To determine the efficacy and safety of ustekinumab in patients with PsA in a daily clinical setting. In addition, the effect of treatment with ustekinumab on the lipid profile, markers of bone metabolism, and risk factors for cardiovascular disease…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- DAS28 score and response is defined as the EULAR criteria of a good or
moderate response and a score of <3.2
- PASI response
- Effect on HAQ-DI
Secondary outcome
- The number of adverse events (infections, malignancies, mortality)
- LEI improvement
- Number of nails with nail psoriasis
- ESR and/or CRP
- The lipid profile
- Inflammation processes
- Relation between genetic polymorphisms and the efficacy of ustekinumab
- Radiographic progression
- Changes in bone mineral density
- Cardiovascular risk factors
Background summary
Recently, ustekinumab is available in the Netherlands for the treatment of
psoriatic arthritis. It is important to determine efficacy and safety in daily
clinical practice, because this can differ from clinical trials. Further,
prognostic markers can be determined.
Study objective
To determine the efficacy and safety of ustekinumab in patients with PsA in a
daily clinical setting. In addition, the effect of treatment with ustekinumab
on the lipid profile, markers of bone metabolism, and risk factors for
cardiovascular disease will be monitored during this study.
Study design
Prospective observational study of all patients with PsA treated with
ustekinumab. The first visit will take place before the start of the treatment
and the patient will be followed at 1 month, 4 months, 6 months, 1 year, 1.5
year, 2 years, and once yearly thereafter.
Study burden and risks
During every visit questionnaires are taken and physical examination is
performed, which is part of routine patient care. Also blood samples are
collected. Next to the routine blood samples an extra extra blood sample is
taken for the study. There are no additional risks for the patient.
Jan van Breemenstraat 2
Amsterdam 1056AB
NL
Jan van Breemenstraat 2
Amsterdam 1056AB
NL
Listed location countries
Age
Inclusion criteria
Patients:
- who are diagnosed with psoriatic arthritis;
- in whom ustekinumab is prescribed by their treating rheumatologist; and
- who gave written informed consent.
Both biological naive patients as patients who failed on TNF-blocking agents are included.
Exclusion criteria
Patients with contraindications for ustekinumab treatment.
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 | NL50530.048.14 |