL | Standard Deviation 317.27 |
| Placebo | Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 35 or Early Termination | IL-15 | 8.00 pg/mL | Standard Deviation 0 |
Primary
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 1
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
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 1 | MMP3 | 37.30 ng/mL | Standard Deviation 32.4 |
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 1 | Osteocalcin | 18.90 ng/mL | Standard Deviation 8.12 |
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 1 | Osteopontin | 101.10 ng/mL | Standard Deviation 40.23 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 1 | MMP3 | 22.42 ng/mL | Standard Deviation 12.06 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 1 | Osteocalcin | 18.01 ng/mL | Standard Deviation 11.38 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 1 | Osteopontin | 94.37 ng/mL | Standard Deviation 39.02 |
Primary
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 28
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
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 28 | MMP3 | 21.59 ng/mL | Standard Deviation 19.3 |
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 28 | Osteocalcin | 21.45 ng/mL | Standard Deviation 9.65 |
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 28 | Osteopontin | 78.60 ng/mL | Standard Deviation 19.24 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 28 | MMP3 | 18.86 ng/mL | Standard Deviation 11.73 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 28 | Osteocalcin | 17.37 ng/mL | Standard Deviation 8.85 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 28 | Osteopontin | 86.66 ng/mL | Standard Deviation 29.65 |
Primary
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 24 Hours Post-dose on Day 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 24 Hours Post-dose on Day 28 | MMP3 | 24.48 ng/mL | Standard Deviation 20.82 |
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 24 Hours Post-dose on Day 28 | Osteocalcin | 20.96 ng/mL | Standard Deviation 9.45 |
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 24 Hours Post-dose on Day 28 | Osteopontin | 82.60 ng/mL | Standard Deviation 22.28 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 24 Hours Post-dose on Day 28 | MMP3 | 26.20 ng/mL | Standard Deviation 15.56 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 24 Hours Post-dose on Day 28 | Osteocalcin | 17.49 ng/mL | Standard Deviation 9.57 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 24 Hours Post-dose on Day 28 | Osteopontin | 95.51 ng/mL | Standard Deviation 28.5 |
Primary
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 1
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
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 1 | MMP3 | 36.98 ng/mL | Standard Deviation 30.72 |
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 1 | Osteocalcin | 18.17 ng/mL | Standard Deviation 7.3 |
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 1 | Osteopontin | 99.82 ng/mL | Standard Deviation 36.77 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 1 | MMP3 | 22.09 ng/mL | Standard Deviation 12.08 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 1 | Osteocalcin | 19.01 ng/mL | Standard Deviation 13.17 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 1 | Osteopontin | 95.23 ng/mL | Standard Deviation 38.37 |
Primary
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 28 | MMP3 | 19.71 ng/mL | Standard Deviation 17.65 |
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 28 | Osteocalcin | 21.09 ng/mL | Standard Deviation 8.26 |
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 28 | Osteopontin | 71.52 ng/mL | Standard Deviation 24.92 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 28 | MMP3 | 16.67 ng/mL | Standard Deviation 10.7 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 28 | Osteocalcin | 15.45 ng/mL | Standard Deviation 7.22 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 28 | Osteopontin | 86.56 ng/mL | Standard Deviation 33 |
Primary
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 8 Hours Post-dose on Day 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 8 Hours Post-dose on Day 28 | MMP3 | 17.94 ng/mL | Standard Deviation 14.38 |
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 8 Hours Post-dose on Day 28 | Osteocalcin | 20.93 ng/mL | Standard Deviation 6.37 |
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 8 Hours Post-dose on Day 28 | Osteopontin | 75.32 ng/mL | Standard Deviation 21.32 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 8 Hours Post-dose on Day 28 | MMP3 | 16.68 ng/mL | Standard Deviation 11.75 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 8 Hours Post-dose on Day 28 | Osteocalcin | 16.67 ng/mL | Standard Deviation 8.63 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 8 Hours Post-dose on Day 28 | Osteopontin | 89.84 ng/mL | Standard Deviation 33.02 |
Primary
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 1
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
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 1 | MMP3 | 38.31 nanogram per milliliter (ng/mL) | Standard Deviation 32.24 |
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 1 | Osteocalcin | 19.54 nanogram per milliliter (ng/mL) | Standard Deviation 8.23 |
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 1 | Osteopontin | 108.40 nanogram per milliliter (ng/mL) | Standard Deviation 42.59 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 1 | MMP3 | 24.52 nanogram per milliliter (ng/mL) | Standard Deviation 12.65 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 1 | Osteocalcin | 18.54 nanogram per milliliter (ng/mL) | Standard Deviation 12.31 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 1 | Osteopontin | 98.11 nanogram per milliliter (ng/mL) | Standard Deviation 37.04 |
Primary
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 10
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
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 10 | MMP3 | 32.10 ng/mL | Standard Deviation 26.89 |
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 10 | Osteocalcin | 21.35 ng/mL | Standard Deviation 8.87 |
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 10 | Osteopontin | 91.13 ng/mL | Standard Deviation 29.16 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 10 | MMP3 | 21.05 ng/mL | Standard Deviation 12.28 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 10 | Osteocalcin | 18.60 ng/mL | Standard Deviation 11.28 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 10 | Osteopontin | 91.12 ng/mL | Standard Deviation 34.13 |
Primary
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 28
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
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 28 | MMP3 | 25.18 ng/mL | Standard Deviation 22.33 |
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 28 | Osteocalcin | 22.05 ng/mL | Standard Deviation 9.28 |
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 28 | Osteopontin | 78.23 ng/mL | Standard Deviation 17.23 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 28 | MMP3 | 19.26 ng/mL | Standard Deviation 11.64 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 28 | Osteocalcin | 16.51 ng/mL | Standard Deviation 9.06 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 28 | Osteopontin | 79.93 ng/mL | Standard Deviation 18.63 |
Primary
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 35 or Early Termination
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
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 35 or Early Termination | MMP3 | 28.98 ng/mL | Standard Deviation 21.36 |
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 35 or Early Termination | Osteocalcin | 21.79 ng/mL | Standard Deviation 9.38 |
| CP-690,550 | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 35 or Early Termination | Osteopontin | 95.93 ng/mL | Standard Deviation 29.73 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 35 or Early Termination | MMP3 | 28.72 ng/mL | Standard Deviation 24.48 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 35 or Early Termination | Osteocalcin | 16.60 ng/mL | Standard Deviation 10.48 |
| Placebo | Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 35 or Early Termination | Osteopontin | 86.48 ng/mL | Standard Deviation 29.69 |
Primary
Osteoprotegerin (OPG) Level at 1 Hour Post-dose on Day 1
Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Time frame: 1 Hour Post-dose on Day 1
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Osteoprotegerin (OPG) Level at 1 Hour Post-dose on Day 1 | 6.13 pmol/L | Standard Deviation 1.99 |
| Placebo | Osteoprotegerin (OPG) Level at 1 Hour Post-dose on Day 1 | 5.72 pmol/L | Standard Deviation 2.16 |
Primary
Osteoprotegerin (OPG) Level at 1 Hour Post-dose on Day 28
Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Time frame: 1 Hour Post-dose on Day 28
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Osteoprotegerin (OPG) Level at 1 Hour Post-dose on Day 28 | 5.72 pmol/L | Standard Deviation 1.86 |
| Placebo | Osteoprotegerin (OPG) Level at 1 Hour Post-dose on Day 28 | 5.56 pmol/L | Standard Deviation 2.14 |
Primary
Osteoprotegerin (OPG) Level at 24 Hours Post-dose on Day 28
Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Time frame: 24 Hours Post-dose on Day 28
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Osteoprotegerin (OPG) Level at 24 Hours Post-dose on Day 28 | 7.22 pmol/L | Standard Deviation 2.74 |
| Placebo | Osteoprotegerin (OPG) Level at 24 Hours Post-dose on Day 28 | 6.20 pmol/L | Standard Deviation 2.07 |
Primary
Osteoprotegerin (OPG) Level at 4 Hours Post-dose on Day 1
Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Time frame: 4 Hours Post-dose on Day 1
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Osteoprotegerin (OPG) Level at 4 Hours Post-dose on Day 1 | 5.50 picomole per liter (pmol/L) | Standard Deviation 1.53 |
| Placebo | Osteoprotegerin (OPG) Level at 4 Hours Post-dose on Day 1 | 5.35 picomole per liter (pmol/L) | Standard Deviation 1.86 |
Primary
Osteoprotegerin (OPG) Level at 4 Hours Post-dose on Day 28
Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Time frame: 4 Hours Post-dose on Day 28
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Osteoprotegerin (OPG) Level at 4 Hours Post-dose on Day 28 | 5.18 pmol/L | Standard Deviation 1.55 |
| Placebo | Osteoprotegerin (OPG) Level at 4 Hours Post-dose on Day 28 | 5.69 pmol/L | Standard Deviation 2.13 |
Primary
Osteoprotegerin (OPG) Level at 8 Hours Post-dose on Day 28
Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Time frame: 8 Hours Post-dose on Day 28
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Osteoprotegerin (OPG) Level at 8 Hours Post-dose on Day 28 | 4.64 pmol/L | Standard Deviation 1.28 |
| Placebo | Osteoprotegerin (OPG) Level at 8 Hours Post-dose on Day 28 | 5.64 pmol/L | Standard Deviation 2.39 |
Primary
Osteoprotegerin (OPG) Level at Pre-dose on Day 1
Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Time frame: Pre-dose on Day 1
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Osteoprotegerin (OPG) Level at Pre-dose on Day 1 | 5.99 picomole per liter (pmol/L) | Standard Deviation 2.04 |
| Placebo | Osteoprotegerin (OPG) Level at Pre-dose on Day 1 | 6.21 picomole per liter (pmol/L) | Standard Deviation 1.91 |
Primary
Osteoprotegerin (OPG) Level at Pre-dose on Day 10
Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Time frame: Pre-dose on Day 10
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Osteoprotegerin (OPG) Level at Pre-dose on Day 10 | 6.02 pmol/L | Standard Deviation 1.88 |
| Placebo | Osteoprotegerin (OPG) Level at Pre-dose on Day 10 | 5.82 pmol/L | Standard Deviation 2.22 |
Primary
Osteoprotegerin (OPG) Level at Pre-dose on Day 28
Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Time frame: Pre-dose on Day 28
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Osteoprotegerin (OPG) Level at Pre-dose on Day 28 | 5.53 pmol/L | Standard Deviation 1.79 |
| Placebo | Osteoprotegerin (OPG) Level at Pre-dose on Day 28 | 5.64 pmol/L | Standard Deviation 2.48 |
Primary
Osteoprotegerin(OPG) Level at Pre-dose on Day 35 or Early Termination
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
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Osteoprotegerin(OPG) Level at Pre-dose on Day 35 or Early Termination | 6.31 pmol/L | Standard Deviation 1.7 |
| Placebo | Osteoprotegerin(OPG) Level at Pre-dose on Day 35 or Early Termination | 5.65 pmol/L | Standard Deviation 2.01 |
Primary
Parathyroid Hormone (PTH) Level at 1 Hour Post-dose on Day 1
Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Time frame: 1 Hour Post-dose on Day 1
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Parathyroid Hormone (PTH) Level at 1 Hour Post-dose on Day 1 | 33.89 pg/mL | Standard Deviation 13.44 |
| Placebo | Parathyroid Hormone (PTH) Level at 1 Hour Post-dose on Day 1 | 31.48 pg/mL | Standard Deviation 8.77 |
Primary
Parathyroid Hormone (PTH) Level at 1 Hour Post-dose on Day 28
Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Time frame: 1 Hour Post-dose on Day 28
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Parathyroid Hormone (PTH) Level at 1 Hour Post-dose on Day 28 | 37.97 pg/mL | Standard Deviation 14.05 |
| Placebo | Parathyroid Hormone (PTH) Level at 1 Hour Post-dose on Day 28 | 33.93 pg/mL | Standard Deviation 7.51 |
Primary
Parathyroid Hormone (PTH) Level at 24 Hours Post-dose on Day 28
Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Time frame: 24 Hours Post-dose on Day 28
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Parathyroid Hormone (PTH) Level at 24 Hours Post-dose on Day 28 | 35.91 pg/mL | Standard Deviation 19.94 |
| Placebo | Parathyroid Hormone (PTH) Level at 24 Hours Post-dose on Day 28 | 36.08 pg/mL | Standard Deviation 10.17 |
Primary
Parathyroid Hormone (PTH) Level at 4 Hours Post-dose on Day 1
Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Time frame: 4 Hours Post-dose on Day 1
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Parathyroid Hormone (PTH) Level at 4 Hours Post-dose on Day 1 | 32.97 pg/mL | Standard Deviation 13.31 |
| Placebo | Parathyroid Hormone (PTH) Level at 4 Hours Post-dose on Day 1 | 33.35 pg/mL | Standard Deviation 7.12 |
Primary
Parathyroid Hormone (PTH) Level at 4 Hours Post-dose on Day 28
Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Time frame: 4 Hours Post-dose on Day 28
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Parathyroid Hormone (PTH) Level at 4 Hours Post-dose on Day 28 | 38.70 pg/mL | Standard Deviation 13.25 |
| Placebo | Parathyroid Hormone (PTH) Level at 4 Hours Post-dose on Day 28 | 36.65 pg/mL | Standard Deviation 12.54 |
Primary
Parathyroid Hormone (PTH) Level at 8 Hours Post-dose on Day 28
Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Time frame: 8 Hours Post-dose on Day 28
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Parathyroid Hormone (PTH) Level at 8 Hours Post-dose on Day 28 | 37.76 pg/mL | Standard Deviation 15.9 |
| Placebo | Parathyroid Hormone (PTH) Level at 8 Hours Post-dose on Day 28 | 37.82 pg/mL | Standard Deviation 18.84 |
Primary
Parathyroid Hormone (PTH) Level at Pre-dose on Day 1
Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Time frame: Pre-dose on Day 1
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Parathyroid Hormone (PTH) Level at Pre-dose on Day 1 | 38.40 pg/mL | Standard Deviation 17.44 |
| Placebo | Parathyroid Hormone (PTH) Level at Pre-dose on Day 1 | 33.32 pg/mL | Standard Deviation 5.8 |
Primary
Parathyroid Hormone (PTH) Level at Pre-dose on Day 10
Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Time frame: Pre-dose on Day 10
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Parathyroid Hormone (PTH) Level at Pre-dose on Day 10 | 34.93 pg/mL | Standard Deviation 11.76 |
| Placebo | Parathyroid Hormone (PTH) Level at Pre-dose on Day 10 | 31.48 pg/mL | Standard Deviation 8.37 |
Primary
Parathyroid Hormone (PTH) Level at Pre-dose on Day 28
Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Time frame: Pre-dose on Day 28
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Parathyroid Hormone (PTH) Level at Pre-dose on Day 28 | 38.46 pg/mL | Standard Deviation 12.64 |
| Placebo | Parathyroid Hormone (PTH) Level at Pre-dose on Day 28 | 33.39 pg/mL | Standard Deviation 8.94 |
Primary
Parathyroid Hormone (PTH) Level at Pre-dose on Day 35 or Early Termination
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
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Parathyroid Hormone (PTH) Level at Pre-dose on Day 35 or Early Termination | 37.30 pg/mL | Standard Deviation 14.86 |
| Placebo | Parathyroid Hormone (PTH) Level at Pre-dose on Day 35 or Early Termination | 34.59 pg/mL | Standard Deviation 10.4 |
Primary
Plasma Level of Interleukin-34 (IL-34) and Interleukin-18 (IL-18)
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
Population: Analyses of IL-34 and IL-18 were not performed as a valid assay was not available.
Primary
Plasma Level of Matrix Metallopeptidase (MMP13)
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
Population: Analyses of MMP13 was not performed as valid assay for MMP13 was not available.
Primary
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 1
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 1 | SAA | 25716.93 ng/mL | Standard Deviation 42986.7 |
| CP-690,550 | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 1 | CTX-1 | 0.36 ng/mL | Standard Deviation 0.25 |
| Placebo | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 1 | SAA | 23308.57 ng/mL | Standard Deviation 41911.51 |
| Placebo | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 1 | CTX-1 | 0.32 ng/mL | Standard Deviation 0.22 |
Primary
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 28 | SAA | 3921.49 ng/mL | Standard Deviation 2291.33 |
| CP-690,550 | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 28 | CTX-1 | 0.32 ng/mL | Standard Deviation 0.16 |
| Placebo | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 28 | SAA | 18976.74 ng/mL | Standard Deviation 29228.65 |
| Placebo | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 28 | CTX-1 | 0.35 ng/mL | Standard Deviation 0.25 |
Primary
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 24 Hours Post-dose on Day 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 24 Hours Post-dose on Day 28 | SAA | 6643.14 ng/mL | Standard Deviation 6504.55 |
| CP-690,550 | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 24 Hours Post-dose on Day 28 | CTX-1 | 0.28 ng/mL | Standard Deviation 0.16 |
| Placebo | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 24 Hours Post-dose on Day 28 | SAA | 14627.28 ng/mL | Standard Deviation 16685.62 |
| Placebo | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 24 Hours Post-dose on Day 28 | CTX-1 | 0.28 ng/mL | Standard Deviation 0.13 |
Primary
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 1
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 1 | SAA | 26460.26 ng/mL | Standard Deviation 46059.64 |
| CP-690,550 | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 1 | CTX-1 | 0.25 ng/mL | Standard Deviation 0.12 |
| Placebo | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 1 | SAA | 27297.36 ng/mL | Standard Deviation 52346.36 |
| Placebo | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 1 | CTX-1 | 0.25 ng/mL | Standard Deviation 0.19 |
Primary
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 28 | SAA | 4042.21 ng/mL | Standard Deviation 2974.03 |
| CP-690,550 | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 28 | CTX-1 | 0.29 ng/mL | Standard Deviation 0.17 |
| Placebo | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 28 | SAA | 20123.97 ng/mL | Standard Deviation 31463.56 |
| Placebo | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 28 | CTX-1 | 0.20 ng/mL | Standard Deviation 0.12 |
Primary
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 8 Hours Post-dose on Day 28
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 8 Hours Post-dose on Day 28 | SAA (n=14, 12) | 4113.05 ng/mL | Standard Deviation 2939.86 |
| CP-690,550 | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 8 Hours Post-dose on Day 28 | CTX-1 (n=12, 12) | 0.28 ng/mL | Standard Deviation 0.17 |
| Placebo | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 8 Hours Post-dose on Day 28 | SAA (n=14, 12) | 15403.08 ng/mL | Standard Deviation 24616.14 |
| Placebo | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 8 Hours Post-dose on Day 28 | CTX-1 (n=12, 12) | 0.31 ng/mL | Standard Deviation 0.21 |
Primary
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 1
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 1 | SAA (n=14, 14) | 26383.03 ng/mL | Standard Deviation 43196.37 |
| CP-690,550 | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 1 | CTX-1 (n=14, 12) | 0.43 ng/mL | Standard Deviation 0.26 |
| Placebo | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 1 | SAA (n=14, 14) | 23427.00 ng/mL | Standard Deviation 43431.26 |
| Placebo | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 1 | CTX-1 (n=14, 12) | 0.37 ng/mL | Standard Deviation 0.27 |
Primary
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 10
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 10 | SAA | 5968.89 ng/mL | Standard Deviation 5509.18 |
| CP-690,550 | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 10 | CTX-1 | 0.34 ng/mL | Standard Deviation 0.16 |
| Placebo | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 10 | SAA | 31666.50 ng/mL | Standard Deviation 92833.52 |
| Placebo | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 10 | CTX-1 | 0.35 ng/mL | Standard Deviation 0.22 |
Primary
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 28
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
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 28 | SAA | 4094.94 ng/mL | Standard Deviation 2527.72 |
| CP-690,550 | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 28 | CTX-1 | 0.36 ng/mL | Standard Deviation 0.19 |
| Placebo | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 28 | SAA | 14818.88 ng/mL | Standard Deviation 18346.19 |
| Placebo | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 28 | CTX-1 | 0.35 ng/mL | Standard Deviation 0.19 |
Primary
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 35 or Early Termination
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
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 35 or Early Termination | SAA | 22174.19 ng/mL | Standard Deviation 25387.79 |
| CP-690,550 | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 35 or Early Termination | CTX-1 | 0.27 ng/mL | Standard Deviation 0.15 |
| Placebo | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 35 or Early Termination | SAA | 33853.61 ng/mL | Standard Deviation 88542.43 |
| Placebo | Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 35 or Early Termination | CTX-1 | 0.34 ng/mL | Standard Deviation 0.16 |
Primary
Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at 24 Hours Post-dose on Day 28
Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.
Time frame: 24 Hours Post-dose on Day 28
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at 24 Hours Post-dose on Day 28 | 267.86 ng/mmol Cr | Standard Deviation 159.63 |
| Placebo | Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at 24 Hours Post-dose on Day 28 | 284.87 ng/mmol Cr | Standard Deviation 202.92 |
Primary
Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 1
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 1 | 454.74 ng/mmol Cr | Standard Deviation 216.74 |
| Placebo | Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 1 | 345.87 ng/mmol Cr | Standard Deviation 259.83 |
Primary
Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 10
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 10 | 318.10 ng/mmol Cr | Standard Deviation 208.07 |
| Placebo | Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 10 | 423.76 ng/mmol Cr | Standard Deviation 389.15 |
Primary
Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 28
Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.
Time frame: Pre-dose on Day 28
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 28 | 320.42 ng/mmol Cr | Standard Deviation 192.31 |
| Placebo | Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 28 | 409.89 ng/mmol Cr | Standard Deviation 338.67 |
Primary
Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 35 or Early Termination
Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.
Time frame: Pre-dose on Day 35 or Early Termination
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 | Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 35 or Early Termination | 278.55 ng/mmol Cr | Standard Deviation 198.9 |
| Placebo | Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 35 or Early Termination | 340.83 ng/mmol Cr | Standard Deviation 379.42 |
Secondary
Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 28 and 35
DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP (mg/mL). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \<= 3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Day 1 (Baseline), 28, 35 or Early Termination
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 28 and 35 | Day 28 | -1.51 units on a scale | Standard Deviation 0.97 |
| CP-690,550 | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 28 and 35 | Day 35 or Early Termination | -0.66 units on a scale | Standard Deviation 0.96 |
| Placebo | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 28 and 35 | Day 28 | -0.31 units on a scale | Standard Deviation 0.49 |
| Placebo | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 28 and 35 | Day 35 or Early Termination | -0.43 units on a scale | Standard Deviation 0.4 |
Secondary
Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Day 28 and 35
DAS28-4 (ESR) was calculated from the number of SJC, TJC using the 28 joints count, ESR \[mm/hour\] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity, \> 3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Day 1 (Baseline), 28, 35 or Early Termination
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Day 28 and 35 | Day 28 | -1.58 units on a scale | Standard Deviation 1.02 |
| CP-690,550 | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Day 28 and 35 | Day 35 or Early Termination | -0.73 units on a scale | Standard Deviation 0.91 |
| Placebo | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Day 28 and 35 | Day 28 | -0.30 units on a scale | Standard Deviation 0.6 |
| Placebo | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Day 28 and 35 | Day 35 or Early Termination | -0.32 units on a scale | Standard Deviation 0.5 |
Secondary
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP) (milligram per liter \[mg/L\]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (\<=) 3.2 implied low disease activity, greater than (\>) 3.2 to 5.1 implied moderate to high disease activity and less than (\<) 2.6 implied remission.
Time frame: Day -7, 1 (Baseline), 28, 35 or Early Termination
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Day -7 | 5.58 units on a scale | Standard Deviation 0.87 |
| CP-690,550 | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Day 1 (Baseline) | 5.57 units on a scale | Standard Deviation 0.78 |
| CP-690,550 | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Day 28 | 4.06 units on a scale | Standard Deviation 0.97 |
| CP-690,550 | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Day 35 or Early Termination | 4.91 units on a scale | Standard Deviation 1.1 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Day 35 or Early Termination | 4.79 units on a scale | Standard Deviation 1.1 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Day -7 | 5.06 units on a scale | Standard Deviation 1.16 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Day 28 | 4.91 units on a scale | Standard Deviation 0.92 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | Day 1 (Baseline) | 5.22 units on a scale | Standard Deviation 0.96 |
Secondary
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
DAS28-4 (ESR) was calculated from the number of SJC, TJC using the 28 joints count, ESR (millimeters per hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity, \> 3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Day -7, 1 (Baseline), 28, 35 or Early Termination
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Day -7 | 6.60 units on a scale | Standard Deviation 0.98 |
| CP-690,550 | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Day 1 (Baseline) | 6.55 units on a scale | Standard Deviation 0.98 |
| CP-690,550 | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Day 28 | 4.90 units on a scale | Standard Deviation 1.11 |
| CP-690,550 | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Day 35 or Early Termination | 5.83 units on a scale | Standard Deviation 1.23 |
| Placebo | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Day 35 or Early Termination | 6.00 units on a scale | Standard Deviation 1.01 |
| Placebo | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Day -7 | 6.17 units on a scale | Standard Deviation 1.12 |
| Placebo | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Day 28 | 6.03 units on a scale | Standard Deviation 0.98 |
| Placebo | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Day 1 (Baseline) | 6.32 units on a scale | Standard Deviation 1.01 |
Secondary
Percentage of Participants Achieving American College of Rheumatology 20% Response
ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Time frame: Day 28, 35 or Early Termination
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 | Percentage of Participants Achieving American College of Rheumatology 20% Response | Day 28 | 60.0 percentage of participants |
| CP-690,550 | Percentage of Participants Achieving American College of Rheumatology 20% Response | Day 35 or Early Termination | 33.3 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% Response | Day 28 | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% Response | Day 35 or Early Termination | 0.0 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
ACR50 response: \>=50% improvement in TJC; \>= 50% improvement in SJC; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Day 28, 35 or Early Termination
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Day 28 | 40.0 percentage of participants |
| CP-690,550 | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Day 35 or Early Termination | 13.3 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Day 28 | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | Day 35 or Early Termination | 0.0 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
ACR70 response: \>=70% improvement in TJC; \>= 70% improvement in SJC; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Day 28, 35 or Early Termination
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Day 28 | 6.7 percentage of participants |
| CP-690,550 | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Day 35 or Early Termination | 6.7 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Day 28 | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | Day 35 or Early Termination | 0.0 percentage of participants |
Secondary
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6
DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP (mg/mL). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \<= 3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Day -7, 1 (Baseline), 28, 35 or Early Termination
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6 | Day 28: DAS28-3 (CRP) <2.6 | 0.0 percentage of participants |
| CP-690,550 | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6 | Day -7: DAS28-3 (CRP) <2.6 | 0.0 percentage of participants |
| CP-690,550 | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6 | Day 1 (Baseline): DAS28-3 (CRP) <=3.2 | 0.0 percentage of participants |
| CP-690,550 | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6 | Day 1 (Baseline): DAS28-3 (CRP) <2.6 | 0.0 percentage of participants |
| CP-690,550 | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6 | Day 28: DAS28-3 (CRP) <=3.2 | 20.0 percentage of participants |
| CP-690,550 | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6 | Day 35 or Early Termination: DAS28-3 (CRP) <=3.2 | 6.7 percentage of participants |
| CP-690,550 | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6 | Day 35 or Early Termination: DAS28-3 (CRP) <2.6 | 0.0 percentage of participants |
| CP-690,550 | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6 | Day -7: DAS28-3 (CRP) <=3.2 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6 | Day 35 or Early Termination: DAS28-3 (CRP) <=3.2 | 7.1 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6 | Day 35 or Early Termination: DAS28-3 (CRP) <2.6 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6 | Day 28: DAS28-3 (CRP) <=3.2 | 14.3 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6 | Day -7: DAS28-3 (CRP) <2.6 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6 | Day 28: DAS28-3 (CRP) <2.6 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6 | Day 1 (Baseline): DAS28-3 (CRP) <=3.2 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6 | Day -7: DAS28-3 (CRP) <=3.2 | 7.1 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6 | Day 1 (Baseline): DAS28-3 (CRP) <2.6 | 0.0 percentage of participants |
Secondary
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6
DAS28-4 (ESR) was calculated from the number of SJC, TJC using the 28 joints count, ESR \[mm/hour\] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity, \> 3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Day -7, 1 (Baseline), 28, 35 or Early Termination
Population: FAS included all randomized participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6 | Day -7: DAS28-4 (ESR) =<3.2 | 0.0 percentage of participants |
| CP-690,550 | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6 | Day -7: DAS28-4 (ESR) <2.6 | 0.0 percentage of participants |
| CP-690,550 | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6 | Day 1 (Baseline): DAS28-4 (ESR) =<3.2 | 0.0 percentage of participants |
| CP-690,550 | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6 | Day 1 (Baseline): DAS28-4 (ESR) <2.6 | 0.0 percentage of participants |
| CP-690,550 | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6 | Day 28: DAS28-4 (ESR) =<3.2 | 7.1 percentage of participants |
| CP-690,550 | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6 | Day 28: DAS28-4 (ESR) <2.6 | 0.0 percentage of participants |
| CP-690,550 | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6 | Day 35 or Early Termination: DAS28-4 (ESR) =<3.2 | 0.0 percentage of participants |
| CP-690,550 | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6 | Day 35 or Early Termination: DAS28-4 (ESR) <2.6 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6 | Day 35 or Early Termination: DAS28-4 (ESR) <2.6 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6 | Day -7: DAS28-4 (ESR) =<3.2 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6 | Day 28: DAS28-4 (ESR) =<3.2 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6 | Day -7: DAS28-4 (ESR) <2.6 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6 | Day 35 or Early Termination: DAS28-4 (ESR) =<3.2 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6 | Day 1 (Baseline): DAS28-4 (ESR) =<3.2 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6 | Day 28: DAS28-4 (ESR) <2.6 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6 | Day 1 (Baseline): DAS28-4 (ESR) <2.6 | 0.0 percentage of participants |