Psoriatic Arthritis Observational Study of Persistence of Treatment
Research type
Research Study
Full title
Psoriatic Arthritis Observational Study of Persistence of Treatment (PRO-SPIRIT Study)
IRAS ID
271096
Contact name
Nicola J Gullick
Contact email
Sponsor organisation
Eli Lilly
Duration of Study in the UK
4 years, 3 months, 29 days
Research summary
This study is a 24-month non-interventional study of patients with Psoriatic Arthritis who start treatment in a normal clinical setting with either a biologic or targeted systemic disease-modifying anti-rheumatic drug (bDMARD or tsDMARD) after failing to respond to a conventional synthetic DMARD (csDMARD) (e.g. methotrexate, sulfasalazine, leflunomide, hydroxychloroquine or gold salts).
Patients will be observed for up to 24 months. Treatment start and any treatment changes during the 24-month observation period are solely at the discretion of the participating physicians. Physicians will be asked to follow their normal treatment practice and prescribing habits. Any treatment changes will be documented, and follow-up will continue until the end of the 24-month observation period.
Study data will be collected at baseline and at routine visits post-baseline (or post-first dose if first dose occurs after baseline). Visits will occur as per normal clinical practice at approximately 12 weeks, 6, 12, 18, and 24 months (±4 weeks) after the start of the bDMARD or tsDMARD. 8 questionnaires will be completed by the patient once per visit at the time points outlined below.REC name
South West - Frenchay Research Ethics Committee
REC reference
19/SW/0222
Date of REC Opinion
28 Apr 2020
REC opinion
Further Information Favourable Opinion