A Phase 3 interventional study of Certolizumab Pegol + Methotrexate (MTX) and Placebo + Methotrexate (MTX) in Rheumatoid Arthritis, sponsored by UCB Pharma. Completed at 178 sites in 22 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by UCB Pharma (part of UCB S.A.) · Phase 3, Interventional, and Treatment
This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for sustaining clinical response achieved in study RA0055 Period 1 [NCT01519791]. Subjects entering this study RA0055 Period 2 achieved sustained Low Disease Activity at Week 52 in study RA0055 Period 1.
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- Those subjects in previous study RA0055 Period 1 who are in sustained LDA (defined as DAS28[ESR] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1
Exclusion Criteria:
- Those subjects in previous study RA0055 Period 1 who are NOT in sustained LDA (defined as DAS28[ESR] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1
Biological: Certolizumab Pegol + Methotrexate (MTX)
Biological: Certolizumab Pegol + Methotrexate (MTX)
Biological: Placebo + Methotrexate (MTX)
Drug pages: Certolizumab Pegol · Methotrexate
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at dosage strength of 200 mg/ml. On a maintenance dose of 200 mg every 2 Weeks (Q2W) until Week 102. On a maintenance dose of 200 mg every 4 Weeks (Q4W) until Week 102/ Placebo (PBO) 1 syringe every 4 Weeks (Q4W). CZP and PBO administration to be staggered 2 Weeks apart to maintain blind. The MTX treatment is to remain between 15-25 mg/week.
Also known as: Cimzia, CZP, MTX
1 syringe of Placebo every 2 Weeks and MTX. The MTX treatment is to remain between 15-25 mg/week.
Also known as: MTX
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.
Time frame: Week 104 in RA0055 Period 2
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.
Time frame: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
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.
Time frame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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.
Time frame: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
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.
Time frame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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.
Time frame: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
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.
Time frame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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.
Time frame: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
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.
Time frame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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.
Time frame: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
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).
Time frame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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).
Time frame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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).
Time frame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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.
Time frame: Week 104 in RA0055 Period 2
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.
Time frame: Week 104 in RA0055 Period 2
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.
Time frame: Week 104 in RA0055 Period 2
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.
Time frame: Week 104 in RA0055 Period 2
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.
Time frame: Week 104 in RA0055 Period 2
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
Time frame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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.
Time frame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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.
Time frame: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
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.
Time frame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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.
Time frame: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
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.
Time frame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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.
Time frame: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
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.
Time frame: Week 104 in RA0055 Period 2
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.
Time frame: Week 104 in RA0055 Period 2
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.
Time frame: Week 104 in RA0055 Period 2
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.
Time frame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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.
Time frame: Week 104 in RA0055 Period 2
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.
Time frame: Week 104 in RA0055 Period 2
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.
Time frame: Week 104 in RA0055 Period 2
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.
Time frame: Week 104 in RA0055 Period 2
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.
Time frame: Week 104 in RA0055 Period 2
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.
Time frame: Week 104 in RA0055 Period 2
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.
Time frame: Week 104 in RA0055 Period 2
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).
Time frame: Week 104 in RA0055 Period 2
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.
Time frame: Week 104 in RA0055 Period 2
This study started to enroll subjects in January 2012.
| Milestone | PBO+MTX / PBO+MTX | CZP+MTX / PBO+MTX | CZP+MTX / CZP Q4W+MTX | CZP+MTX / CZP Q2W+MTX |
|---|---|---|---|---|
| Started | 66 | 81 | 127 | 83 |
| Completed | 59 | 72 | 112 | 70 |
| Not completed | 7 | 9 | 15 | 13 |
| Withdrew: Ae, serious fatal | 1 | 0 | 0 | 0 |
| Withdrew: Sae, non-fatal | 0 | 2 | 2 | 0 |
| Withdrew: Ae, non-serious, non-fatal | 1 | 3 | 6 | 2 |
| Withdrew: Sae, nonfatal + ae, non-serious nonfatal | 0 | 0 | 0 | 1 |
| Withdrew: Lack of efficacy | 1 | 1 | 0 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 2 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 | 1 | 2 |
| Withdrew: Other | 2 | 1 | 3 | 6 |
| Withdrew: Ae, captured in period 1 | 0 | 1 | 0 | 1 |
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.
| percentage of subjects | CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2 Without Flaring | 39.2 | 53.2 | 48.8 |
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.
| percentage of subjects | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| 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 | 33.3 | 43.4 | 44.0 |
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.
| units on a scale | CZP+MTX / PBO+MTX (Radiographic Set) | CZP+MTX / CZP Q4W+MTX (Radiographic Set) | CZP+MTX / CZP Q2W+MTX (Radiographic Set) |
|---|---|---|---|
| Change From Baseline in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2 | 0 (-5 to 28) | 0 (-9 to 9) | 0 (-2 to 9) |
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.
| units on a scale | CZP+MTX / PBO+MTX (Radiographic Set) | CZP+MTX / CZP Q4W+MTX (Radiographic Set) | CZP+MTX / CZP Q2W+MTX (Radiographic Set) |
|---|---|---|---|
| Change From Week 52 in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2 | 0 (-3 to 50) | 0 (-9 to 7) | 0 (-4 to 4) |
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.
| percentage of subjects | CZP+MTX / PBO+MTX (Radiographic Set) | CZP+MTX / CZP Q4W+MTX (Radiographic Set) | CZP+MTX / CZP Q2W+MTX (Radiographic Set) |
|---|---|---|---|
| Percentage of Subjects With Radiographic Non-progression From Baseline in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2 | 69.3 | 77.9 | 79.2 |
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.
| percentage of subjects | CZP+MTX / PBO+MTX (Radiographic Set) | CZP+MTX / CZP Q4W+MTX (Radiographic Set) | CZP+MTX / CZP Q2W+MTX (Radiographic Set) |
|---|---|---|---|
| Percentage of Subjects With Radiographic Non-progression From Week 52 in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2 | 80.0 | 84.1 | 90.3 |
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.
| units on a scale | CZP+MTX / PBO+MTX (Radiographic Set) | CZP+MTX / CZP Q4W+MTX (Radiographic Set) | CZP+MTX / CZP Q2W+MTX (Radiographic Set) |
|---|---|---|---|
| Change From Baseline in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2 | 0 (-4 to 18) | 0 (-8 to 7) | 0 (-2 to 9) |
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.
| units on a scale | CZP+MTX / PBO+MTX (Radiographic Set) | CZP+MTX / CZP Q4W+MTX (Radiographic Set) | CZP+MTX / CZP Q2W+MTX (Radiographic Set) |
|---|---|---|---|
| Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2 | 0 (-3 to 36) | 0 (-8 to 5) | 0 (-2 to 4) |
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.
| units on a scale | CZP+MTX / PBO+MTX (Radiographic Set) | CZP+MTX / CZP Q4W+MTX (Radiographic Set) | CZP+MTX / CZP Q2W+MTX (Radiographic Set) |
|---|---|---|---|
| Change From Baseline in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2 | 0 (-3 to 12) | 0 (-4 to 4) | 0 (-2 to 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.
| units on a scale | CZP+MTX / PBO+MTX (Radiographic Set) | CZP+MTX / CZP Q4W+MTX (Radiographic Set) | CZP+MTX / CZP Q2W+MTX (Radiographic Set) |
|---|---|---|---|
| Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2 | 0 (-2 to 14) | 0 (-3 to 5) | 0 (-4 to 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).
| percentage of subjects | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 104 in RA0055 Period 2 | 74.7 | 86.5 | 73.8 |
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).
| percentage of subjects | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 104 in RA0055 Period 2 | 68.4 | 80.2 | 71.4 |
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).
| percentage of subjects | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 104 in RA0055 Period 2 | 60.8 | 70.6 | 63.1 |
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.
| percentage of subjects | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| 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 | 34.2 | 52.4 | 46.4 |
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.
| percentage of subjects | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Percentage of Subjects With Clinical Disease Activity Index (CDAI) <= 2.8 at Week 104 in RA0055 Period 2 | 43.0 | 55.6 | 52.4 |
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.
| percentage of subjects | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Percentage of Subjects With Simplified Disease Activity Index (SDAI) <= 3.3 at Week 104 in RA0055 Period 2 | 41.8 | 57.1 | 53.6 |
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.
| percentage of subjects | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) < 2.6 at Week 104 in RA0055 Period 2 | 44.3 | 63.5 | 52.4 |
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.
| percentage of subjects | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| 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 | 35.4 | 52.4 | 50.0 |
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
| percentage of subjects | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 104 in RA0055 Period 2 | 88.6 | 98.4 | 94.0 |
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.
| units on a scale | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| 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 | -3.436 ± 1.711 | -4.252 ± 1.275 | -3.901 ± 1.546 |
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.
| units on a scale | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| 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 | 1.145 ± 1.372 | 0.414 ± 1.033 | 0.511 ± 1.215 |
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.
| units on a scale | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Change From Baseline in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2 | -30.7 ± 16.4 | -37.2 ± 12.1 | -32.6 ± 15.5 |
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.
| units on a scale | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Change From Week 52 in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2 | 6.0 ± 10.4 | 1.7 ± 5.9 | 2.5 ± 7.9 |
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.
| units on a scale | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Change From Baseline in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2 | -31.6 ± 17.4 | -39.1 ± 13.5 | -34.3 ± 16.8 |
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.
| units on a scale | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Change From Week 52 in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2 | 6.5 ± 10.9 | 1.7 ± 6.0 | 2.6 ± 7.8 |
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.
| percentage of subjects | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 104 in RA0055 Period 2 | 49.4 | 63.5 | 61.9 |
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.
| percentage of subjects | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2 | 59.5 | 73.8 | 65.5 |
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.
| days | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Time to Flare From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2 | NA ± NA | NA ± NA | NA ± NA |
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.
| units on a scale | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| 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 | -15.9 ± 16.7 | -21.6 ± 16.9 | -20.7 ± 17.3 |
Number of work days missed in the last month for employed subjects.
| days | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2 | 0.5 ± 1.46 | 0.2 ± 0.89 | 0.3 ± 0.86 |
Number of work days with reduced productivity in the last month for employed subjects. Only the employed subjects were analyzed.
| days | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2 | 1.5 ± 4.88 | 0.6 ± 2.01 | 0.8 ± 2.29 |
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.
| units on a scale | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2 | 2.3 ± 2.84 | 0.9 ± 1.60 | 1.2 ± 2.19 |
Number of days with no household work in the last month.
| days | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2 | 1.4 ± 3.35 | 0.7 ± 2.29 | 0.8 ± 2.76 |
Number of days with reduced household work productivity in the last month.
| days | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2 | 1.8 ± 4.49 | 0.9 ± 3.01 | 1.0 ± 3.37 |
Number of days with hired outside help days in the last month.
| days | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2 | 0.3 ± 0.98 | 0.3 ± 2.70 | 0.1 ± 0.45 |
Number of days missed of family/social/leisure activities in the last month.
| days | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2 | 1.2 ± 3.36 | 0.2 ± 1.80 | 0.2 ± 0.75 |
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).
| units on a scale | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2 | 2.0 ± 2.63 | 1.0 ± 1.53 | 1.1 ± 1.95 |
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.
| percentage of subjects | CZP+MTX / PBO+MTX (Full Analysis Set) | CZP+MTX / CZP Q4W+MTX (Full Analysis Set) | CZP+MTX / CZP Q2W+MTX (Full Analysis Set) |
|---|---|---|---|
| Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 104 in RA0055 Period 2 | 68.4 | 74.6 | 70.2 |
Collected over Adverse events for Period 2 were collected from the date of the Week 52 study medication up to 70 days after the last (most recent) Certolizumab pegol (CZP) or Placebo (PBO) dose. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PBO+MTX / PBO+MTX | — | 4/66 (6.1%) | 3/66 (4.5%) |
| CZP+MTX / PBO+MTX | — | 6/81 (7.4%) | 13/81 (16%) |
| CZP+MTX / CZP Q4W+MTX | — | 9/127 (7.1%) | 32/127 (25.2%) |
| CZP+MTX / CZP Q2W+MTX | — | 4/83 (4.8%) | 13/83 (15.7%) |
| Event | PBO+MTX / PBO+MTX | CZP+MTX / PBO+MTX | CZP+MTX / CZP Q4W+MTX | CZP+MTX / CZP Q2W+MTX |
|---|---|---|---|---|
| Influenza like illnessGeneral disorders | 0/3 | 0/10 | 0/3 | 1/7 |
| Bronchial carcinomaRespiratory, thoracic and mediastinal disorders | 0/3 | 1/10 | 0/3 | 0/7 |
| DepressionPsychiatric disorders | 0/3 | 1/10 | 0/3 | 0/7 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/66 | 2/81 | 0/127 | 0/83 |
| Acute myocardial infarctionCardiac disorders | 1/66 | 0/81 | 0/127 | 0/83 |
| Cardiac failureCardiac disorders | 1/66 | 0/81 | 0/127 | 0/83 |
| Pancreatitis acuteGastrointestinal disorders | 1/66 | 0/81 | 0/127 | 0/83 |
| Gastroenteritis salmonellaInfections and infestations | 1/66 | 0/81 | 0/127 | 0/83 |
| Tendon disorderMusculoskeletal and connective tissue disorders | 1/66 | 0/81 | 0/127 | 0/83 |
| Meniere's diseaseEar and labyrinth disorders | 0/66 | 1/81 | 0/127 | 0/83 |
| Event | PBO+MTX / PBO+MTX | CZP+MTX / PBO+MTX | CZP+MTX / CZP Q4W+MTX | CZP+MTX / CZP Q2W+MTX |
|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 0/66 | 5/81 | 13/127 | 4/83 |
| HypercholesterolaemiaMetabolism and nutrition disorders | 2/66 | 3/81 | 8/127 | 2/83 |
| PharyngitisInfections and infestations | 0/66 | 5/81 | 5/127 | 2/83 |
| Urinary tract infectionInfections and infestations | 1/66 | 2/81 | 4/127 | 5/83 |
| Latent tuberculosisInfections and infestations | 0/66 | 0/81 | 7/127 | 1/83 |
Baseline refers to Baseline from Period 1. Only subjects who entered Period 2 are included. Characteristics refer to the Safety Set 2 (SS2).
| Age, Categorical(Participants) | PBO+MTX / PBO+MTX | CZP+MTX / PBO+MTX | CZP+MTX / CZP Q4W+MTX | CZP+MTX / CZP Q2W+MTX | Total Title |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 2 | 0 | 2 |
| Between 18 and 65 years | 54 | 70 | 114 | 72 | 310 |
| >=65 years | 12 | 11 | 11 | 11 | 45 |
| Age, Continuous(years) | PBO+MTX / PBO+MTX | CZP+MTX / PBO+MTX | CZP+MTX / CZP Q4W+MTX | CZP+MTX / CZP Q2W+MTX | Total Title |
|---|---|---|---|---|---|
| Mean | 51.2 ± 13.7 | 47.9 ± 14.1 | 49.1 ± 12.5 | 49.1 ± 13.2 | 49.2 ± 13.3 |
| Sex: Female, Male(Participants) | PBO+MTX / PBO+MTX | CZP+MTX / PBO+MTX | CZP+MTX / CZP Q4W+MTX | CZP+MTX / CZP Q2W+MTX | Total Title |
|---|---|---|---|---|---|
| Female | 54 | 59 | 87 | 65 | 265 |
| Male | 12 | 22 | 40 | 18 | 92 |
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Certolizumab Pegol · Methotrexate