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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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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United States of America
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Alabama
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United States of America
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Arizona
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California
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Illinois
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Kansas
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Maryland
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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Nevada
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New Hampshire
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North Carolina
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Ohio
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West Virginia
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Austria
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Belgium
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Brussels
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Belgium
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Gilly
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Kortrijk
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Belgium
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Yvoir
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Canada
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British Columbia
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Canada
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Ontario
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Quebec
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Colombia
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Brno
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Bruntal
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Hradec Kralove
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Praha
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Montpellier Cedex 5
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Orleans
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Bayreuth
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Erfurt
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Germany
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Frankfurt
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Hamburg
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Germany
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Hildesheim
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Lingen
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München
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Germany
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Planegg
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Germany
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Ratingen
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Germany
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Rendsburg
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Rheine
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Würzburg
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Germany
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Zerbst
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Hungary
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Budapest
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Eger
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Szolnok
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Szombathely
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Veszprem
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Ireland
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Cork
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Dublin
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Limerick
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Italy
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Ferrara
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Italy
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Milano
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Italy
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Reggio Emilia
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Roma
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Verona
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Mexico
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Durango
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Guadalajara
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Merida
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Monterrey
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Mexico
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San Luis Potosi
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Monaco
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Monaco
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Netherlands
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Leiden
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Poland
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Bydgoszcz
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Poland
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Elblag
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Poland
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Krakow
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Poland
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Poznan
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Poland
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Torun
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Poland
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Warszawa
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Poland
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Wroclaw
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Romania
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Brasov
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Romania
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Bucharest
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Romania
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Iasi
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Romania
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Lasi
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Spain
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Coruna
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Spain
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Madrid
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Spain
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Santiago de Compostela
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Sweden
State/province [108] 0 0
Göteborg
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Sweden
State/province [109] 0 0
Huddinge
Country [110] 0 0
Sweden
State/province [110] 0 0
Lund
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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
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Switzerland
State/province [114] 0 0
Fribourg
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Switzerland
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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
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for sustaining clinical response achieved in study RA0055 Period 1 \[NCT01519791\]. Subjects entering this study RA0055 Period 2 achieved sustained Low Disease Activity at Week 52 in study RA0055 Period 1.
Trial website
https://clinicaltrials.gov/study/NCT01521923
Trial related presentations / publications
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.
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
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01521923