| Primary | Number of Participants With at Least One Serious Adverse Event (SAE) | Adverse events (AEs) were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The number of participants with at least one SAE regardless of treatment relationship was reported. | | Posted | | Number | | participants | | From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall) | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Primary | Percentage of Participants With at Least One SAE | AEs were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The percentage of participants with at least one SAE regardless of treatment relationship was calculated. | | Posted | | Number | | percentage of participants | | From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall) | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Primary | Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Any Timepoint | Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated. | Safety Population; only participants with a valid assay at Screening were included. | Posted | | Number | | percentage of participants | | From Baseline to 8 weeks after last dose; assessed at Baseline; Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall) | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Primary | Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Baseline | Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated. | Safety Population; only participants with a valid assay at Screening were included. | Posted | | Number | | percentage of participants | | Baseline | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Primary | Percentage of Participants With a Positive Anti-TCZ Antibody Assay Post-Baseline | Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated. Positive assay results obtained post-Baseline were further investigated via confirmation assay and a neutralization assay. | Safety Population; only participants with a valid assay at Screening were included. | Posted | | Number | | percentage of participants | | From Week 12 up to 8 weeks after last dose; assessed at Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall) | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Percentage of Participants Who Correctly Administered All SC TCZ Doses | Compliance was assessed using drug dispensing logs, diary cards kept by the participant, and return records, as reviewed by the Investigator at regular visits. Total compliance up to the end of treatment was defined as the percentage of participants who correctly administered all scheduled doses of SC TCZ. Correct administration was defined as proper injection technique, injection of the correct amount (162 mg), device not left at room temperature for greater than (>) 8 hours, and absence of other medication errors. | Intent-to-Treat (ITT) Population: All participants who received at least one dose of study medication and had at least one post-dose efficacy assessment. | Posted | | Number | | percentage of participants | | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Disease Activity Score Based on 28 Joints (DAS28) Score | The DAS28 was calculated using the Swollen Joint Count (SJC), Tender Joint Count (TJC), erythrocyte sedimentation rate (ESR), and Global Assessment of Disease Activity by the participant according to Visual Analog Scale (VAS) score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-millimeter (mm) scale to a 10-point score. The DAS28 was calculated as (0.56 multiplied by [×] square root of TJC) + (0.28 × square root of SJC) + (0.7 × log natural [ln] ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Change From Baseline in DAS28 Score | The DAS28 was calculated using the SJC, TJC, ESR, and Global Assessment of Disease Activity by the participant according to VAS score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Clinical Disease Activity Index (CDAI) Score | The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity. | ITT Population; only those participants who provided evaluable data (n) were included in the analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Change From Baseline in CDAI Score | The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Simplified Disease Activity Index (SDAI) Score | The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and high-sensitivity C-reactive protein (hsCRP) level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 milligram per deciliter (mg/dL), scores would be expected to fall within less than or equal to (≤) 77 points. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | |
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| Secondary | Change From Baseline in SDAI Score | The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and hsCRP level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW |
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| Secondary | Tender Joint Count (TJC) Score | Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68. | ITT Population; only those participants who provided evaluable data (n) were included in the analysis. | Posted | | Mean | Standard Deviation | tender joints | | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Change From Baseline in TJC Score | Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of tender joints. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table. | Posted | | Mean | Standard Deviation | tender joints | | Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Swollen Joint Count (SJC) Score | Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66. | ITT Population; only those participants who provided evaluable data (n) were included in the analysis. | Posted | | Mean | Standard Deviation | swollen joints | | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Change From Baseline in SJC Score | Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of swollen joints. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table. | Posted | | Mean | Standard Deviation | swollen joints | | Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation | Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. | ITT Population; only participants receiving at least one DMARD at Baseline were included. | Posted | | Number | | participants | | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation | Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. | ITT Population; only participants receiving at least one DMARD at Baseline were included. | Posted | | Number | | percentage of participants | | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Percentage of Reasons Given for DMARD Dose Reduction or Interruption | Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD dose reduction/interruption ≤60 days were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed. | ITT Population; only participants with a DMARD dose reduction/interruption ≤60 days were included. | Posted | | Number | | percentage of reasons | | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | Reasons | Participants | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Percentage of Reasons Given for DMARD Discontinuation | Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD discontinuation were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed. | ITT Population; only participants with a DMARD discontinuation >60 days were included. | Posted | | Number | | percentage of reasons | | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | Reasons | Participants | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Number of Participants With a Corticosteroid (CCS) Dose Reduction, Interruption, or Discontinuation | Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. | ITT Population; only participants who received at least one CCS before the last dose of TCZ were included. | Posted | | Number | | participants | | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Percentage of Participants With a CCS Dose Reduction, Interruption, or Discontinuation | Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. | ITT Population; only participants who received at least one CCS before the last dose of TCZ were included. | Posted | | Number | | percentage of participants | | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Percentage of Reasons Given for CCS Dose Reduction | Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose reduction were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed. | ITT Population; only participants with a CCS dose reduction were included. | Posted | | Number | | percentage of reasons | | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | Reasons | Participants | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Percentage of Reasons Given for CCS Dose Interruption | Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose interruption ≤14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed. | ITT Population; only participants with a CCS dose interruption ≤14 days were included. Results were only reported for the QW arm because no participants in the Q2W arm had a CCS dose interruption. | Posted | | Number | | percentage of reasons | | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | Reasons | Participants | | ID | Title | Description |
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| OG000 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Percentage of Reasons Given for CCS Discontinuation | Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS discontinuation >14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed. | ITT Population; only participants with a CCS discontinuation >14 days were included. | Posted | | Number | | percentage of reasons | | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | Reasons | Participants | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Number of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen | Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was reported. | ITT Population. The results were presented for all participants to account for multiple switches between arms (i.e., participants who started in the Q2W arm could have switched to QW and then switched back to Q2W, making them analyzable for the outcome measure). | Posted | | Number | | participants | | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | | | | ID | Title | Description |
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| OG000 | SC TCZ/All Participants | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W. |
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| Secondary | Percentage of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen | Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The percentage of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was calculated. | ITT Population. The results were presented for all participants to account for multiple switches between arms (i.e., participants who started in the Q2W arm could have switched to QW and then switched back to Q2W, making them analyzable for the outcome measure). | Posted | | Number | | percentage of participants | | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | | | | ID | Title | Description |
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| OG000 | SC TCZ/All Participants | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W. |
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| Secondary | Number of Participants Who Returned to the QW Regimen After Switching to the Q2W Regimen | Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and thereafter returned to the QW regimen was reported with the reason for returning to the QW regimen. | ITT Population; only participants who switched from the QW to Q2W regimen were included. | Posted | | Number | | participants | | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | | | | ID | Title | Description |
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| OG000 | SC TCZ/All Participants | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W. |
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| Secondary | Time to Return to the QW Regimen After Switching to the Q2W Regimen | Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. Time to return was defined as the time between switching to the Q2W regimen and returning to the previous QW regimen. | ITT Population; only participants who switched from the QW to Q2W regimen and returned to the QW regimen were included. | Posted | | Median | Full Range | weeks | | From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) | | | | ID | Title | Description |
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| OG000 | SC TCZ/All Participants | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W. |
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| Secondary | Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score | The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm ("no disease activity") to 100 mm ("maximum disease activity"), with higher scores representing an increase in perceived symptoms. | ITT Population; only those participants who provided evaluable data (n) were included in the analysis. | Posted | | Mean | Standard Deviation | mm | | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score | The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm ("no disease activity") to 100 mm ("maximum disease activity"), with higher scores representing an increase in perceived symptoms. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in perceived disease activity. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table. | Posted | | Mean | Standard Deviation | mm | | Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Global Assessment of Pain by the Participant According to VAS Score | The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm ("no pain") to 100 mm ("unbearable pain"), with higher scores representing an increase in pain. | ITT Population; only those participants who provided evaluable data (n) were included in the analysis. | Posted | | Mean | Standard Deviation | mm | | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score | The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm ("no pain") to 100 mm ("unbearable pain"), with higher scores representing an increase in pain. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in pain. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table. | Posted | | Mean | Standard Deviation | mm | | Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score | The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. | ITT Population; only those participants who provided evaluable data (n) were included in the analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Change From Baseline in HAQ-DI Score | The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The change from Baseline to each visit was calculated, where positive changes represent an increased need for assistance with daily activities. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Percentage of Participants With HAQ-DI Score <0.5 | The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The percentage of participants achieving a score <0.5 was calculated at each visit. | ITT Population; only those participants who provided evaluable data (n) were included in the analysis. | Posted | | Number | | percentage of participants | | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW. |
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| Secondary | Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The number of participants who met criteria for low disease activity was reported at each visit. | ITT Population; only those participants who provided evaluable data (n) were included in the analysis. | Posted | | Number | | participants | | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW |
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| Secondary | Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria | Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for low disease activity was calculated at each visit. | ITT Population; only those participants who provided evaluable data (n) were included in the analysis. | Posted | | Number | | percentage of participants | | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 | SC TCZ QW |
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| Secondary | Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Remission was defined as DAS28 <2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The number of participants who met criteria for remission was reported at each visit. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table. | Posted | | Number | | participants | | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 |
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| Secondary | Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria | Remission was defined as DAS28 <2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for remission was calculated at each visit. | ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table. | Posted | | Number | | percentage of participants | | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 | | | | ID | Title | Description |
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| OG000 | SC TCZ Q2W | Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W. | | OG001 |
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