The purpose of this study is to determine whether psoriatic arthritis (PsA) can be detected in an early stage by the dermatologist, with the diagnosis of the rheumatologist as a "gold standard" for presence of this disorder. Futhermore it…
ID
Source
Brief title
Condition
- Joint disorders
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the prevalence of PsA in subjects with psoriasis presenting to
dermatologists* offices.
Secondary outcome
To assess the prevalence of undiagnosed PsA in psoriasis subjects presenting to
dermatologists*
offices as determined by a clinical assessment by a rheumatologist.
Background summary
Psoriatic arthritis is a joint inflammation associated with psoriasis that can
develop over time. The exact number of patients with psoriasis who will develop
psoriatic arthritis is not specifically known. Left untreated, patients with
PsA can have persistent inflammation, progressive joint damage.
Study objective
The purpose of this study is to determine whether psoriatic arthritis (PsA) can
be detected in an early stage by the dermatologist, with the diagnosis of the
rheumatologist as a "gold standard" for presence of this disorder. Futhermore
it will be investigated which of the following three questionnaires is the most
suitable: The Toronto Psoriatic Arthritis Screen (TOPAS), Psoriasis and
Arthritis Screening Questionnaire (PASQi) or Psoriasis Epidemiology Screening
Tool (PEST). Also the prevalence of psoriatic arthritis in subjects with
psoriasis being seen at a dermatologist*s office will be investigated.
Therefore, the research is not focused on treating the disease, but on an early
diagnosis of PsA.
Study design
Phase IV, multinational, randomized, non-therapeutic, interventional study
Intervention
n/a
Study burden and risks
A part of the subjects that will visit the rheumatologist and complete
questionnaires (for this study) will have no PsA. In the normal situation
(without studies) these subjects would not have been referred to the
rheumatolgist. This additional rheumatologist visit and blood drawing will be
an additonal burden for a percentage of the subjects (which are finally
diagnosed as not having PsA).
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Rivium Westlaan 142
2909 LD Capelle a/d IJssel
Nederland
Rivium Westlaan 142
2909 LD Capelle a/d IJssel
Nederland
Listed location countries
Age
Inclusion criteria
1. Subject has a confirmed diagnosis of plaque psoriasis by clinical judgement.
2. Subject is >18 years of age at the time of consent.
3. Subject is able to read and complete questionnaires.
Exclusion criteria
none
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 |
|---|---|
| ClinicalTrials.gov | NCT01147874 |
| CCMO | NL34436.028.10 |