Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.



Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01521923




Registration number
NCT01521923
Ethics application status
Date submitted
19/01/2012
Date registered
31/01/2012
Date last updated
31/07/2018

Titles & IDs
Public title
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis
Scientific title
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid Arthritis
Secondary ID [1] 0 0
2011-001729-25
Secondary ID [2] 0 0
RA0055 Period 2
Universal Trial Number (UTN)
Trial acronym
C-early
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Other - Certolizumab Pegol + Methotrexate (MTX)
Treatment: Other - Placebo + Methotrexate (MTX)

Experimental: CZP 200 mg Q2W + Methotrexate -

Experimental: CZP 200 mg Q4W + Methotrexate -

Placebo comparator: Placebo + Methotrexate -


Treatment: Other: 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.

Treatment: Other: Placebo + Methotrexate (MTX)
1 syringe of Placebo every 2 Weeks and MTX.

The MTX treatment is to remain between 15-25 mg/week.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2 Without Flaring
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Week 104 in RA0055 Period 2
Secondary outcome [1] 0 0
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
Assessment method [1] 0 0
DAS28\[ESR\] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x v(TJC) + 0.28 x v(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.
Timepoint [1] 0 0
From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
Secondary outcome [2] 0 0
Change From Baseline in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2
Assessment method [2] 0 0
Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage.
Timepoint [2] 0 0
From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Secondary outcome [3] 0 0
Change From Week 52 in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2
Assessment method [3] 0 0
Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage.
Timepoint [3] 0 0
From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
Secondary outcome [4] 0 0
Percentage of Subjects With Radiographic Non-progression From Baseline in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Secondary outcome [5] 0 0
Percentage of Subjects With Radiographic Non-progression From Week 52 in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
Secondary outcome [6] 0 0
Change From Baseline in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Secondary outcome [7] 0 0
Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
Secondary outcome [8] 0 0
Change From Baseline in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2
Assessment method [8] 0 0
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.
Timepoint [8] 0 0
From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Secondary outcome [9] 0 0
Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2
Assessment method [9] 0 0
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.
Timepoint [9] 0 0
From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
Secondary outcome [10] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 104 in RA0055 Period 2
Assessment method [10] 0 0
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).
Timepoint [10] 0 0
From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Secondary outcome [11] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 104 in RA0055 Period 2
Assessment method [11] 0 0
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).
Timepoint [11] 0 0
From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Secondary outcome [12] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 104 in RA0055 Period 2
Assessment method [12] 0 0
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).
Timepoint [12] 0 0
From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Secondary outcome [13] 0 0
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
Assessment method [13] 0 0
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.
Timepoint [13] 0 0
Week 104 in RA0055 Period 2
Secondary outcome [14] 0 0
Percentage of Subjects With Clinical Disease Activity Index (CDAI) <= 2.8 at Week 104 in RA0055 Period 2
Assessment method [14] 0 0
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined where a lower score indicates less disease activity.
Timepoint [14] 0 0
Week 104 in RA0055 Period 2
Secondary outcome [15] 0 0
Percentage of Subjects With Simplified Disease Activity Index (SDAI) <= 3.3 at Week 104 in RA0055 Period 2
Assessment method [15] 0 0
SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity. The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline.
Timepoint [15] 0 0
Week 104 in RA0055 Period 2
Secondary outcome [16] 0 0
Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) < 2.6 at Week 104 in RA0055 Period 2
Assessment method [16] 0 0
DAS28\[ESR\] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x v(TJC) + 0.28 x v(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.
Timepoint [16] 0 0
Week 104 in RA0055 Period 2
Secondary outcome [17] 0 0
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
Assessment method [17] 0 0
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.
Timepoint [17] 0 0
Week 104 in RA0055 Period 2
Secondary outcome [18] 0 0
Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 104 in RA0055 Period 2
Assessment method [18] 0 0
Good response is defined as: DAS28\[ESR\] \<= 3.2 and decrease from Baseline by \>1.2; moderate response is defined as achievement of one of the following: * DAS28\[ESR\] \<= 3.2 and decrease from Baseline \> 0.6 and = 1.2 * DAS28\[ESR\] \> 3.2 and = 5.1 and decrease from Baseline \> 0.6 * DAS28\[ESR\] \> 5.1 and decrease from Baseline \>1.2. LOCF= Last Observation Carried Forward
Timepoint [18] 0 0
From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Secondary outcome [19] 0 0
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
Assessment method [19] 0 0
DAS28\[ESR\] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x v(TJC) + 0.28 x v(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity. 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.
Timepoint [19] 0 0
From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Secondary outcome [20] 0 0
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
Assessment method [20] 0 0
DAS28\[ESR\] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x v(TJC) + 0.28 x v(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity. 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.
Timepoint [20] 0 0
From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
Secondary outcome [21] 0 0
Change From Baseline in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2
Assessment method [21] 0 0
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined. CDAI ranges from 0-76 with lower scores indicating less disease activity and higher scores indicating higher disease activity. A negative value in CDAI change from Baseline indicates an improvement from Baseline.
Timepoint [21] 0 0
From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Secondary outcome [22] 0 0
Change From Week 52 in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2
Assessment method [22] 0 0
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined. CDAI ranges from 0-76 with lower scores indicating less disease activity and higher scores indicating higher disease activity.A negative value in CDAI change from Baseline indicates an improvement from Baseline.
Timepoint [22] 0 0
From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
Secondary outcome [23] 0 0
Change From Baseline in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2
Assessment method [23] 0 0
SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity. The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline.
Timepoint [23] 0 0
From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Secondary outcome [24] 0 0
Change From Week 52 in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2
Assessment method [24] 0 0
SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity. The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline.
Timepoint [24] 0 0
From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
Secondary outcome [25] 0 0
Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) = 0.5 at Week 104 in RA0055 Period 2
Assessment method [25] 0 0
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.
Timepoint [25] 0 0
Week 104 in RA0055 Period 2
Secondary outcome [26] 0 0
Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2
Assessment method [26] 0 0
DAS28\[ESR\] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x v(TJC) + 0.28 x v(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.
Timepoint [26] 0 0
Week 104 in RA0055 Period 2
Secondary outcome [27] 0 0
Time to Flare From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
Assessment method [27] 0 0
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.
Timepoint [27] 0 0
Week 104 in RA0055 Period 2
Secondary outcome [28] 0 0
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
Assessment method [28] 0 0
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.
Timepoint [28] 0 0
From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Secondary outcome [29] 0 0
Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Assessment method [29] 0 0
Number of work days missed in the last month for employed subjects.
Timepoint [29] 0 0
Week 104 in RA0055 Period 2
Secondary outcome [30] 0 0
Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Assessment method [30] 0 0
Number of work days with reduced productivity in the last month for employed subjects. Only the employed subjects were analyzed.
Timepoint [30] 0 0
Week 104 in RA0055 Period 2
Secondary outcome [31] 0 0
Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Assessment method [31] 0 0
The Arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference) for employed subjects. Only the employed subjects were analyzed.
Timepoint [31] 0 0
Week 104 in RA0055 Period 2
Secondary outcome [32] 0 0
Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Assessment method [32] 0 0
Number of days with no household work in the last month.
Timepoint [32] 0 0
Week 104 in RA0055 Period 2
Secondary outcome [33] 0 0
Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Assessment method [33] 0 0
Number of days with reduced household work productivity in the last month.
Timepoint [33] 0 0
Week 104 in RA0055 Period 2
Secondary outcome [34] 0 0
Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Assessment method [34] 0 0
Number of days with hired outside help days in the last month.
Timepoint [34] 0 0
Week 104 in RA0055 Period 2
Secondary outcome [35] 0 0
Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Assessment method [35] 0 0
Number of days missed of family/social/leisure activities in the last month.
Timepoint [35] 0 0
Week 104 in RA0055 Period 2
Secondary outcome [36] 0 0
Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Assessment method [36] 0 0
The Arthritis interference in the last month with household productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).
Timepoint [36] 0 0
Week 104 in RA0055 Period 2
Secondary outcome [37] 0 0
Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 104 in RA0055 Period 2
Assessment method [37] 0 0
LDA is defined as achieving a Disease Activity Score 28 \[Erythrocyte Sedimentation Rate\] (DAS28 \[ESR\]) \<= 3.2. DAS28 values range from 2.0 to 10.0 with a higher value indicating a higher disease activity.
Timepoint [37] 0 0
Week 104 in RA0055 Period 2

Eligibility
Key inclusion criteria
- Those subjects in previous study RA0055 Period 1 who are in sustained LDA (defined as DAS28[ESR] = 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Those subjects in previous study RA0055 Period 1 who are NOT in sustained LDA (defined as DAS28[ESR] = 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
359
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
6 - Coffs Harbour
Recruitment hospital [2] 0 0
2 - Herson
Recruitment hospital [3] 0 0
1 - Maroochydore
Recruitment hospital [4] 0 0
8 - Woodville South
Recruitment hospital [5] 0 0
5 - Fitzroy
Recruitment hospital [6] 0 0
4 - Geelong
Recruitment hospital [7] 0 0
3 - Malvern
Recruitment hospital [8] 0 0
7 - Perth
Recruitment postcode(s) [1] 0 0
- Coffs Harbour
Recruitment postcode(s) [2] 0 0
- Herson
Recruitment postcode(s) [3] 0 0
- Maroochydore
Recruitment postcode(s) [4] 0 0
- Woodville South
Recruitment postcode(s) [5] 0 0
- Fitzroy
Recruitment postcode(s) [6] 0 0
- Geelong
Recruitment postcode(s) [7] 0 0
- Malvern
Recruitment postcode(s) [8] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Mississippi
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
Nevada
Country [17] 0 0
United States of America
State/province [17] 0 0
New Hampshire
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
State/province [19] 0 0
New Mexico
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Oklahoma
Country [24] 0 0
United States of America
State/province [24] 0 0
Oregon
Country [25] 0 0
United States of America
State/province [25] 0 0
Pennsylvania
Country [26] 0 0
United States of America
State/province [26] 0 0
South Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Washington
Country [30] 0 0
United States of America
State/province [30] 0 0
West Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
Wisconsin
Country [32] 0 0
Argentina
State/province [32] 0 0
Buenos Aires
Country [33] 0 0
Argentina
State/province [33] 0 0
Rosario
Country [34] 0 0
Argentina
State/province [34] 0 0
San Juan
Country [35] 0 0
Argentina
State/province [35] 0 0
Tucuman
Country [36] 0 0
Austria
State/province [36] 0 0
Wien
Country [37] 0 0
Belgium
State/province [37] 0 0
Brussels
Country [38] 0 0
Belgium
State/province [38] 0 0
Gilly
Country [39] 0 0
Belgium
State/province [39] 0 0
Kortrijk
Country [40] 0 0
Belgium
State/province [40] 0 0
Yvoir
Country [41] 0 0
Canada
State/province [41] 0 0
British Columbia
Country [42] 0 0
Canada
State/province [42] 0 0
Ontario
Country [43] 0 0
Canada
State/province [43] 0 0
Quebec
Country [44] 0 0
Colombia
State/province [44] 0 0
Barranquilla
Country [45] 0 0
Colombia
State/province [45] 0 0
Bogota
Country [46] 0 0
Colombia
State/province [46] 0 0
Bucaramanga
Country [47] 0 0
Colombia
State/province [47] 0 0
Chia
Country [48] 0 0
Colombia
State/province [48] 0 0
Medellin
Country [49] 0 0
Czechia
State/province [49] 0 0
Brno
Country [50] 0 0
Czechia
State/province [50] 0 0
Bruntal
Country [51] 0 0
Czechia
State/province [51] 0 0
Hradec Kralove
Country [52] 0 0
Czechia
State/province [52] 0 0
Praha
Country [53] 0 0
France
State/province [53] 0 0
Le Kremlin Bicetre
Country [54] 0 0
France
State/province [54] 0 0
Le Mans
Country [55] 0 0
France
State/province [55] 0 0
Montpellier Cedex 5
Country [56] 0 0
France
State/province [56] 0 0
Orleans
Country [57] 0 0
France
State/province [57] 0 0
Strasbourg
Country [58] 0 0
Germany
State/province [58] 0 0
Bad Doberan
Country [59] 0 0
Germany
State/province [59] 0 0
Bayreuth
Country [60] 0 0
Germany
State/province [60] 0 0
Berlin
Country [61] 0 0
Germany
State/province [61] 0 0
Erfurt
Country [62] 0 0
Germany
State/province [62] 0 0
Frankfurt
Country [63] 0 0
Germany
State/province [63] 0 0
Hamburg
Country [64] 0 0
Germany
State/province [64] 0 0
Hildesheim
Country [65] 0 0
Germany
State/province [65] 0 0
Lingen
Country [66] 0 0
Germany
State/province [66] 0 0
München
Country [67] 0 0
Germany
State/province [67] 0 0
Planegg
Country [68] 0 0
Germany
State/province [68] 0 0
Ratingen
Country [69] 0 0
Germany
State/province [69] 0 0
Rendsburg
Country [70] 0 0
Germany
State/province [70] 0 0
Rheine
Country [71] 0 0
Germany
State/province [71] 0 0
Würzburg
Country [72] 0 0
Germany
State/province [72] 0 0
Zerbst
Country [73] 0 0
Hungary
State/province [73] 0 0
Budapest
Country [74] 0 0
Hungary
State/province [74] 0 0
Eger
Country [75] 0 0
Hungary
State/province [75] 0 0
Szolnok
Country [76] 0 0
Hungary
State/province [76] 0 0
Szombathely
Country [77] 0 0
Hungary
State/province [77] 0 0
Veszprem
Country [78] 0 0
Ireland
State/province [78] 0 0
Cork
Country [79] 0 0
Ireland
State/province [79] 0 0
Dublin
Country [80] 0 0
Ireland
State/province [80] 0 0
Limerick
Country [81] 0 0
Italy
State/province [81] 0 0
Ferrara
Country [82] 0 0
Italy
State/province [82] 0 0
Milano
Country [83] 0 0
Italy
State/province [83] 0 0
Reggio Emilia
Country [84] 0 0
Italy
State/province [84] 0 0
Roma
Country [85] 0 0
Italy
State/province [85] 0 0
Verona
Country [86] 0 0
Mexico
State/province [86] 0 0
Durango
Country [87] 0 0
Mexico
State/province [87] 0 0
Guadalajara
Country [88] 0 0
Mexico
State/province [88] 0 0
Merida
Country [89] 0 0
Mexico
State/province [89] 0 0
Mexico D.F.
Country [90] 0 0
Mexico
State/province [90] 0 0
Monterrey
Country [91] 0 0
Mexico
State/province [91] 0 0
San Luis Potosi
Country [92] 0 0
Monaco
State/province [92] 0 0
Monaco
Country [93] 0 0
Netherlands
State/province [93] 0 0
Leiden
Country [94] 0 0
Poland
State/province [94] 0 0
Bydgoszcz
Country [95] 0 0
Poland
State/province [95] 0 0
Elblag
Country [96] 0 0
Poland
State/province [96] 0 0
Krakow
Country [97] 0 0
Poland
State/province [97] 0 0
Poznan
Country [98] 0 0
Poland
State/province [98] 0 0
Torun
Country [99] 0 0
Poland
State/province [99] 0 0
Warszawa
Country [100] 0 0
Poland
State/province [100] 0 0
Wroclaw
Country [101] 0 0
Romania
State/province [101] 0 0
Brasov
Country [102] 0 0
Romania
State/province [102] 0 0
Bucharest
Country [103] 0 0
Romania
State/province [103] 0 0
Iasi
Country [104] 0 0
Romania
State/province [104] 0 0
Lasi
Country [105] 0 0
Spain
State/province [105] 0 0
Coruna
Country [106] 0 0
Spain
State/province [106] 0 0
Madrid
Country [107] 0 0
Spain
State/province [107] 0 0
Santiago de Compostela
Country [108] 0 0
Sweden
State/province [108] 0 0
Göteborg
Country [109] 0 0
Sweden
State/province [109] 0 0
Huddinge
Country [110] 0 0
Sweden
State/province [110] 0 0
Lund
Country [111] 0 0
Sweden
State/province [111] 0 0
Malmö
Country [112] 0 0
Sweden
State/province [112] 0 0
Stockholm
Country [113] 0 0
Sweden
State/province [113] 0 0
Uppsala
Country [114] 0 0
Switzerland
State/province [114] 0 0
Fribourg
Country [115] 0 0
Switzerland
State/province [115] 0 0
St. Gallen
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Cannock
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Dudley
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Leeds
Country [119] 0 0
United Kingdom
State/province [119] 0 0
London
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Sheffield
Country [121] 0 0
United Kingdom
State/province [121] 0 0
York

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Pharma
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Clinical Trial Call Center
Address 0 0
+1 877 822 9493 (UCB)
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results are available at https://clinicaltrials.gov/study/NCT01521923