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PsoriasisPhase 4NCT00195507

Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis

A Phase 4 study testing Etanercept in people with Psoriasis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 127 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will provide a direct comparison of 'continuous therapy' and 'intermittent therapy' with withdrawal and retreatment upon return of psoriasis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
Etanercept
How many people
720 participants
Where
127 sitesin 19 countries
Study dates
Dec 2004to Feb 2007
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Stable, active plaque psoriasis
  • Failure to respond to the following systemic therapies: Methotrexate, Cyclosporine, PUVA or Fumarate

Who cannot join

  • Evidence of skin conditions other than psoriasis that would interfere with evaluations of the effect of the study
  • Systemic psoriasis therapy within 28 days prior

Trial locations and contacts

127 sites in 19 countries.

127 sites in 19 countries

France26 sites

  • Study site

    Besançon, 25030

  • Study site

    Bordeaux, 33075

  • Study site

    Boulogne-Billancourt, 92104

  • Study site

    Brest, 29609

  • Study site

    Créteil, 94000

  • Study site

    Dijon, 21079

  • Study site

    Lille, 59037

  • Study site

    Lyon, 60002

  • Study site

    Lyon, 69437

  • Study site

    Marseille, 13915

  • Study site

    Marseille Cédex 09, 13009

  • Study site

    Montpellier Cédex 5, 34000

  • Study site

    Nancy, 54000

  • Study site

    Nantes, 44093

  • Study site

    Nice, 06200

  • Study site

    Nîmes, 30029

  • Study site

    Paris, 75018

  • Study site

    Pessac, 33600

  • Study site

    Pierre-Bénite, 69495

  • Study site

    Poitiers, 86000

  • Study site

    Reims, 51092

  • Study site

    Rouen, 76000

  • Study site

    Saint-Etienne, 42055

  • Study site

    Strasbourg, 6700

  • Study site

    Toulouse, 31059

  • Study site

    Tours, 37044

Other trials in France

United Kingdom22 sites

  • Study site

    Aberdeen, AB25 1LD

  • Study site

    Airdrie, ML6 0JS

  • Study site

    Birmingham

  • Study site

    Cardiff, CF14 4XW

  • Study site

    Coventry, CV2 2DX

  • Study site

    Dublin

  • Study site

    Dundee, DD1 9SY

  • Study site

    Glasgow, G11 6NT

  • Study site

    Lancaster, LA1 4RP

  • Study site

    Leeds, LS1 3EX

  • Study site

    Leicester, LE1 5WW

  • Study site

    Liverpool

  • Study site

    London, E11 1NR

  • Study site

    London, NW3 2QG

  • Study site

    London, SE1 7EH

  • Study site

    London, W 12

  • Study site

    Newcastle upon Tyne, NE1 4LP

  • Study site

    Newport

  • Study site

    Norwich, NR4 7UY

  • Study site

    Salford, M6 8HD

  • Study site

    Sheffield, 1OUK - S10

  • Study site

    Suffolk, IP4 5PD

Other trials in United Kingdom

Germany15 sites

  • Study site

    Bochum, 44791

  • Study site

    Düsseldorf, 40225

  • Study site

    Erlangen, 91052

  • Study site

    Essen, 45147

  • Study site

    Frankfurt, 60590

  • Study site

    Hamburg, 20158

  • Study site

    Kiel, 24105

  • Study site

    Leipzig, 04103

  • Study site

    Magdeburg, 39120

  • Study site

    Mainz, D-55101

  • Study site

    Münster, 48149

  • Study site

    Nordheide, 21244

  • Study site

    Osnabrück, 48149

  • Study site

    Tübingen, 72076

  • Study site

    Würzburg, 97080

Other trials in Germany

Italy11 sites

  • Study site

    Ancona, 60020

  • Study site

    Cagliari, 09124

  • Study site

    Genova, 16132

  • Study site

    Modena, 41100

  • Study site

    Padova, 35100

  • Study site

    Pavia, 27100

  • Study site

    Roma, 00133

  • Study site

    Roma, 00168

  • Study site

    Roma, 00185

  • Study site

    Terni, 05100

  • Study site

    Torino

Other trials in Italy

Netherlands8 sites

  • Study site

    Amsterdam, 1081 HV

  • Study site

    Amsterdam, 1105 - AZ

  • Study site

    Capelle aan den IJssel, 2906 ZC

  • Study site

    Heerlen, 6419 PC

  • Study site

    Nijmegen, 6525 GL

  • Study site

    Rotterdam, 1081 HV

  • Study site

    Utrecht, 3584 CX

  • Study site

    Voorburg, 2275 CX

Other trials in Netherlands

Spain8 sites

  • Study site

    Barcelona, 08915

  • Study site

    Bilbao, 48009

  • Study site

    Llobregat, 8907

  • Study site

    Madrid, 28006

  • Study site

    Madrid, 28007

  • Study site

    Madrid, 28041

  • Study site

    Málaga, 29010

  • Study site

    Valencia, 46014

Other trials in Spain

Belgium6 sites

  • Study site

    Brussels, B-1070

  • Study site

    Brussels, B-1200

  • Study site

    Edegem, B-2650

  • Study site

    Ghent, B-9000

  • Study site

    Leuven, B-3000

  • Study site

    Liège, 4000

Other trials in Belgium

Sweden6 sites

  • Study site

    Danderyds, 182 88

  • Study site

    Gothenburg, 413 45

  • Study site

    Linköping, 581 85

  • Study site

    Lund, 221 85

  • Study site

    Stockholm, 171 76

  • Study site

    Umeå, 901 85

Other trials in Sweden

Austria3 sites

  • Study site

    Feldkirch

  • Study site

    Vienna, 1090

  • Study site

    Vienna, 1160

Other trials in Austria

Denmark3 sites

  • Study site

    Aarhus C, 8000

  • Study site

    Odense C, 5000

  • Study site

    Roskilde, 4000

Other trials in Denmark

Greece3 sites

  • Study site

    Athens, 124 62

  • Study site

    Athens

  • Study site

    Thessaloniki, 54636

Other trials in Greece

Norway3 sites

  • Study site

    Bergen, 5021

  • Study site

    Oslo, 0407

  • Study site

    Stavanger, 4068

Other trials in Norway

Switzerland3 sites

  • Study site

    Basel, 4056

  • Study site

    Bern, 3010

  • Study site

    Geneva, 1205

Other trials in Switzerland

Turkey (Türkiye)3 sites

  • Study site

    Bornova-Izmir, 35100

  • Study site

    Capa-Istanbul, 34390

  • Study site

    Kocamustafapasa-Istanbul, 34122

Other trials in Turkey (Türkiye)

Finland2 sites

  • Study site

    Kuopio, 702 11

  • Study site

    Lahti, 151 70

Other trials in Finland

Portugal2 sites

  • Study site

    Lisbon, 1069-166

  • Study site

    Lisbon, 1169-100

Other trials in Portugal

Czechia1 site

  • Study site

    Prague, 180 01

Other trials in Czechia

Hungary1 site

  • Study site

    Budapest, 1135

Other trials in Hungary

Poland1 site

  • Study site

    Warsaw, 02-008

Other trials in Poland

About this study

Official title: A Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etanercept in the Treatment of Subjects With Psoriasis

This study will provide a direct comparison of 'continuous therapy' and 'intermittent therapy' with withdrawal and retreatment upon return of psoriasis.

Conditions
Psoriasis
Being tested
Etanercept
Keywords
Psoriasis
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks

    Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=severe psoriasis, 7=clear).

    Measured: 54 weeks

Secondary outcomes (3)

  1. Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline

    Patients were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe.

    Measured: 54 weeks

  2. Time to Achieve a Physician Global Assessment of Psoriasis Score of "Clear" or "Almost Clear"

    Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=sever psoriasis, 7=clear). This assessment measured the time (in days) from baseline to the visit where a patient achieved a PGA status of 0 or 1. Patients who did not achieve this status by their last visit were not included.

    Measured: 54 weeks

  3. Number of Patients With Survey Response of "Somewhat Satisfied" or Better

    Patients completed a patient satisfaction survey at baseline and throughout the study. Patients were asked to rate, based on their experienced during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 7-point scale: Very satisfied, Satisfied, Somewhat Satisfied, Neutral, Somewhat Dissatisfied, Dissatisfied and Very Dissatisfied.

    Measured: 54 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2005 (estimated)
  2. Study startDec 2004
  3. Study completionFeb 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
720 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00195507
Sponsor's protocol ID
0881A6-101764
Status last verified
Apr 2010
First submitted
13 Sep 2005
Last updated
25 Feb 2013

Publications

  • 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.

    PubMed 25913550

  • Griffiths CE, Luger TA, Brault Y, Germain JM, Mallbris L. Retreatment in patients with psoriasis achieving response with etanercept after relapse due to treatment interruption: results from the CRYSTEL study. J Eur Acad Dermatol Venereol. 2015 Mar;29(3):468-73. doi: 10.1111/jdv.12585. Epub 2014 Aug 4.

    PubMed 25087839

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Etanercept in people with Psoriasis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 127 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 sites in France, United Kingdom, Germany, Italy, Netherlands and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks (time frame: 54 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00195507, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2013.

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