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An observational study to investigate whether fatigue is a side effect of etanercept in patients with moderate to severe psoriasis.


- candidate number2755
- NTR NumberNTR1075
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-sep-2007
- Secondary IDsincomplete 
- Public TitleAn observational study to investigate whether fatigue is a side effect of etanercept in patients with moderate to severe psoriasis.
- Scientific TitleAn observational study to investigate whether fatigue is a side effect of etanercept in patients with moderate to severe psoriasis.
- ACRONYMN/A
- hypothesisOur hypothesis is that although treatment with etanercept improves the psoriasis and thereby the quality of lives in most people who are treated, in some people fatigue occurs as adverse event.
- Healt Condition(s) or Problem(s) studiedPsoriasis, Fatigue
- Inclusion criteria1. Patients who start with etanercept or UVB therapy (control group) for psoriasis.
2. Patients who have a PASI > or = 10.
- Exclusion criteria1. Patients who have another active disease which is known to cause fatigue;
2. Patients who use therapeuticals which are known to cause fatigue;
3. Unability to comply with study procedures, like filling in questionnaires in Dutch.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type[default]
- Studytypeobservational
- planned startdate 30-okt-2006
- planned closingdate1-apr-2009
- Target number of participants30
- InterventionsNone, this is an observational study.
- Primary outcomeThe results of fatigue specific questionnaires.
- Secondary outcome
- Timepoints
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs L.L.A. Lecluse
- CONTACT for SCIENTIFIC QUERIESDrs L.L.A. Lecluse
- Sponsor/Initiator Academic Medical Center (AMC), Department of Dermatology
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryWe have noticed that patients who are treated with etanercept for moderate to severe plaque type psoriasis remarkably often spontaneously report fatigue as adverse event . However, fatigue is not a known adverse event of etanercept and data in the literature are not univocal. Therefore, we have designed this pilot study to objectify whether fatigue is an adverse event of etanercept. Fatigue specific questionnaires are completed at week 0, week 6 and week 12 of treatment. At these moments blood and urine will be analysed to reveal some common disease that are known to cause fatigue. The same study procedures will be carried out in a comparable group of patients who start witj UVB therapy.
- Main changes (audit trail)
- RECORD19-sep-2007 - 21-jan-2009


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