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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/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
Treatment: Drugs - etanercept
Treatment: Drugs - etanercept
Treatment: Drugs - Placebo

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.


Treatment: Drugs: etanercept


Treatment: Drugs: etanercept


Treatment: Drugs: Placebo
Intervention code [1] 0 0
Treatment: Drugs
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
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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
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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
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France
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Cedex
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France
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Bordeaux
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France
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Brest cedex 2
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France
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Caen
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France
State/province [27] 0 0
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
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Paris
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France
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Pierre Bénite
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France
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Poitiers
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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
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Goettingen
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Germany
State/province [41] 0 0
Hamburg-Eilbek
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Germany
State/province [42] 0 0
Hamburg
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Germany
State/province [43] 0 0
Jena
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Germany
State/province [44] 0 0
Mahlow
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Germany
State/province [45] 0 0
Muenchen
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Germany
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Osnabrueck
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Germany
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Rostock
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Germany
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Wuerzburg
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Greece
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Athens
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Hungary
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Budapest
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Hungary
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Debrecen
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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
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Italy
State/province [56] 0 0
Brescia
Country [57] 0 0
Italy
State/province [57] 0 0
Cagliari
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Italy
State/province [58] 0 0
Catania
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Italy
State/province [59] 0 0
Milano
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Italy
State/province [60] 0 0
Parma
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Italy
State/province [61] 0 0
Roma
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Italy
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Siena
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Korea, Republic of
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Seoul
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Mexico
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Jalisco
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Mexico
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Mexico City
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Netherlands
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GA
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Netherlands
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THE Netherlands
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Netherlands
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Maastricht
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Netherlands
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Vlissingen
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Netherlands
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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
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Taiwan
State/province [87] 0 0
Taiwan, R.o.c.
Country [88] 0 0
Taiwan
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Taipei TOC
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Turkey
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Ankara
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United Kingdom
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Hampstead
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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
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United Kingdom
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Aberdeen
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United Kingdom
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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/ct2/show/NCT00245960
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