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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01521923
Registration number
NCT01521923
Ethics application status
Date submitted
19/01/2012
Date registered
31/01/2012
Date last updated
31/07/2018
Titles & IDs
Public title
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis
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Scientific title
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid Arthritis
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Secondary ID [1]
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2011-001729-25
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Secondary ID [2]
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RA0055 Period 2
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Universal Trial Number (UTN)
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Trial acronym
C-early
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Other interventions - Certolizumab Pegol + Methotrexate (MTX)
Other interventions - Placebo + Methotrexate (MTX)
Experimental: CZP 200 mg Q2W + Methotrexate -
Experimental: CZP 200 mg Q4W + Methotrexate -
Placebo Comparator: Placebo + Methotrexate -
Other interventions: Certolizumab Pegol + Methotrexate (MTX)
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.
Other interventions: Placebo + Methotrexate (MTX)
1 syringe of Placebo every 2 Weeks and MTX.
The MTX treatment is to remain between 15-25 mg/week.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2 Without Flaring
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Assessment method [1]
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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.
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Timepoint [1]
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Week 104 in RA0055 Period 2
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Secondary outcome [1]
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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
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Assessment method [1]
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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 v(TJC) + 0.28 x v(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.
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Timepoint [1]
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From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
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Secondary outcome [2]
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Change From Baseline in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2
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Assessment method [2]
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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.
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Timepoint [2]
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From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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Secondary outcome [3]
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Change From Week 52 in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2
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Assessment method [3]
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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.
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Timepoint [3]
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From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
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Secondary outcome [4]
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Percentage of Subjects With Radiographic Non-progression From Baseline in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2
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Assessment method [4]
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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.
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Timepoint [4]
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From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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Secondary outcome [5]
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Percentage of Subjects With Radiographic Non-progression From Week 52 in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2
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Assessment method [5]
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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.
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Timepoint [5]
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From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
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Secondary outcome [6]
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Change From Baseline in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2
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Assessment method [6]
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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.
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Timepoint [6]
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From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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Secondary outcome [7]
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Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2
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Assessment method [7]
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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.
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Timepoint [7]
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From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
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Secondary outcome [8]
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Change From Baseline in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2
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Assessment method [8]
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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.
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Timepoint [8]
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From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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Secondary outcome [9]
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Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2
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Assessment method [9]
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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.
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Timepoint [9]
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From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
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Secondary outcome [10]
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Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 104 in RA0055 Period 2
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Assessment method [10]
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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).
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Timepoint [10]
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From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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Secondary outcome [11]
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Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 104 in RA0055 Period 2
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Assessment method [11]
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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).
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Timepoint [11]
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From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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Secondary outcome [12]
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Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 104 in RA0055 Period 2
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Assessment method [12]
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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).
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Timepoint [12]
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From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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Secondary outcome [13]
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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
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Assessment method [13]
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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.
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Timepoint [13]
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Week 104 in RA0055 Period 2
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Secondary outcome [14]
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Percentage of Subjects With Clinical Disease Activity Index (CDAI) <= 2.8 at Week 104 in RA0055 Period 2
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Assessment method [14]
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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.
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Timepoint [14]
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Week 104 in RA0055 Period 2
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Secondary outcome [15]
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Percentage of Subjects With Simplified Disease Activity Index (SDAI) <= 3.3 at Week 104 in RA0055 Period 2
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Assessment method [15]
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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.
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Timepoint [15]
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Week 104 in RA0055 Period 2
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Secondary outcome [16]
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Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) < 2.6 at Week 104 in RA0055 Period 2
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Assessment method [16]
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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 v(TJC) + 0.28 x v(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.
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Timepoint [16]
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Week 104 in RA0055 Period 2
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Secondary outcome [17]
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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
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Assessment method [17]
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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.
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Timepoint [17]
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Week 104 in RA0055 Period 2
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Secondary outcome [18]
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Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 104 in RA0055 Period 2
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Assessment method [18]
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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
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Timepoint [18]
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From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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Secondary outcome [19]
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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
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Assessment method [19]
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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 v(TJC) + 0.28 x v(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.
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Timepoint [19]
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From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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Secondary outcome [20]
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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
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Assessment method [20]
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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 v(TJC) + 0.28 x v(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.
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Timepoint [20]
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From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
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Secondary outcome [21]
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Change From Baseline in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2
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Assessment method [21]
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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.
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Timepoint [21]
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From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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Secondary outcome [22]
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Change From Week 52 in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2
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Assessment method [22]
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0
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.
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Timepoint [22]
0
0
From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
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Secondary outcome [23]
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Change From Baseline in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2
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Assessment method [23]
0
0
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.
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Timepoint [23]
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0
From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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Secondary outcome [24]
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0
Change From Week 52 in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2
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Assessment method [24]
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0
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.
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Timepoint [24]
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From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
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Secondary outcome [25]
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Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) = 0.5 at Week 104 in RA0055 Period 2
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Assessment method [25]
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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.
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Timepoint [25]
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Week 104 in RA0055 Period 2
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Secondary outcome [26]
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Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2
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Assessment method [26]
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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 v(TJC) + 0.28 x v(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.
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Timepoint [26]
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0
Week 104 in RA0055 Period 2
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Secondary outcome [27]
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Time to Flare From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
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Assessment method [27]
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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.
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Timepoint [27]
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0
Week 104 in RA0055 Period 2
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Secondary outcome [28]
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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
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Assessment method [28]
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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.
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Timepoint [28]
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0
From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
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Secondary outcome [29]
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Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
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Assessment method [29]
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Number of work days missed in the last month for employed subjects.
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Timepoint [29]
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0
Week 104 in RA0055 Period 2
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Secondary outcome [30]
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Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
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Assessment method [30]
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0
Number of work days with reduced productivity in the last month for employed subjects.
Only the employed subjects were analyzed.
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Timepoint [30]
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0
Week 104 in RA0055 Period 2
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Secondary outcome [31]
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0
Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
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Assessment method [31]
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0
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.
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Timepoint [31]
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0
Week 104 in RA0055 Period 2
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Secondary outcome [32]
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Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
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Assessment method [32]
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0
Number of days with no household work in the last month.
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Timepoint [32]
0
0
Week 104 in RA0055 Period 2
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Secondary outcome [33]
0
0
Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
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Assessment method [33]
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0
Number of days with reduced household work productivity in the last month.
Query!
Timepoint [33]
0
0
Week 104 in RA0055 Period 2
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Secondary outcome [34]
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0
Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
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Assessment method [34]
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0
Number of days with hired outside help days in the last month.
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Timepoint [34]
0
0
Week 104 in RA0055 Period 2
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Secondary outcome [35]
0
0
Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
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Assessment method [35]
0
0
Number of days missed of family/social/leisure activities in the last month.
Query!
Timepoint [35]
0
0
Week 104 in RA0055 Period 2
Query!
Secondary outcome [36]
0
0
Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
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Assessment method [36]
0
0
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).
Query!
Timepoint [36]
0
0
Week 104 in RA0055 Period 2
Query!
Secondary outcome [37]
0
0
Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 104 in RA0055 Period 2
Query!
Assessment method [37]
0
0
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.
Query!
Timepoint [37]
0
0
Week 104 in RA0055 Period 2
Query!
Eligibility
Key inclusion criteria
- 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/01/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/09/2015
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
359
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
6 - Coffs Harbour
Query!
Recruitment hospital [2]
0
0
2 - Herson
Query!
Recruitment hospital [3]
0
0
1 - Maroochydore
Query!
Recruitment hospital [4]
0
0
8 - Woodville South
Query!
Recruitment hospital [5]
0
0
5 - Fitzroy
Query!
Recruitment hospital [6]
0
0
4 - Geelong
Query!
Recruitment hospital [7]
0
0
3 - Malvern
Query!
Recruitment hospital [8]
0
0
7 - Perth
Query!
Recruitment postcode(s) [1]
0
0
- Coffs Harbour
Query!
Recruitment postcode(s) [2]
0
0
- Herson
Query!
Recruitment postcode(s) [3]
0
0
- Maroochydore
Query!
Recruitment postcode(s) [4]
0
0
- Woodville South
Query!
Recruitment postcode(s) [5]
0
0
- Fitzroy
Query!
Recruitment postcode(s) [6]
0
0
- Geelong
Query!
Recruitment postcode(s) [7]
0
0
- Malvern
Query!
Recruitment postcode(s) [8]
0
0
- Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Idaho
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Indiana
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Iowa
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kansas
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Maryland
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Minnesota
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Mississippi
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Missouri
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Nebraska
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Nevada
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New Hampshire
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New Jersey
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New Mexico
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New York
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
North Carolina
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Ohio
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Oklahoma
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Oregon
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Pennsylvania
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
South Carolina
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Tennessee
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Texas
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Washington
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
West Virginia
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Wisconsin
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
Buenos Aires
Query!
Country [33]
0
0
Argentina
Query!
State/province [33]
0
0
Rosario
Query!
Country [34]
0
0
Argentina
Query!
State/province [34]
0
0
San Juan
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
Tucuman
Query!
Country [36]
0
0
Austria
Query!
State/province [36]
0
0
Wien
Query!
Country [37]
0
0
Belgium
Query!
State/province [37]
0
0
Brussels
Query!
Country [38]
0
0
Belgium
Query!
State/province [38]
0
0
Gilly
Query!
Country [39]
0
0
Belgium
Query!
State/province [39]
0
0
Kortrijk
Query!
Country [40]
0
0
Belgium
Query!
State/province [40]
0
0
Yvoir
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
British Columbia
Query!
Country [42]
0
0
Canada
Query!
State/province [42]
0
0
Ontario
Query!
Country [43]
0
0
Canada
Query!
State/province [43]
0
0
Quebec
Query!
Country [44]
0
0
Colombia
Query!
State/province [44]
0
0
Barranquilla
Query!
Country [45]
0
0
Colombia
Query!
State/province [45]
0
0
Bogota
Query!
Country [46]
0
0
Colombia
Query!
State/province [46]
0
0
Bucaramanga
Query!
Country [47]
0
0
Colombia
Query!
State/province [47]
0
0
Chia
Query!
Country [48]
0
0
Colombia
Query!
State/province [48]
0
0
Medellin
Query!
Country [49]
0
0
Czechia
Query!
State/province [49]
0
0
Brno
Query!
Country [50]
0
0
Czechia
Query!
State/province [50]
0
0
Bruntal
Query!
Country [51]
0
0
Czechia
Query!
State/province [51]
0
0
Hradec Kralove
Query!
Country [52]
0
0
Czechia
Query!
State/province [52]
0
0
Praha
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Le Kremlin Bicetre
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Le Mans
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Montpellier Cedex 5
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Orleans
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Strasbourg
Query!
Country [58]
0
0
Germany
Query!
State/province [58]
0
0
Bad Doberan
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Bayreuth
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Berlin
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
Erfurt
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Frankfurt
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Hamburg
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Hildesheim
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Lingen
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
München
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Planegg
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Ratingen
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
Rendsburg
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
Rheine
Query!
Country [71]
0
0
Germany
Query!
State/province [71]
0
0
Würzburg
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Zerbst
Query!
Country [73]
0
0
Hungary
Query!
State/province [73]
0
0
Budapest
Query!
Country [74]
0
0
Hungary
Query!
State/province [74]
0
0
Eger
Query!
Country [75]
0
0
Hungary
Query!
State/province [75]
0
0
Szolnok
Query!
Country [76]
0
0
Hungary
Query!
State/province [76]
0
0
Szombathely
Query!
Country [77]
0
0
Hungary
Query!
State/province [77]
0
0
Veszprem
Query!
Country [78]
0
0
Ireland
Query!
State/province [78]
0
0
Cork
Query!
Country [79]
0
0
Ireland
Query!
State/province [79]
0
0
Dublin
Query!
Country [80]
0
0
Ireland
Query!
State/province [80]
0
0
Limerick
Query!
Country [81]
0
0
Italy
Query!
State/province [81]
0
0
Ferrara
Query!
Country [82]
0
0
Italy
Query!
State/province [82]
0
0
Milano
Query!
Country [83]
0
0
Italy
Query!
State/province [83]
0
0
Reggio Emilia
Query!
Country [84]
0
0
Italy
Query!
State/province [84]
0
0
Roma
Query!
Country [85]
0
0
Italy
Query!
State/province [85]
0
0
Verona
Query!
Country [86]
0
0
Mexico
Query!
State/province [86]
0
0
Durango
Query!
Country [87]
0
0
Mexico
Query!
State/province [87]
0
0
Guadalajara
Query!
Country [88]
0
0
Mexico
Query!
State/province [88]
0
0
Merida
Query!
Country [89]
0
0
Mexico
Query!
State/province [89]
0
0
Mexico D.F.
Query!
Country [90]
0
0
Mexico
Query!
State/province [90]
0
0
Monterrey
Query!
Country [91]
0
0
Mexico
Query!
State/province [91]
0
0
San Luis Potosi
Query!
Country [92]
0
0
Monaco
Query!
State/province [92]
0
0
Monaco
Query!
Country [93]
0
0
Netherlands
Query!
State/province [93]
0
0
Leiden
Query!
Country [94]
0
0
Poland
Query!
State/province [94]
0
0
Bydgoszcz
Query!
Country [95]
0
0
Poland
Query!
State/province [95]
0
0
Elblag
Query!
Country [96]
0
0
Poland
Query!
State/province [96]
0
0
Krakow
Query!
Country [97]
0
0
Poland
Query!
State/province [97]
0
0
Poznan
Query!
Country [98]
0
0
Poland
Query!
State/province [98]
0
0
Torun
Query!
Country [99]
0
0
Poland
Query!
State/province [99]
0
0
Warszawa
Query!
Country [100]
0
0
Poland
Query!
State/province [100]
0
0
Wroclaw
Query!
Country [101]
0
0
Romania
Query!
State/province [101]
0
0
Brasov
Query!
Country [102]
0
0
Romania
Query!
State/province [102]
0
0
Bucharest
Query!
Country [103]
0
0
Romania
Query!
State/province [103]
0
0
Iasi
Query!
Country [104]
0
0
Romania
Query!
State/province [104]
0
0
Lasi
Query!
Country [105]
0
0
Spain
Query!
State/province [105]
0
0
Coruna
Query!
Country [106]
0
0
Spain
Query!
State/province [106]
0
0
Madrid
Query!
Country [107]
0
0
Spain
Query!
State/province [107]
0
0
Santiago de Compostela
Query!
Country [108]
0
0
Sweden
Query!
State/province [108]
0
0
Göteborg
Query!
Country [109]
0
0
Sweden
Query!
State/province [109]
0
0
Huddinge
Query!
Country [110]
0
0
Sweden
Query!
State/province [110]
0
0
Lund
Query!
Country [111]
0
0
Sweden
Query!
State/province [111]
0
0
Malmö
Query!
Country [112]
0
0
Sweden
Query!
State/province [112]
0
0
Stockholm
Query!
Country [113]
0
0
Sweden
Query!
State/province [113]
0
0
Uppsala
Query!
Country [114]
0
0
Switzerland
Query!
State/province [114]
0
0
Fribourg
Query!
Country [115]
0
0
Switzerland
Query!
State/province [115]
0
0
St. Gallen
Query!
Country [116]
0
0
United Kingdom
Query!
State/province [116]
0
0
Cannock
Query!
Country [117]
0
0
United Kingdom
Query!
State/province [117]
0
0
Dudley
Query!
Country [118]
0
0
United Kingdom
Query!
State/province [118]
0
0
Leeds
Query!
Country [119]
0
0
United Kingdom
Query!
State/province [119]
0
0
London
Query!
Country [120]
0
0
United Kingdom
Query!
State/province [120]
0
0
Sheffield
Query!
Country [121]
0
0
United Kingdom
Query!
State/province [121]
0
0
York
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
UCB Pharma
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01521923
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
UCB Clinical Trial Call Center
Query!
Address
0
0
+1 877 822 9493 (UCB)
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01521923
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