| 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. | 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. | Posted | | Mean | Standard Deviation | relative expression unit (REU) | | Day -7 (Baseline), Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| | | Title | Denominators | Categories |
|---|
| Baseline: IL-1beta mRNA | | | Title | Measurements |
|---|
| - OG000-2.73± 0.77
- OG001-2.83± 0.80
|
| | Baseline: IL-6 mRNA | | |
| |
| 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. | 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. | Posted | | | | | | Baseline (Day -7), Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | percentage area stained | | Baseline (Day -7), Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | REU | | Baseline (Day -7) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | REU | | Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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). | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | pg/mL | | Pre-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | pg/mL | | 1 hour post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | pg/mL | | 4 hours post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | pg/mL | | Pre-dose on Day 10 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | pg/mL | | Pre-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | pg/mL | | 1 Hour Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | pg/mL | | 4 Hours Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | pg/mL | | 8 Hours Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | pg/mL | | 24 Hours Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | pg/mL | | Pre-dose on Day 35 or Early Termination | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | cells per microliter (cells/mcL) | | Pre-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | cells/mcL | | 1 Hour Post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | cells/mcL | | 4 Hours Post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | cells/mcL | | Pre-dose on Day 10 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | cells/mcL | | Pre-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | cells/mcL | | 1 Hour Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | cells/mcL | | 4 Hours Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | cells/mcL | | 8 Hours Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | cells/mcL | | 24 Hours Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | cells/mcL | | Pre-dose on Day 35 or Early Termination | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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). | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | | Pre-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | ng/mL | | 1 Hour Post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | ng/mL | | 4 Hours Post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 10 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | ng/mL | | 1 Hour Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | ng/mL | | 4 Hours Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | ng/mL | | 8 Hours Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | ng/mL | | 24 Hours Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 35 or Early Termination | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | pg/mL | | Pre-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | pg/mL | | 1 Hour Post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | pg/mL | | 4 Hours Post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | pg/mL | | Pre-dose on Day 10 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | pg/mL | | Pre-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | pg/mL | | 1 Hour Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | pg/mL | | 4 Hours Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | pg/mL | | 8 Hours Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | pg/mL | | 24 Hours Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | pg/mL | | Pre-dose on Day 35 or Early Termination | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | picomole per liter (pmol/L) | | Pre-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | pmol/L | | 1 Hour Post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | picomole per liter (pmol/L) | | 4 Hours Post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | pmol/L | | Pre-dose on Day 10 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | pmol/L | | Pre-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | pmol/L | | 1 Hour Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | pmol/L | | 4 Hours Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | pmol/L | | 8 Hours Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | pmol/L | | 24 Hours Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | pmol/L | | Pre-dose on Day 35 or Early Termination | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| Primary | Plasma Level of Matrix Metallopeptidase (MMP13) | | Analyses of MMP13 was not performed as valid assay for MMP13 was not available. | Posted | | | | | | 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 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| Primary | Plasma Level of Interleukin-34 (IL-34) and Interleukin-18 (IL-18) | | Analyses of IL-34 and IL-18 were not performed as a valid assay was not available. | Posted | | | | | | 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 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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). | 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. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | ng/mL | | 1 Hour Post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | ng/mL | | 4 Hours Post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 10 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | ng/mL | | 1 Hour Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | ng/mL | | 4 Hours Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | ng/mL | | 8 Hours Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | ng/mL | | 24 Hours Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 35 or Early Termination | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | pg/mL | | Pre-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | pg/mL | | 1 Hour Post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | pg/mL | | 4 Hours Post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | pg/mL | | Pre-dose on Day 10 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | pg/mL | | Pre-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | pg/mL | | 1 Hour Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | pg/mL | | 4 Hours Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | pg/mL | | 8 Hours Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | pg/mL | | 24 Hours Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
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| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | pg/mL | | Pre-dose on Day 35 or Early Termination | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
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| 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). | 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. | Posted | | Mean | Standard Deviation | ng/mmol Cr | | Pre-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | ng/mmol Cr | | Pre-dose on Day 10 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | ng/mmol Cr | | Pre-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | ng/mmol Cr | | 24 Hours Post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | ng/mmol Cr | | Pre-dose on Day 35 or Early Termination | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
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| 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). | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Number | | percentage of participants | | Day 28, 35 or Early Termination | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
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| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Number | | percentage of participants | | Day 28, 35 or Early Termination | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
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| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Number | | percentage of participants | | Day 28, 35 or Early Termination | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | units on a scale | | Day -7, 1 (Baseline), 28, 35 or Early Termination | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
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| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | units on a scale | | Day 1 (Baseline), 28, 35 or Early Termination | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Number | | percentage of participants | | Day -7, 1 (Baseline), 28, 35 or Early Termination | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | units on a scale | | Day -7, 1 (Baseline), 28, 35 or Early Termination | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Mean | Standard Deviation | units on a scale | | Day 1 (Baseline), 28, 35 or Early Termination | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |
| 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. | FAS included all randomized participants who received at least 1 dose of the study medication. | Posted | | Number | | percentage of participants | | Day -7, 1 (Baseline), 28, 35 or Early Termination | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 | CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28. | | OG001 | 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. |
| |