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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 (C-early)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Certolizumab Pegol + Methotrexate (MTX)
Placebo + Methotrexate (MTX)
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Certolizumab Pegol - Cimzia, Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

CZP 200 mg Q2W + Methotrexate

CZP 200 mg Q4W + Methotrexate

Placebo + Methotrexate

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.

Full Information

First Posted
January 19, 2012
Last Updated
July 4, 2018
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01521923
Brief 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
Acronym
C-early
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Certolizumab Pegol - Cimzia, Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
359 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CZP 200 mg Q2W + Methotrexate
Arm Type
Experimental
Arm Title
CZP 200 mg Q4W + Methotrexate
Arm Type
Experimental
Arm Title
Placebo + Methotrexate
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Certolizumab Pegol + Methotrexate (MTX)
Other Intervention Name(s)
Cimzia, CZP, MTX
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Placebo + Methotrexate (MTX)
Other Intervention Name(s)
MTX
Intervention Description
1 syringe of Placebo every 2 Weeks and MTX. The MTX treatment is to remain between 15-25 mg/week.
Primary Outcome Measure Information:
Title
Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2 Without Flaring
Description
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
Secondary Outcome Measure Information:
Title
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
Description
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
Title
Change From Baseline in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2
Description
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
Title
Change From Week 52 in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2
Description
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
Title
Percentage of Subjects With Radiographic Non-progression From Baseline in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2
Description
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
Title
Percentage of Subjects With Radiographic Non-progression From Week 52 in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2
Description
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
Title
Change From Baseline in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2
Description
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
Title
Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2
Description
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
Title
Change From Baseline in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2
Description
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
Title
Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2
Description
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
Title
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 104 in RA0055 Period 2
Description
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
Title
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 104 in RA0055 Period 2
Description
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
Title
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 104 in RA0055 Period 2
Description
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
Title
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
Description
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
Title
Percentage of Subjects With Clinical Disease Activity Index (CDAI) <= 2.8 at Week 104 in RA0055 Period 2
Description
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
Title
Percentage of Subjects With Simplified Disease Activity Index (SDAI) <= 3.3 at Week 104 in RA0055 Period 2
Description
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
Title
Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) < 2.6 at Week 104 in RA0055 Period 2
Description
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
Title
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
Description
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
Title
Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 104 in RA0055 Period 2
Description
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
Title
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
Description
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
Title
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
Description
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
Title
Change From Baseline in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2
Description
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
Title
Change From Week 52 in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2
Description
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
Title
Change From Baseline in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2
Description
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
Title
Change From Week 52 in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2
Description
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
Title
Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 104 in RA0055 Period 2
Description
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
Title
Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2
Description
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
Title
Time to Flare From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
Description
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
Title
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
Description
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
Title
Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Description
Number of work days missed in the last month for employed subjects.
Time Frame
Week 104 in RA0055 Period 2
Title
Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Description
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
Title
Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Description
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
Title
Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Description
Number of days with no household work in the last month.
Time Frame
Week 104 in RA0055 Period 2
Title
Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Description
Number of days with reduced household work productivity in the last month.
Time Frame
Week 104 in RA0055 Period 2
Title
Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Description
Number of days with hired outside help days in the last month.
Time Frame
Week 104 in RA0055 Period 2
Title
Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Description
Number of days missed of family/social/leisure activities in the last month.
Time Frame
Week 104 in RA0055 Period 2
Title
Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Description
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
Title
Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 104 in RA0055 Period 2
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
209
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
170
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
180
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
247
City
Glendale
State/Province
Arizona
Country
United States
Facility Name
165
City
Paradise Valley
State/Province
Arizona
Country
United States
Facility Name
234
City
Paradise Valley
State/Province
Arizona
Country
United States
Facility Name
243
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
251
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
160
City
Covina
State/Province
California
Country
United States
Facility Name
257
City
Hemet
State/Province
California
Country
United States
Facility Name
159
City
Los Angeles
State/Province
California
Country
United States
Facility Name
201
City
San Leandro
State/Province
California
Country
United States
Facility Name
202
City
Upland
State/Province
California
Country
United States
Facility Name
172
City
Whittier
State/Province
California
Country
United States
Facility Name
190
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
196
City
Jupiter
State/Province
Florida
Country
United States
Facility Name
238
City
Lake Mary
State/Province
Florida
Country
United States
Facility Name
232
City
Miami
State/Province
Florida
Country
United States
Facility Name
213
City
Naples
State/Province
Florida
Country
United States
Facility Name
214
City
Ocala
State/Province
Florida
Country
United States
Facility Name
237
City
Orange Park
State/Province
Florida
Country
United States
Facility Name
255
City
Orlando
State/Province
Florida
Country
United States
Facility Name
163
City
Palm Harbor
State/Province
Florida
Country
United States
Facility Name
166
City
Plantation
State/Province
Florida
Country
United States
Facility Name
192
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
200
City
Vero Beach
State/Province
Florida
Country
United States
Facility Name
226
City
Coeur d'Alene
State/Province
Idaho
Country
United States
Facility Name
244
City
Springfield
State/Province
Illinois
Country
United States
Facility Name
224
City
South Bend
State/Province
Indiana
Country
United States
Facility Name
215
City
Cedar Rapids
State/Province
Iowa
Country
United States
Facility Name
191
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
210
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
177
City
Hagerstown
State/Province
Maryland
Country
United States
Facility Name
199
City
Kalamazoo
State/Province
Michigan
Country
United States
Facility Name
198
City
Eagan
State/Province
Minnesota
Country
United States
Facility Name
203
City
Tupelo
State/Province
Mississippi
Country
United States
Facility Name
179
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
181
City
Lincoln
State/Province
Nebraska
Country
United States
Facility Name
256
City
Reno
State/Province
Nevada
Country
United States
Facility Name
229
City
Lebanon
State/Province
New Hampshire
Country
United States
Facility Name
228
City
Clifton
State/Province
New Jersey
Country
United States
Facility Name
207
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
176
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
242
City
Plainview
State/Province
New York
Country
United States
Facility Name
227
City
Rochester
State/Province
New York
Country
United States
Facility Name
236
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
245
City
Middleburg Heights
State/Province
Ohio
Country
United States
Facility Name
241
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
186
City
Portland
State/Province
Oregon
Country
United States
Facility Name
195
City
Bethlehem
State/Province
Pennsylvania
Country
United States
Facility Name
167
City
Duncansville
State/Province
Pennsylvania
Country
United States
Facility Name
168
City
Wyomissing
State/Province
Pennsylvania
Country
United States
Facility Name
189
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
205
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
204
City
Hendersonville
State/Province
Tennessee
Country
United States
Facility Name
217
City
Allen
State/Province
Texas
Country
United States
Facility Name
185
City
Amarillo
State/Province
Texas
Country
United States
Facility Name
161
City
Austin
State/Province
Texas
Country
United States
Facility Name
178
City
Corpus Christi
State/Province
Texas
Country
United States
Facility Name
162
City
Dallas
State/Province
Texas
Country
United States
Facility Name
184
City
Houston
State/Province
Texas
Country
United States
Facility Name
206
City
Houston
State/Province
Texas
Country
United States
Facility Name
223
City
Houston
State/Province
Texas
Country
United States
Facility Name
158
City
Mesquite
State/Province
Texas
Country
United States
Facility Name
175
City
Nassau Bay
State/Province
Texas
Country
United States
Facility Name
249
City
Plano
State/Province
Texas
Country
United States
Facility Name
197
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
233
City
Kennewick
State/Province
Washington
Country
United States
Facility Name
183
City
Clarksburg
State/Province
West Virginia
Country
United States
Facility Name
174
City
Glendale
State/Province
Wisconsin
Country
United States
Facility Name
276
City
Buenos Aires
Country
Argentina
Facility Name
284
City
Rosario
Country
Argentina
Facility Name
279
City
San Juan
Country
Argentina
Facility Name
291
City
Tucuman
Country
Argentina
Facility Name
6
City
Coffs Harbour
State/Province
New South Wales
Country
Australia
Facility Name
2
City
Herson
State/Province
Queensland
Country
Australia
Facility Name
1
City
Maroochydore
State/Province
Queensland
Country
Australia
Facility Name
8
City
Woodville South
State/Province
South Australia
Country
Australia
Facility Name
5
City
Fitzroy
State/Province
Victoria
Country
Australia
Facility Name
4
City
Geelong
State/Province
Victoria
Country
Australia
Facility Name
3
City
Malvern
State/Province
Victoria
Country
Australia
Facility Name
7
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
50
City
Wien
Country
Austria
Facility Name
51
City
Brussels
Country
Belgium
Facility Name
126
City
Gilly
Country
Belgium
Facility Name
36
City
Kortrijk
Country
Belgium
Facility Name
65
City
Yvoir
Country
Belgium
Facility Name
240
City
Kelowna
State/Province
British Columbia
Country
Canada
Facility Name
235
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
188
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
194
City
Trois-rivieres
State/Province
Quebec
Country
Canada
Facility Name
303
City
Barranquilla
Country
Colombia
Facility Name
272
City
Bogota
Country
Colombia
Facility Name
293
City
Bogota
Country
Colombia
Facility Name
299
City
Bogota
Country
Colombia
Facility Name
297
City
Bucaramanga
Country
Colombia
Facility Name
288
City
Chia
Country
Colombia
Facility Name
271
City
Medellin
Country
Colombia
Facility Name
298
City
Medellin
Country
Colombia
Facility Name
108
City
Brno
Country
Czechia
Facility Name
124
City
Bruntal
Country
Czechia
Facility Name
38
City
Hradec Kralove
Country
Czechia
Facility Name
37
City
Praha
Country
Czechia
Facility Name
16
City
Le Kremlin Bicetre
Country
France
Facility Name
85
City
Le Mans
Country
France
Facility Name
88
City
Montpellier Cedex 5
Country
France
Facility Name
34
City
Orleans
Country
France
Facility Name
79
City
Strasbourg
Country
France
Facility Name
52
City
Bad Doberan
Country
Germany
Facility Name
17
City
Bayreuth
Country
Germany
Facility Name
113
City
Berlin
Country
Germany
Facility Name
120
City
Berlin
Country
Germany
Facility Name
89
City
Erfurt
Country
Germany
Facility Name
70
City
Frankfurt
Country
Germany
Facility Name
71
City
Hamburg
Country
Germany
Facility Name
81
City
Hildesheim
Country
Germany
Facility Name
127
City
Lingen
Country
Germany
Facility Name
61
City
München
Country
Germany
Facility Name
53
City
Planegg
Country
Germany
Facility Name
132
City
Ratingen
Country
Germany
Facility Name
49
City
Rendsburg
Country
Germany
Facility Name
69
City
Rheine
Country
Germany
Facility Name
114
City
Würzburg
Country
Germany
Facility Name
59
City
Zerbst
Country
Germany
Facility Name
18
City
Budapest
Country
Hungary
Facility Name
21
City
Budapest
Country
Hungary
Facility Name
86
City
Eger
Country
Hungary
Facility Name
131
City
Szolnok
Country
Hungary
Facility Name
110
City
Szombathely
Country
Hungary
Facility Name
19
City
Veszprem
Country
Hungary
Facility Name
33
City
Cork
Country
Ireland
Facility Name
54
City
Dublin
Country
Ireland
Facility Name
32
City
Limerick
Country
Ireland
Facility Name
115
City
Ferrara
Country
Italy
Facility Name
122
City
Milano
Country
Italy
Facility Name
40
City
Reggio Emilia
Country
Italy
Facility Name
72
City
Roma
Country
Italy
Facility Name
41
City
Verona
Country
Italy
Facility Name
281
City
Durango
Country
Mexico
Facility Name
286
City
Guadalajara
Country
Mexico
Facility Name
302
City
Merida
Country
Mexico
Facility Name
292
City
Mexico D.F.
Country
Mexico
Facility Name
280
City
Monterrey
Country
Mexico
Facility Name
294
City
San Luis Potosi
Country
Mexico
Facility Name
78
City
Monaco
Country
Monaco
Facility Name
42
City
Leiden
Country
Netherlands
Facility Name
128
City
Bydgoszcz
Country
Poland
Facility Name
67
City
Elblag
Country
Poland
Facility Name
99
City
Krakow
Country
Poland
Facility Name
92
City
Poznan
Country
Poland
Facility Name
74
City
Torun
Country
Poland
Facility Name
100
City
Warszawa
Country
Poland
Facility Name
44
City
Wroclaw
Country
Poland
Facility Name
58
City
Brasov
Country
Romania
Facility Name
111
City
Bucharest
Country
Romania
Facility Name
22
City
Bucharest
Country
Romania
Facility Name
25
City
Bucharest
Country
Romania
Facility Name
26
City
Bucharest
Country
Romania
Facility Name
24
City
Iasi
Country
Romania
Facility Name
57
City
Lasi
Country
Romania
Facility Name
93
City
Coruna
Country
Spain
Facility Name
47
City
Madrid
Country
Spain
Facility Name
63
City
Santiago de Compostela
Country
Spain
Facility Name
76
City
Göteborg
Country
Sweden
Facility Name
82
City
Huddinge
Country
Sweden
Facility Name
106
City
Lund
Country
Sweden
Facility Name
123
City
Malmö
Country
Sweden
Facility Name
77
City
Stockholm
Country
Sweden
Facility Name
75
City
Uppsala
Country
Sweden
Facility Name
118
City
Fribourg
Country
Switzerland
Facility Name
68
City
St. Gallen
Country
Switzerland
Facility Name
125
City
Cannock
Country
United Kingdom
Facility Name
105
City
Dudley
Country
United Kingdom
Facility Name
56
City
Leeds
Country
United Kingdom
Facility Name
121
City
London
Country
United Kingdom
Facility Name
27
City
London
Country
United Kingdom
Facility Name
80
City
Sheffield
Country
United Kingdom
Facility Name
119
City
York
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27165179
Citation
Emery P, Bingham CO 3rd, Burmester GR, Bykerk VP, Furst DE, Mariette X, van der Heijde D, van Vollenhoven R, Arendt C, Mountian I, Purcaru O, Tatla D, VanLunen B, Weinblatt ME. Certolizumab pegol in combination with dose-optimised methotrexate in DMARD-naive patients with early, active rheumatoid arthritis with poor prognostic factors: 1-year results from C-EARLY, a randomised, double-blind, placebo-controlled phase III study. Ann Rheum Dis. 2017 Jan;76(1):96-104. doi: 10.1136/annrheumdis-2015-209057. Epub 2016 May 10.
Results Reference
result
PubMed Identifier
28666080
Citation
Weinblatt ME, Bingham CO 3rd, Burmester GR, Bykerk VP, Furst DE, Mariette X, van der Heijde D, van Vollenhoven R, VanLunen B, Ecoffet C, Cioffi C, Emery P. A Phase III Study Evaluating Continuation, Tapering, and Withdrawal of Certolizumab Pegol After One Year of Therapy in Patients With Early Rheumatoid Arthritis. Arthritis Rheumatol. 2017 Oct;69(10):1937-1948. doi: 10.1002/art.40196. Epub 2017 Sep 12.
Results Reference
result

Learn more about this trial

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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