| Primary | Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18 | 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, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI) | Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI). | Posted | | Number | | percentage of subjects | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | | OG002 | Placebo + Methotrexate | Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00065.2
- OG00167.1
- OG00244.9
|
|
| |
| Secondary | Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 16 in All Patients | 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, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI) | Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis | Posted | | Number | | percentage of subjects | | Baseline, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Run-in Overall | Overall includes all 333 subjects that entered the Run-in period of the study |
| |
| Secondary | Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 16 in All Patients | 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, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI) | Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis | Posted | | Number | | percentage of subjects | | Baseline, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Run-in Overall | Overall includes all 333 subjects that entered the Run-in period of the study |
| |
| Secondary | Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 16 in All Patients | 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, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI) | Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis | Posted | | Number | | percentage of subjects | | Baseline, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Run-in Overall | Overall includes all 333 subjects that entered the Run-in period of the study |
| |
| Secondary | Change From Baseline in DAS28 (Disease Activity Score-28 Items) at Week 16 in All Patients | DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. < 2.6 Remission, > = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High | Of the 333 subjects in the Run-in period, 325 are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Run-in Overall | Overall includes all 333 subjects that entered the Run-in period of the study |
| |
| Secondary | Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 16 in All Patients | 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 Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. <= 3.3 Remission, > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High | Of the 333 subjects in the Run-in period, 326 are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Run-in Overall | Overall includes all 333 subjects that entered the Run-in period of the study |
| |
| Secondary | Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 16 in All Patients | CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. | Of the 333 subjects in the Run-in period, 328 are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Run-in Overall | Overall includes all 333 subjects that entered the Run-in period of the study |
| |
| Secondary | DAS28 (Disease Activity Score-28 Items) Remission (DAS28 <2.6) at Week 16 in All Patients | DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI). < 2.6 (Remission), > = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High | Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis | Posted | | Number | | percentage of subjects | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Run-in Overall | Overall includes all 333 subjects that entered the Run-in period of the study |
| |
| Secondary | SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Week 16 in All Patients | 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 Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI). <= 3.3 (Remission), > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High | Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis | Posted | | Number | | percentage of subjects | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Run-in Overall | Overall includes all 333 subjects that entered the Run-in period of the study |
| |
| Secondary | CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Week 16 in All Patients | CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI). The range for the CDAI is 0 - 76 with a lower CDAI score indicating approvement in activity and a higher score indicating a decline activity. | Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis | Posted | | Number | | percentage of subjects | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Run-in Overall | Overall includes all 333 subjects that entered the Run-in period of the study |
| |
| Secondary | Ratio From Baseline in CRP (C-reactive Protein) Level at Week 16 in All Patients | Ratio is defined as the CRP value at Week 16 divided by the CRP value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. | Of the 333 subjects in the Run-in period, 330 are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | Baseline, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Run-in Overall | Overall includes all 333 subjects that entered the Run-in period of the study |
| |
| Secondary | Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) Score at Week 16 in All Patients | 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). Thus, the mean also has a range from 0-3. Change from baseline is computed as the value at Week 16 minus the 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 333 subjects in the Run-in period, 330 are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Run-in Overall | Overall includes all 333 subjects that entered the Run-in period of the study |
| |
| Secondary | Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 34 in Patients Randomized at Week 18 | 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, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI) | Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI). | Posted | | Number | | percentage of subjects | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | |
|
| Secondary | Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 34 in Patients Randomized at Week 18 | 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, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI) | Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI). | Posted | | Number | | percentage of subjects | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | |
|
| Secondary | Change From Baseline in DAS28 (Disease Activity Score-28 Items) at Week 34 in Patients Randomized at Week 18 | DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward. < 2.6 Remission, > = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High | Of the 208 subjects in the Full Analysis Set (FAS) 204 subjects (69 400 mg CZP, 68 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate |
|
| Secondary | Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 34 in Patients Randomized at Week 18 | 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 Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. <= 3.3 Remission, > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High | Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate |
|
| Secondary | Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 34 in Patients Randomized at Week 18 | CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. Range for CDAI is 0-76 with a lower CDAI score reflects approvement in activity and a higher score reflects a decline. | Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate |
|
| Secondary | DAS28 (Disease Activity Score-28 Items) Remission (DAS28 <2.6) at Week 34 in Patients Randomized at Week 18 | DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI). < 2.6 (Remission), > = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High | Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI). | Posted | | Number | | percentage of subjects | | Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | |
|
| Secondary | SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Week 34 in Patients Randomized at Week 18 | 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 Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI). <= 3.3 (Remission), > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High | Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI). | Posted | | Number | | percentage of subjects | | Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | | OG002 |
|
| Secondary | CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Week 34 in Patients Randomized at Week 18 | CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI). The range for the CDAI is 0 - 76 with a lower CDAI score indicating approvement in activity and a higher score indicating a decline activity. | Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI). | Posted | | Number | | percentage of subjects | | Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | | OG002 |
|
| Secondary | Ratio From Baseline in CRP (C-reactive Protein) Level at Week 34 in Patients Randomized at Week 18 | Ratio is defined as the CRP value at Week 34 divided by the CRP value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method with an ANCOVA model on observed log transformed data with factors treatment and log transformed Baseline CRP level. The number presented is the geometric least squares mean with it's 95% confidence interval. | Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | 95% Confidence Interval | Ratio | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | | OG002 | Placebo + Methotrexate | |
|
| Secondary | Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) Score at Week 34 in Patients Randomized at Week 18 | 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). Thus, the mean also has a range from 0-3. Change from baseline is computed as the value at Week 34 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. | Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate |
|
| Secondary | Change From Baseline in Fatigue Assessment Scale (FAS) at Week 34 in Patients Randomized at Week 18 | Change from Baseline in Fatigue Assessment scale (0 to 10, 0 is "No Fatigue" and 10 is "Fatigue as bad as you can imagine") is computed as the value at Week 34 minus the Baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. | Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | | OG002 | Placebo + Methotrexate |
|
| Secondary | Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 | There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. | Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | | OG002 |
|
| Secondary | Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 | There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. | Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | | OG002 |
|
| Secondary | Change From Baseline in Bodily Pain (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 | There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. | Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | | OG002 |
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| Secondary | Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 | There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. | Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | | OG002 |
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| Secondary | Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 | There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. | Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | | OG002 |
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| Secondary | Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 | There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. | Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | | OG002 |
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| Secondary | Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 | There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. | Of the 208 subjects in the Full Analysis Set (FAS) 204 subjects (67 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | | OG002 |
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| Secondary | Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 | There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. | Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | | OG002 |
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| Secondary | Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Week 34 in Patients Randomized at Week 18 | PCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from 1 to 81, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. | Of the 208 subjects in the Full Analysis Set (FAS) 202 subjects (66 400 mg CZP, 68 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | |
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| Secondary | Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Week 34 in Patients Randomized at Week 18 | MCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from -9 to 82, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. | Of the 208 subjects in the Full Analysis Set (FAS) 202 subjects (66 400 mg CZP, 68 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | |
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| Secondary | Change From Baseline in PAAP (Patient's Assessment of Arthritis Pain) at Week 34 in Patients Randomized at Week 18 | Change from Baseline in Patient's Assessment of Arthritis Pain-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 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. | Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | | OG002 | Placebo + Methotrexate |
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| Secondary | Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Week 34 in Patients Randomized at Week 18 | Change from Baseline in Patient's Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. | Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | | OG002 |
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| Secondary | Median Time to Loss of ACR20 (American College of Rheumatology 20% Improvement) Response After Week 18 in Patients Randomized at Week 18. | ACR20 loss are subjects with <20% improvement from Baseline for tender joint count, swollen joint count, and at least 3/5 core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein, 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale at 2 consecutive visits. Subjects losing response for 2 consecutive visits are considered as having the event on the day of the visit where response was first lost. | Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis. | Posted | | Median | Inter-Quartile Range | days | | Week 18 up to Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate |
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| Other Pre-specified | Ratio From Baseline in ESR (Erythrocyte Sedimentation Rate) Level at Week 16 in All Patients | Ratio is defined as the ESR value at Week 16 divided by the ESR value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. | Of the 333 subjects in the Run-in period, 328 are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | Baseline, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Run-in Overall | Overall includes all 333 subjects that entered the Run-in period of the study |
| |
| Other Pre-specified | Ratio From Baseline in ESR (Erythrocyte Sedimentation Rate) Level at Week 34 in Patients Randomized at Week 18 | Ratio is defined as the ESR value at Week 34 divided by the ESR value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method with an ANCOVA model on observed log transformed data with factors treatment and log transformed Baseline CRP level. The number presented is the geometric least squares mean with it's 95% confidence interval. | Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (69 400 mg CZP, 68 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | 95% Confidence Interval | Ratio | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | | OG002 | Placebo + Methotrexate |
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| Other Pre-specified | Change From Baseline in PhGADA (Physician's Global Assessment of Disease Activity) at Week 34 in Patients Randomized at Week 18 | Change from Baseline in Physician's Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. | Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | | OG002 |
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| Other Pre-specified | Change From Baseline in TJC (Tender Joint Count) at Week 34 in Patients Randomized at Week 18 | Change from Baseline in Tender Joint Count is computed as the value at Week 34 minus the Baseline value (28 joints were assessed at each visit). A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. | Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | Joints | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | | OG002 | Placebo + Methotrexate | |
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| Other Pre-specified | Change From Baseline in SJC (Swollen Joint Count) at Week 34 in Patients Randomized at Week 18 | Change from Baseline in Swollen Joint Count is computed as the value at Week 34 minus the Baseline value (28 joints were assessed at each visit). A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. | Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | Joints | | Baseline, Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 400 mg and Placebo + Methotrexate | 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate | | OG001 | Certolizumab Pegol 200 mg and Placebo + Methotrexate | 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate | | OG002 | Placebo + Methotrexate | |
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