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Prospective follow-up study of ustekinumab treatment in psoriatic arthritis

Prospective follow-up study of ustekinumab treatment in psoriatic arthritis - Ustekinumab in psoriatic arthritis

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON40967
Enrollment
50
Registered
2014-10-15
Start date
2016-01-15
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psoriatic arthritis rheumatic disease

Interventions

None listed

Sponsors

Jan van Breemen Instituut
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Patients with contraindications for ustekinumab treatment.

Design outcomes

Primary

MeasureTime frame
- DAS28 score and response is defined as the EULAR criteria of a good or moderate response and a score of

Secondary

MeasureTime frame
- 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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)