No registrations found.
ID
Source
Brief title
Health condition
1. Fatigue (moeheid);
2. Psoriasis.
Sponsors and support
Intervention
Outcome measures
Primary outcome
The results of fatigue specific questionnaires.
Background summary
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.
Study objective
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.
Intervention
None, this is an observational study.
L.L.A. Lecluse
Amsterdam 1105 AZ
The Netherlands
++31 20 5662530
onderzoeksteamhuidziekten@amc.uva.nl
L.L.A. Lecluse
Amsterdam 1105 AZ
The Netherlands
++31 20 5662530
onderzoeksteamhuidziekten@amc.uva.nl
Inclusion criteria
1. Patients who start with etanercept or UVB therapy (control group) for psoriasis.
2. Patients who have a PASI > or = 10.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1042 |
| NTR-old | NTR1075 |
| Other | : incomplete |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |