| Primary | American College of Rheumatology 20% (ACR20) Response at Week 12 | ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) | All 1063 subjects (851 CZP, 212 Placebo) included in the Full Analysis Set (FAS) are included in this analysis | Posted | | Number | | percentage of subjects | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Secondary | American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Concomitant Methotrexate (MTX) Use. | ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) | Of the 1063 subjects in the Full Analysis Set (FAS), 732 were in the concomitant methotrexate use stratum (589 CZP, 143 Placebo) and are included in this analysis. | Posted | | Number | | percentage of subjects | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
|
| Secondary | American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Concomitant Methotrexate (MTX) Use. | ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) | Of the 1063 subjects in the Full Analysis Set (FAS), 331 were in the no concomitant methotrexate use stratum (262 CZP, 69 Placebo) and are included in this analysis. | Posted | | Number | | percentage of subjects | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
|
| Secondary | American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Prior Anti-tumor Necrosis (Anti-TNF) Use | ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) | Of the 1063 subjects in the Full Analysis Set (FAS), 400 were in the prior anti-tumor necrosis (anti-TNF) use stratum (320 CZP, 80 Placebo) and are included in this analysis. | Posted | | Number | | percentage of subjects | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
|
| Secondary | American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Prior Anti-tumor Necrosis (Anti-TNF) Use | ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) | Of the 1063 subjects in the Full Analysis Set (FAS), 663 were in the no prior anti-tumor necrosis (anti-TNF) use stratum (531 CZP, 132 Placebo) and are included in this analysis. | Posted | | Number | | percentage of subjects | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
|
| Secondary | American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration < 2 Years | ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) | Of the 1063 subjects in the Full Analysis Set (FAS), 256 were in the disease duration less than 2 years stratum (206 CZP, 50 Placebo) and are included in this analysis. | Posted | | Number | | percentage of subjects | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
|
| Secondary | American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration ≥ 2 Years. | ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) | Of the 1063 subjects in the Full Analysis Set (FAS), 807 were in the disease duration greater than or equal to 2 years stratum (645 CZP, 162 Placebo) and are included in this analysis. | Posted | | Number | | percentage of subjects | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
|
| Secondary | American College of Rheumatology 50% (ACR50) Response at Week 12 | ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) | All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis. | Posted | Mar 2012 | Number | | percentage of subjects | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
|
| Secondary | American College of Rheumatology 70% (ACR70) Response at Week 12. | ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) | All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis. | Posted | Mar 2012 | Number | | percentage of subjects | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
|
| Secondary | Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 12 | DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. | Of the 1063 subjects in the Full Analysis Set (FAS) 1037(834 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | Mar 2012 | Mean | Standard Deviation | units on a scale | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
|
| Secondary | Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12 | SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. | Of the 1063 subjects in the Full Analysis Set (FAS) 1024 (824 CZP, 200 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | Mar 2012 | Mean | Standard Deviation | units on a scale | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
|
| Secondary | Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12 | CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. | Of the 1063 subjects in the Full Analysis Set (FAS) 1024 (824 CZP, 200 Placebo) are included in this analysis. | Posted | Mar 2012 | Mean | Standard Deviation | units on a scale | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
|
| Secondary | DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 12 | DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. | All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis. | Posted | Mar 2012 | Number | | percentage of subjects | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 12 | SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. | All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis. | Posted | Mar 2012 | Number | | percentage of subjects | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 12 | CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. | All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis. | Posted | Mar 2012 | Number | | percentage of subjects | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | Change From Baseline in Tender Joint Count (TJC) at Week 12 | TJC is calculated based on tenderness response of 28 joints. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. | Of the 1063 subjects in the Full Analysis Set (FAS) 1043 (838 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | Mar 2012 | Mean | Standard Deviation | units on a scale | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | Change From Baseline in Swollen Joint Count (SJC) at Week 12 | SJC is calculated based on swelling response of 28 joints. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. | Of the 1063 subjects in the Full Analysis Set (FAS) 1043 (838 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | Mar 2012 | Mean | Standard Deviation | units on a scale | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12 | HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. | Of the 1063 subjects in the Full Analysis Set (FAS) 1029 (826 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | Mar 2012 | Mean | Standard Deviation | units on a scale | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
|
| Secondary | Change From Baseline in C-reactive Protein (CRP) at Week 12 | Change from baseline in CRP (mg/L) is computed as the ratio of Week 12 value divided by baseline value. A ratio less then 1 indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. | Of the 1063 subjects in the Full Analysis Set (FAS) 1046 (841 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | Mar 2012 | Geometric Mean | Geometric Coefficient of Variation | mg/L | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 12 | Change from Baseline in PAAP-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. | Of the 1063 subjects in the Full Analysis Set (FAS) 1038 (835 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | Mar 2012 | Mean | Standard Deviation | mm | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | Change From Baseline in Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 12 | Change from Baseline in PtGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. | Of the 1063 subjects in the Full Analysis Set (FAS) 1038 (835 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | Mar 2012 | Mean | Standard Deviation | mm | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | Change From Baseline in Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 12 | Change from Baseline in PhGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. | Of the 1063 subjects in the Full Analysis Set (FAS) 1029 (827 CZP, 202 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | Mar 2012 | Mean | Standard Deviation | mm | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | Time to Sustained American College of Rheumatology 20% (ACR20) Response | The time from randomization to sustained ACR20 response at 2 consecutive visits (at the latest on Week 12). | All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis. | Posted | Mar 2012 | Number | | percentage of subjects | | Baseline up to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | European League Against Rheumatism (EULAR) Response at Week 12 | EULAR response (good response, moderate response, or no response) is defined based on the present value and improvement from baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive protein)]. | All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis. | Posted | Mar 2012 | Number | | percentage of subjects | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol (CZP) | 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. | | OG001 | Placebo | Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | American College of Rheumatology 20% (ACR20) Response at Week 28 | ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation. | Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis | Posted | Mar 2012 | Number | | percentage of subjects | | Baseline, Week 28 | | | | ID | Title | Description |
|---|
| OG000 | Open Label Certolizumab Pegol (CZP) | Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | American College of Rheumatology 50% (ACR50) Response at Week 28 | ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation. | Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis | Posted | Mar 2012 | Number | | percentage of subjects | | Baseline, Week 28 | | | | ID | Title | Description |
|---|
| OG000 | Open Label Certolizumab Pegol (CZP) | Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | American College of Rheumatology 70% (ACR70) Response at Week 28 | ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation. | Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis | Posted | Mar 2012 | Number | | percentage of subjects | | Baseline, Week 28 | | | | ID | Title | Description |
|---|
| OG000 | Open Label Certolizumab Pegol (CZP) | Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 28 | DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. Change from Baseline is computed as the value at Week 28 minus Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM). | Of the 954 subjects in the Open Label Set (OLS) 840 had observed values at Week 28 and Baseline and are included in this analysis. | Posted | Mar 2012 | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 28 | | | | ID | Title | Description |
|---|
| OG000 | Open Label Certolizumab Pegol (CZP) | Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 28 | SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from Baseline is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM). | Of the 954 subjects in the Open Label Set (OLS) 828 had observed values at Week 28 and Baseline and are included in this analysis. | Posted | Mar 2012 | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 28 | | | | ID | Title | Description |
|---|
| OG000 | Open Label Certolizumab Pegol (CZP) | Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 28 | CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from Baseline is computed as value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM). | Of the 954 subjects in the Open Label Set (OLS) 840 had observed values at Week 28 and Baseline and are included in this analysis. | Posted | Mar 2012 | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 28 | | | | ID | Title | Description |
|---|
| OG000 | Open Label Certolizumab Pegol (CZP) | Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 28 | DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. This analysis was carried out using imputation. | Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis | Posted | Mar 2012 | Number | | percentage of subjects | | Week 28 | | | | ID | Title | Description |
|---|
| OG000 | Open Label Certolizumab Pegol (CZP) | Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 28 | SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. This analysis was carried out using imputation. | Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis | Posted | Mar 2012 | Number | | percentage of subjects | | Week 28 | | | | ID | Title | Description |
|---|
| OG000 | Open Label Certolizumab Pegol (CZP) | Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 28 | CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. This analysis was carried out using imputation. | Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis | Posted | Mar 2012 | Number | | percentage of subjects | | Week 28 | | | | ID | Title | Description |
|---|
| OG000 | Open Label Certolizumab Pegol (CZP) | Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | Change From Baseline in Tender Joint Count (TJC) at Week 28 | TJC is calculated based on tenderness response of 28 joints. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness. Change from Baseline is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM). | Of the 954 subjects in the Open Label Set (OLS) 861 had observed values at Week 28 and Baseline and are included in this analysis. | Posted | Mar 2012 | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 28 | | | | ID | Title | Description |
|---|
| OG000 | Open Label Certolizumab Pegol (CZP) | Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | Change From Baseline in Swollen Joint Count (SJC) at Week 28 | SJC is calculated based on swelling response of 28 joints. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling. Change from baseline is computed as the value at Week 28 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM). | Of the 954 subjects in the Open Label Set (OLS) 861 had observed values at Week 28 and Baseline and are included in this analysis. | Posted | Mar 2012 | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 28 | | | | ID | Title | Description |
|---|
| OG000 | Open Label Certolizumab Pegol (CZP) | Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 28 | HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from baseline is computed as the value at Week 28 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM). | Of the 954 subjects in the Open Label Set (OLS) 854 had observed values at Week 28 and Baseline and are included in this analysis | Posted | Mar 2012 | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 28 | | | | ID | Title | Description |
|---|
| OG000 | Open Label Certolizumab Pegol (CZP) | Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | Change From Baseline in C-reactive Protein (CRP) at Week 28 | Change from Baseline in CRP (mg/L) is computed as the ratio of the value at Week 28 divided by Baseline value. A ratio less then 1 indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM). | Of the 954 subjects in the Open Label Set (OLS) 851 had observed values at Week 28 and Baseline and are included in this analysis | Posted | Mar 2012 | Least Squares Mean | 95% Confidence Interval | mg/L | | Baseline, Week 28 | | | | ID | Title | Description |
|---|
| OG000 | Open Label Certolizumab Pegol (CZP) | Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 28 | Change from Baseline in PAAP-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM). | Of the 954 subjects in the Open Label Set (OLS) 856 had observed values at Week 28 and Baseline and are included in this analysis | Posted | Mar 2012 | Least Squares Mean | Standard Error | mm | | Baseline, Week 28 | | | | ID | Title | Description |
|---|
| OG000 | Open Label Certolizumab Pegol (CZP) | Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | Change From Baseline in Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 28 | Change from Baseline in PtGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM). | Of the 954 subjects in the Open Label Set (OLS) 857 had observed values at Week 28 and Baseline and are included in this analysis | Posted | Mar 2012 | Least Squares Mean | Standard Error | mm | | Baseline, Week 28 | | | | ID | Title | Description |
|---|
| OG000 | Open Label Certolizumab Pegol (CZP) | Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |
| Secondary | Change From Baseline in Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 28 | Change from Baseline in PhGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM). | Of the 954 subjects in the Open Label Set (OLS) 848 had observed values at Week 28 and Baseline and are included in this analysis | Posted | Mar 2012 | Least Squares Mean | Standard Error | mm | | Baseline, Week 28 | | | | ID | Title | Description |
|---|
| OG000 | Open Label Certolizumab Pegol (CZP) | Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available. |
| |