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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Treatment: Other - Certolizumab Pegol
Other interventions - Placebo
Treatment: Other - Methotrexate

Experimental: Certolizumab Pegol + Methotrexate -

Placebo comparator: Placebo + Methotrexate -


Treatment: Other: 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.

Treatment: Other: 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 Patients who could not tolerate = 15 mg/week MTX by Week 8 were withdrawn while the maximum tolerated dose per patient (optimized dose) was maintained to Week 52.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
Treatment: Other
Intervention code [2] 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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
Country [3] 0 0
United States of America
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California
Country [4] 0 0
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Florida
Country [5] 0 0
United States of America
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Idaho
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United States of America
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Illinois
Country [7] 0 0
United States of America
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Indiana
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Iowa
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United States of America
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Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
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Michigan
Country [12] 0 0
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Minnesota
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Mississippi
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Missouri
Country [15] 0 0
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Nebraska
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Nevada
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New Hampshire
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Washington
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West Virginia
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Rosario
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Argentina
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San Juan
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Argentina
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Tucuman
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Austria
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Wien
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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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Yvoir
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Ontario
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Bucaramanga
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Chia
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Medellin
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Brno
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Bruntal
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Le Mans
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Lingen
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München
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Planegg
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Ratingen
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Rendsburg
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Rheine
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Würzburg
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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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Cork
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Dublin
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Limerick
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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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Monaco
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Leiden
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Bydgoszcz
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Elblag
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Krakow
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Poznan
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Torun
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Warszawa
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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
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Göteborg
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Sweden
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Huddinge
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Lund
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Malmö
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Stockholm
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Uppsala
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Switzerland
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Fribourg
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Switzerland
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St. Gallen
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United Kingdom
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Cannock
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Dudley
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Leeds
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London
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Sheffield
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United Kingdom
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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
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
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

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/NCT01519791