| Primary | Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24 | 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 (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI) | All 194 subjects in the Full Analysis Set (FAS) are included in this analysis. | Posted | | Number | | percentage of subjects | | Week 20 and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Secondary | 28-joint Count Disease Activity Score (DAS28-ESR) Remission (<2.6) at Both Week 20 and Week 24 | 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 (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Patient 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) | Since imputation was used, all 194 subjects are included in the analysis | Posted | | Number | | percentage of subjects | | Week 20 and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Secondary | Simplified Disease Activity Index (SDAI) Remission (≤3.3) at Both Week 20 and Week 24 | 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 (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI) | Since imputation was used, all 194 subjects are included in the analysis | Posted | | Number | | percentage of subjects | | Week 20 and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Secondary | Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Clinical Disease Activity Index (CDAI) Scores at 2 Consecutive Visits | 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 (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Patients losing remission (CDAI >2.8) for two consecutive visits will be considered as having the event on the day of the visit where remission was first lost. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1. | All 194 subjects in the Full Analysis Set (FAS) are included in this analysis. | Posted | | Mean | Standard Deviation | days | | Week 24 up to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Secondary | Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Simplified Disease Activity Index (SDAI) Scores at 2 Consecutive Visits | SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm) and Physician's Global Assessment of Disease Activity (PhGADA-VAS in cm). 28 joints are examined. A lower score indicates less disease activity. Patients losing remission (SDAI >3.3) for two consecutive visits will be considered as having the event on the day of the visit where remission was first lost. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1. | All 194 subjects in the Full Analysis Set (FAS) are included in this analysis. | Posted | | Mean | Standard Deviation | days | | Week 24 up to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Secondary | Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using DAS28-ESR Scores at 2 Consecutive Visits | DAS28-ESR is calculated using tender joint count (TJC), swollen joint count (SJC), erythrocyte sedimentation rate (ESR mm/hour) and Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS mm). 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat(ESR) + 0.014xPtGADA-VAS. 28 joints are examined. Lower score indicates less disease activity. Patients losing remission (DAS28-ESR≥2.6) for two consecutive visits will be considered as having the event on the first of the two visits. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1. | All 194 subjects in the Full Analysis Set (FAS) are included in this analysis. | Posted | | Mean | Standard Deviation | Days | | Week 24 up to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Secondary | American College of Rheumatology 20% (ACR20) Response at Week 24 | 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 imputation was used, all 194 subjects are included in the analysis | Posted | | Number | | percentage of subjects | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Secondary | American College of Rheumatology 50% (ACR50) Response at Week 24 | 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 imputation was used, all 194 subjects are included in the analysis | Posted | | Number | | percentage of subjects | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Secondary | American College of Rheumatology 70% (ACR70) Response at Week 24 | 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 imputation was used, all 194 subjects are included in the analysis | Posted | | Number | | percentage of subjects | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Secondary | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 | 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 24 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 194 subjects, 182 (91 CZP, 91 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Secondary | Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Scores at Week 24 | 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. | Of the 194 subjects in the Full Analysis Set (FAS), 164 (82 CZP, 82 Placebo) had values at Baseline and Week 24 and are included in this analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Secondary | Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Component Summary (MCS) Scores at Week 24 | 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 | Of the 194 subjects in the Full Analysis Set (FAS), 164 (82 CZP, 82 Placebo) had values at Baseline and Week 24 and are included in this analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Secondary | Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Functioning Domain at Week 24 | 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 | Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Secondary | Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Physical Domain at Week 24 | 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 | Of the 194 subjects in the Full Analysis Set (FAS), 167 (83 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Secondary | Change From Baseline in Short Form 36-items Health Survey (SF-36) Bodily Pain Domain at Week 24 | 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 | Of the 194 subjects in the Full Analysis Set (FAS), 167 (83 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Secondary | Change From Baseline in Short Form 36-items Health Survey (SF-36) General Health Domain at Week 24 | 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 | Of the 194 subjects in the Full Analysis Set (FAS), 166 (82 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Secondary | Change From Baseline in Short Form 36-items Health Survey (SF-36) Vitality Domain at Week 24 | 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 | Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Secondary | Change From Baseline in Short Form 36-items Health Survey (SF-36) Social Functioning Domain at Week 24 | 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 | Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Secondary | Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Emotional Domain at Week 24 | 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 | Of the 194 subjects in the Full Analysis Set (FAS), 166 (83 CZP, 83 Placebo) had values at Baseline and Week 24 and are included in this analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Secondary | Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Health Domain at Week 24 | 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 | Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Secondary | Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (VAS) at Week 24 | 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 24 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 194 subjects, 162 (81 CZP, 81 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method | Posted | | Mean | Standard Deviation | mm | | Baseline, Week 24 | | | | ID | Title | Description |
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| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Secondary | Change From Baseline in Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS) at Week 24 | 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 24 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 194 subjects, 183 (92 CZP, 91 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method | Posted | | Mean | Standard Deviation | mm | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Secondary | Change From Baseline in Fatigue Assessment Scale at Week 24 | 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 24 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 194 subjects, 180 (90 CZP, 90 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Other Pre-specified | Time From Stopping Treatment (Week 24) to First Flare (up to Week 52) Using Clinical Disease Activity Index (CDAI) at 2 Consecutive Visits | Subjects having a flare (CDAI ≥11) between Week 24 and Week 52 for two consecutive visits will be considered as having the event on the day of the visit where flare first appeared. | All 194 subjects in the Full Analysis Set (FAS) are included in this analysis. An ad-hoc analysis has been performed on the Week 24 Responder Set (W24RS) which showed similar results. | Posted | | Mean | Standard Error | days | | From Week 24 up to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Other Pre-specified | Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Activity States at Week 24 | The number representing the association is the Kappa Correlation Coefficient for CDAI/SDAI for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA). | Of the 194 subjects in the Full Analysis Set (FAS) 143 (76 CZP, 67 Placebo) had measures for both CDAI and SDAI at Week 24 and are included in this analysis. | Posted | | Number | 95% Confidence Interval | Kappa Correlation Coefficient | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Other Pre-specified | Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Activity States at Week 24 | The number representing the association is the Kappa Correlation Coefficient for CDAI/DAS28-ESR for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA). | Of the 194 subjects in the Full Analysis Set (FAS) 148 (79 CZP, 69 Placebo) had measures for both CDAI and DAS28-ESR at Week 24 and are included in this analysis. | Posted | | Number | 95% Confidence Interval | Kappa Correlation Coefficient | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Other Pre-specified | Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Activity States at Week 24 | The number representing the association is the Kappa Correlation Coefficient for DAS28-ESR/SDAI for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA). | Of the 194 subjects in the Full Analysis Set (FAS) 142 (76 CZP, 66 Placebo) had measures for both DAS28-ESR and SDAI at Week 24 and are included in this analysis. | Posted | | Number | 95% Confidence Interval | Kappa Correlation Coefficient | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Other Pre-specified | Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Remission at Week 24 | The number representing the association is the Kappa Correlation Coefficient for CDAI/SDAI remission. | Of the 194 subjects in the Full Analysis Set (FAS) 143 (76 CZP, 67 Placebo) had measures for both CDAI and SDAI at Week 24 and are included in this analysis. | Posted | | Number | 95% Confidence Interval | Kappa Correlation Coefficient | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Other Pre-specified | Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Remission at Week 24 | The number representing the association is the Kappa Correlation Coefficient for CDAI/DAS28-ESR remission | Of the 194 subjects in the Full Analysis Set (FAS) 148 (79 CZP, 69 Placebo) had measures for both CDAI and DAS28-ESR at Week 24 and are included in this analysis. | Posted | | Number | 95% Confidence Interval | Kappa Correlation Coefficient | | Week 24 | | | | ID | Title | Description |
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| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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| Other Pre-specified | Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Remission at Week 24 | The number representing the association is the Kappa Correlation Coefficient for DAS28-ESR/SDAI remission. | Of the 194 subjects in the Full Analysis Set (FAS) 142 (76 CZP, 66 Placebo) had measures for both DAS28-ESR and SDAI at Week 24 and are included in this analysis. | Posted | | Number | 95% Confidence Interval | Kappa Correlation Coefficient | | Week 24 | | | | ID | Title | Description |
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| OG000 | Certolizumab Pegol 200 mg (CDP870) | Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | | OG001 | Placebo | Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) |
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