A Phase 3 interventional study of Certolizumab Pegol and Placebo in Rheumatoid Arthritis, sponsored by UCB Pharma SA. 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 SA (part of UCB S.A.) · Phase 3, Interventional, and Treatment
Among 46 studies testing Certolizumab Pegol in Arthritis, Rheumatoid — 2 open to participants now, 2 under way, 1 of them phase 3. Certolizumab Pegol · Arthritis, Rheumatoid.
Among the 46 studies testing Certolizumab Pegol in Arthritis, Rheumatoid, this one is the 4th largest by enrollment, is one of 3 that started in 2012, is one of 28 in phase 3, and was the 31st registered.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's enrollment of 880 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →2 of the 46 studies testing Certolizumab Pegol in Arthritis, Rheumatoid are open now, in 1 country. Each count lists the studies.
Certolizumab Pegol: first FDA approval 2008 (CIMZIA), first EMA approval 2009. What it is approved for, and how studies give it, is on its page →
Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →46 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 3 started in 2012.
Median enrollment 201 across the 46 interventional studies. Of the 40 that completed or were terminated, 30 (75%) have results posted.
33 of 46 have an industry lead sponsor. The 10 most frequent:
UCB Pharma SA is the lead sponsor of 28 studies on the registry; none are open to participants now.
UCB Pharma SA has 5 studies filed under Arthritis, Rheumatoid — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 46 studies testing Certolizumab Pegol in Arthritis, Rheumatoid, from their registry updates:
Nothing recorded among them since 2026-09-25.
This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for inducing and sustaining clinical response in the treatment of Disease Modifying Antirheumatic Drug (DMARD)-naïve adults with early active Rheumatoid Arthritis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Biological: Certolizumab Pegol · Biological: Methotrexate
Other: Placebo · Biological: Methotrexate
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml. Injections will be given subcutaneously. CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 50.
Also known as: Cimzia, CZP
2 syringes Placebo at Baseline, Week 2 and Week 4, followed by 1 syringe Placebo every 2 Weeks.
The MTX treatment is to be initiated at a dose of 10 mg per Week (oral tablets at the strength of 2.5 mg/tablet). The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8. Patients who could not tolerate ≥ 15 mg/week MTX by Week 8 were withdrawn while the maximum tolerated dose per patient (optimized dose) was maintained to Week 52.
Also known as: MTX
Percentage of Subjects in Sustained Remission at Week 52
Sustained remission is defined as a Disease Activity Score \[Erythrocyte Sedimentation Rate\] (DAS28\[ESR\]) \< 2.6 at both Weeks 40 and 52. 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 52
Percentage of Subjects in Sustained Low Disease Activity (LDA) at Week 52
Sustained LDA is defined as a Disease Activity Score \[Erythrocyte Sedimentation Rate\] (DAS28\[ESR\]) ≤ 3.2 at both Weeks 40 and 52.
Time frame: Week 52
Change From Baseline in Modified Total Sharp Score (mTSS) to Week 52
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) to Week 52
Percentage of Subjects With Radiographic Non-progression From Baseline to Week 52
Radiographic non-progression is defined as change in mTSS ≤ 0.5.
Time frame: From Baseline (Week 0) to Week 52
Change From Baseline in the Joint Erosion Score to Week 52
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 maximum possible erosion score for all 32-hand joints was 160. The maximum possible erosion score for all 12 feet joints was 120. Thus, the maximum possible total erosion score for hands and feet was 280.
Time frame: From Baseline (Week 0) to Week 52
Change From Baseline in the Joint Narrowing Score to Week 52
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 maximum possible score for JSN in all 30 hand joints was 120. The maximum possible score for JSN in all 12 feet joints was 48. Thus, the maximum possible total JSN score for Hands and feet was 168.
Time frame: From Baseline (Week 0) to Week 52
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52
The assessments are based on a 20 % or greater improvement from Baseline 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) to Week 52
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52
The assessments are based on a 50 % or greater improvement from Baseline 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) to Week 52
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52
The assessments are based on a 70 % or greater improvement from Baseline 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) to Week 52
Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria at Week 52
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) ≤ 1.
Time frame: Week 52
Percentage of Subjects With Clinical Disease Activity Index (CDAI) ≤ 2.8 at Week 52
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 52
Percentage of Subjects With Simplified Disease Activity Index (SDAI) ≤ 3.3 at Week 52
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.
Time frame: Week 52
Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) < 2.6 at Week 52
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 52
Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice at Week 52
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) ≤ 1.
Time frame: Week 52
Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 52
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.
Time frame: From Baseline (Week 0) to Week 52
Change From Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 52
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. A negative value in DAS28\[ESR\] change from Baseline indicates an improvement from Baseline.
Time frame: From Baseline (Week 0) to Week 52
Change From Baseline in Clinical Disease Activity Index (CDAI) to Week 52
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. The CDAI score ranges from 0 to 76, with a negative value in CDAI change from Baseline indicating an improvement from Baseline.
Time frame: From Baseline (Week 0) to Week 52
Change From Baseline in Simplified Disease Activity Index (SDAI) to Week 52
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) to Week 52
Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 52
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 52
Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) to Week 52
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 (no difficulty) to 3 (unable to do) with lower scores meaning lower disability. A negative value in HAQ-DI change from Baseline indicates an improvement from Baseline.
Time frame: From Baseline (Week 0) to Week 52
Change From Baseline in the Bristol Rheumatoid Arthritis Fatigue- Multidimensional Questionnaire (BRAF-MDQ) Total Score to Week 52
BRAF-MDQ total score ranges from 0 to 70 (with higher scores indicating worse fatigue). A negative value in BRAF-MDQ change from Baseline indicates an improvement from Baseline.
Time frame: From Baseline (Week 0) to Week 52
Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Number of work days missed in the last month for employed subjects.
Time frame: Week 52
Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Number of work days with reduced productivity in the last month for employed subjects.
Time frame: Week 52
Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
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.
Time frame: Week 52
Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Number of days with no household work in the last month.
Time frame: Week 52
Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Number of days with reduced household work productivity in the last month.
Time frame: Week 52
Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Number of days with hired outside help in the last month.
Time frame: Week 52
Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Number of days missed of family/social/leisure activities in the last month.
Time frame: Week 52
Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
The Arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).
Time frame: Week 52
Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 52
LDA is defined as achieving a Disease Activity Score 28 \[Erythrocyte Sedimentation Rate\] (DAS28 \[ESR\]) ≤ 3.2.
Time frame: Week 52
This study started to enroll subjects in January 2012.
| Milestone | Placebo + Methotrexate | Certolizumab Pegol + Methotrexate |
|---|---|---|
| Started | 219 | 660 |
| Completed week 52 | 143 | 500 |
| Completed | 67 | 292 |
| Not completed | 152 | 368 |
| Withdrew: Sae,non-fatal + ae,non-serious non-fatal | 2 | 1 |
| Withdrew: Protocol violation | 6 | 19 |
| Withdrew: Other reason | 87 | 222 |
| Withdrew: Subjects randomized in error | 2 | 0 |
| Withdrew: Lack of efficacy | 16 | 20 |
| Withdrew: Sae, non-fatal | 6 | 22 |
| Withdrew: Ae, serious fatal | 0 | 1 |
| Withdrew: Sae, fatal + sae, non-fatal | 0 | 1 |
| Withdrew: Ae, non-serious non-fatal | 12 | 31 |
| Withdrew: Withdrawal by subject | 15 | 37 |
| Withdrew: Lost to follow-up | 6 | 14 |
Sustained remission is defined as a Disease Activity Score \[Erythrocyte Sedimentation Rate\] (DAS28\[ESR\]) \< 2.6 at both Weeks 40 and 52. 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 | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Percentage of Subjects in Sustained Remission at Week 52 | 15.0 | 28.9 |
Sustained LDA is defined as a Disease Activity Score \[Erythrocyte Sedimentation Rate\] (DAS28\[ESR\]) ≤ 3.2 at both Weeks 40 and 52.
| percentage of subjects | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Percentage of Subjects in Sustained Low Disease Activity (LDA) at Week 52 | 28.6 | 43.8 |
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 | Placebo + Methotrexate (Radiographic Set) | Certolizumab Pegol + Methotrexate (Radiographic Set) |
|---|---|---|
| Change From Baseline in Modified Total Sharp Score (mTSS) to Week 52 | 1.8 ± 4.3 | 0.2 ± 3.2 |
Radiographic non-progression is defined as change in mTSS ≤ 0.5.
| percentage of subjects | Placebo + Methotrexate (Radiographic Set) | Certolizumab Pegol + Methotrexate (Radiographic Set) |
|---|---|---|
| Percentage of Subjects With Radiographic Non-progression From Baseline to Week 52 | 49.7 | 70.3 |
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 maximum possible erosion score for all 32-hand joints was 160. The maximum possible erosion score for all 12 feet joints was 120. Thus, the maximum possible total erosion score for hands and feet was 280.
| units on a scale | Placebo + Methotrexate (Radiographic Set) | Certolizumab Pegol + Methotrexate (Radiographic Set) |
|---|---|---|
| Change From Baseline in the Joint Erosion Score to Week 52 | 1.1 ± 3.0 | 0.1 ± 2.1 |
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 maximum possible score for JSN in all 30 hand joints was 120. The maximum possible score for JSN in all 12 feet joints was 48. Thus, the maximum possible total JSN score for Hands and feet was 168.
| units on a scale | Placebo + Methotrexate (Radiographic Set) | Certolizumab Pegol + Methotrexate (Radiographic Set) |
|---|---|---|
| Change From Baseline in the Joint Narrowing Score to Week 52 | 0.7 ± 2.3 | 0.1 ± 1.7 |
The assessments are based on a 20 % or greater improvement from Baseline 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 | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52 | 61.5 | 69.0 |
The assessments are based on a 50 % or greater improvement from Baseline 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 | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52 | 52.6 | 61.8 |
The assessments are based on a 70 % or greater improvement from Baseline 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 | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52 | 39.9 | 51.3 |
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) ≤ 1.
| percentage of subjects | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria at Week 52 | 20.7 | 32.4 |
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 | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Percentage of Subjects With Clinical Disease Activity Index (CDAI) ≤ 2.8 at Week 52 | 26.3 | 38.9 |
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.
| percentage of subjects | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Percentage of Subjects With Simplified Disease Activity Index (SDAI) ≤ 3.3 at Week 52 | 24.9 | 38.9 |
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 | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) < 2.6 at Week 52 | 26.8 | 42.6 |
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) ≤ 1.
| percentage of subjects | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (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 52 | 24.9 | 35.3 |
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.
| percentage of subjects | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 52 | 82.2 | 89.9 |
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. A negative value in DAS28\[ESR\] change from Baseline indicates an improvement from Baseline.
| units on a scale | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Change From Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 52 | -3.014 ± 0.109 | -3.615 ± 0.069 |
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. The CDAI score ranges from 0 to 76, with a negative value in CDAI change from Baseline indicating an improvement from Baseline.
| units on a scale | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Change From Baseline in Clinical Disease Activity Index (CDAI) to Week 52 | -29.09 ± 0.84 | -33.11 ± 0.52 |
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 | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Change From Baseline in Simplified Disease Activity Index (SDAI) to Week 52 | -30.24 ± 0.88 | -34.55 ± 0.55 |
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 | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 52 | 35.7 | 48.1 |
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 (no difficulty) to 3 (unable to do) with lower scores meaning lower disability. A negative value in HAQ-DI change from Baseline indicates an improvement from Baseline.
| units on a scale | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) to Week 52 | -0.819 ± 0.044 | -0.997 ± 0.028 |
BRAF-MDQ total score ranges from 0 to 70 (with higher scores indicating worse fatigue). A negative value in BRAF-MDQ change from Baseline indicates an improvement from Baseline.
| units on a scale | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Change From Baseline in the Bristol Rheumatoid Arthritis Fatigue- Multidimensional Questionnaire (BRAF-MDQ) Total Score to Week 52 | -15.6 ± 1.0 | -17.8 ± 0.6 |
Number of work days missed in the last month for employed subjects.
| days | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 | 0.9 ± 2.5 | 0.6 ± 2.6 |
Number of work days with reduced productivity in the last month for employed subjects.
| days | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 | 1.8 ± 4.7 | 1.0 ± 3.4 |
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.
| units on a scale | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 | 1.9 ± 2.3 | 1.4 ± 2.0 |
Number of days with no household work in the last month.
| days | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 | 3.0 ± 6.7 | 1.9 ± 5.1 |
Number of days with reduced household work productivity in the last month.
| days | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 | 3.0 ± 6.6 | 2.1 ± 5.3 |
Number of days with hired outside help in the last month.
| days | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 | 0.7 ± 3.3 | 0.6 ± 3.2 |
Number of days missed of family/social/leisure activities in the last month.
| days | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 | 0.9 ± 3.1 | 0.9 ± 3.6 |
The Arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).
| units on a scale | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 | 2.5 ± 2.8 | 1.9 ± 2.5 |
LDA is defined as achieving a Disease Activity Score 28 \[Erythrocyte Sedimentation Rate\] (DAS28 \[ESR\]) ≤ 3.2.
| percentage of subjects | Placebo + Methotrexate (Full Analysis Set) | Certolizumab Pegol + Methotrexate (Full Analysis Set) |
|---|---|---|
| Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 52 | 39.4 | 54.7 |
Collected over Adverse Events were collected from Screening over Baseline (Week 0) and Treatment Period 1 (Week 2 to Week 52) to the Safety Follow-Up Visit (Week 60).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo + Methotrexate | — | 20/217 (9.2%) | 63/217 (29%) |
| Certolizumab Pegol + Methotrexate | — | 70/659 (10.6%) | 248/659 (37.6%) |
| Event | Placebo + Methotrexate | Certolizumab Pegol + Methotrexate |
|---|---|---|
| PneumoniaInfections and infestations | 3/217 | 4/659 |
| Latent tuberculosisInfections and infestations | 2/217 | 1/659 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 2/217 | 0/659 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 2/217 | 1/659 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/217 | 4/659 |
| Atrial fibrillationCardiac disorders | 1/217 | 1/659 |
| Cardiac tamponadeCardiac disorders | 1/217 | 0/659 |
| PericarditisCardiac disorders | 1/217 | 0/659 |
| CellulitisInfections and infestations | 1/217 | 2/659 |
| GastroenteritisInfections and infestations | 1/217 | 0/659 |
| Event | Placebo + Methotrexate | Certolizumab Pegol + Methotrexate |
|---|---|---|
| NauseaGastrointestinal disorders | 22/217 | 83/659 |
| Upper respiratory tract infectionInfections and infestations | 11/217 | 72/659 |
| Urinary tract infectionInfections and infestations | 16/217 | 48/659 |
| NasopharyngitisInfections and infestations | 13/217 | 46/659 |
| HeadacheNervous system disorders | 8/217 | 45/659 |
| Alanine aminotransferase increasedInvestigations | 9/217 | 42/659 |
Baseline Charactersitics refer to the Randomized Set (RS).
| Age, Categorical(Participants) | Placebo + Methotrexate | Certolizumab Pegol + Methotrexate | Total Title |
|---|---|---|---|
| <=18 years | 1 | 2 | 3 |
| Between 18 and 65 years | 182 | 560 | 742 |
| >=65 years | 36 | 98 | 134 |
| Age, Continuous(years) | Placebo + Methotrexate | Certolizumab Pegol + Methotrexate | Total Title |
|---|---|---|---|
| Mean | 51.3 ± 13.2 | 50.5 ± 13.6 | 50.7 ± 13.5 |
| Sex: Female, Male(Participants) | Placebo + Methotrexate | Certolizumab Pegol + Methotrexate | Total Title |
|---|---|---|---|
| Female | 175 | 499 | 674 |
| Male | 44 | 161 | 205 |
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Studies of the drug tested here: Certolizumab Pegol