| Primary | Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2 Without Flaring | This Outcome Measure includes all subjects that have a DAS28 [ESR] <= 3.2 from the start of RA0055 Period 2 (Week 52 of RA0055 Period 1) to Week 104 in RA0055 Period 2 without flaring. | FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2 | Posted | | Number | | percentage of subjects | | Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 | | OG002 | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2 |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00039.2
- OG00153.2
- OG00248.8
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in a hierarchical order beginning with the CZP standard maintenance dosing (200 mg Q2W) + MTX group vs the CZP stopped dosing (PBO) + MTX group. If this analysis was statistically significant at the alpha =0.05 level, then an additional comparison of the CZP reduced frequency dosing (200 mg Q4W) + MTX group vs the CZP stopped dosing + MTX group was performed with testing at the alpha =0.05 level | Regression, Logistic | | =0.112 | | Odds Ratio (OR) | 1.719 | | | 2-Sided | 95 | 0.881 | 3.354 | | | | | Superiority or Other | |
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| Secondary | Percentage of Subjects With Disease Activity Score 28 [ESR] (DAS28 [ESR]) < 2.6 at Week 52 in Previous Study RA0055 Period 1 Who Maintain a DAS28 [ESR] < 2.6 From Week 52 in RA0055 Period 1 Through Week 104 in RA0055 Period 2 Without Flaring | 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 PtGADA, where 28 joints are examined and a lower score indicates less disease activity. | Full Analysis Set Period 2 (FAS2) with Non-Responder Imputation (NRI). FAS2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses. | Posted | | Number | | percentage of subjects | | From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 |
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| Secondary | Change From Baseline in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2 | Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage. | The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit. RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses. | Posted | | Median | Full Range | units on a scale | | From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Radiographic Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Radiographic Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 | | OG002 |
|
| Secondary | Change From Week 52 in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2 | Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage. | The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit. RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses. | Posted | | Median | Full Range | units on a scale | | From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Radiographic Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Radiographic Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 | | OG002 |
|
| Secondary | Percentage of Subjects With Radiographic Non-progression From Baseline in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2 | Radiographic nonprogression is defined as change in modified Total Sharp Score (mTSS) <= 0.5. Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage. | The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit. RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses. | Posted | | Number | | percentage of subjects | | From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Radiographic Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Radiographic Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 |
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| Secondary | Percentage of Subjects With Radiographic Non-progression From Week 52 in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2 | Radiographic nonprogression is defined as change in modified Total Sharp Score (mTSS) <= 0.5. Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage. | The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit. RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses. | Posted | | Number | | percentage of subjects | | From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Radiographic Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Radiographic Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 |
|
| Secondary | Change From Baseline in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2 | Erosions were assessed in 16 locations per hand and 6 joints per foot. Erosions for each hand location were scored from 0 to 5, with 0 indicating no erosion. Scores 1 to 5 may have included combinations of discrete erosion(s) and/or large erosions. Erosions for each foot joint were scored from 0 to 10, with 0 indicating no erosions. The minimum possible total erosion score for all 32-hand joints was 0, the maximum possible erosion score for all 32-hand joints was 160. The minimum possible total erosion score for all 12-feet joints was 0, the maximum possible erosion score for all 12 feet joints was 120. Thus, the minimum possible total erosion score for hands and feet was 0, the maximum possible total erosion score for hands and feet was 280. Higher values represent greater damage. | The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit. RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses. | Posted | | Median | Full Range | units on a scale | | From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Radiographic Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Radiographic Set) |
|
| Secondary | Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2 | Erosions were assessed in 16 locations per hand and 6 joints per foot. Erosions for each hand location were scored from 0 to 5, with 0 indicating no erosion. Scores 1 to 5 may have included combinations of discrete erosion(s) and/or large erosions. Erosions for each foot joint were scored from 0 to 10, with 0 indicating no erosions. The minimum possible total erosion score for all 32-hand joints was 0, the maximum possible erosion score for all 32-hand joints was 160. The minimum possible total erosion score for all 12-feet joints was 0, the maximum possible erosion score for all 12 feet joints was 120. Thus, the minimum possible total erosion score for hands and feet was 0, the maximum possible total erosion score for hands and feet was 280. Higher values represent greater damage. | The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit. RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses. | Posted | | Median | Full Range | units on a scale | | From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Radiographic Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Radiographic Set) |
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| Secondary | Change From Baseline in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2 | Joint space narrowing (JSN) was assessed in 15 locations per hand and 6 locations per foot. Joint space narrowing for each location was scored from 0 to 4, with 0 indicating no narrowing. The minimum possible score for JSN in all 30 hand joints was 0, the maximum possible score for JSN in all 30 hand joints was 120. The minimum possible score for JSN in all 12 feet joints was 0, the maximum possible score for JSN in all 12 feet joints was 48. Thus, the minimum possible total JSN score for hands and feet was 0, the the maximum possible total JSN score for Hands and feet was 168. Higher values represent greater damage. | The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit. RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses. | Posted | | Median | Full Range | units on a scale | | From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Radiographic Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Radiographic Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 |
|
| Secondary | Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2 | Joint space narrowing (JSN) was assessed in 15 locations per hand and 6 locations per foot. Joint space narrowing for each location was scored from 0 to 4, with 0 indicating no narrowing. The minimum possible score for JSN in all 30 hand joints was 0, the maximum possible score for JSN in all 30 hand joints was 120. The minimum possible score for JSN in all 12 feet joints was 0, the maximum possible score for JSN in all 12 feet joints was 48. Thus, the minimum possible total JSN score for hands and feet was 0, the the maximum possible total JSN score for Hands and feet was 168. Higher values represent greater damage. | The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit. RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses. | Posted | | Median | Full Range | units on a scale | | From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Radiographic Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Radiographic Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 |
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| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 104 in RA0055 Period 2 | The assessments are based on a 20 % or greater improvement from Baseline in previous study RA0055 Period 1 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). | FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2 | Posted | | Number | | percentage of subjects | | From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 |
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| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 104 in RA0055 Period 2 | The assessments are based on a 50 % or greater improvement from Baseline in previous study RA0055 Period 1 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). | FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2 | Posted | | Number | | percentage of subjects | | From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 |
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| Secondary | Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 104 in RA0055 Period 2 | The assessments are based on a 70 % or greater improvement from Baseline in previous study RA0055 Period 1 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). | FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2 | Posted | | Number | | percentage of subjects | | From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 |
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| Secondary | Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria at Week 104 in RA0055 Period 2 | The ACR/EULAR 2011 remission criteria is defined as: Tender Joint Count (TJC) <= 1, Swollen Joint Count (SJC) <= 1, C-Reactive Protein (CRP) <= 1 mg/dl and Patient's Global Assessment of Disease Activity (PtGADA) <= 10 mm. | FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2 | Posted | | Number | | percentage of subjects | | Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 | | OG002 |
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| Secondary | Percentage of Subjects With Clinical Disease Activity Index (CDAI) <= 2.8 at Week 104 in RA0055 Period 2 | 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 mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined where a lower score indicates less disease activity. | FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2 | Posted | | Number | | percentage of subjects | | Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 | |
|
| Secondary | Percentage of Subjects With Simplified Disease Activity Index (SDAI) <= 3.3 at Week 104 in RA0055 Period 2 | SDAI 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 mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity. The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline. | FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2 | Posted | | Number | | percentage of subjects | | Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 |
|
| Secondary | Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) < 2.6 at Week 104 in RA0055 Period 2 | 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 PtGADA, where 28 joints are examined and a lower score indicates less disease activity. | FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2 | Posted | | Number | | percentage of subjects | | Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 |
|
| Secondary | Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice at Week 104 in RA0055 Period 2 | The 2011 ACR/EULAR remission criteria simplified for clinical practice is defined as: Tender Joint Count (TJC) <= 1, Swollen Joint Count (SJC) <= 1 and Patient's Global Assessment of Disease Activity (PtGADA) <= 10 mm. | FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2 | Posted | | Number | | percentage of subjects | | Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 | | OG002 |
|
| Secondary | Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 104 in RA0055 Period 2 | Good response is defined as: DAS28[ESR] <= 3.2 and decrease from Baseline by >1.2; moderate response is defined as achievement of one of the following:
- DAS28[ESR] <= 3.2 and decrease from Baseline > 0.6 and ≤ 1.2
- DAS28[ESR] > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6
- DAS28[ESR] > 5.1 and decrease from Baseline >1.2.
LOCF= Last Observation Carried Forward | FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2 | Posted | | Number | | percentage of subjects | | From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 |
|
| Secondary | Change From Baseline in Previous Study RA0055 Period 1 in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 104 in RA0055 Period 2 | 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 PtGADA, where 28 joints are examined and a lower score indicates less disease activity. DAS28[ESR] ranges from 0-10 with higher values representing higher disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline. | FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2 | Posted | | Mean | Standard Deviation | units on a scale | | From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | |
|
| Secondary | Change From Week 52 in Previous Study RA0055 Period 1 in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 104 in RA0055 Period 2 | 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 PtGADA, where 28 joints are examined and a lower score indicates less disease activity. DAS28[ESR] ranges from 0-10 with higher values representing higher disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline. | FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2 | Posted | | Mean | Standard Deviation | units on a scale | | From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 |
|
| Secondary | Change From Baseline in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2 | 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 mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined. CDAI ranges from 0-76 with lower scores indicating less disease activity and higher scores indicating higher disease activity. A negative value in CDAI change from Baseline indicates an improvement from Baseline. | FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2 | Posted | | Mean | Standard Deviation | units on a scale | | From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 |
|
| Secondary | Change From Week 52 in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2 | 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 mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined. CDAI ranges from 0-76 with lower scores indicating less disease activity and higher scores indicating higher disease activity.A negative value in CDAI change from Baseline indicates an improvement from Baseline. | FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2 | Posted | | Mean | Standard Deviation | units on a scale | | From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 |
|
| Secondary | Change From Baseline in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2 | SDAI 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 mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity. The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline. | FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2 | Posted | | Mean | Standard Deviation | units on a scale | | From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 |
|
| Secondary | Change From Week 52 in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2 | SDAI 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 mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity. The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline. | FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2 | Posted | | Mean | Standard Deviation | units on a scale | | From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 |
|
| Secondary | Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 104 in RA0055 Period 2 | Normative physical function is defined as HAQ-DI score <= 0.5. The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. The total score ranges from 0 to 3 with lower scores meaning lower disability. | FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2 | Posted | | Number | | percentage of subjects | | Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 | | OG002 |
|
| Secondary | Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2 | 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 PtGADA, where 28 joints are examined and a lower score indicates less disease activity. | FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2 | Posted | | Number | | percentage of subjects | | Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 |
|
| Secondary | Time to Flare From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2 | Time to flare, defined as an increase of DAS28[ESR] >= 0.6 above Week 52 DAS28[ESR] level, having a DAS28[ESR] >= 3.2 and judged by the Investigator as due to RA and all three criteria confirmed at an additional visit two weeks thereafter, from Week 52 onwards. Data not available as > 75% of the participants failed to meet flare criteria. | FAS2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses. 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2 | Posted | | Geometric Mean | Geometric Coefficient of Variation | days | | Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 | |
|
| Secondary | Change From Baseline in Previous Study RA0055 Period 1 in the Bristol Rheumatoid Arthritis Fatigue- Multidimensional Questionnaire (BRAF-MDQ) Total Score to Week 104 in RA0055 Period 2 | BRAF-MDQ total score ranges from 0 to 70 (with higher scores indicating worse fatigue), whereas the score for each dimension is different due to the varied number of questions (0 -22 for physical, 0- 21 for living, 0- 15 for cognition, and 0- 12 for emotion). A negative value in BRAF-MDQ change from Baseline indicates an improvement from Baseline. | FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2 | Posted | | Mean | Standard Deviation | units on a scale | | From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 |
|
| Secondary | Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2 | Number of work days missed in the last month for employed subjects. | FAS2 with LOCF. FAS2 did not include subjects who had received PBO + MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2 | Posted | | Mean | Standard Deviation | days | | Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 | | OG002 | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2 |
|
| Secondary | Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2 | Number of work days with reduced productivity in the last month for employed subjects. Only the employed subjects were analyzed. | FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2 | Posted | | Mean | Standard Deviation | days | | Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 | | OG002 | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) | |
|
| Secondary | Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2 | The Arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference) for employed subjects. Only the employed subjects were analyzed. | FAS2 with LOCF. FAS2 did not include subjects who had received PBO + MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2 | Posted | | Mean | Standard Deviation | units on a scale | | Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 | | OG002 | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|
| Secondary | Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2 | Number of days with no household work in the last month. | FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2. | Posted | | Mean | Standard Deviation | days | | Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 | | OG002 | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2 |
|
| Secondary | Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2 | Number of days with reduced household work productivity in the last month. | FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2 | Posted | | Mean | Standard Deviation | days | | Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
|---|
| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 | | OG002 | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2 |
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| Secondary | Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2 | Number of days with hired outside help days in the last month. | FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2 | Posted | | Mean | Standard Deviation | days | | Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
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| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 | | OG002 | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2 |
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| Secondary | Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2 | Number of days missed of family/social/leisure activities in the last month. | FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2 | Posted | | Mean | Standard Deviation | days | | Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
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| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 | | OG002 | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2 |
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| Secondary | Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2 | The Arthritis interference in the last month with household productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). | FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2 | Posted | | Mean | Standard Deviation | units on a scale | | Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
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| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 | | OG002 | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
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| Secondary | Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 104 in RA0055 Period 2 | LDA is defined as achieving a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2. DAS28 values range from 2.0 to 10.0 with a higher value indicating a higher disease activity. | FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses 1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2 | Posted | | Number | | percentage of subjects | | Week 104 in RA0055 Period 2 | | | | ID | Title | Description |
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| OG000 | CZP+MTX / PBO+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2 | | OG001 | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 | | OG002 | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
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