To investigate whether fatigue is a side effect of etanercept.
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of patients on etanercept therapy who report fatigue, as
identified by three validated questionnaires, compared to a similar group of
psoriasis patients receiving phototherapy.
Secondary outcome
not applicable
Background summary
Previous retrospective analysis of the use of etanercept in psoriasis patients
compared with four randomized controlled trials revealed that 10% of the
patients spontaneously reported fatigue as an adverse event during etanercept
treatment. In randomized placebo controlled clinical trials with etanercept
fatigue as adverse event was reported in 4 to 13%. Fatigue is not mentioned in
the instructiion leaflet of etanercept.
Study objective
To investigate whether fatigue is a side effect of etanercept.
Study design
A prospective, non-randomised comparative multi-center pilot study in
approximately 30 patients with moderate to severe psoriasis.
Study burden and risks
At three different time points (week 0, 6 and 12) during the study patients
will be asked to fill in four questionnaires: three questionnaires validated to
objectify fatigue and one to reveal depression and anxiety.
At the same time points blood samples will be collected to check for underlying
co-morbidities able to cause fatigue.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
- Adult patients at the outpatient clinic diagnosed psoriasis with a PASI score *10
- Patients selected for treatment with etanercept
- Patients selected for treatment with narrowband UVB therapy
Exclusion criteria
- PASI<10
- unable to complete the questionnaires
- uncontrolled co-morbidity known to cause fatigue
- concomitant medication known to have fatigue as aside effect
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 |
|---|---|
| CCMO | NL13485.018.06 |