Rheumatoid Arthritis
Conditions
Brief summary
This open-label, single-arm study will evaluate the efficacy and safety of tocilizumab in combination with DMARDs in participants with moderate to severe active rheumatoid arthritis who have an inadequate response to DMARDs. Participants will receive tocilizumab as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 4 weeks in addition to their current DMARD therapy.
Interventions
DRUGDMARDs
Participants may continue on a stable dose of their current DMARD therapy as prescribed. The choice of DMARD is at the discretion of the treating physician and is not specified by the protocol.
DRUGTocilizumab
Tocilizumab will be given as 8 mg/kg via IV infusion every 4 weeks for a total of 12 infusions. The maximum allowed dose is 800 mg.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Moderate to severe active RA of ≥6 months duration * DAS28 \>3.2 * Inadequate response to a stable dose of non-biologic DMARD for ≥2 months * Those receiving oral corticosteroids must have been at stable dose for ≥25 days in the 28 days prior to first study treatment
Exclusion criteria
* Rheumatic autoimmune disease other than RA * History of or current inflammatory joint disease other than RA * Previous treatment with alkylating agents or total lymphoid irradiation * Intra-articular or parenteral corticosteroids within 6 weeks prior to Baseline * Previous treatment with any cell-depleting therapies * American College of Rheumatology (ACR) Functional Class IV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 4 in Synovitis of the Wrist According to Rheumatoid Arthritis Magnetic Resonance Imaging (RAMRIS) Score | Baseline and Week 4 | Synovitis of the wrist was assessed at three sites including the radioulnar joint (RUJ), the radiocarpal joint (RCJ), and the intercarpal-carpometacarpal joints (IC-CMCJ). Global RAMRIS scores were assigned on a scale of 0 to 3 at each site, where 0 represented normal appearance with no synovial enhancement and each 1-point increase reflected one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. The scores for all three sites were added to give an aggregated score of 0 to 9. Baseline absolute value (AV) and change from Baseline to Week 4 were averaged among all participants, where negative changes indicated improvement in synovitis. |
| Change From Baseline to Week 4 in Synovitis of the Wrist According to Relative Enhancement (RE) Before and After Contrast Injection | Baseline and Week 4 | RE was calculated as \[S0 minus (-) S55\] divided by (÷) S0, multiplied by (×) 100 percent (%), where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. Baseline AV and change from Baseline to Week 4 were averaged among all participants, where negative changes indicated improvement in synovitis. |
| Change From Baseline to Week 4 in Synovitis of the Wrist According to Rate of Early Enhancement (REE) Per Second Before and After Contrast Injection | Baseline and Week 4 | REE per second was calculated as \[S55 - S0\] ÷ \[S0 × 55 seconds\] × 100%, where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. Baseline AV and change from Baseline to Week 4 were averaged among all participants, where negative changes indicated improvement in synovitis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to REE Per Second Before and After Contrast Injection | Baseline and Weeks 2, 12, 24, 48 | REE per second was calculated as \[S55 - S0\] ÷ \[S0 × 55 seconds\] × 100%, where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. The changes from Baseline to Weeks 2, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in synovitis. |
| Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score | Baseline and Weeks 2, 4, 12, 24, 48 | Edema was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone edema was scored on a scale of 0 to 3, where 0 represented no bone edema and each 1-point increase reflected one-third increase in extent of edema. Global RAMRIS scores were calculated as the sum of all joint sites for the wrist (range, 0 to 45) and MCP joints (range, 0 to 24). Aggregate wrist and MCP joint scores could range from 0 to 69 points. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in edema. |
| Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Baseline and Weeks 2, 4, 12, 24, 48 | Synovitis of the wrist was assessed at three sites including the RUJ, the RCJ, and the IC-CMCJ. Global RAMRIS scores were assigned on a scale of 0 to 3 at each site, where 0 represented normal appearance with no synovial enhancement and each 1-point increase reflected one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. The scores for all three sites were added to give an aggregated score of 0 to 9. Synovitis of MCP joints was determined on the basis of Short Inversion Time Inversion Recovery (STIR) sequence evaluation with modification of the RAMRIS score. Four MCP joint compartments were each assessed 0 to 3, so the aggregated MCP joint score ranged from 0 to 12. Combined synovitis in wrist and MCP joints was determined on the basis of STIR sequences to produce overall score from 0 to 21. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, 48 were averaged among all participants, where negative changes indicated improvement in synovitis. |
| Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Erosion in the Wrist and MCP Joints | Baseline and Weeks 2, 4, 12, 24, 48 | Erosion was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone erosion was scored on a scale of 0 to 10, where 0 represented no bone erosion and each 1-point increase reflected up to a 10% increase in extent of erosion. The number of bones with erosion was taken as the count of joints with a bone erosion score greater than or equal to (≥) 1. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in erosion. |
| Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score | Baseline and Weeks 2, 4, 12, 24, 48 | Erosion was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone erosion was scored on a scale of 0 to 10, where 0 represented no bone erosion and each 1-point increase reflected up to 10% increase in extent of erosion. Global RAMRIS scores were calculated as the sum of all joint sites for the wrist (range, 0 to 150) and MCP joints (range, 0 to 80). Aggregate wrist and MCP joint scores could range from 0 to 230 points. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in erosion. |
| Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Bone Marrow Edema in the Wrist and MCP Joints | Baseline and Weeks 2, 4, 12, 24, 48 | Edema was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone edema was scored on a scale of 0 to 3, where 0 represented no bone edema and each 1-point increase reflected one-third increase in extent of edema. The number of bones with edema was taken as the count of joints with a bone edema score greater than or equal to (≥) 1. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in edema. |
| Change From Baseline to Weeks 24 and 48 in Total Modified Sharp Score (TMSS), Erosion Score (ES), and Joint Space Narrowing Score (JSNS) | Baseline and Weeks 24, 48 | The TMSS was calculated as the sum of ES and JSNS and ranged from 0 to 202. The ES was taken as the sum of joint scores collected for 14 joints in each hand (individually scored from 0 to 7) and ranged from 0 to 98 for both hands. The JSNS was the sum of joint scores collected for 13 joints in each hand (individually scored from 0 to 8) and ranged from 0 to 104 for both hands. Scores of 0 reflected no change, while higher scores reflected increased disease activity. Baseline AV and changes from Baseline to Weeks 24 and 48 were averaged among all participants, where negative changes indicated improvement in disease activity. |
| Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Ritchie Articular Index Score | Baseline and Weeks 2, 4, 12, 24, 48 | The Ritchie Articular Index was scored on a scale of 0 to 3, according to the grades of tenderness in each of 26 assessed joints. The total score was taken as the sum of joint scores and ranged from 0 to 78. Scores of 0 reflected no tenderness, while higher scores reflected increased tenderness. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in joint tenderness. |
| Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived Pain According to Visual Analog Scale (VAS) Score | Baseline and Weeks 2, 4, 12, 24, 48 | Perceived pain was assessed on a 0- to 100-millimeter (mm) VAS, where the distance from 0 mm represented the participant's self evaluation of pain (0 mm = no pain, 100 mm = maximum pain). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated a decrease in perceived pain. |
| Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived General Health According to VAS Score | Baseline and Weeks 2, 4, 12, 24, 48 | Global assessment of disease activity was performed using a 0- to 100-mm VAS, where the distance from 0 mm represented the investigator's evaluation or the participant's self evaluation of disease activity (0 mm = no disease activity, 100 mm = maximum disease activity). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in disease activity. |
| Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Health Assessment Questionnaire Disability Index (HAQ-DI) Score | Baseline and Weeks 2, 4, 12, 24, 48 | The HAQ-DI assessed 20 items in eight functional activity domains including dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item was scored on a scale of 0 to 3, where 0 represented activities performed without difficulty and 3 represented inability to perform activities alone. The total score was calculated as an average of all item scores, and thus also ranged from 0 to 3. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated an increase in ability to perform activities independently. |
| Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Disease Activity Score of 28 Joints (DAS28) Score | Baseline and Weeks 2, 4, 12, 24, 48 | The DAS28 was derived from assessments of C-reactive protein (CRP), tender joint count (TJC), swollen joint count (SJC), and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] plus (+) \[0.28 × square root of SJC\] + \[0.36 × natural log (CRP + 1)\] + \[0.014 × VAS\] + 0.96. TJC was defined as the number of painful joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. CRP was measured in milligrams per deciliter (mg/dL). DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated an improvement in disease activity. |
| Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Vascular Endothelial Growth Factor (VEGF) Concentration | Baseline and Weeks 2, 4, 12, 24, 48 | Level of VEGF was measured in picograms per milliliter (pg/mL). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants. |
| Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erythrocyte Sedimentation Rate (ESR) | Baseline and Weeks 2, 4, 12, 24, 48 | ESR was measured in millimeters per hour (mm/h). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants. |
| Change From Baseline to Weeks 2, 4, 12, 24, and 48 in High-Sensitivity C-Reactive Protein (hsCRP) Concentration | Baseline and Weeks 2, 4, 12, 24, 48 | Level of hsCRP was measured in mg/dL. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Soluble Interleukin-6 Receptor (sIL6R) Level | Baseline and Weeks 2, 4 | Level of sIL6R was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Messenger Ribonucleic Acid (mRNA) for Interleukin (IL)-17 (2^Delta Cycle Threshold [ΔCt]) Level | Baseline and Weeks 2, 4 | Level of mRNA for IL-17 (2\^ΔCt) was quantified by polymerase chain reaction (PCR). Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in mRNA for RAR-Related Orphan Receptor (ROR)-γT (2^ΔCt) Level | Baseline and Weeks 2, 4 | Level of ROR-γT (2\^ΔCt) was quantified by PCR. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in mRNA for Forkhead Box Protein (FOXP) 3 (2^ΔCt) Level | Baseline and Weeks 2, 4 | Level of mRNA for FOXP3 (2\^ΔCt) was quantified by PCR. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Cluster of Differentiation (CD) 4-Positive Cells as a Percentage of Peripheral Blood Mononuclear Cells (PBMCs) | Baseline and Weeks 2, 4 | The intensity of CD4-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in CD4 Mean Intensity of Fluorescence | Baseline and Weeks 2, 4 | The mean fluorescence intensity of CD4-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in CD25-Positive Cells as a Percentage of PBMCs | Baseline and Weeks 2, 4 | The intensity of CD25-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in CD25 Mean Intensity of Fluorescence | Baseline and Weeks 2, 4 | The mean fluorescence intensity of CD25-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in CD45 RO Isoform (RO)-Positive Cells as a Percentage of PBMCs | Baseline and Weeks 2, 4 | The intensity of CD45RO-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in CD45RO Mean Intensity of Fluorescence | Baseline and Weeks 2, 4 | The mean fluorescence intensity of CD45RO-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Cysteine-Cysteine Chemokine Receptor (CCR) 6-Positive Cells as a Percentage of PBMCs | Baseline and Weeks 2, 4 | The intensity of CCR6-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in CCR6 Mean Intensity of Fluorescence | Baseline and Weeks 2, 4 | The mean fluorescence intensity of CCR6-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in CCR4-Positive Cells as a Percentage of PBMCs | Baseline and Weeks 2, 4 | The intensity of CCR4-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in CCR4 Mean Intensity of Fluorescence | Baseline and Weeks 2, 4 | The mean fluorescence intensity of CCR4-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in IL-23 Receptor p19 Subunit (IL-23Rp19)-Positive Cells as a Percentage of PBMCs | Baseline and Weeks 2, 4 | The intensity of IL-23Rp19-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in IL-23Rp19 Mean Intensity of Fluorescence | Baseline and Weeks 2, 4 | The mean fluorescence intensity of IL-23Rp19-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Regulatory T (Treg) Cells as a Percentage of PBMCs | Baseline and Weeks 2, 4 | The intensity of Treg cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Treg Cells as a Percentage of T Cells | Baseline and Weeks 2, 4 | The intensity of Treg cell infiltration was expressed as the percentage of T cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Treg Cell Level | Baseline and Weeks 2, 4 | The absolute number of Treg cells was expressed as cells per microliter (cells/mcL). Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Helper T (Th) 17 Cells as a Percentage of PBMCs | Baseline and Weeks 2, 4 | The intensity of Th17 cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Th17 Cells as a Percentage of T Cells | Baseline and Weeks 2, 4 | The intensity of Th17 cell infiltration was expressed as the percentage of T cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Th17 Cell Level | Baseline and Weeks 2, 4 | The absolute number of Th17 cells was expressed as cells/mcL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in CD19-Positive Cells as a Percentage of PBMCs | Baseline and Weeks 2, 4 | The intensity of CD19-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in CD19 Mean Intensity of Fluorescence | Baseline and Weeks 2, 4 | The mean fluorescence intensity of CD19-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in CD24-Positive Cells as a Percentage of PBMCs | Baseline and Weeks 2, 4 | The intensity of CD24-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in CD24 Mean Intensity of Fluorescence | Baseline and Weeks 2, 4 | The mean fluorescence intensity of CD24-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in CD27-Positive Cells as a Percentage of PBMCs | Baseline and Weeks 2, 4 | The intensity of CD27-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in CD27 Mean Intensity of Fluorescence | Baseline and Weeks 2, 4 | The mean fluorescence intensity of CD27-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in CD38-Positive Cells as a Percentage of PBMCs | Baseline and Weeks 2, 4 | The intensity of CD38-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in CD38 Mean Intensity of Fluorescence | Baseline and Weeks 2, 4 | The mean fluorescence intensity of CD38-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Immunoglobulin (Ig) M-Positive Cells as a Percentage of PBMCs | Baseline and Weeks 2, 4 | The intensity of IgM-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in IgM Mean Intensity of Fluorescence | Baseline and Weeks 2, 4 | The mean fluorescence intensity of IgM-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Mature B Cells as a Percentage of PBMCs | Baseline and Weeks 2, 4 | The intensity of mature B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Mature B Cells as a Percentage of B Cells | Baseline and Weeks 2, 4 | The intensity of mature B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Week 4 in Mature B Cell Level | Baseline and Week 4 | The absolute number of mature B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Memory B Cells as a Percentage of PBMCs | Baseline and Weeks 2, 4 | The intensity of memory B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Memory B Cells as a Percentage of B Cells | Baseline and Weeks 2, 4 | The intensity of memory B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Week 4 in Memory B Cell Level | Baseline and Week 4 | The absolute number of memory B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Transitional B Cells as a Percentage of PBMCs | Baseline and Weeks 2, 4 | The intensity of transitional B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Transitional B Cells as a Percentage of B Cells | Baseline and Weeks 2, 4 | The intensity of transitional B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Week 4 in Transitional B Cell Level | Baseline and Week 4 | The absolute number of transitional B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Plasma B Cells as a Percentage of PBMCs | Baseline and Weeks 2, 4 | The intensity of plasma B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Plasma B Cells as a Percentage of B Cells | Baseline and Weeks 2, 4 | The intensity of plasma B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Week 4 in Plasma B Cell Level | Baseline and Week 4 | The absolute number of plasma B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Th17 Cysteine-Cysteine Chemokine Ligand (CCL) 20 Level | Baseline and Weeks 2, 4 | Level of Th17CCL20 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Th17CCL17 Level | Baseline and Weeks 2, 4 | Level of Th17CCL20 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in B Cell-Attracting Chemokine (BCA) Level | Baseline and Weeks 2, 4 | Level of BCA was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Stromal Cell-Derived Factor (SDF) 1 Level | Baseline and Weeks 2, 4 | Level of SDF1 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in B Cell-Activating Factor (BAFF) Level | Baseline and Weeks 2, 4 | Level of BAFF was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in A Proliferation-Inducing Ligand (APRIL) Level | Baseline and Weeks 2, 4 | Level of APRIL was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Tumor Necrosis Factor (TNF)-α Level | Baseline and Weeks 2, 4 | Level of TNF-α was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in IL-1β Level | Baseline and Weeks 2, 4 | Level of IL-1β was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in IL-17 Level | Baseline and Weeks 2, 4 | Level of IL-17 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Monocyte Chemoattractant Protein (MCaP)-1 Level | Baseline and Weeks 2, 4 | Level of MCaP-1 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Osteocalcin Level | Baseline and Weeks 2, 4 | Level of osteocalcin was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Type I Collagen N-Propeptide Level | Baseline and Weeks 2, 4 | Level of Type I collagen N-propeptide was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in C-Terminal Telopeptide (CTX)-1 Level | Baseline and Weeks 2, 4 | Level of CTX-1 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Type I Collagen C-Terminal Telopeptide (ICTP) Level | Baseline and Weeks 2, 4 | Level of ICTP was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Type II Collagen N-Propeptide (PIIANP) Level | Baseline and Weeks 2, 4 | Level of PIIANP was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in Type II Collagen Helical Peptide (HELIX-II) Level | Baseline and Weeks 2, 4 | Level of HELIX-II was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Hemoglobin (Hb) Concentration | Baseline and Weeks 2, 4, 12, 24, 48 | Level of Hb was measured in grams per liter (g/L). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants. |
| Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to RAMRIS Score | Baseline and Weeks 2, 12, 24, 48 | Synovitis of the wrist was assessed at three sites including the RUJ, the RCJ, and the IC-CMCJ. Global RAMRIS scores were assigned on a scale of 0 to 3 at each site, where 0 represented normal appearance with no synovial enhancement and each 1-point increase reflected one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. The scores for all three sites were added to give an aggregated score of 0 to 9. The changes from Baseline to Weeks 2, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in synovitis. |
| Change From Baseline to Week 48 in Initial Rate of Enhancement (IRE) by DYNAMIKA Software Analysis | Baseline and Week 48 | IRE was approximated by parametric mapping via DYNAMIKA software and expressed as change in relative signal intensity per second (ΔI/sec). The mean of three different slices was used in the determination of IRE. Each slice consisted of a two-dimensional (2D) sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants. |
| Change From Baseline to Week 48 in Maximum Enhancement (ME) by DYNAMIKA Software Analysis | Baseline and Week 48 | ME was approximated by parametric mapping via DYNAMIKA software and expressed as ratio of signal enhancement before and after contrast injection. The mean of three different slices was used in the determination of ME. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants. |
| Change From Baseline to Week 48 in Number of Enhancing Voxels (Ntotal) by DYNAMIKA Software Analysis | Baseline and Week 48 | Ntotal was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Ntotal. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants. |
| Change From Baseline to Week 48 in Number of Persistent Enhancing Voxels (Npersistent) by DYNAMIKA Software Analysis | Baseline and Week 48 | Npersistent was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Npersistent. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants. |
| Change From Baseline to Week 48 in Number of Plateau Enhancing Voxels (Nplateau) by DYNAMIKA Software Analysis | Baseline and Week 48 | Nplateau was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Nplateau. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants. |
| Change From Baseline to Week 48 in Number of Washout Enhancing Voxels (Nwashout) by DYNAMIKA Software Analysis | Baseline and Week 48 | Nwashout was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Nwashout. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants. |
| Change From Baseline to Week 48 in Ntotal×IRE by DYNAMIKA Software Analysis | Baseline and Week 48 | Ntotal and IRE were approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Ntotal. The mean of three different slices was used in the determination of IRE. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Function of Ntotal×IRE was expressed as voxels times change in relative intensity per second (v\*ΔI/sec). Baseline AV and change from Baseline to Week 48 were averaged among all participants. |
| Change From Baseline to Week 48 in Ntotal×ME by DYNAMIKA Software Analysis | Baseline and Week 48 | Ntotal and ME were approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Ntotal. The mean of three different slices was used in the determination of ME. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Function of NtotalME was expressed as voxels times ratio of signal intensity before and after contrast injection (v\*ratio). Baseline AV and change from Baseline to Week 48 were averaged among all participants. |
| Change From Baseline to Day 2 and Weeks 2 and 4 in Soluble Transferrin Receptor (STR) Concentration | Baseline; Day 2; and Weeks 2, 4 | Level of STR was measured in pg/mL. Baseline AV and changes from Baseline to Day 2 and Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2 and 4 in mRNA for IL-23 Receptor (2^ΔCt) Level | Baseline and Weeks 2, 4 | Level of mRNA for IL-23 receptor (2\^ΔCt) was quantified by PCR. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants. |
| Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to RE Before and After Contrast Injection | Baseline and Weeks 2, 12, 24, 48 | RE was calculated as \[S0 - S55\] ÷ S0 × 100%, where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. The changes from Baseline to Weeks 2, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in synovitis. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tocilizumab in Active RA Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48. | 58 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event or Intercurrent Illness | 2 |
| Overall Study | Insufficient Therapeutic Response | 2 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Tocilizumab in Active RA |
|---|---|
| Age, Continuous | 51.5 years STANDARD_DEVIATION 13 |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 50 / 58 |
| serious Total, serious adverse events | 5 / 58 |
Outcome results
Primary
Change From Baseline to Week 4 in Synovitis of the Wrist According to Rate of Early Enhancement (REE) Per Second Before and After Contrast Injection
REE per second was calculated as \[S55 - S0\] ÷ \[S0 × 55 seconds\] × 100%, where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. Baseline AV and change from Baseline to Week 4 were averaged among all participants, where negative changes indicated improvement in synovitis.
Time frame: Baseline and Week 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Week 4 in Synovitis of the Wrist According to Rate of Early Enhancement (REE) Per Second Before and After Contrast Injection | Baseline AV (n=54) | 1.19 percent rate of early enhancement | Standard Deviation 1.04 |
| Tocilizumab in Active RA | Change From Baseline to Week 4 in Synovitis of the Wrist According to Rate of Early Enhancement (REE) Per Second Before and After Contrast Injection | Week 4 (n=45) | -0.10 percent rate of early enhancement | Standard Deviation 0.86 |
Primary
Change From Baseline to Week 4 in Synovitis of the Wrist According to Relative Enhancement (RE) Before and After Contrast Injection
RE was calculated as \[S0 minus (-) S55\] divided by (÷) S0, multiplied by (×) 100 percent (%), where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. Baseline AV and change from Baseline to Week 4 were averaged among all participants, where negative changes indicated improvement in synovitis.
Time frame: Baseline and Week 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Week 4 in Synovitis of the Wrist According to Relative Enhancement (RE) Before and After Contrast Injection | Baseline AV (n=54) | 99.25 percent relative enhancement | Standard Deviation 57.85 |
| Tocilizumab in Active RA | Change From Baseline to Week 4 in Synovitis of the Wrist According to Relative Enhancement (RE) Before and After Contrast Injection | Week 4 (n=45) | -0.48 percent relative enhancement | Standard Deviation 47.85 |
Primary
Change From Baseline to Week 4 in Synovitis of the Wrist According to Rheumatoid Arthritis Magnetic Resonance Imaging (RAMRIS) Score
Synovitis of the wrist was assessed at three sites including the radioulnar joint (RUJ), the radiocarpal joint (RCJ), and the intercarpal-carpometacarpal joints (IC-CMCJ). Global RAMRIS scores were assigned on a scale of 0 to 3 at each site, where 0 represented normal appearance with no synovial enhancement and each 1-point increase reflected one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. The scores for all three sites were added to give an aggregated score of 0 to 9. Baseline absolute value (AV) and change from Baseline to Week 4 were averaged among all participants, where negative changes indicated improvement in synovitis.
Time frame: Baseline and Week 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Week 4 in Synovitis of the Wrist According to Rheumatoid Arthritis Magnetic Resonance Imaging (RAMRIS) Score | Baseline AV (n=55) | 5.78 units on a scale | Standard Deviation 2.72 |
| Tocilizumab in Active RA | Change From Baseline to Week 4 in Synovitis of the Wrist According to Rheumatoid Arthritis Magnetic Resonance Imaging (RAMRIS) Score | Week 4 (n=49) | -0.88 units on a scale | Standard Deviation 1.56 |
Secondary
Change From Baseline to Day 2 and Weeks 2 and 4 in Soluble Transferrin Receptor (STR) Concentration
Level of STR was measured in pg/mL. Baseline AV and changes from Baseline to Day 2 and Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline; Day 2; and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Day 2 and Weeks 2 and 4 in Soluble Transferrin Receptor (STR) Concentration | Baseline AV (n=57) | 4536413 pg/mL | Standard Deviation 1336641 |
| Tocilizumab in Active RA | Change From Baseline to Day 2 and Weeks 2 and 4 in Soluble Transferrin Receptor (STR) Concentration | Day 2 (n=10) | -83532.0 pg/mL | Standard Deviation 446321.3 |
| Tocilizumab in Active RA | Change From Baseline to Day 2 and Weeks 2 and 4 in Soluble Transferrin Receptor (STR) Concentration | Week 2 (n=46) | 15712.17 pg/mL | Standard Deviation 821775 |
| Tocilizumab in Active RA | Change From Baseline to Day 2 and Weeks 2 and 4 in Soluble Transferrin Receptor (STR) Concentration | Week 4 (n=52) | -89722.7 pg/mL | Standard Deviation 959232.1 |
Secondary
Change From Baseline to Week 48 in Initial Rate of Enhancement (IRE) by DYNAMIKA Software Analysis
IRE was approximated by parametric mapping via DYNAMIKA software and expressed as change in relative signal intensity per second (ΔI/sec). The mean of three different slices was used in the determination of IRE. Each slice consisted of a two-dimensional (2D) sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.
Time frame: Baseline and Week 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Week 48 in Initial Rate of Enhancement (IRE) by DYNAMIKA Software Analysis | Baseline AV (n=49) | 0.00503 ΔI/sec | Standard Deviation 0.00371 |
| Tocilizumab in Active RA | Change From Baseline to Week 48 in Initial Rate of Enhancement (IRE) by DYNAMIKA Software Analysis | Week 48 (n=32) | -0.00246 ΔI/sec | Standard Deviation 0.00363 |
Secondary
Change From Baseline to Week 48 in Maximum Enhancement (ME) by DYNAMIKA Software Analysis
ME was approximated by parametric mapping via DYNAMIKA software and expressed as ratio of signal enhancement before and after contrast injection. The mean of three different slices was used in the determination of ME. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.
Time frame: Baseline and Week 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Week 48 in Maximum Enhancement (ME) by DYNAMIKA Software Analysis | Baseline AV (n=49) | 1.606 ratio | Standard Deviation 0.422 |
| Tocilizumab in Active RA | Change From Baseline to Week 48 in Maximum Enhancement (ME) by DYNAMIKA Software Analysis | Week 48 (n=32) | -0.177 ratio | Standard Deviation 0.416 |
Secondary
Change From Baseline to Week 48 in Ntotal×IRE by DYNAMIKA Software Analysis
Ntotal and IRE were approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Ntotal. The mean of three different slices was used in the determination of IRE. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Function of Ntotal×IRE was expressed as voxels times change in relative intensity per second (v\*ΔI/sec). Baseline AV and change from Baseline to Week 48 were averaged among all participants.
Time frame: Baseline and Week 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Week 48 in Ntotal×IRE by DYNAMIKA Software Analysis | Baseline AV (n=48) | 6.01 v*ΔI/sec | Standard Deviation 5.93 |
| Tocilizumab in Active RA | Change From Baseline to Week 48 in Ntotal×IRE by DYNAMIKA Software Analysis | Week 48 (n=31) | -4.84 v*ΔI/sec | Standard Deviation 6.13 |
Secondary
Change From Baseline to Week 48 in Ntotal×ME by DYNAMIKA Software Analysis
Ntotal and ME were approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Ntotal. The mean of three different slices was used in the determination of ME. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Function of NtotalME was expressed as voxels times ratio of signal intensity before and after contrast injection (v\*ratio). Baseline AV and change from Baseline to Week 48 were averaged among all participants.
Time frame: Baseline and Week 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Week 48 in Ntotal×ME by DYNAMIKA Software Analysis | Baseline AV (n=48) | 1882.40 v*ratio | Standard Deviation 1267.48 |
| Tocilizumab in Active RA | Change From Baseline to Week 48 in Ntotal×ME by DYNAMIKA Software Analysis | Week 48 (n=31) | -793.59 v*ratio | Standard Deviation 1168.57 |
Secondary
Change From Baseline to Week 48 in Number of Enhancing Voxels (Ntotal) by DYNAMIKA Software Analysis
Ntotal was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Ntotal. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.
Time frame: Baseline and Week 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Week 48 in Number of Enhancing Voxels (Ntotal) by DYNAMIKA Software Analysis | Baseline AV (n=48) | 3155.69 enhancing voxels | Standard Deviation 1677.22 |
| Tocilizumab in Active RA | Change From Baseline to Week 48 in Number of Enhancing Voxels (Ntotal) by DYNAMIKA Software Analysis | Week 48 (n=31) | -974.16 enhancing voxels | Standard Deviation 1606.14 |
Secondary
Change From Baseline to Week 48 in Number of Persistent Enhancing Voxels (Npersistent) by DYNAMIKA Software Analysis
Npersistent was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Npersistent. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.
Time frame: Baseline and Week 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Week 48 in Number of Persistent Enhancing Voxels (Npersistent) by DYNAMIKA Software Analysis | Baseline AV (n=49) | 182.04 persistent enhancing voxels | Standard Deviation 157.15 |
| Tocilizumab in Active RA | Change From Baseline to Week 48 in Number of Persistent Enhancing Voxels (Npersistent) by DYNAMIKA Software Analysis | Week 48 (n=32) | -0.53 persistent enhancing voxels | Standard Deviation 219.74 |
Secondary
Change From Baseline to Week 48 in Number of Plateau Enhancing Voxels (Nplateau) by DYNAMIKA Software Analysis
Nplateau was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Nplateau. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.
Time frame: Baseline and Week 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Week 48 in Number of Plateau Enhancing Voxels (Nplateau) by DYNAMIKA Software Analysis | Baseline AV (n=49) | 1839.63 plateau enhancing voxels | Standard Deviation 994.07 |
| Tocilizumab in Active RA | Change From Baseline to Week 48 in Number of Plateau Enhancing Voxels (Nplateau) by DYNAMIKA Software Analysis | Week 48 (n=32) | -635.72 plateau enhancing voxels | Standard Deviation 1019.13 |
Secondary
Change From Baseline to Week 48 in Number of Washout Enhancing Voxels (Nwashout) by DYNAMIKA Software Analysis
Nwashout was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Nwashout. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.
Time frame: Baseline and Week 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Week 48 in Number of Washout Enhancing Voxels (Nwashout) by DYNAMIKA Software Analysis | Baseline AV (n=49) | 1167.16 washout enhancing voxels | Standard Deviation 783.19 |
| Tocilizumab in Active RA | Change From Baseline to Week 48 in Number of Washout Enhancing Voxels (Nwashout) by DYNAMIKA Software Analysis | Week 48 (n=32) | -358.25 washout enhancing voxels | Standard Deviation 798.88 |
Secondary
Change From Baseline to Week 4 in Mature B Cell Level
The absolute number of mature B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants.
Time frame: Baseline and Week 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Week 4 in Mature B Cell Level | Baseline AV (n=47) | 78.27 cells/mcL | Standard Deviation 73.37 |
| Tocilizumab in Active RA | Change From Baseline to Week 4 in Mature B Cell Level | Week 4 (n=42) | 2.29 cells/mcL | Standard Deviation 74.72 |
Secondary
Change From Baseline to Week 4 in Memory B Cell Level
The absolute number of memory B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants.
Time frame: Baseline and Week 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Week 4 in Memory B Cell Level | Baseline AV (n=47) | 29.29 cells/mcL | Standard Deviation 40.81 |
| Tocilizumab in Active RA | Change From Baseline to Week 4 in Memory B Cell Level | Week 4 (n=42) | 2.85 cells/mcL | Standard Deviation 37.6 |
Secondary
Change From Baseline to Week 4 in Plasma B Cell Level
The absolute number of plasma B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants.
Time frame: Baseline and Week 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Week 4 in Plasma B Cell Level | Baseline AV (n=47) | 3.13 cells/mcL | Standard Deviation 6.5 |
| Tocilizumab in Active RA | Change From Baseline to Week 4 in Plasma B Cell Level | Week 4 (n=42) | -1.11 cells/mcL | Standard Deviation 6.31 |
Secondary
Change From Baseline to Week 4 in Transitional B Cell Level
The absolute number of transitional B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants.
Time frame: Baseline and Week 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Week 4 in Transitional B Cell Level | Baseline AV (n=47) | 6.70 cells/mcL | Standard Deviation 7.79 |
| Tocilizumab in Active RA | Change From Baseline to Week 4 in Transitional B Cell Level | Week 4 (n=42) | -0.62 cells/mcL | Standard Deviation 7.51 |
Secondary
Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to RAMRIS Score
Synovitis of the wrist was assessed at three sites including the RUJ, the RCJ, and the IC-CMCJ. Global RAMRIS scores were assigned on a scale of 0 to 3 at each site, where 0 represented normal appearance with no synovial enhancement and each 1-point increase reflected one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. The scores for all three sites were added to give an aggregated score of 0 to 9. The changes from Baseline to Weeks 2, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in synovitis.
Time frame: Baseline and Weeks 2, 12, 24, 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to RAMRIS Score | Week 2 (n=45) | -0.44 units on a scale | Standard Deviation 1.03 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to RAMRIS Score | Week 12 (n=50) | -1.28 units on a scale | Standard Deviation 1.96 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to RAMRIS Score | Week 24 (n=49) | -1.94 units on a scale | Standard Deviation 2.34 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to RAMRIS Score | Week 48 (n=47) | -1.60 units on a scale | Standard Deviation 2.42 |
Secondary
Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to RE Before and After Contrast Injection
RE was calculated as \[S0 - S55\] ÷ S0 × 100%, where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. The changes from Baseline to Weeks 2, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in synovitis.
Time frame: Baseline and Weeks 2, 12, 24, 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to RE Before and After Contrast Injection | Week 2 (n=44) | 5.80 percent relative enhancement | Standard Deviation 46.14 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to RE Before and After Contrast Injection | Week 12 (n=49) | -9.27 percent relative enhancement | Standard Deviation 50.07 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to RE Before and After Contrast Injection | Week 24 (n=48) | -26.48 percent relative enhancement | Standard Deviation 57.99 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to RE Before and After Contrast Injection | Week 48 (n=45) | -19.74 percent relative enhancement | Standard Deviation 74.08 |
Secondary
Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to REE Per Second Before and After Contrast Injection
REE per second was calculated as \[S55 - S0\] ÷ \[S0 × 55 seconds\] × 100%, where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. The changes from Baseline to Weeks 2, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in synovitis.
Time frame: Baseline and Weeks 2, 12, 24, 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to REE Per Second Before and After Contrast Injection | Week 2 (n=44) | -0.04 percent rate of early enhancement | Standard Deviation 1.11 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to REE Per Second Before and After Contrast Injection | Week 12 (n=49) | -0.48 percent rate of early enhancement | Standard Deviation 0.96 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to REE Per Second Before and After Contrast Injection | Week 24 (n=48) | -0.57 percent rate of early enhancement | Standard Deviation 0.87 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to REE Per Second Before and After Contrast Injection | Week 48 (n=45) | -0.66 percent rate of early enhancement | Standard Deviation 1.24 |
Secondary
Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score
Edema was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone edema was scored on a scale of 0 to 3, where 0 represented no bone edema and each 1-point increase reflected one-third increase in extent of edema. Global RAMRIS scores were calculated as the sum of all joint sites for the wrist (range, 0 to 45) and MCP joints (range, 0 to 24). Aggregate wrist and MCP joint scores could range from 0 to 69 points. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in edema.
Time frame: Baseline and Weeks 2, 4, 12, 24, 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score | Wrist Score, Baseline AV (n=56) | 13.11 units on a scale | Standard Deviation 12.88 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score | Wrist Score, Week 2 (n=46) | -0.61 units on a scale | Standard Deviation 6.23 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score | Wrist Score, Week 4 (n=50) | -0.68 units on a scale | Standard Deviation 5.87 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score | Wrist Score, Week 12 (n=51) | -3.02 units on a scale | Standard Deviation 8.55 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score | Wrist Score, Week 24 (n=50) | -4.94 units on a scale | Standard Deviation 10.8 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score | Wrist Score, Week 48 (n=47) | -6.45 units on a scale | Standard Deviation 11.9 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score | MCP Score, Baseline AV (n=54) | 3.17 units on a scale | Standard Deviation 4.64 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score | MCP Score, Week 2 (n=41) | -0.32 units on a scale | Standard Deviation 3.66 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score | MCP Score, Week 4 (n=47) | -0.89 units on a scale | Standard Deviation 4.17 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score | MCP Score, Week 12 (n=45) | -1.47 units on a scale | Standard Deviation 4.01 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score | MCP Score, Week 24 (n=46) | -1.70 units on a scale | Standard Deviation 3.35 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score | MCP Score, Week 48 (n=44) | -1.98 units on a scale | Standard Deviation 4.13 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score | Wrist and MCP Aggregate Score, Baseline AV (n=56) | 16.16 units on a scale | Standard Deviation 15.2 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score | Wrist and MCP Aggregate Score, Week 2 (n=46) | -0.89 units on a scale | Standard Deviation 7.71 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score | Wrist and MCP Aggregate Score, Week 4 (n=50) | -1.52 units on a scale | Standard Deviation 7.9 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score | Wrist and MCP Aggregate Score, Week 12 (n=51) | -4.67 units on a scale | Standard Deviation 9.29 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score | Wrist and MCP Aggregate Score, Week 24 (n=50) | -6.70 units on a scale | Standard Deviation 10.98 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score | Wrist and MCP Aggregate Score, Week 48 (n=47) | -8.30 units on a scale | Standard Deviation 13.06 |
Secondary
Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Disease Activity Score of 28 Joints (DAS28) Score
The DAS28 was derived from assessments of C-reactive protein (CRP), tender joint count (TJC), swollen joint count (SJC), and general health according to 100-mm VAS. DAS28 scores were calculated as \[0.56 × square root of TJC\] plus (+) \[0.28 × square root of SJC\] + \[0.36 × natural log (CRP + 1)\] + \[0.014 × VAS\] + 0.96. TJC was defined as the number of painful joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. CRP was measured in milligrams per deciliter (mg/dL). DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated an improvement in disease activity.
Time frame: Baseline and Weeks 2, 4, 12, 24, 48
Population: ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Disease Activity Score of 28 Joints (DAS28) Score | Baseline AV (n=58) | 5.44 units on a scale | Standard Deviation 0.9 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Disease Activity Score of 28 Joints (DAS28) Score | Week 2 (n=50) | -1.22 units on a scale | Standard Deviation 0.88 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Disease Activity Score of 28 Joints (DAS28) Score | Week 4 (n=53) | -1.62 units on a scale | Standard Deviation 1.05 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Disease Activity Score of 28 Joints (DAS28) Score | Week 12 (n=53) | -2.29 units on a scale | Standard Deviation 1.31 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Disease Activity Score of 28 Joints (DAS28) Score | Week 24 (n=53) | -2.88 units on a scale | Standard Deviation 1.17 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Disease Activity Score of 28 Joints (DAS28) Score | Week 48 (n=53) | -3.07 units on a scale | Standard Deviation 1.27 |
Secondary
Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score
Erosion was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone erosion was scored on a scale of 0 to 10, where 0 represented no bone erosion and each 1-point increase reflected up to 10% increase in extent of erosion. Global RAMRIS scores were calculated as the sum of all joint sites for the wrist (range, 0 to 150) and MCP joints (range, 0 to 80). Aggregate wrist and MCP joint scores could range from 0 to 230 points. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in erosion.
Time frame: Baseline and Weeks 2, 4, 12, 24, 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score | Wrist Score, Baseline AV (n=56) | 7.32 units on a scale | Standard Deviation 5.34 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score | Wrist Score, Week 2 (n=46) | -0.24 units on a scale | Standard Deviation 1.14 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score | Wrist Score, Week 4 (n=50) | -0.16 units on a scale | Standard Deviation 1.11 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score | Wrist Score, Week 12 (n=51) | 0.08 units on a scale | Standard Deviation 1.4 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score | Wrist Score, Week 24 (n=50) | 0.28 units on a scale | Standard Deviation 3.16 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score | Wrist Score, Week 48 (n=47) | 0.34 units on a scale | Standard Deviation 3.67 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score | MCP Score, Baseline AV (n=54) | 4.26 units on a scale | Standard Deviation 7.42 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score | MCP Score, Week 2 (n=41) | -0.02 units on a scale | Standard Deviation 0.88 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score | MCP Score, Week 4 (n=47) | -0.04 units on a scale | Standard Deviation 0.66 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score | MCP Score, Week 12 (n=45) | 0.04 units on a scale | Standard Deviation 1.19 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score | MCP Score, Week 24 (n=46) | -0.07 units on a scale | Standard Deviation 1.65 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score | MCP Score, Week 48 (n=44) | 0.09 units on a scale | Standard Deviation 1.18 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score | Wrist and MCP Aggregate Score, Baseline AV (n=56) | 11.43 units on a scale | Standard Deviation 9.98 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score | Wrist and MCP Aggregate Score, Week 2 (n=46) | -0.39 units on a scale | Standard Deviation 1.86 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score | Wrist and MCP Aggregate Score, Week 4 (n=50) | -0.24 units on a scale | Standard Deviation 1.55 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score | Wrist and MCP Aggregate Score, Week 12 (n=51) | -0.41 units on a scale | Standard Deviation 3.14 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score | Wrist and MCP Aggregate Score, Week 24 (n=50) | -0.18 units on a scale | Standard Deviation 4.77 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score | Wrist and MCP Aggregate Score, Week 48 (n=47) | 0.36 units on a scale | Standard Deviation 4.17 |
Secondary
Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erythrocyte Sedimentation Rate (ESR)
ESR was measured in millimeters per hour (mm/h). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4, 12, 24, 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erythrocyte Sedimentation Rate (ESR) | Baseline AV (n=56) | 37.39 mm/h | Standard Deviation 23.79 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erythrocyte Sedimentation Rate (ESR) | Week 2 (n=47) | -27.30 mm/h | Standard Deviation 20.08 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erythrocyte Sedimentation Rate (ESR) | Week 4 (n=52) | -27.63 mm/h | Standard Deviation 21.17 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erythrocyte Sedimentation Rate (ESR) | Week 12 (n=51) | -28.75 mm/h | Standard Deviation 23 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erythrocyte Sedimentation Rate (ESR) | Week 24 (n=50) | -30.58 mm/h | Standard Deviation 22.96 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erythrocyte Sedimentation Rate (ESR) | Week 48 (n=51) | -27.22 mm/h | Standard Deviation 21.79 |
Secondary
Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Health Assessment Questionnaire Disability Index (HAQ-DI) Score
The HAQ-DI assessed 20 items in eight functional activity domains including dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item was scored on a scale of 0 to 3, where 0 represented activities performed without difficulty and 3 represented inability to perform activities alone. The total score was calculated as an average of all item scores, and thus also ranged from 0 to 3. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated an increase in ability to perform activities independently.
Time frame: Baseline and Weeks 2, 4, 12, 24, 48
Population: ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Health Assessment Questionnaire Disability Index (HAQ-DI) Score | Baseline AV (n=58) | 1.33 units on a scale | Standard Deviation 0.78 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Health Assessment Questionnaire Disability Index (HAQ-DI) Score | Week 2 (n=52) | -0.34 units on a scale | Standard Deviation 0.51 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Health Assessment Questionnaire Disability Index (HAQ-DI) Score | Week 4 (n=53) | -0.35 units on a scale | Standard Deviation 0.49 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Health Assessment Questionnaire Disability Index (HAQ-DI) Score | Week 12 (n=54) | -0.52 units on a scale | Standard Deviation 0.68 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Health Assessment Questionnaire Disability Index (HAQ-DI) Score | Week 24 (n=53) | -0.61 units on a scale | Standard Deviation 0.58 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Health Assessment Questionnaire Disability Index (HAQ-DI) Score | Week 48 (n=54) | -0.67 units on a scale | Standard Deviation 0.61 |
Secondary
Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Hemoglobin (Hb) Concentration
Level of Hb was measured in grams per liter (g/L). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4, 12, 24, 48
Population: ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Hemoglobin (Hb) Concentration | Baseline AV (n=58) | 128.28 g/L | Standard Deviation 12.1 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Hemoglobin (Hb) Concentration | Week 2 (n=50) | 3.86 g/L | Standard Deviation 5.87 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Hemoglobin (Hb) Concentration | Week 4 (n=54) | 2.09 g/L | Standard Deviation 5.35 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Hemoglobin (Hb) Concentration | Week 12 (n=55) | 4.31 g/L | Standard Deviation 9.13 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Hemoglobin (Hb) Concentration | Week 24 (n=53) | 6.23 g/L | Standard Deviation 8.99 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Hemoglobin (Hb) Concentration | Week 48 (n=53) | 7.17 g/L | Standard Deviation 8.28 |
Secondary
Change From Baseline to Weeks 2, 4, 12, 24, and 48 in High-Sensitivity C-Reactive Protein (hsCRP) Concentration
Level of hsCRP was measured in mg/dL. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4, 12, 24, 48
Population: ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in High-Sensitivity C-Reactive Protein (hsCRP) Concentration | Baseline AV (n=58) | 14.43 mg/dL | Standard Deviation 20.46 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in High-Sensitivity C-Reactive Protein (hsCRP) Concentration | Week 2 (n=50) | -13.44 mg/dL | Standard Deviation 21.56 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in High-Sensitivity C-Reactive Protein (hsCRP) Concentration | Week 4 (n=53) | -11.96 mg/dL | Standard Deviation 18.23 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in High-Sensitivity C-Reactive Protein (hsCRP) Concentration | Week 12 (n=55) | -11.56 mg/dL | Standard Deviation 22.51 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in High-Sensitivity C-Reactive Protein (hsCRP) Concentration | Week 24 (n=53) | -13.43 mg/dL | Standard Deviation 21.1 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in High-Sensitivity C-Reactive Protein (hsCRP) Concentration | Week 48 (n=53) | -10.49 mg/dL | Standard Deviation 12.31 |
Secondary
Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Bone Marrow Edema in the Wrist and MCP Joints
Edema was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone edema was scored on a scale of 0 to 3, where 0 represented no bone edema and each 1-point increase reflected one-third increase in extent of edema. The number of bones with edema was taken as the count of joints with a bone edema score greater than or equal to (≥) 1. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in edema.
Time frame: Baseline and Weeks 2, 4, 12, 24, 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Bone Marrow Edema in the Wrist and MCP Joints | Baseline AV (n=56) | 7.91 bones with bone marrow edema | Standard Deviation 6.27 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Bone Marrow Edema in the Wrist and MCP Joints | Week 2 (n=46) | -0.57 bones with bone marrow edema | Standard Deviation 3.46 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Bone Marrow Edema in the Wrist and MCP Joints | Week 4 (n=50) | -0.78 bones with bone marrow edema | Standard Deviation 3.51 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Bone Marrow Edema in the Wrist and MCP Joints | Week 12 (n=51) | -1.80 bones with bone marrow edema | Standard Deviation 3.98 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Bone Marrow Edema in the Wrist and MCP Joints | Week 24 (n=50) | -2.56 bones with bone marrow edema | Standard Deviation 4.13 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Bone Marrow Edema in the Wrist and MCP Joints | Week 48 (n=48) | -3.56 bones with bone marrow edema | Standard Deviation 5.07 |
Secondary
Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Erosion in the Wrist and MCP Joints
Erosion was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone erosion was scored on a scale of 0 to 10, where 0 represented no bone erosion and each 1-point increase reflected up to a 10% increase in extent of erosion. The number of bones with erosion was taken as the count of joints with a bone erosion score greater than or equal to (≥) 1. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in erosion.
Time frame: Baseline and Weeks 2, 4, 12, 24, 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Erosion in the Wrist and MCP Joints | Baseline AV (n=56) | 8.07 bones with erosion | Standard Deviation 4.71 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Erosion in the Wrist and MCP Joints | Week 2 (n=46) | -0.26 bones with erosion | Standard Deviation 1.16 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Erosion in the Wrist and MCP Joints | Week 4 (n=50) | -0.16 bones with erosion | Standard Deviation 1.04 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Erosion in the Wrist and MCP Joints | Week 12 (n=51) | -0.14 bones with erosion | Standard Deviation 1.61 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Erosion in the Wrist and MCP Joints | Week 24 (n=50) | -0.06 bones with erosion | Standard Deviation 1.82 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Erosion in the Wrist and MCP Joints | Week 48 (n=48) | -0.04 bones with erosion | Standard Deviation 2.81 |
Secondary
Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived General Health According to VAS Score
Global assessment of disease activity was performed using a 0- to 100-mm VAS, where the distance from 0 mm represented the investigator's evaluation or the participant's self evaluation of disease activity (0 mm = no disease activity, 100 mm = maximum disease activity). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in disease activity.
Time frame: Baseline and Weeks 2, 4, 12, 24, 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived General Health According to VAS Score | Participant Evaluation, Baseline AV (n=55) | 59.51 mm | Standard Deviation 23.32 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived General Health According to VAS Score | Participant Evaluation, Week 2 (n=50) | -19.58 mm | Standard Deviation 20.75 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived General Health According to VAS Score | Participant Evaluation, Week 4 (n=52) | -19.73 mm | Standard Deviation 23.46 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived General Health According to VAS Score | Participant Evaluation, Week 12 (n=53) | -32.64 mm | Standard Deviation 28.59 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived General Health According to VAS Score | Participant Evaluation, Week 24 (n=51) | -36.55 mm | Standard Deviation 23.84 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived General Health According to VAS Score | Participant Evaluation, Week 48 (n=51) | -40.41 mm | Standard Deviation 25.69 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived General Health According to VAS Score | Investigator Evaluation, Baseline AV (n=54) | 58.89 mm | Standard Deviation 16.26 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived General Health According to VAS Score | Investigator Evaluation, Week 2 (n=47) | -19.21 mm | Standard Deviation 16.71 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived General Health According to VAS Score | Investigator Evaluation, Week 4 (n=51) | -27.55 mm | Standard Deviation 20.49 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived General Health According to VAS Score | Investigator Evaluation, Week 12 (n=51) | -37.61 mm | Standard Deviation 21.63 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived General Health According to VAS Score | Investigator Evaluation, Week 24 (n=50) | -43.94 mm | Standard Deviation 19.55 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived General Health According to VAS Score | Investigator Evaluation, Week 48 (n=50) | -44.72 mm | Standard Deviation 18.98 |
Secondary
Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived Pain According to Visual Analog Scale (VAS) Score
Perceived pain was assessed on a 0- to 100-millimeter (mm) VAS, where the distance from 0 mm represented the participant's self evaluation of pain (0 mm = no pain, 100 mm = maximum pain). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated a decrease in perceived pain.
Time frame: Baseline and Weeks 2, 4, 12, 24, 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived Pain According to Visual Analog Scale (VAS) Score | Baseline AV (n=54) | 57.69 mm | Standard Deviation 24.07 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived Pain According to Visual Analog Scale (VAS) Score | Week 2 (n=50) | -18.56 mm | Standard Deviation 20.73 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived Pain According to Visual Analog Scale (VAS) Score | Week 4 (n=51) | -20.57 mm | Standard Deviation 22.44 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived Pain According to Visual Analog Scale (VAS) Score | Week 12 (n=52) | -32.75 mm | Standard Deviation 29 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived Pain According to Visual Analog Scale (VAS) Score | Week 24 (n=50) | -35.36 mm | Standard Deviation 24.62 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived Pain According to Visual Analog Scale (VAS) Score | Week 48 (n=50) | -39.44 mm | Standard Deviation 25.26 |
Secondary
Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Ritchie Articular Index Score
The Ritchie Articular Index was scored on a scale of 0 to 3, according to the grades of tenderness in each of 26 assessed joints. The total score was taken as the sum of joint scores and ranged from 0 to 78. Scores of 0 reflected no tenderness, while higher scores reflected increased tenderness. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in joint tenderness.
Time frame: Baseline and Weeks 2, 4, 12, 24, 48
Population: ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Ritchie Articular Index Score | Baseline AV (n=58) | 16.69 units on a scale | Standard Deviation 7.5 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Ritchie Articular Index Score | Week 2 (n=53) | -4.85 units on a scale | Standard Deviation 5.37 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Ritchie Articular Index Score | Week 4 (n=54) | -7.06 units on a scale | Standard Deviation 6.5 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Ritchie Articular Index Score | Week 12 (n=52) | -9.37 units on a scale | Standard Deviation 6.65 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Ritchie Articular Index Score | Week 24 (n=53) | -11.60 units on a scale | Standard Deviation 6.71 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Ritchie Articular Index Score | Week 48 (n=54) | -12.09 units on a scale | Standard Deviation 6.95 |
Secondary
Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score
Synovitis of the wrist was assessed at three sites including the RUJ, the RCJ, and the IC-CMCJ. Global RAMRIS scores were assigned on a scale of 0 to 3 at each site, where 0 represented normal appearance with no synovial enhancement and each 1-point increase reflected one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. The scores for all three sites were added to give an aggregated score of 0 to 9. Synovitis of MCP joints was determined on the basis of Short Inversion Time Inversion Recovery (STIR) sequence evaluation with modification of the RAMRIS score. Four MCP joint compartments were each assessed 0 to 3, so the aggregated MCP joint score ranged from 0 to 12. Combined synovitis in wrist and MCP joints was determined on the basis of STIR sequences to produce overall score from 0 to 21. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, 48 were averaged among all participants, where negative changes indicated improvement in synovitis.
Time frame: Baseline and Weeks 2, 4, 12, 24, 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist Global Score, Baseline AV (n=55) | 5.04 units on a scale | Standard Deviation 2.24 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist Global Score, Week 2 (n=45) | -0.02 units on a scale | Standard Deviation 1.7 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist Global Score, Week 4 (n=50) | -0.20 units on a scale | Standard Deviation 1.5 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist Global Score, Week 12 (n=51) | -0.47 units on a scale | Standard Deviation 2.07 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist Global Score, Week 24 (n=50) | -1.06 units on a scale | Standard Deviation 2.11 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist Global Score, Week 48 (n=47) | -1.23 units on a scale | Standard Deviation 2.28 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist Distal RUJ Score, Baseline AV (n=53) | 1.62 units on a scale | Standard Deviation 0.95 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist Distal RUJ Score, Week 2 (n=43) | -0.09 units on a scale | Standard Deviation 0.78 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist Distal RUJ Score, Week 4 (n=48) | -0.15 units on a scale | Standard Deviation 0.62 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist Distal RUJ Score, Week 12 (n=48) | -0.21 units on a scale | Standard Deviation 0.87 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist Distal RUJ Score, Week 24 (n=48) | -0.44 units on a scale | Standard Deviation 0.74 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist Distal RUJ Score, Week 48 (n=45) | -0.58 units on a scale | Standard Deviation 0.94 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist Distal RCJ Score, Baseline AV (n=55) | 1.73 units on a scale | Standard Deviation 0.78 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist Distal RCJ Score, Week 2 (n=45) | 0.11 units on a scale | Standard Deviation 0.8 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist Distal RCJ Score, Week 4 (n=50) | -0.06 units on a scale | Standard Deviation 0.62 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist Distal RCJ Score, Week 12 (n=51) | -0.12 units on a scale | Standard Deviation 0.77 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist Distal RCJ Score, Week 24 (n=50) | -0.30 units on a scale | Standard Deviation 0.91 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist Distal RCJ Score, Week 48 (n=47) | -0.38 units on a scale | Standard Deviation 0.92 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist IC-CMCJ Score, Baseline AV (n=55) | 1.75 units on a scale | Standard Deviation 0.89 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist IC-CMCJ Score, Week 2 (n=44) | 0.00 units on a scale | Standard Deviation 0.72 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist IC-CMCJ Score, Week 4 (n=50) | 0.00 units on a scale | Standard Deviation 0.7 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist IC-CMCJ Score, Week 12 (n=51) | -0.22 units on a scale | Standard Deviation 0.88 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist IC-CMCJ Score, Week 24 (n=50) | -0.40 units on a scale | Standard Deviation 0.88 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist IC-CMCJ Score, Week 48 (n=47) | -0.34 units on a scale | Standard Deviation 0.96 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | MCP STIR Joint Score, Baseline AV (n=54) | 4.57 units on a scale | Standard Deviation 3.1 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | MCP STIR Joint Score, Week 2 (n=40) | -0.13 units on a scale | Standard Deviation 1.76 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | MCP STIR Joint Score, Week 4 (n=47) | -0.53 units on a scale | Standard Deviation 1.9 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | MCP STIR Joint Score, Week 12 (n=45) | -0.53 units on a scale | Standard Deviation 2.07 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | MCP STIR Joint Score, Week 24 (n=46) | -1.02 units on a scale | Standard Deviation 2.24 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | MCP STIR Joint Score, Week 48 (n=44) | -1.25 units on a scale | Standard Deviation 2.53 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist and MCP Aggregate Score, Baseline AV (n=56) | 9.36 units on a scale | Standard Deviation 4.49 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist and MCP Aggregate Score, Week 2 (n=46) | -0.54 units on a scale | Standard Deviation 2.67 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist and MCP Aggregate Score, Week 4 (n=50) | -0.74 units on a scale | Standard Deviation 2.62 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist and MCP Aggregate Score, Week 12 (n=51) | -1.33 units on a scale | Standard Deviation 3.58 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist and MCP Aggregate Score, Week 24 (n=50) | -2.24 units on a scale | Standard Deviation 3.54 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score | Wrist and MCP Aggregate Score, Week 48 (n=47) | -2.49 units on a scale | Standard Deviation 3.59 |
Secondary
Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Vascular Endothelial Growth Factor (VEGF) Concentration
Level of VEGF was measured in picograms per milliliter (pg/mL). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4, 12, 24, 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Vascular Endothelial Growth Factor (VEGF) Concentration | Baseline AV (n=53) | 154.37 pg/mL | Standard Deviation 130.97 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Vascular Endothelial Growth Factor (VEGF) Concentration | Week 2 (n=45) | -53.06 pg/mL | Standard Deviation 145.81 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Vascular Endothelial Growth Factor (VEGF) Concentration | Week 4 (n=48) | -63.61 pg/mL | Standard Deviation 121.55 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Vascular Endothelial Growth Factor (VEGF) Concentration | Week 12 (n=47) | -36.33 pg/mL | Standard Deviation 189.04 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Vascular Endothelial Growth Factor (VEGF) Concentration | Week 24 (n=45) | -66.10 pg/mL | Standard Deviation 139.38 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Vascular Endothelial Growth Factor (VEGF) Concentration | Week 48 (n=45) | -29.35 pg/mL | Standard Deviation 183.46 |
Secondary
Change From Baseline to Weeks 24 and 48 in Total Modified Sharp Score (TMSS), Erosion Score (ES), and Joint Space Narrowing Score (JSNS)
The TMSS was calculated as the sum of ES and JSNS and ranged from 0 to 202. The ES was taken as the sum of joint scores collected for 14 joints in each hand (individually scored from 0 to 7) and ranged from 0 to 98 for both hands. The JSNS was the sum of joint scores collected for 13 joints in each hand (individually scored from 0 to 8) and ranged from 0 to 104 for both hands. Scores of 0 reflected no change, while higher scores reflected increased disease activity. Baseline AV and changes from Baseline to Weeks 24 and 48 were averaged among all participants, where negative changes indicated improvement in disease activity.
Time frame: Baseline and Weeks 24, 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 24 and 48 in Total Modified Sharp Score (TMSS), Erosion Score (ES), and Joint Space Narrowing Score (JSNS) | TMSS, Baseline AV (n=55) | 18.25 units on a scale | Standard Deviation 26.37 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 24 and 48 in Total Modified Sharp Score (TMSS), Erosion Score (ES), and Joint Space Narrowing Score (JSNS) | TMSS, Week 24 (n=46) | 0.41 units on a scale | Standard Deviation 3.03 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 24 and 48 in Total Modified Sharp Score (TMSS), Erosion Score (ES), and Joint Space Narrowing Score (JSNS) | TMSS, Week 48 (n=47) | 1.46 units on a scale | Standard Deviation 5.66 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 24 and 48 in Total Modified Sharp Score (TMSS), Erosion Score (ES), and Joint Space Narrowing Score (JSNS) | ES, Baseline AV (n=55) | 4.78 units on a scale | Standard Deviation 11.85 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 24 and 48 in Total Modified Sharp Score (TMSS), Erosion Score (ES), and Joint Space Narrowing Score (JSNS) | ES, Week 24 (n=46) | 0.05 units on a scale | Standard Deviation 0.6 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 24 and 48 in Total Modified Sharp Score (TMSS), Erosion Score (ES), and Joint Space Narrowing Score (JSNS) | ES, Week 48 (n=47) | 0.31 units on a scale | Standard Deviation 1.07 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 24 and 48 in Total Modified Sharp Score (TMSS), Erosion Score (ES), and Joint Space Narrowing Score (JSNS) | JSNS, Baseline AV (n=55) | 13.46 units on a scale | Standard Deviation 17.39 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 24 and 48 in Total Modified Sharp Score (TMSS), Erosion Score (ES), and Joint Space Narrowing Score (JSNS) | JSNS, Week 24 (n=46) | 0.36 units on a scale | Standard Deviation 3 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 24 and 48 in Total Modified Sharp Score (TMSS), Erosion Score (ES), and Joint Space Narrowing Score (JSNS) | JSNS, Week 48 (n=47) | 1.15 units on a scale | Standard Deviation 5.42 |
Secondary
Change From Baseline to Weeks 2 and 4 in A Proliferation-Inducing Ligand (APRIL) Level
Level of APRIL was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in A Proliferation-Inducing Ligand (APRIL) Level | Baseline AV (n=57) | 6807.49 pg/mL | Standard Deviation 11178.42 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in A Proliferation-Inducing Ligand (APRIL) Level | Week 2 (n=45) | -816.13 pg/mL | Standard Deviation 4036.61 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in A Proliferation-Inducing Ligand (APRIL) Level | Week 4 (n=51) | 7.82 pg/mL | Standard Deviation 3843.69 |
Secondary
Change From Baseline to Weeks 2 and 4 in B Cell-Activating Factor (BAFF) Level
Level of BAFF was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in B Cell-Activating Factor (BAFF) Level | Baseline AV (n=57) | 802.98 pg/mL | Standard Deviation 317.98 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in B Cell-Activating Factor (BAFF) Level | Week 2 (n=45) | 28.04 pg/mL | Standard Deviation 217.89 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in B Cell-Activating Factor (BAFF) Level | Week 4 (n=52) | 36.17 pg/mL | Standard Deviation 223.64 |
Secondary
Change From Baseline to Weeks 2 and 4 in B Cell-Attracting Chemokine (BCA) Level
Level of BCA was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in B Cell-Attracting Chemokine (BCA) Level | Baseline AV (n=56) | 122.28 pg/mL | Standard Deviation 87.48 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in B Cell-Attracting Chemokine (BCA) Level | Week 2 (n=45) | -21.37 pg/mL | Standard Deviation 70.4 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in B Cell-Attracting Chemokine (BCA) Level | Week 4 (n=51) | -18.26 pg/mL | Standard Deviation 103.62 |
Secondary
Change From Baseline to Weeks 2 and 4 in CCR4 Mean Intensity of Fluorescence
The mean fluorescence intensity of CCR4-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CCR4 Mean Intensity of Fluorescence | Baseline AV (n=27) | 2534.67 fluorescence intensity units | Standard Deviation 570 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CCR4 Mean Intensity of Fluorescence | Week 2 (n=19) | 262.95 fluorescence intensity units | Standard Deviation 755.79 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CCR4 Mean Intensity of Fluorescence | Week 4 (n=16) | 273.19 fluorescence intensity units | Standard Deviation 687.01 |
Secondary
Change From Baseline to Weeks 2 and 4 in CCR4-Positive Cells as a Percentage of PBMCs
The intensity of CCR4-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CCR4-Positive Cells as a Percentage of PBMCs | Baseline AV (n=27) | 11.79 percentage of PBMCs | Standard Deviation 5.45 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CCR4-Positive Cells as a Percentage of PBMCs | Week 2 (n=19) | -1.64 percentage of PBMCs | Standard Deviation 4.01 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CCR4-Positive Cells as a Percentage of PBMCs | Week 4 (n=16) | 0.35 percentage of PBMCs | Standard Deviation 3.11 |
Secondary
Change From Baseline to Weeks 2 and 4 in CCR6 Mean Intensity of Fluorescence
The mean fluorescence intensity of CCR6-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CCR6 Mean Intensity of Fluorescence | Baseline AV (n=27) | 4651.85 fluorescence intensity units | Standard Deviation 1211.33 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CCR6 Mean Intensity of Fluorescence | Week 2 (n=19) | 291.63 fluorescence intensity units | Standard Deviation 1820.02 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CCR6 Mean Intensity of Fluorescence | Week 4 (n=16) | 376.56 fluorescence intensity units | Standard Deviation 1306.58 |
Secondary
Change From Baseline to Weeks 2 and 4 in CD19 Mean Intensity of Fluorescence
The mean fluorescence intensity of CD19-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD19 Mean Intensity of Fluorescence | Baseline AV (n=49) | 19268.58 fluorescence intensity units | Standard Deviation 5482.1 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD19 Mean Intensity of Fluorescence | Week 2 (n=1) | -3656.00 fluorescence intensity units | — |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD19 Mean Intensity of Fluorescence | Week 4 (n=44) | 251.34 fluorescence intensity units | Standard Deviation 5251.35 |
Secondary
Change From Baseline to Weeks 2 and 4 in CD19-Positive Cells as a Percentage of PBMCs
The intensity of CD19-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD19-Positive Cells as a Percentage of PBMCs | Baseline AV (n=49) | 8.40 percentage of PBMCs | Standard Deviation 4.68 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD19-Positive Cells as a Percentage of PBMCs | Week 2 (n=1) | -4.80 percentage of PBMCs | — |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD19-Positive Cells as a Percentage of PBMCs | Week 4 (n=44) | -0.12 percentage of PBMCs | Standard Deviation 6.39 |
Secondary
Change From Baseline to Weeks 2 and 4 in CD24 Mean Intensity of Fluorescence
The mean fluorescence intensity of CD24-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD24 Mean Intensity of Fluorescence | Baseline AV (n=49) | 3133.63 fluorescence intensity units | Standard Deviation 1652.36 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD24 Mean Intensity of Fluorescence | Week 2 (n=1) | 1015.00 fluorescence intensity units | — |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD24 Mean Intensity of Fluorescence | Week 4 (n=44) | 436.05 fluorescence intensity units | Standard Deviation 1827.22 |
Secondary
Change From Baseline to Weeks 2 and 4 in CD24-Positive Cells as a Percentage of PBMCs
The intensity of CD24-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD24-Positive Cells as a Percentage of PBMCs | Baseline AV (n=49) | 8.02 percentage of PBMCs | Standard Deviation 4.64 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD24-Positive Cells as a Percentage of PBMCs | Week 2 (n=1) | -4.90 percentage of PBMCs | — |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD24-Positive Cells as a Percentage of PBMCs | Week 4 (n=44) | -0.73 percentage of PBMCs | Standard Deviation 6.21 |
Secondary
Change From Baseline to Weeks 2 and 4 in CD25 Mean Intensity of Fluorescence
The mean fluorescence intensity of CD25-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD25 Mean Intensity of Fluorescence | Baseline AV (n=51) | 2326.25 fluorescence intensity units | Standard Deviation 923.68 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD25 Mean Intensity of Fluorescence | Week 2 (n=28) | 74.76 fluorescence intensity units | Standard Deviation 1850.13 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD25 Mean Intensity of Fluorescence | Week 4 (n=45) | 162.27 fluorescence intensity units | Standard Deviation 632.62 |
Secondary
Change From Baseline to Weeks 2 and 4 in CD25-Positive Cells as a Percentage of PBMCs
The intensity of CD25-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD25-Positive Cells as a Percentage of PBMCs | Baseline AV (n=51) | 7.27 percentage of PBMCs | Standard Deviation 4.92 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD25-Positive Cells as a Percentage of PBMCs | Week 2 (n=28) | -0.95 percentage of PBMCs | Standard Deviation 6.54 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD25-Positive Cells as a Percentage of PBMCs | Week 4 (n=45) | 0.04 percentage of PBMCs | Standard Deviation 5.63 |
Secondary
Change From Baseline to Weeks 2 and 4 in CD27 Mean Intensity of Fluorescence
The mean fluorescence intensity of CD27-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD27 Mean Intensity of Fluorescence | Baseline AV (n=49) | 1288.10 fluorescence intensity units | Standard Deviation 302.9 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD27 Mean Intensity of Fluorescence | Week 2 (n=1) | -349.00 fluorescence intensity units | — |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD27 Mean Intensity of Fluorescence | Week 4 (n=44) | -53.98 fluorescence intensity units | Standard Deviation 390.89 |
Secondary
Change From Baseline to Weeks 2 and 4 in CD27-Positive Cells as a Percentage of PBMCs
The intensity of CD27-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD27-Positive Cells as a Percentage of PBMCs | Baseline AV (n=49) | 57.51 percentage of PBMCs | Standard Deviation 16.48 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD27-Positive Cells as a Percentage of PBMCs | Week 2 (n=1) | -12.40 percentage of PBMCs | — |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD27-Positive Cells as a Percentage of PBMCs | Week 4 (n=44) | 1.44 percentage of PBMCs | Standard Deviation 12.22 |
Secondary
Change From Baseline to Weeks 2 and 4 in CD38 Mean Intensity of Fluorescence
The mean fluorescence intensity of CD38-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD38 Mean Intensity of Fluorescence | Baseline AV (n=49) | 5746.98 fluorescence intensity units | Standard Deviation 2082.63 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD38 Mean Intensity of Fluorescence | Week 2 (n=1) | -193.00 fluorescence intensity units | — |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD38 Mean Intensity of Fluorescence | Week 4 (n=44) | 162.66 fluorescence intensity units | Standard Deviation 1602.09 |
Secondary
Change From Baseline to Weeks 2 and 4 in CD38-Positive Cells as a Percentage of PBMCs
The intensity of CD38-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD38-Positive Cells as a Percentage of PBMCs | Baseline AV (n=49) | 49.51 percentage of PBMCs | Standard Deviation 11.51 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD38-Positive Cells as a Percentage of PBMCs | Week 2 (n=1) | -4.30 percentage of PBMCs | — |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD38-Positive Cells as a Percentage of PBMCs | Week 4 (n=44) | -0.78 percentage of PBMCs | Standard Deviation 10.87 |
Secondary
Change From Baseline to Weeks 2 and 4 in CD45 RO Isoform (RO)-Positive Cells as a Percentage of PBMCs
The intensity of CD45RO-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD45 RO Isoform (RO)-Positive Cells as a Percentage of PBMCs | Baseline AV (n=50) | 37.16 percentage of PBMCs | Standard Deviation 11.5 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD45 RO Isoform (RO)-Positive Cells as a Percentage of PBMCs | Week 2 (n=23) | 1.77 percentage of PBMCs | Standard Deviation 13.88 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD45 RO Isoform (RO)-Positive Cells as a Percentage of PBMCs | Week 4 (n=45) | 3.06 percentage of PBMCs | Standard Deviation 11.65 |
Secondary
Change From Baseline to Weeks 2 and 4 in CD45RO Mean Intensity of Fluorescence
The mean fluorescence intensity of CD45RO-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD45RO Mean Intensity of Fluorescence | Baseline AV (n=49) | 5138.47 fluorescence intensity units | Standard Deviation 2184.11 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD45RO Mean Intensity of Fluorescence | Week 2 (n=22) | -1779.59 fluorescence intensity units | Standard Deviation 2088.51 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD45RO Mean Intensity of Fluorescence | Week 4 (n=44) | -131.75 fluorescence intensity units | Standard Deviation 1908.48 |
Secondary
Change From Baseline to Weeks 2 and 4 in CD4 Mean Intensity of Fluorescence
The mean fluorescence intensity of CD4-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD4 Mean Intensity of Fluorescence | Baseline AV (n=51) | 6970.94 fluorescence intensity units | Standard Deviation 2725.05 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD4 Mean Intensity of Fluorescence | Week 2 (n=29) | 464.04 fluorescence intensity units | Standard Deviation 3341.91 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in CD4 Mean Intensity of Fluorescence | Week 4 (n=45) | -1139.29 fluorescence intensity units | Standard Deviation 3024.58 |
Secondary
Change From Baseline to Weeks 2 and 4 in Cluster of Differentiation (CD) 4-Positive Cells as a Percentage of Peripheral Blood Mononuclear Cells (PBMCs)
The intensity of CD4-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Cluster of Differentiation (CD) 4-Positive Cells as a Percentage of Peripheral Blood Mononuclear Cells (PBMCs) | Baseline AV (n=51) | 56.15 percentage of PBMCs | Standard Deviation 12.63 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Cluster of Differentiation (CD) 4-Positive Cells as a Percentage of Peripheral Blood Mononuclear Cells (PBMCs) | Week 2 (n=29) | -1.47 percentage of PBMCs | Standard Deviation 13.64 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Cluster of Differentiation (CD) 4-Positive Cells as a Percentage of Peripheral Blood Mononuclear Cells (PBMCs) | Week 4 (n=45) | 0.77 percentage of PBMCs | Standard Deviation 8.97 |
Secondary
Change From Baseline to Weeks 2 and 4 in C-Terminal Telopeptide (CTX)-1 Level
Level of CTX-1 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in C-Terminal Telopeptide (CTX)-1 Level | Baseline AV (n=57) | 487.28 pg/mL | Standard Deviation 248.61 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in C-Terminal Telopeptide (CTX)-1 Level | Week 2 (n=48) | 43.33 pg/mL | Standard Deviation 193.11 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in C-Terminal Telopeptide (CTX)-1 Level | Week 4 (n=50) | 48.80 pg/mL | Standard Deviation 233.25 |
Secondary
Change From Baseline to Weeks 2 and 4 in Cysteine-Cysteine Chemokine Receptor (CCR) 6-Positive Cells as a Percentage of PBMCs
The intensity of CCR6-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Cysteine-Cysteine Chemokine Receptor (CCR) 6-Positive Cells as a Percentage of PBMCs | Baseline AV (n=27) | 12.75 percentage of PBMCs | Standard Deviation 6.4 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Cysteine-Cysteine Chemokine Receptor (CCR) 6-Positive Cells as a Percentage of PBMCs | Week 2 (n=19) | 2.34 percentage of PBMCs | Standard Deviation 7.06 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Cysteine-Cysteine Chemokine Receptor (CCR) 6-Positive Cells as a Percentage of PBMCs | Week 4 (n=16) | 3.09 percentage of PBMCs | Standard Deviation 6.76 |
Secondary
Change From Baseline to Weeks 2 and 4 in Helper T (Th) 17 Cells as a Percentage of PBMCs
The intensity of Th17 cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Helper T (Th) 17 Cells as a Percentage of PBMCs | Baseline AV (n=27) | 0.024 percentage of PBMCs | Standard Deviation 0.036 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Helper T (Th) 17 Cells as a Percentage of PBMCs | Week 2 (n=18) | 0.006 percentage of PBMCs | Standard Deviation 0.059 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Helper T (Th) 17 Cells as a Percentage of PBMCs | Week 4 (n=16) | -0.002 percentage of PBMCs | Standard Deviation 0.064 |
Secondary
Change From Baseline to Weeks 2 and 4 in IgM Mean Intensity of Fluorescence
The mean fluorescence intensity of IgM-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in IgM Mean Intensity of Fluorescence | Baseline AV (n=49) | 15545.94 fluorescence intensity units | Standard Deviation 7231.8 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in IgM Mean Intensity of Fluorescence | Week 2 (n=1) | -10381.0 fluorescence intensity units | — |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in IgM Mean Intensity of Fluorescence | Week 4 (n=44) | -56.45 fluorescence intensity units | Standard Deviation 5681.03 |
Secondary
Change From Baseline to Weeks 2 and 4 in IL-17 Level
Level of IL-17 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in IL-17 Level | Baseline AV (n=57) | 15.00 pg/mL | Standard Deviation 0 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in IL-17 Level | Week 2 (n=47) | 0.00 pg/mL | Standard Deviation 0 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in IL-17 Level | Week 4 (n=52) | 0.00 pg/mL | Standard Deviation 0 |
Secondary
Change From Baseline to Weeks 2 and 4 in IL-1β Level
Level of IL-1β was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in IL-1β Level | Baseline AV (n=37) | 0.699 pg/mL | Standard Deviation 0.692 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in IL-1β Level | Week 2 (n=27) | -0.160 pg/mL | Standard Deviation 0.598 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in IL-1β Level | Week 4 (n=31) | -0.243 pg/mL | Standard Deviation 0.62 |
Secondary
Change From Baseline to Weeks 2 and 4 in IL-23 Receptor p19 Subunit (IL-23Rp19)-Positive Cells as a Percentage of PBMCs
The intensity of IL-23Rp19-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in IL-23 Receptor p19 Subunit (IL-23Rp19)-Positive Cells as a Percentage of PBMCs | Baseline AV (n=27) | 1.10 percentage of PBMCs | Standard Deviation 1.19 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in IL-23 Receptor p19 Subunit (IL-23Rp19)-Positive Cells as a Percentage of PBMCs | Week 2 (n=19) | -0.32 percentage of PBMCs | Standard Deviation 0.92 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in IL-23 Receptor p19 Subunit (IL-23Rp19)-Positive Cells as a Percentage of PBMCs | Week 4 (n=16) | -0.34 percentage of PBMCs | Standard Deviation 0.49 |
Secondary
Change From Baseline to Weeks 2 and 4 in IL-23Rp19 Mean Intensity of Fluorescence
The mean fluorescence intensity of IL-23Rp19-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in IL-23Rp19 Mean Intensity of Fluorescence | Baseline AV (n=27) | 1416.30 fluorescence intensity units | Standard Deviation 331.05 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in IL-23Rp19 Mean Intensity of Fluorescence | Week 2 (n=19) | 284.42 fluorescence intensity units | Standard Deviation 1145.08 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in IL-23Rp19 Mean Intensity of Fluorescence | Week 4 (n=16) | 82.88 fluorescence intensity units | Standard Deviation 552.61 |
Secondary
Change From Baseline to Weeks 2 and 4 in Immunoglobulin (Ig) M-Positive Cells as a Percentage of PBMCs
The intensity of IgM-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Immunoglobulin (Ig) M-Positive Cells as a Percentage of PBMCs | Baseline AV (n=49) | 17.06 percentage of PBMCs | Standard Deviation 14.5 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Immunoglobulin (Ig) M-Positive Cells as a Percentage of PBMCs | Week 2 (n=1) | -3.60 percentage of PBMCs | — |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Immunoglobulin (Ig) M-Positive Cells as a Percentage of PBMCs | Week 4 (n=44) | 1.19 percentage of PBMCs | Standard Deviation 11.61 |
Secondary
Change From Baseline to Weeks 2 and 4 in Mature B Cells as a Percentage of B Cells
The intensity of mature B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Mature B Cells as a Percentage of B Cells | Baseline AV (n=49) | 48.58 percentage of B cells | Standard Deviation 14.72 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Mature B Cells as a Percentage of B Cells | Week 2 (n=1) | -9.40 percentage of B cells | — |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Mature B Cells as a Percentage of B Cells | Week 4 (n=44) | -0.11 percentage of B cells | Standard Deviation 13.79 |
Secondary
Change From Baseline to Weeks 2 and 4 in Mature B Cells as a Percentage of PBMCs
The intensity of mature B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Mature B Cells as a Percentage of PBMCs | Baseline AV (n=49) | 4.72 percentage of PBMCs | Standard Deviation 3.56 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Mature B Cells as a Percentage of PBMCs | Week 2 (n=1) | -3.40 percentage of PBMCs | — |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Mature B Cells as a Percentage of PBMCs | Week 4 (n=44) | -0.35 percentage of PBMCs | Standard Deviation 4.24 |
Secondary
Change From Baseline to Weeks 2 and 4 in Memory B Cells as a Percentage of B Cells
The intensity of memory B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Memory B Cells as a Percentage of B Cells | Baseline AV (n=49) | 18.95 percentage of B cells | Standard Deviation 13.36 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Memory B Cells as a Percentage of B Cells | Week 2 (n=1) | 4.30 percentage of B cells | — |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Memory B Cells as a Percentage of B Cells | Week 4 (n=44) | 0.62 percentage of B cells | Standard Deviation 10.87 |
Secondary
Change From Baseline to Weeks 2 and 4 in Memory B Cells as a Percentage of PBMCs
The intensity of memory B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Memory B Cells as a Percentage of PBMCs | Baseline AV (n=49) | 1.49 percentage of PBMCs | Standard Deviation 1.56 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Memory B Cells as a Percentage of PBMCs | Week 2 (n=1) | -0.90 percentage of PBMCs | — |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Memory B Cells as a Percentage of PBMCs | Week 4 (n=44) | 0.13 percentage of PBMCs | Standard Deviation 1.28 |
Secondary
Change From Baseline to Weeks 2 and 4 in Messenger Ribonucleic Acid (mRNA) for Interleukin (IL)-17 (2^Delta Cycle Threshold [ΔCt]) Level
Level of mRNA for IL-17 (2\^ΔCt) was quantified by polymerase chain reaction (PCR). Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Messenger Ribonucleic Acid (mRNA) for Interleukin (IL)-17 (2^Delta Cycle Threshold [ΔCt]) Level | Baseline AV (n=51) | 0.0 2^ΔCt | Standard Deviation 0 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Messenger Ribonucleic Acid (mRNA) for Interleukin (IL)-17 (2^Delta Cycle Threshold [ΔCt]) Level | Week 2 (n=37) | 0.0 2^ΔCt | Standard Deviation 0 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Messenger Ribonucleic Acid (mRNA) for Interleukin (IL)-17 (2^Delta Cycle Threshold [ΔCt]) Level | Week 4 (n=44) | 0.0 2^ΔCt | Standard Deviation 0 |
Secondary
Change From Baseline to Weeks 2 and 4 in Monocyte Chemoattractant Protein (MCaP)-1 Level
Level of MCaP-1 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Monocyte Chemoattractant Protein (MCaP)-1 Level | Baseline AV (n=57) | 343.86 pg/mL | Standard Deviation 283.29 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Monocyte Chemoattractant Protein (MCaP)-1 Level | Week 2 (n=47) | 22.70 pg/mL | Standard Deviation 143.82 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Monocyte Chemoattractant Protein (MCaP)-1 Level | Week 4 (n=51) | -33.20 pg/mL | Standard Deviation 133.52 |
Secondary
Change From Baseline to Weeks 2 and 4 in mRNA for Forkhead Box Protein (FOXP) 3 (2^ΔCt) Level
Level of mRNA for FOXP3 (2\^ΔCt) was quantified by PCR. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in mRNA for Forkhead Box Protein (FOXP) 3 (2^ΔCt) Level | Baseline AV (n=51) | 1.035 2^ΔCt | Standard Deviation 2.509 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in mRNA for Forkhead Box Protein (FOXP) 3 (2^ΔCt) Level | Week 2 (n=37) | -0.315 2^ΔCt | Standard Deviation 1.446 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in mRNA for Forkhead Box Protein (FOXP) 3 (2^ΔCt) Level | Week 4 (n=44) | -0.059 2^ΔCt | Standard Deviation 1.615 |
Secondary
Change From Baseline to Weeks 2 and 4 in mRNA for IL-23 Receptor (2^ΔCt) Level
Level of mRNA for IL-23 receptor (2\^ΔCt) was quantified by PCR. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in mRNA for IL-23 Receptor (2^ΔCt) Level | Baseline AV (n=41) | 0.224 2^ΔCt | Standard Deviation 0.415 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in mRNA for IL-23 Receptor (2^ΔCt) Level | Week 2 (n=31) | -0.007 2^ΔCt | Standard Deviation 0.268 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in mRNA for IL-23 Receptor (2^ΔCt) Level | Week 4 (n=35) | 0.015 2^ΔCt | Standard Deviation 0.495 |
Secondary
Change From Baseline to Weeks 2 and 4 in mRNA for RAR-Related Orphan Receptor (ROR)-γT (2^ΔCt) Level
Level of ROR-γT (2\^ΔCt) was quantified by PCR. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in mRNA for RAR-Related Orphan Receptor (ROR)-γT (2^ΔCt) Level | Baseline AV (n=51) | 0.083 2^ΔCt | Standard Deviation 0.269 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in mRNA for RAR-Related Orphan Receptor (ROR)-γT (2^ΔCt) Level | Week 2 (n=37) | -0.027 2^ΔCt | Standard Deviation 0.259 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in mRNA for RAR-Related Orphan Receptor (ROR)-γT (2^ΔCt) Level | Week 4 (n=44) | -0.004 2^ΔCt | Standard Deviation 0.31 |
Secondary
Change From Baseline to Weeks 2 and 4 in Osteocalcin Level
Level of osteocalcin was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Osteocalcin Level | Baseline AV (n=57) | 14069.60 pg/mL | Standard Deviation 8770.17 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Osteocalcin Level | Week 2 (n=47) | -616.34 pg/mL | Standard Deviation 6899.51 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Osteocalcin Level | Week 4 (n=52) | -99.00 pg/mL | Standard Deviation 6938.56 |
Secondary
Change From Baseline to Weeks 2 and 4 in Plasma B Cells as a Percentage of B Cells
The intensity of plasma B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Plasma B Cells as a Percentage of B Cells | Baseline AV (n=49) | 1.52 percentage of B cells | Standard Deviation 4.54 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Plasma B Cells as a Percentage of B Cells | Week 2 (n=1) | -0.20 percentage of B cells | — |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Plasma B Cells as a Percentage of B Cells | Week 4 (n=44) | -0.06 percentage of B cells | Standard Deviation 5.77 |
Secondary
Change From Baseline to Weeks 2 and 4 in Plasma B Cells as a Percentage of PBMCs
The intensity of plasma B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Plasma B Cells as a Percentage of PBMCs | Baseline AV (n=49) | 0.22 percentage of PBMCs | Standard Deviation 0.57 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Plasma B Cells as a Percentage of PBMCs | Week 2 (n=1) | 0.00 percentage of PBMCs | — |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Plasma B Cells as a Percentage of PBMCs | Week 4 (n=44) | -0.08 percentage of PBMCs | Standard Deviation 0.6 |
Secondary
Change From Baseline to Weeks 2 and 4 in Regulatory T (Treg) Cells as a Percentage of PBMCs
The intensity of Treg cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Regulatory T (Treg) Cells as a Percentage of PBMCs | Baseline AV (n=50) | 2.03 percentage of PBMCs | Standard Deviation 1.02 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Regulatory T (Treg) Cells as a Percentage of PBMCs | Week 2 (n=39) | -0.07 percentage of PBMCs | Standard Deviation 0.86 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Regulatory T (Treg) Cells as a Percentage of PBMCs | Week 4 (n=42) | 0.35 percentage of PBMCs | Standard Deviation 1.41 |
Secondary
Change From Baseline to Weeks 2 and 4 in Soluble Interleukin-6 Receptor (sIL6R) Level
Level of sIL6R was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Soluble Interleukin-6 Receptor (sIL6R) Level | Baseline AV (n=57) | 45270.8 pg/mL | Standard Deviation 19965 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Soluble Interleukin-6 Receptor (sIL6R) Level | Week 2 (n=44) | 332597.2 pg/mL | Standard Deviation 264433 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Soluble Interleukin-6 Receptor (sIL6R) Level | Week 4 (n=50) | 303037.2 pg/mL | Standard Deviation 253261.4 |
Secondary
Change From Baseline to Weeks 2 and 4 in Stromal Cell-Derived Factor (SDF) 1 Level
Level of SDF1 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Stromal Cell-Derived Factor (SDF) 1 Level | Baseline AV (n=57) | 2151.47 pg/mL | Standard Deviation 1133.79 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Stromal Cell-Derived Factor (SDF) 1 Level | Week 2 (n=46) | -1.85 pg/mL | Standard Deviation 343.1 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Stromal Cell-Derived Factor (SDF) 1 Level | Week 4 (n=52) | -26.46 pg/mL | Standard Deviation 390.8 |
Secondary
Change From Baseline to Weeks 2 and 4 in Th17CCL17 Level
Level of Th17CCL20 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Th17CCL17 Level | Baseline AV (n=56) | 456.02 pg/mL | Standard Deviation 404.17 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Th17CCL17 Level | Week 2 (n=45) | 119.58 pg/mL | Standard Deviation 453.39 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Th17CCL17 Level | Week 4 (n=51) | 75.84 pg/mL | Standard Deviation 333.43 |
Secondary
Change From Baseline to Weeks 2 and 4 in Th17 Cell Level
The absolute number of Th17 cells was expressed as cells/mcL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Th17 Cell Level | Baseline AV (n=27) | 0.295 cells/mcL | Standard Deviation 0.368 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Th17 Cell Level | Week 2 (n=18) | 0.050 cells/mcL | Standard Deviation 0.344 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Th17 Cell Level | Week 4 (n=17) | -0.068 cells/mcL | Standard Deviation 0.288 |
Secondary
Change From Baseline to Weeks 2 and 4 in Th17 Cells as a Percentage of T Cells
The intensity of Th17 cell infiltration was expressed as the percentage of T cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Th17 Cells as a Percentage of T Cells | Baseline AV (n=27) | 0.031 percentage of T cells | Standard Deviation 0.049 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Th17 Cells as a Percentage of T Cells | Week 2 (n=18) | -0.003 percentage of T cells | Standard Deviation 0.076 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Th17 Cells as a Percentage of T Cells | Week 4 (n=16) | -0.007 percentage of T cells | Standard Deviation 0.027 |
Secondary
Change From Baseline to Weeks 2 and 4 in Th17 Cysteine-Cysteine Chemokine Ligand (CCL) 20 Level
Level of Th17CCL20 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Th17 Cysteine-Cysteine Chemokine Ligand (CCL) 20 Level | Baseline AV (n=57) | 35.03 pg/mL | Standard Deviation 69.5 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Th17 Cysteine-Cysteine Chemokine Ligand (CCL) 20 Level | Week 2 (n=46) | 2.57 pg/mL | Standard Deviation 20.72 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Th17 Cysteine-Cysteine Chemokine Ligand (CCL) 20 Level | Week 4 (n=52) | -2.65 pg/mL | Standard Deviation 23.18 |
Secondary
Change From Baseline to Weeks 2 and 4 in Transitional B Cells as a Percentage of B Cells
The intensity of transitional B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Transitional B Cells as a Percentage of B Cells | Baseline AV (n=49) | 5.26 percentage of B cells | Standard Deviation 5.61 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Transitional B Cells as a Percentage of B Cells | Week 2 (n=1) | 5.80 percentage of B cells | — |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Transitional B Cells as a Percentage of B Cells | Week 4 (n=44) | -1.09 percentage of B cells | Standard Deviation 4.54 |
Secondary
Change From Baseline to Weeks 2 and 4 in Transitional B Cells as a Percentage of PBMCs
The intensity of transitional B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Transitional B Cells as a Percentage of PBMCs | Baseline AV (n=49) | 0.58 percentage of PBMCs | Standard Deviation 1.12 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Transitional B Cells as a Percentage of PBMCs | Week 2 (n=1) | 0.00 percentage of PBMCs | — |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Transitional B Cells as a Percentage of PBMCs | Week 4 (n=44) | -0.22 percentage of PBMCs | Standard Deviation 1.21 |
Secondary
Change From Baseline to Weeks 2 and 4 in Treg Cell Level
The absolute number of Treg cells was expressed as cells per microliter (cells/mcL). Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Treg Cell Level | Baseline AV (n=49) | 34.51 cells/mcL | Standard Deviation 18.35 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Treg Cell Level | Week 2 (n=35) | 1.25 cells/mcL | Standard Deviation 13.75 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Treg Cell Level | Week 4 (n=42) | 6.30 cells/mcL | Standard Deviation 34.6 |
Secondary
Change From Baseline to Weeks 2 and 4 in Treg Cells as a Percentage of T Cells
The intensity of Treg cell infiltration was expressed as the percentage of T cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Treg Cells as a Percentage of T Cells | Baseline AV (n=50) | 2.42 percentage of T cells | Standard Deviation 1.18 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Treg Cells as a Percentage of T Cells | Week 2 (n=39) | -0.19 percentage of T cells | Standard Deviation 0.98 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Treg Cells as a Percentage of T Cells | Week 4 (n=42) | 0.44 percentage of T cells | Standard Deviation 1.8 |
Secondary
Change From Baseline to Weeks 2 and 4 in Tumor Necrosis Factor (TNF)-α Level
Level of TNF-α was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Tumor Necrosis Factor (TNF)-α Level | Baseline AV (n=55) | 2.285 pg/mL | Standard Deviation 4.234 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Tumor Necrosis Factor (TNF)-α Level | Week 2 (n=42) | 0.077 pg/mL | Standard Deviation 1.228 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Tumor Necrosis Factor (TNF)-α Level | Week 4 (n=46) | 0.254 pg/mL | Standard Deviation 0.978 |
Secondary
Change From Baseline to Weeks 2 and 4 in Type I Collagen C-Terminal Telopeptide (ICTP) Level
Level of ICTP was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Type I Collagen C-Terminal Telopeptide (ICTP) Level | Baseline AV (n=57) | 6381.12 pg/mL | Standard Deviation 2456.54 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Type I Collagen C-Terminal Telopeptide (ICTP) Level | Week 2 (n=48) | 306.60 pg/mL | Standard Deviation 1568.45 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Type I Collagen C-Terminal Telopeptide (ICTP) Level | Week 4 (n=51) | 193.25 pg/mL | Standard Deviation 1657.43 |
Secondary
Change From Baseline to Weeks 2 and 4 in Type I Collagen N-Propeptide Level
Level of Type I collagen N-propeptide was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Type I Collagen N-Propeptide Level | Baseline AV (n=57) | 7731.89 pg/mL | Standard Deviation 4625.23 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Type I Collagen N-Propeptide Level | Week 2 (n=46) | 842.65 pg/mL | Standard Deviation 4318.91 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Type I Collagen N-Propeptide Level | Week 4 (n=51) | -576.49 pg/mL | Standard Deviation 4108.27 |
Secondary
Change From Baseline to Weeks 2 and 4 in Type II Collagen Helical Peptide (HELIX-II) Level
Level of HELIX-II was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Type II Collagen Helical Peptide (HELIX-II) Level | Baseline AV (n=57) | 2521.12 pg/mL | Standard Deviation 1960.76 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Type II Collagen Helical Peptide (HELIX-II) Level | Week 2 (n=48) | 126.02 pg/mL | Standard Deviation 1480.97 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Type II Collagen Helical Peptide (HELIX-II) Level | Week 4 (n=51) | -78.29 pg/mL | Standard Deviation 1586.43 |
Secondary
Change From Baseline to Weeks 2 and 4 in Type II Collagen N-Propeptide (PIIANP) Level
Level of PIIANP was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.
Time frame: Baseline and Weeks 2, 4
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Type II Collagen N-Propeptide (PIIANP) Level | Baseline AV (n=57) | 1329158 pg/mL | Standard Deviation 908163.5 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Type II Collagen N-Propeptide (PIIANP) Level | Week 2 (n=47) | -37518.8 pg/mL | Standard Deviation 1008994 |
| Tocilizumab in Active RA | Change From Baseline to Weeks 2 and 4 in Type II Collagen N-Propeptide (PIIANP) Level | Week 4 (n=51) | -69799.1 pg/mL | Standard Deviation 673406.7 |