Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/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
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 City
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 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