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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00245960




Registration number
NCT00245960
Ethics application status
Date submitted
26/10/2005
Date registered
28/10/2005
Date last updated
31/01/2022

Titles & IDs
Public title
Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis
Scientific title
A RANDOMIZED, OPEN-LABEL, TWO-PERIOD STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ETANERCEPT ON SKIN AND JOINT DISEASE IN PSORIASIS SUBJECTS WITH PSORIATIC ARTHRITIS
Secondary ID [1] 0 0
2005-001533-15
Secondary ID [2] 0 0
0881A5-401
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active comparator: A - Period 1 (Double Blind): 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): 50 mg weekly (QW).

Active comparator: B - Period 1 (Double Blind): 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): 50 mg weekly (QW) for weeks 13-24.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC)
Timepoint [1] 0 0
12 and 24 weeks

Eligibility
Key inclusion criteria
* 18 years of age or older at time of consent
* Active Psoriatic Arthritis
* Clinically stable, plaque psoriasis involving more than 10% of the body surface area
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Evidence of skin conditions other than psoriasis that would interfere with skin examinations.
* Systemic anti-psoriasis therapy or DMARD within 28 days of study drug initiation
* Prior exposure to any TNF-inhibitor, including etanercept

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


Intervention assignment
Parallel
Other design features
Phase
Phase 4
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
27/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/03/2008
Sample size
Target
Accrual to date
Final
752
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Goulburn Street Medical Centre - Liverpool
Recruitment hospital [2] 0 0
St Vincent's Hospital VIC - Fitzroy
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
VIC 3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Austria
State/province [2] 0 0
SM
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
Country [4] 0 0
Belgium
State/province [4] 0 0
Gent
Country [5] 0 0
Belgium
State/province [5] 0 0
Liege
Country [6] 0 0
Colombia
State/province [6] 0 0
Atlantico
Country [7] 0 0
Colombia
State/province [7] 0 0
Bogota
Country [8] 0 0
Czechia
State/province [8] 0 0
Czech Republic
Country [9] 0 0
Czechia
State/province [9] 0 0
Praha 2
Country [10] 0 0
Czechia
State/province [10] 0 0
Uherske Hradiste
Country [11] 0 0
Denmark
State/province [11] 0 0
Copenhagen
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Denmark
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Hellerup
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Denmark
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Hørsholm
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Denmark
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Odense C
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Denmark
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Roskilde
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Finland
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Helsinki
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Finland
State/province [17] 0 0
Tampere
Country [18] 0 0
Finland
State/province [18] 0 0
Turku
Country [19] 0 0
Former Serbia and Montenegro
State/province [19] 0 0
Belgrade
Country [20] 0 0
Former Serbia and Montenegro
State/province [20] 0 0
Niska Banja
Country [21] 0 0
Former Serbia and Montenegro
State/province [21] 0 0
Novi Sad
Country [22] 0 0
Former Serbia and Montenegro
State/province [22] 0 0
Zemun
Country [23] 0 0
France
State/province [23] 0 0
Cedex
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France
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Bordeaux
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France
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Brest cedex 2
Country [26] 0 0
France
State/province [26] 0 0
Caen
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France
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Créteil cedex
Country [28] 0 0
France
State/province [28] 0 0
Limoges
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France
State/province [29] 0 0
Nice
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France
State/province [30] 0 0
Paris
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France
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Pierre Bénite
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France
State/province [32] 0 0
Poitiers
Country [33] 0 0
France
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Rouen
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France
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Tours
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Germany
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Bad Bentheim
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Erlangen
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Germany
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Frankfurt
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Germany
State/province [40] 0 0
Goettingen
Country [41] 0 0
Germany
State/province [41] 0 0
Hamburg-Eilbek
Country [42] 0 0
Germany
State/province [42] 0 0
Hamburg
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Germany
State/province [43] 0 0
Jena
Country [44] 0 0
Germany
State/province [44] 0 0
Mahlow
Country [45] 0 0
Germany
State/province [45] 0 0
Muenchen
Country [46] 0 0
Germany
State/province [46] 0 0
Osnabrueck
Country [47] 0 0
Germany
State/province [47] 0 0
Rostock
Country [48] 0 0
Germany
State/province [48] 0 0
Wuerzburg
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Greece
State/province [49] 0 0
Athens
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Hungary
State/province [50] 0 0
Budapest
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Hungary
State/province [51] 0 0
Debrecen
Country [52] 0 0
Hungary
State/province [52] 0 0
Miskolc
Country [53] 0 0
Hungary
State/province [53] 0 0
Pecs
Country [54] 0 0
Hungary
State/province [54] 0 0
Szeged
Country [55] 0 0
Hungary
State/province [55] 0 0
Szolnok
Country [56] 0 0
Italy
State/province [56] 0 0
Brescia
Country [57] 0 0
Italy
State/province [57] 0 0
Cagliari
Country [58] 0 0
Italy
State/province [58] 0 0
Catania
Country [59] 0 0
Italy
State/province [59] 0 0
Milano
Country [60] 0 0
Italy
State/province [60] 0 0
Parma
Country [61] 0 0
Italy
State/province [61] 0 0
Roma
Country [62] 0 0
Italy
State/province [62] 0 0
Siena
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Seoul
Country [64] 0 0
Mexico
State/province [64] 0 0
Jalisco
Country [65] 0 0
Mexico
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Mexico City
Country [66] 0 0
Netherlands
State/province [66] 0 0
GA
Country [67] 0 0
Netherlands
State/province [67] 0 0
THE Netherlands
Country [68] 0 0
Netherlands
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Maastricht
Country [69] 0 0
Netherlands
State/province [69] 0 0
Vlissingen
Country [70] 0 0
Netherlands
State/province [70] 0 0
Voorburg
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Poland
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Bydgoszcz
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Poland
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Lublin
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Poland
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Warszawa
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Portugal
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Coimbra
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Portugal
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Porto
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Saudi Arabia
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Riyadh
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Spain
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Cadiz
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Spain
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Guipúzcua
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Spain
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Isalas Canarias
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Spain
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Madrid
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Spain
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Barcelona
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Sweden
State/province [82] 0 0
Jönköping
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Sweden
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Umeå
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Sweden
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Uppsala
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Switzerland
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Lausanne
Country [86] 0 0
Switzerland
State/province [86] 0 0
Zurich
Country [87] 0 0
Taiwan
State/province [87] 0 0
Taiwan, R.o.c.
Country [88] 0 0
Taiwan
State/province [88] 0 0
Taipei TOC
Country [89] 0 0
Turkey
State/province [89] 0 0
Ankara
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Hampstead
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Lancashire
Country [92] 0 0
United Kingdom
State/province [92] 0 0
North Yorkshire
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Yorkshire
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Aberdeen
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Cardiff
Country [96] 0 0
United Kingdom
State/province [96] 0 0
London
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Nuneaton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Wyeth is now a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study was to compare the efficacy of 2 different Etanercept regimens for the treatment of skin and joint manifestations of psoriatic arthritis.
Trial website
https://clinicaltrials.gov/study/NCT00245960
Trial related presentations / publications
Coates LC, Gottlieb AB, Merola JF, Boone C, Szumski A, Chhabra A. Comparison of Different Remission and Low Disease Definitions in Psoriatic Arthritis and Evaluation of Their Prognostic Value. J Rheumatol. 2019 Feb;46(2):160-165. doi: 10.3899/jrheum.180249. Epub 2018 Oct 15.
Griffiths CE, Christophers E, Szumski A, Jones H, Mallbris L. Impact of early vs. late disease onset on treatment response to etanercept in patients with psoriasis. Br J Dermatol. 2015 Nov;173(5):1271-3. doi: 10.1111/bjd.13865. Epub 2015 Aug 17. No abstract available.
Kirkham B, de Vlam K, Li W, Boggs R, Mallbris L, Nab HW, Tarallo M. Early treatment of psoriatic arthritis is associated with improved patient-reported outcomes: findings from the etanercept PRESTA trial. Clin Exp Rheumatol. 2015 Jan-Feb;33(1):11-9. Epub 2014 Dec 22.
Griffiths CE, Sterry W, Brock F, Dilleen M, Stefanidis D, Germain JM, Mallbris L. Pattern of response in patients with moderate-to-severe psoriasis treated with etanercept. Br J Dermatol. 2015 Jan;172(1):230-8. doi: 10.1111/bjd.13139. Epub 2014 Nov 13.
Gniadecki R, Robertson D, Molta CT, Freundlich B, Pedersen R, Li W, Boggs R, Zbrozek AS. Self-reported health outcomes in patients with psoriasis and psoriatic arthritis randomized to two etanercept regimens. J Eur Acad Dermatol Venereol. 2012 Nov;26(11):1436-43. doi: 10.1111/j.1468-3083.2011.04308.x. Epub 2011 Oct 31.
Sterry W, Ortonne JP, Kirkham B, Brocq O, Robertson D, Pedersen RD, Estojak J, Molta CT, Freundlich B. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial. BMJ. 2010 Feb 2;340:c147. doi: 10.1136/bmj.c147.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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/NCT00245960