PsABIO
Research type
Research Study
Full title
Assessment of STELARA® (Ustekinumab) and Tumor Necrosis Factor Alpha Inhibitor Therapies in Patients With Psoriatic Arthritis in Standard Health-Care Practice; A Prospective, Observational Cohort
IRAS ID
186845
Contact name
Stefan Siebert
Contact email
Sponsor organisation
Janssen Pharmaceutica NV
Duration of Study in the UK
5 years, 2 months, 31 days
Research summary
Psoriatic arthritis (PsA) is an inflammatory disease, associated with psoriasis (PsO), that can cause pain and swelling in the joints, sausage-shaped swelling of the fingers and toes, muscle inflammation, and skin lesions.
A range of treatments are available for PsA. Long-term efficacy and safety data is vital to support healthcare professionals in their decision-making on the most suitable treatment option for patients.
This observational study aims to document the use of STELARA and approved TNFi therapies in clinical practice in PsA patients who are starting STELARA or a TNFi as a first, second, or third line of biological disease-modifying antirheumatic drug (bDMARD) therapy as part of their standard care, at the time of enrolment into the study, or within a maximum 1-month window after the baseline visit.
The following parameters will be described over a period of 36 months in each participant in clinical practice settings: treatment retention, clinical features of concomitant psoriasis (PsO), effectiveness, safety, treatment patterns, and other outcomes including clinical, quality of life, productivity, health economic, comorbidities, and co-medication.
Approximately 1400 adult PsA patients will be enrolled into this study worldwide; 700 patients receiving STELARA, and 700 patients receiving a TNFi therapy. Participants must have a confirmed diagnosis of PsA as determined by a rheumatologist according to ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria. The treatment decision must be taken by the patient's usual doctor prior to, and independently of, the patient’s inclusion into the study, following local clinical practice and regulations. Patients will not be eligible if they are starting STELARA or a TNFi therapy as fourth or further line of biologic treatment or are unwilling or unable to participate in long-term data collection.
In the UK, the study will be conducted in NHS hospitals. Recruitment will continue for 2 years, with a follow up period of 3 years.REC name
East of Scotland Research Ethics Service REC 2
REC reference
15/ES/0166
Date of REC Opinion
24 Sep 2015
REC opinion
Favourable Opinion