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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
29
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
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
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
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
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
Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7)
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Birmingham, Alabama, United States
Pfizer Investigational Site
La Jolla, California, United States
Pfizer Investigational Site
Frederick, Maryland, United States
Pfizer Investigational Site
Battle Creek, Michigan, United States
Pfizer Investigational Site
Mayfield Village, Ohio, United States
Pfizer Investigational Site
Mentor, Ohio, United States
Pfizer Investigational Site
Willoughby, Ohio, United States
Pfizer Investigational Site
Dallas, Texas, United States
...and 5 more locations
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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