临床试验/NCT00976599

NCT00976599已完成2 期

An Exploratory Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess The Pharmacodynamics Of CP-690,550, Administered Orally Twice Daily (BID) For 4 Weeks, In Subjects With Active Rheumatoid Arthritis

Pfizer1 个研究点分布在 1 个国家目标入组 29 人开始时间: 2009年11月最近更新: 2013年1月9日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Pfizer
入组人数: 29
试验地点: 1
主要终点: Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

•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 .

研究组 & 干预措施

Placebo + methotrexate

Placebo Comparator

干预措施: Placebo + Methotrexate (Drug)

CP-690,550 + methotrexate

Experimental

干预措施: CP-690,550 + methotrexate (Drug)

结局指标

主要结局

Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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.

Osteoprotegerin (OPG) Level at 8 Hours Post-dose on Day 28

时间窗: 8 Hours Post-dose on Day 28

Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.

Blood Cytokine Level at Pre-dose on Day 1

时间窗: 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 Cytokine Level at 1 Hour Post-dose on Day 1

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

Osteoprotegerin (OPG) Level at 24 Hours Post-dose on Day 28

时间窗: 24 Hours Post-dose on Day 28

Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.

Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1

时间窗: 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 4 Hours Post-dose on Day 1

时间窗: 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 T, B and NK Lymphocyte Counts at Pre-dose on Day 10

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

Parathyroid Hormone (PTH) Level at Pre-dose on Day 28

时间窗: Pre-dose on Day 28

Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.

Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 4 Hours Post-dose on Day 1

Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 10

时间窗: Pre-dose on Day 10

Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 28

时间窗: Pre-dose on Day 28

Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 28

时间窗: 1 Hour Post-dose on Day 28

Osteoprotegerin(OPG) Level at Pre-dose on Day 35 or Early Termination

时间窗: Pre-dose on Day 35 or Early Termination

Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.

Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 28

时间窗: 4 Hours Post-dose on Day 28

Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 8 Hours Post-dose on Day 28

时间窗: 8 Hours Post-dose on Day 28

Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 24 Hours Post-dose on Day 28

时间窗: 24 Hours Post-dose on Day 28

Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 35 or Early Termination

时间窗: Pre-dose on Day 35 or Early Termination

Parathyroid Hormone (PTH) Level at Pre-dose on Day 1

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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 1 Hour Post-dose on Day 28

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 4 Hours Post-dose on Day 28

Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.

Plasma Level of Matrix Metallopeptidase (MMP13)

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 35 or Early Termination

时间窗: 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.

Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 28

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: Pre-dose on Day 10

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 28

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at 24 Hours Post-dose on Day 28

时间窗: 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.

次要结局

Percentage of Participants Achieving American College of Rheumatology 20% Response(Day 28, 35 or Early Termination)
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response(Day 28, 35 or Early Termination)
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response(Day 28, 35 or Early Termination)
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)
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)
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)
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)
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)
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)

研究者

发起方

Pfizer

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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