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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01521923

Recruitment Status : Completed

First Posted : January 31, 2012

Results First Posted : January 10, 2017

Last Update Posted : July 31, 2018

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

UCB Pharma

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.

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis	Biological: Certolizumab Pegol + Methotrexate (MTX) Biological: Placebo + Methotrexate (MTX)	Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	359 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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 Start Date :	January 2012
Actual Primary Completion Date :	July 2015
Actual Study Completion Date :	September 2015

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rheumatoid arthritis

MedlinePlus related topics: Arthritis Rheumatoid Arthritis

Drug Information available for: Methotrexate Certolizumab pegol

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: CZP 200 mg Q2W + Methotrexate	Biological: 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 Names: Cimzia CZP MTX
Experimental: CZP 200 mg Q4W + Methotrexate	Biological: 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 Names: Cimzia CZP MTX
Placebo Comparator: Placebo + Methotrexate	Biological: Placebo + Methotrexate (MTX) 1 syringe of Placebo every 2 Weeks and MTX. The MTX treatment is to remain between 15-25 mg/week. Other Name: MTX

Outcome Measures

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 [ Time Frame: Week 104 in RA0055 Period 2 ]
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 [ Time Frame: From Week 52 in RA0055 Period 1 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.
Change From Baseline in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2 [ Time Frame: From Baseline (Week 0) in RA0055 Period 1 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 [ Time Frame: From Week 52 in RA0055 Period 1 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 [ Time Frame: From Baseline (Week 0) in 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 [ Time Frame: From Week 52 in 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 [ Time Frame: From Baseline (Week 0) in RA0055 Period 1 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 [ Time Frame: From Week 52 in RA0055 Period 1 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 [ Time Frame: From Baseline (Week 0) in RA0055 Period 1 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 [ Time Frame: From Week 52 in RA0055 Period 1 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 [ Time Frame: From Baseline (Week 0) in RA0055 Period 1 to 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 [ Time Frame: From Baseline (Week 0) in RA0055 Period 1 to 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 [ Time Frame: From Baseline (Week 0) in RA0055 Period 1 to 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From Baseline (Week 0) in RA0055 Period 1 to 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 [ Time Frame: From Baseline (Week 0) in RA0055 Period 1 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 [ Time Frame: From Week 52 in RA0055 Period 1 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 [ Time Frame: From Baseline (Week 0) in RA0055 Period 1 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 [ Time Frame: From Week 52 in RA0055 Period 1 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 [ Time Frame: From Baseline (Week 0) in RA0055 Period 1 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 [ Time Frame: From Week 52 in RA0055 Period 1 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 [ Time Frame: 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 [ Time Frame: 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 Frame: 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 [ Time Frame: From Baseline (Week 0) in RA0055 Period 1 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521923

Locations

Show 178 study locations

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United States, Alabama
209
Birmingham, Alabama, United States
170
Huntsville, Alabama, United States
180
Mobile, Alabama, United States
United States, Arizona
247
Glendale, Arizona, United States
165
Paradise Valley, Arizona, United States
234
Paradise Valley, Arizona, United States
243
Phoenix, Arizona, United States
251
Tucson, Arizona, United States
United States, California
160
Covina, California, United States
257
Hemet, California, United States
159
Los Angeles, California, United States
201
San Leandro, California, United States
202
Upland, California, United States
172
Whittier, California, United States
United States, Florida
190
Fort Lauderdale, Florida, United States
196
Jupiter, Florida, United States
238
Lake Mary, Florida, United States
232
Miami, Florida, United States
213
Naples, Florida, United States
214
Ocala, Florida, United States
237
Orange Park, Florida, United States
255
Orlando, Florida, United States
163
Palm Harbor, Florida, United States
166
Plantation, Florida, United States
192
Sarasota, Florida, United States
200
Vero Beach, Florida, United States
United States, Idaho
226
Coeur d'Alene, Idaho, United States
United States, Illinois
244
Springfield, Illinois, United States
United States, Indiana
224
South Bend, Indiana, United States
United States, Iowa
215
Cedar Rapids, Iowa, United States
United States, Kansas
191
Wichita, Kansas, United States
210
Wichita, Kansas, United States
United States, Maryland
177
Hagerstown, Maryland, United States
United States, Michigan
199
Kalamazoo, Michigan, United States
United States, Minnesota
198
Eagan, Minnesota, United States
United States, Mississippi
203
Tupelo, Mississippi, United States
United States, Missouri
179
Saint Louis, Missouri, United States
United States, Nebraska
181
Lincoln, Nebraska, United States
United States, Nevada
256
Reno, Nevada, United States
United States, New Hampshire
229
Lebanon, New Hampshire, United States
United States, New Jersey
228
Clifton, New Jersey, United States
United States, New Mexico
207
Albuquerque, New Mexico, United States
United States, New York
176
Brooklyn, New York, United States
242
Plainview, New York, United States
227
Rochester, New York, United States
United States, North Carolina
236
Durham, North Carolina, United States
United States, Ohio
245
Middleburg Heights, Ohio, United States
United States, Oklahoma
241
Oklahoma City, Oklahoma, United States
United States, Oregon
186
Portland, Oregon, United States
United States, Pennsylvania
195
Bethlehem, Pennsylvania, United States
167
Duncansville, Pennsylvania, United States
168
Wyomissing, Pennsylvania, United States
United States, South Carolina
189
Charleston, South Carolina, United States
205
Columbia, South Carolina, United States
United States, Tennessee
204
Hendersonville, Tennessee, United States
United States, Texas
217
Allen, Texas, United States
185
Amarillo, Texas, United States
161
Austin, Texas, United States
178
Corpus Christi, Texas, United States
162
Dallas, Texas, United States
184
Houston, Texas, United States
206
Houston, Texas, United States
223
Houston, Texas, United States
158
Mesquite, Texas, United States
175
Nassau Bay, Texas, United States
249
Plano, Texas, United States
197
San Antonio, Texas, United States
United States, Washington
233
Kennewick, Washington, United States
United States, West Virginia
183
Clarksburg, West Virginia, United States
United States, Wisconsin
174
Glendale, Wisconsin, United States
Argentina
276
Buenos Aires, Argentina
284
Rosario, Argentina
279
San Juan, Argentina
291
Tucuman, Argentina
Australia, New South Wales
6
Coffs Harbour, New South Wales, Australia
Australia, Queensland
2
Herson, Queensland, Australia
1
Maroochydore, Queensland, Australia
Australia, South Australia
8
Woodville South, South Australia, Australia
Australia, Victoria
5
Fitzroy, Victoria, Australia
4
Geelong, Victoria, Australia
3
Malvern, Victoria, Australia
Australia, Western Australia
7
Perth, Western Australia, Australia
Austria
50
Wien, Austria
Belgium
51
Brussels, Belgium
126
Gilly, Belgium
36
Kortrijk, Belgium
65
Yvoir, Belgium
Canada, British Columbia
240
Kelowna, British Columbia, Canada
Canada, Ontario
235
Hamilton, Ontario, Canada
Canada, Quebec
188
Montreal, Quebec, Canada
194
Trois-rivieres, Quebec, Canada
Colombia
303
Barranquilla, Colombia
272
Bogota, Colombia
293
Bogota, Colombia
299
Bogota, Colombia
297
Bucaramanga, Colombia
288
Chia, Colombia
271
Medellin, Colombia
298
Medellin, Colombia
Czechia
108
Brno, Czechia
124
Bruntal, Czechia
38
Hradec Kralove, Czechia
37
Praha, Czechia
France
16
Le Kremlin Bicetre, France
85
Le Mans, France
88
Montpellier Cedex 5, France
34
Orleans, France
79
Strasbourg, France
Germany
52
Bad Doberan, Germany
17
Bayreuth, Germany
113
Berlin, Germany
120
Berlin, Germany
89
Erfurt, Germany
70
Frankfurt, Germany
71
Hamburg, Germany
81
Hildesheim, Germany
127
Lingen, Germany
61
München, Germany
53
Planegg, Germany
132
Ratingen, Germany
49
Rendsburg, Germany
69
Rheine, Germany
114
Würzburg, Germany
59
Zerbst, Germany
Hungary
18
Budapest, Hungary
21
Budapest, Hungary
86
Eger, Hungary
131
Szolnok, Hungary
110
Szombathely, Hungary
19
Veszprem, Hungary
Ireland
33
Cork, Ireland
54
Dublin, Ireland
32
Limerick, Ireland
Italy
115
Ferrara, Italy
122
Milano, Italy
40
Reggio Emilia, Italy
72
Roma, Italy
41
Verona, Italy
Mexico
281
Durango, Mexico
286
Guadalajara, Mexico
302
Merida, Mexico
292
Mexico D.F., Mexico
280
Monterrey, Mexico
294
San Luis Potosi, Mexico
Monaco
78
Monaco, Monaco
Netherlands
42
Leiden, Netherlands
Poland
128
Bydgoszcz, Poland
67
Elblag, Poland
99
Krakow, Poland
92
Poznan, Poland
74
Torun, Poland
100
Warszawa, Poland
44
Wroclaw, Poland
Romania
58
Brasov, Romania
111
Bucharest, Romania
22
Bucharest, Romania
25
Bucharest, Romania
26
Bucharest, Romania
24
Iasi, Romania
57
Lasi, Romania
Spain
93
Coruna, Spain
47
Madrid, Spain
63
Santiago de Compostela, Spain
Sweden
76
Göteborg, Sweden
82
Huddinge, Sweden
106
Lund, Sweden
123
Malmö, Sweden
77
Stockholm, Sweden
75
Uppsala, Sweden
Switzerland
118
Fribourg, Switzerland
68
St. Gallen, Switzerland
United Kingdom
125
Cannock, United Kingdom
105
Dudley, United Kingdom
56
Leeds, United Kingdom
121
London, United Kingdom
27
London, United Kingdom
80
Sheffield, United Kingdom
119
York, United Kingdom

Sponsors and Collaborators

UCB Pharma

Investigators

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Study Director:	UCB Clinical Trial Call Center	+1 877 822 9493 (UCB)

More Information

Publications of Results:

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.

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.

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Responsible Party:	UCB Pharma
ClinicalTrials.gov Identifier:	NCT01521923
Other Study ID Numbers:	RA0055 Period 2 2011-001729-25 ( EudraCT Number )
First Posted:	January 31, 2012 Key Record Dates
Results First Posted:	January 10, 2017
Last Update Posted:	July 31, 2018
Last Verified:	November 2016

Keywords provided by UCB Pharma:


Certolizumab Pegol - Cimzia Rheumatoid Arthritis

Additional relevant MeSH terms:

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Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Certolizumab Pegol Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs	Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Tumor Necrosis Factor Inhibitors Anti-Inflammatory Agents

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