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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01519791




Registration number
NCT01519791
Ethics application status
Date submitted
19/01/2012
Date registered
27/01/2012
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 1
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
Other interventions - Certolizumab Pegol
Other interventions - Placebo
Other interventions - Methotrexate

Experimental: Certolizumab Pegol + Methotrexate -

Placebo Comparator: Placebo + Methotrexate -


Other interventions: Certolizumab Pegol
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
Injections will be given subcutaneously. CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 50.

Other interventions: Placebo
2 syringes Placebo at Baseline, Week 2 and Week 4, followed by 1 syringe Placebo every 2 Weeks.

Other interventions: Methotrexate
The MTX treatment is to be initiated at a dose of 10 mg per Week (oral tablets at the strength of 2.5 mg/tablet). The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8. Patients who could not tolerate = 15 mg/week MTX by Week 8 were withdrawn while the maximum tolerated dose per patient (optimized dose) was maintained to Week 52.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects in Sustained Remission at Week 52
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Percentage of Subjects in Sustained Low Disease Activity (LDA) at Week 52
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Change From Baseline in Modified Total Sharp Score (mTSS) to Week 52
Timepoint [2] 0 0
From Baseline (Week 0) to Week 52
Secondary outcome [3] 0 0
Percentage of Subjects With Radiographic Non-progression From Baseline to Week 52
Timepoint [3] 0 0
From Baseline (Week 0) to Week 52
Secondary outcome [4] 0 0
Change From Baseline in the Joint Erosion Score to Week 52
Timepoint [4] 0 0
From Baseline (Week 0) to Week 52
Secondary outcome [5] 0 0
Change From Baseline in the Joint Narrowing Score to Week 52
Timepoint [5] 0 0
From Baseline (Week 0) to Week 52
Secondary outcome [6] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52
Timepoint [6] 0 0
From Baseline (Week 0) to Week 52
Secondary outcome [7] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52
Timepoint [7] 0 0
From Baseline (Week 0) to Week 52
Secondary outcome [8] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52
Timepoint [8] 0 0
From Baseline (Week 0) to Week 52
Secondary outcome [9] 0 0
Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria at Week 52
Timepoint [9] 0 0
Week 52
Secondary outcome [10] 0 0
Percentage of Subjects With Clinical Disease Activity Index (CDAI) = 2.8 at Week 52
Timepoint [10] 0 0
Week 52
Secondary outcome [11] 0 0
Percentage of Subjects With Simplified Disease Activity Index (SDAI) = 3.3 at Week 52
Timepoint [11] 0 0
Week 52
Secondary outcome [12] 0 0
Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) < 2.6 at Week 52
Timepoint [12] 0 0
Week 52
Secondary outcome [13] 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 52
Timepoint [13] 0 0
Week 52
Secondary outcome [14] 0 0
Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 52
Timepoint [14] 0 0
From Baseline (Week 0) to Week 52
Secondary outcome [15] 0 0
Change From Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 52
Timepoint [15] 0 0
From Baseline (Week 0) to Week 52
Secondary outcome [16] 0 0
Change From Baseline in Clinical Disease Activity Index (CDAI) to Week 52
Timepoint [16] 0 0
From Baseline (Week 0) to Week 52
Secondary outcome [17] 0 0
Change From Baseline in Simplified Disease Activity Index (SDAI) to Week 52
Timepoint [17] 0 0
From Baseline (Week 0) to Week 52
Secondary outcome [18] 0 0
Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) = 0.5 at Week 52
Timepoint [18] 0 0
Week 52
Secondary outcome [19] 0 0
Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) to Week 52
Timepoint [19] 0 0
From Baseline (Week 0) to Week 52
Secondary outcome [20] 0 0
Change From Baseline in the Bristol Rheumatoid Arthritis Fatigue- Multidimensional Questionnaire (BRAF-MDQ) Total Score to Week 52
Timepoint [20] 0 0
From Baseline (Week 0) to Week 52
Secondary outcome [21] 0 0
Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Timepoint [21] 0 0
Week 52
Secondary outcome [22] 0 0
Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Timepoint [22] 0 0
Week 52
Secondary outcome [23] 0 0
Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Timepoint [23] 0 0
Week 52
Secondary outcome [24] 0 0
Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Timepoint [24] 0 0
Week 52
Secondary outcome [25] 0 0
Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Timepoint [25] 0 0
Week 52
Secondary outcome [26] 0 0
Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Timepoint [26] 0 0
Week 52
Secondary outcome [27] 0 0
Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Timepoint [27] 0 0
Week 52
Secondary outcome [28] 0 0
Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Timepoint [28] 0 0
Week 52
Secondary outcome [29] 0 0
Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 52
Timepoint [29] 0 0
Week 52

Eligibility
Key inclusion criteria
- Subjects must have a time since diagnosis of adult-onset Rheumatoid Arthritis (RA)
less than 1 year as defined by the 2010 ACR/EULAR classification criteria from
Screening Visit

- Positive Rheumatoid Factor (RF) and/or positive anticyclic Citrullinated Peptide
Antibody (anti-CCP)

- Active RA disease

- DMARD-naïve

- Subject is naïve to RA related biologics
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- A diagnosis of any other inflammatory Arthritis

- History of infected joint prosthesis, or other significant infection and other serious
medical condition

- Known Tuberculosis (TB) disease or high risk of acquiring TB infection

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
880
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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Missouri
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Nebraska
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Torun
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Wroclaw
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Brasov
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Bucharest
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Iasi
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Lasi
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Spain
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Coruna
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Madrid
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Santiago de Compostela
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Göteborg
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Huddinge
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Lund
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Stockholm
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Fribourg
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Cannock
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Dudley
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Leeds
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York

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
UCB Pharma SA
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 inducing and sustaining clinical response in the
treatment of Disease Modifying Antirheumatic Drug (DMARD)-naïve adults with early active
Rheumatoid Arthritis.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01519791
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
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