| Primary | Percentage of Participants Achieving Sustained Clinical Remission, Disease Activity Scale 28 - Erythrocyte Sedimentation Rate <26 (DAS28-ESR <2.6) at Week 20 and Week 24 | The DAS 28 is a combined index for measuring disease activity in RA. The index includes the assessment of 28 joints for swelling and tenderness, acute phase response (ESR or CRP) and general health status. For this study ESR was used to calculate the DAS 28 score. | Analyses were conducted on the Full Analysis Set (FAS), i.e. all patients included in the study who received at least one dose of SC TCZ. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 20 and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: Tocilizumab Monotherapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks. | | OG001 | Phase 1: Combination Therapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00048.4(35.75 to 61.27)
- OG00152.9(46.83 to 58.83)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Chi-squared | | 0.5231 | | | | | | | | | | | | | | Other | | |
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| Secondary | Mean Change in Disease Activity Score 28 - Erythrocyte Sedimentation Rate(DAS28-ESR) | The DAS 28 is a combined index for measuring disease activity in RA. The index includes the assessment of 28 joints for swelling and tenderness, acute phase response (ESR or CRP) and general health status. For this study ESR was used to calculate the DAS 28 score. | Analysis was conducted on the FAS | Posted | | Mean | Standard Deviation | mm/hr | | From week 24 up to week 48 | | | | ID | Title | Description |
|---|
| OG000 | Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG001 | Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. |
| |
| Secondary | Percentage of Patients Allocated in Groups A1 and A2 Who Remain With Clinical Remission Activity (DAS 28 ESR <2.6) up to Week 48 | The DAS28 is a combined index for measuring disease activity in RA. The index includes the assessment of 28 joints for swelling and tenderness, acute phase response (ESR or CRP), and general health status. For this study ESR will be used to calculate the DAS28 score. | Analysis was conducted on the FAS | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From week 28 up to week 48 | | | | ID | Title | Description |
|---|
| OG000 | Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG001 | Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. |
| |
| Secondary | Percentage of Patients Reporting Change in DAS 28 ESR >1.2 Until Week 48 | The DAS28 is a combined index for measuring disease activity in RA. The index includes the assessment of 28 joints for swelling and tenderness, acute phase response (ESR or CRP), and general health status. For this study ESR will be used to calculate the DAS28 score. | Analysis was conducted on the FAS | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From week 28 up to week 48 | | | | ID | Title | Description |
|---|
| OG000 | Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG001 | Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. |
| |
| Secondary | Percentage of Patients With American College of Rheumatology (ACR20, 50, 70, 90) Response Scores Until Week 24 | The definition of improvement of ACR core set of outcome measures includes an improvement equal or higher to the 20%, 50%, 70%, 90% compared to Baseline in both Swollen Joint Count (SJC) and Tender Joint Count (TJC) as well as in three out of five additional parameters: Physician's Global Assessment of disease activity VAS, patient's Global Assessment of disease activity VAS, patient's assessment of pain VAS, HAQ-DI, and acute phase reactant (either CRP or erythrocyte sedimentation rate [ESR]). | Analysis was conducted on the FAS | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From week 2 until week 24 | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: Tocilizumab Monotherapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks. | | OG001 | Phase 1: Combination Therapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks. |
| |
| Secondary | Percentage of Patients With American College of Rheumatology (ACR20, 50, 70, 90) Response Scores Until Week 48 | The definition of improvement of ACR core set of outcome measures includes an improvement equal or higher to the 20%, 50%, 70%, 90% compared to Baseline in both Swollen Joint Count (SJC) and Tender Joint Count (TJC) as well as in three out of five additional parameters: Physician's Global Assessment of disease activity VAS, patient's Global Assessment of disease activity VAS, patient's assessment of pain VAS, HAQ-DI, and acute phase reactant (either CRP or erythrocyte sedimentation rate [ESR]). | Analysis was conducted on the FAS | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From week 28 until week 48 | | | | ID | Title | Description |
|---|
| OG000 | Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG001 | Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. |
|
| Secondary | Number of Patients With Good and Moderate Clinical Response According to European League Against Rheumatism (EULAR) Response Scores up to Week 24 | DAS28-based EULAR response criteria were used to measure individual response as good or moderate depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to =<1.2 with DAS28 ≤5.1. | Analysis was conducted on the FAS | Posted | | Number | | Number of participants | | From week 2 until week 24 | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: Tocilizumab Monotherapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks. | | OG001 | Phase 1: Combination Therapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks. |
| |
| Secondary | Number of Patients With Clinical Response According to European League Against Rheumatism (EULAR) Response Scores up to Week 48 | DAS28-based EULAR response criteria were used to measure individual response as good or moderate depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to =<1.2 with DAS28 ≤5.1. | Analysis was conducted on the FAS. | Posted | | Number | | Number of participants | | From week 28 until week 48 | | | | ID | Title | Description |
|---|
| OG000 | Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG001 | Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. |
| |
| Secondary | Mean Change in Clinical Disease Activity Index (CDAI) From Baseline up to Week 24 | Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement. | Analysis was conducted on the FAS. | Posted | | Mean | Standard Deviation | CDAI score | | From baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: Tocilizumab Monotherapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks. | | OG001 | Phase 1: Combination Therapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks. |
| |
| Secondary | Mean Change From Baseline in Clinical Disease Activity Index (CDAI) up to Week 48 | Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement. | Analysis was conducted on the FAS. | Posted | | Mean | Standard Deviation | CDAI score | | From week 24 until week 48 | | | | ID | Title | Description |
|---|
| OG000 | Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG001 | Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. |
|
| Secondary | Mean Change in Simplified Disease Activity Index (SDAI) From Baseline up to Week 24 | Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity. | Analysis was conducted on the FAS | Posted | | Mean | Standard Deviation | SDAI score | | From baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: Tocilizumab Monotherapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks. | | OG001 | Phase 1: Combination Therapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks. |
| |
| Secondary | Mean Change in Simplified Disease Activity Index (SDAI) From Week 24 up to Week 48 | Simplified Disease Activity Index (SDAI) which is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity. | Analysis was conducted on the FAS | Posted | | Mean | Standard Deviation | SDAI score | | From week 24 until week 48 | | | | ID | Title | Description |
|---|
| OG000 | Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG001 | Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. |
|
| Secondary | Mean Change From Baseline in Total Tender Joint Counts (TJC) Until Week 24 | TCJ is a clinical assessment of 68 joints which are classified as tender/not tender by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints are not be taken into consideration. | Analysis was conducted on the FAS. | Posted | | Mean | Standard Deviation | TJC | | From baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: Tocilizumab Monotherapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks. | | OG001 | Phase 1: Combination Therapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks. |
| |
| Secondary | Mean Change From Baseline in Total Tender Joint Counts (TJC) Until Week 48 | TCJ is a clinical assessment of 68 joints which are classified as tender/not tender by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints are not be taken into consideration. | Analysis was conducted on the FAS. | Posted | | Mean | Standard Deviation | TJC | | From week 24 until week 48 | | | | ID | Title | Description |
|---|
| OG000 | Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG001 | Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. |
| |
| Secondary | Mean Change in Total Swollen Joint Counts (SJC) From Baseline Until Week 24 | SJC is a clinical assessment of 66 joints classified as swollen/not swollen by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints will not be taken into consideration for swelling. | Analysis was conducted on the FAS.SJC | Posted | | Mean | Standard Deviation | SJC | | From baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: Tocilizumab Monotherapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks. | | OG001 | Phase 1: Combination Therapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks. |
| |
| Secondary | Mean Change in Total Swollen Joint Counts (SJC) From Baseline Until Week 48 | SJC is a clinical assessment of 66 joints classified as swollen/not swollen by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints will not be taken into consideration for swelling. | Analysis was conducted on the FAS. | Posted | | Mean | Standard Deviation | SJC | | From week 24 until week 48 | | | | ID | Title | Description |
|---|
| OG000 | Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG001 | Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. |
| |
| Secondary | Percentages of Patients Who Achieve DAS28-ESR Remission (DAS28 < 2.6) up to Week 48 | The DAS 28 is a combined index for measuring disease activity in RA. The index includes the assessment of 28 joints for swelling and tenderness, acute phase response (ESR or CRP) and general health status. For this study ESR was used to calculate the DAS 28 score. | Analysis was conducted on the FAS | Posted | | Mean | 95% Confidence Interval | Percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Phase 2 Arm A1 - Monotherapy - qw | Participants who achieved sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy from Week 24 to Week 48. | | OG001 | Phase 2 Arm A1- Combination Therapy - qw | Participants who achieved sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG002 | Phase 2 Arm A2 - Monotherapy - q2w | Participants who achieved sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every 2 weeks monotherapy from Week 24 to Week 48. |
|
| Secondary | Percentages of Patients With Remission (CDAI<2.8) Until Week 24 | Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement. | Analysis was conducted on the FAS | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: Tocilizumab Monotherapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks. | | OG001 | Phase 1: Combination Therapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks. |
| |
| Secondary | Percentages of Patients With Remission (CDAI<2.8) Until Week 48 | Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement. | Analysis was conducted on the FAS | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From week 28 until week 48 | | | | ID | Title | Description |
|---|
| OG000 | Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG001 | Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. |
|
| Secondary | Percentages of Patients With Remission (SDAI<3.3) Until Week 24 | Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity. | Analysis was conducted on the FAS | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: Tocilizumab Monotherapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks. | | OG001 | Phase 1: Combination Therapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks. |
| |
| Secondary | Percentages of Patients With Remission (SDAI<3.3) Until Week 48 | Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity. | Analysis was conducted on the FAS | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From week 28 until week 48 | | | | ID | Title | Description |
|---|
| OG000 | Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG001 | Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. |
|
| Secondary | Percentage of Patients Who Achieve Low Disease Activity Based on DAS28-ESR Criteria (DAS28-ESR </=3.2) up to Week 24 | The DAS28 is a combined index for measuring disease activity in RA. The index includes the assessment of 28 joints for swelling and tenderness, acute phase response (ESR or CRP), and general health status. For this study ESR is used to calculate the DAS28 score. | Analysis was conducted on the FAS. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: Tocilizumab Monotherapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks. | | OG001 | Phase 1: Combination Therapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks. |
| |
| Secondary | Percentage of Patients Who Achieve Low Disease Activity Based on DAS28-ESR Criteria (DAS28-ESR </=3.2) up to Week 48 | The DAS28 is a combined index for measuring disease activity in RA. The index includes the assessment of 28 joints for swelling and tenderness, acute phase response (ESR or CRP), and general health status. For this study ESR was used to calculate the DAS28 score. | Analysis was conducted on the FAS. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From week 28 until week 48 | | | | ID | Title | Description |
|---|
| OG000 | Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG001 | Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. |
| |
| Secondary | Percentage of Patients Who Achieve Low Disease Activity Based on CDAI Score (CDAI<10) Until Week 24 | Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement. | Analysis was conducted on the FAS. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: Tocilizumab Monotherapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks. | | OG001 | Phase 1: Combination Therapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks. |
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| Secondary | Percentage of Patients Who Achieve Low Disease Activity Based on CDAI Score (CDAI<10) Until Week 48 | Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement. | Analysis was conducted on the FAS. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From week 28 until week 48 | | | | ID | Title | Description |
|---|
| OG000 | Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG001 | Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. |
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| Secondary | Percentage of Patients Who Achieved Low Disease Activity (LDA) Based on SDAI Score (SDAI<11) Until Week 24 | Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity. | Analysis was conducted on the FAS. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: Tocilizumab Monotherapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks. | | OG001 | Phase 1: Combination Therapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks. |
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| Secondary | Percentage of Patients Who Achieved Low Disease Activity (LDA) Based on SDAI Score (SDAI<11) Until Week 48 | Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity. | Analysis was conducted on the FAS. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From week 28 until week 48 | | | | ID | Title | Description |
|---|
| OG000 | Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG001 | Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. |
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| Secondary | Safety: Number of Patients Reporting Adverse Events up to Week 24 | Number of patients reporting any treatment emergent adverse event (TEAE), at least one TEAE of special interest, at least one serious TEAE, at least one TEAE leading to dose modification, at least one TEAE leading to discontinuation up to week 24 | Analysis was conducted on the FAS. | Posted | | Number | | Number of participants | | From baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: Tocilizumab Monotherapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks. | | OG001 | Phase 1: Combination Therapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks. |
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| Secondary | Safety: Number of Patients Reporting Adverse Events up to Week 48 | Number of patients reporting any treatment emergent adverse event (TEAE), at least one TEAE of special interest, at least one serious TEAE, at least one TEAE leading to dose modification, at least one TEAE leading to discontinuation up to week 48 | Analysis was conducted on the FAS. | Posted | | Number | | Number of participants | | From week 24 until week 48 | | | | ID | Title | Description |
|---|
| OG000 | Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG001 | Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG002 | Phase 2 Arm B: Participants With Low Disease Activity | Participants who did not achieve sustained clinical remission at Week 20 and Week 24 but achieve low disease activity (DAS 28-ESR ≤ 3.2) at Week 24 continued with initial treatment of tocilizumab as a single fixed dose monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. |
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| Secondary | Immunogenicity: Number of Patients With Anti-tocilizumab Antibodies up to Week 24 | Number of patients resulting positive to anti-tocilizumab antibodies test are reported. | Analysis was conducted on the FAS. | Posted | | Number | | Number of participants | | From baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: Tocilizumab Monotherapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks. | | OG001 | Phase 1: Combination Therapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks. |
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| Secondary | Immunogenicity: Number of Patients With Anti-tocilizumab Antibodies up to Week 48 | Number of patients resulting positive to anti-tocilizumab antibodies test are reported. | Analysis was conducted on the FAS. | Posted | | Number | | Number of participants | | From week 24 until week 48 | | | | ID | Title | Description |
|---|
| OG000 | Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG001 | Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG002 | Phase 2 Arm B: Participants With Low Disease Activity | Participants who did not achieve sustained clinical remission at Week 20 and Week 24 but achieve low disease activity (DAS 28-ESR ≤ 3.2) at Week 24 continued with initial treatment of tocilizumab as a single fixed dose monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. |
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| Secondary | Immunogenicity: TCZ Levels up to Week 24 | Mean concentrations of TCZ in patients' blood are reported. | Analysis was conducted on the FAS. | Posted | | Mean | Standard Deviation | mcg/ml | | From baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: Tocilizumab Monotherapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks. | | OG001 | Phase 1: Combination Therapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks. |
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| Secondary | Immunogenicity: TCZ Levels at Week 36 and Early Withdrawal Visit | Mean concentrations of TCZ in patients' blood are reported. | Analysis was conducted on the FAS. | Posted | | Mean | Standard Deviation | mcg/ml | | week 36 and early withdrawal visit | | | | ID | Title | Description |
|---|
| OG000 | Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG001 | Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG002 | Phase 2 Arm B: Participants With Low Disease Activity | Participants who did not achieve sustained clinical remission at Week 20 and Week 24 but achieve low disease activity (DAS 28-ESR ≤ 3.2) at Week 24 continued with initial treatment of tocilizumab as a single fixed dose monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. Participants who achieved moderate EULAR response at Week 24 continued in the study with initial treatment as per investigator's judgement. |
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| Secondary | Immunogenicity: SIL-6R Levels up to Week 24 | Mean concentration of SIL-6R in patients' blood are reported. | Analysis was conducted on the FAS. | Posted | | Mean | Standard Deviation | mcg/ml | | From baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: Tocilizumab Monotherapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks. | | OG001 | Phase 1: Combination Therapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks. |
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| Secondary | Immunogenicity: SIL-6R Levels at Week 36 and Early Withdrawal Visit | Mean concentration of SIL-6R in patients' blood are reported. | Analysis was conducted on the FAS. | Posted | | Mean | Standard Deviation | mcg/ml | | Baseline, Week 36 and Early Withdrawal Visit | | | | ID | Title | Description |
|---|
| OG000 | Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG001 | Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG002 | Phase 2 Arm B: Participants With Low Disease Activity | Participants who did not achieve sustained clinical remission at Week 20 and Week 24 but achieve low disease activity (DAS 28-ESR ≤ 3.2) at Week 24 continued with initial treatment of tocilizumab as a single fixed dose monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. |
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| Secondary | Patient Global Assessment of Disease Activity Visual Analogue Scale (VAS) up to Week 24 | This patient reported outcome assessment represents the patient's overall assessment of their current disease activity on a 100 mm horizontal VAS. The extreme left end of the line should be described as "no disease activity" (symptom-free and no arthritis symptoms) and the extreme right end as "maximum disease activity" (maximum arthritis disease activity). The line was marked by the participant and the distance from the left edge was recorded and the mean values are reported. | Analysis was conducted on the FAS. | Posted | | Mean | Standard Deviation | Millimeters | | From baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: Tocilizumab Monotherapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks. | | OG001 | Phase 1: Combination Therapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks. |
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| Secondary | Patient Global Assessment of Disease Activity Visual Analogue Scale (VAS) up to Week 48 | This patient reported outcome assessment represents the patient's overall assessment of their current disease activity on a 100 mm horizontal VAS. The extreme left end of the line should be described as "no disease activity" (symptom-free and no arthritis symptoms) and the extreme right end as "maximum disease activity" (maximum arthritis disease activity). The line was marked by the participant and the distance from the left edge was recorded and the mean values are reported. | Analysis was conducted on the FAS. | Posted | | Mean | Standard Deviation | Millimeters | | Baseline, from week 28 until week 48 | | | | ID | Title | Description |
|---|
| OG000 | Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG001 | Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. |
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| Secondary | Assessment of Pain Reported by the Patient (VAS) Until Week 24 | This patient reported outcome assessment represents the patient's assessment of his/her current level of pain on a 100 mm horizontal VAS. The extreme left end of the line should be described as "no pain" and the extreme right end as "unbearable pain". | Analysis was conducted on the FAS. | Posted | | Mean | Standard Deviation | Millimeters | | From baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: Tocilizumab Monotherapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks. | | OG001 | Phase 1: Combination Therapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks. |
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| Secondary | Assessment of Pain Reported by the Patient (VAS) Until Week 48 | This patient reported outcome assessment represents the patient's assessment of his/her current level of pain on a 100 mm horizontal VAS. The extreme left end of the line should be described as "no pain" and the extreme right end as "unbearable pain". | Analysis was conducted on the FAS. | Posted | | Mean | Standard Deviation | Millimeters | | Baseline, from week 28 until week 48 | | | | ID | Title | Description |
|---|
| OG000 | Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG001 | Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. |
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| Secondary | Health Assessment Questionnaire-Disability Index (HAQ-DI) up to Week 24 | The Stanford HAQ-DI is a patient-oriented outcome assessment questionnaire specific for RA. It consists of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. | Analysis was conducted on the FAS. | Posted | | Mean | Standard Deviation | HAQ-DI score | | From baseline to Week 24 | | | | ID | Title | Description |
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| OG000 | Phase 1: Tocilizumab Monotherapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks. | | OG001 | Phase 1: Combination Therapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks. |
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| Secondary | Health Assessment Questionnaire-Disability Index (HAQ-DI) up to Week 48 | The Stanford HAQ-DI is a patient-oriented outcome assessment questionnaire specific for RA. It consists of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. | Analysis was conducted on the FAS. | Posted | | Mean | Standard Deviation | HAQ-DI score | | Baseline, from week 28 until week 48 | | | | ID | Title | Description |
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| OG000 | Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG001 | Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. |
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| Secondary | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) up to Week 24 | The symptom-specific measure FACIT-F assesses chronic illness therapy with special emphasis on fatigue in the past 7 days and consists of 5 dimensions: 1) physical well- being, 2) social/family well-being, 3) emotional well-being, 4) functional well-being, and 5) additional concerns. Each of the questions is categorically answered using the scales 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much for a total possible FACIT-F score of 0 to 160. The figures are reversed during score calculations, so that higher score values indicate more favorable conditions. | Analysis was conducted on the FAS | Posted | | Mean | Standard Deviation | FACIT-F score | | From baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Phase 1: Tocilizumab Monotherapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection as a single fixed dose monotherapy once a week for 24 weeks. | | OG001 | Phase 1: Combination Therapy | Participants received Tocilizumab (TCZ), 162mg, by sub-cutaneous injection in combination with oral or sub-cutaneous methotrexate (MTX) or other non-biologic Disease Modifying Anti Rheumatic Drugs (nbDMARDs) once a week for 24 weeks. |
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| Secondary | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) up to Week 48 | The symptom-specific measure FACIT-F assesses chronic illness therapy with special emphasis on fatigue in the past 7 days and consists of 5 dimensions: 1) physical well- being, 2) social/family well-being, 3) emotional well-being, 4) functional well-being, and 5) additional concerns. Each of the questions is categorically answered using the scales 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much for a total possible FACIT-F score of 0 to 160. The figures are reversed during score calculations, so that higher score values indicate more favorable conditions. | Analysis was conducted on the FAS. | Posted | | Mean | Standard Deviation | FACIT-F score | | Baseline, from week 28 until week 48 | | | | ID | Title | Description |
|---|
| OG000 | Phase 2 Arm A1: TCZ +/- nbDMARD Once Per Week (qw) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 were randomized to tocilizumab given every week monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. | | OG001 | Phase 2 Arm A2: TCZ +/- nbDMARD Every Two Weeks (q2w) | Participants who achieve sustained clinical remission (DAS28-ESR <2.6) at Week 20 and Week 24 in Part 1 will be randomized to tocilizumab given every 2 weeks monotherapy or in combination with methotrexate or other non-biologics DMARDs from Week 24 to Week 48. |
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