Our 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.
ID
Bron
Verkorte titel
Aandoening
1. Fatigue (moeheid);
2. Psoriasis.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The results of fatigue specific questionnaires.
Achtergrond van het onderzoek
We 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.
Doel van het onderzoek
Our 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.
Onderzoeksproduct en/of interventie
None, this is an observational study.
Publiek
L.L.A. Lecluse
Amsterdam 1105 AZ
The Netherlands
++31 20 5662530
onderzoeksteamhuidziekten@amc.uva.nl
Wetenschappelijk
L.L.A. Lecluse
Amsterdam 1105 AZ
The Netherlands
++31 20 5662530
onderzoeksteamhuidziekten@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients who start with etanercept or UVB therapy (control group) for psoriasis.
2. Patients who have a PASI > or = 10.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1042 |
| NTR-old | NTR1075 |
| Ander register | : incomplete |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |