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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

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
State/province [12] 0 0
Hellerup
Country [13] 0 0
Denmark
State/province [13] 0 0
Hørsholm
Country [14] 0 0
Denmark
State/province [14] 0 0
Odense C
Country [15] 0 0
Denmark
State/province [15] 0 0
Roskilde
Country [16] 0 0
Finland
State/province [16] 0 0
Helsinki
Country [17] 0 0
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
Country [24] 0 0
France
State/province [24] 0 0
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
State/province [27] 0 0
Créteil cedex
Country [28] 0 0
France
State/province [28] 0 0
Limoges
Country [29] 0 0
France
State/province [29] 0 0
Nice
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France
State/province [30] 0 0
Paris
Country [31] 0 0
France
State/province [31] 0 0
Pierre Bénite
Country [32] 0 0
France
State/province [32] 0 0
Poitiers
Country [33] 0 0
France
State/province [33] 0 0
Rouen
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France
State/province [34] 0 0
Tours
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Germany
State/province [35] 0 0
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
State/province [38] 0 0
Erlangen
Country [39] 0 0
Germany
State/province [39] 0 0
Frankfurt
Country [40] 0 0
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
Country [43] 0 0
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
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Germany
State/province [46] 0 0
Osnabrueck
Country [47] 0 0
Germany
State/province [47] 0 0
Rostock
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Germany
State/province [48] 0 0
Wuerzburg
Country [49] 0 0
Greece
State/province [49] 0 0
Athens
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Hungary
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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
State/province [65] 0 0
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
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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
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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
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Switzerland
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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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00245960