GUSELKUMAB for Psoriatic arthritis

Inclusion criteria

• {"criterion_text":"- Written informed consent obtained from the subject\n- Adult male or female subject; age ≥ 18 years\n- Diagnosis of PsA according to CASPAR criteria\n- SPARCC Enthesitis ≥ 1 at baseline\n- bDMARD naïve\n- Failure or adverse reaction to at least one csDMARD or indication to start systemic therapy with Guselkumab due to moderate-to-severe plaques psoriasis\n- PD Grade ≥ 2 for at least 1 affected enthesis at baseline or PD Grade ≥ 1 for at least 2 affected entheses at baseline"}

Exclusion criteria

• {"criterion_text":"- Diagnosis of any other rheumatological/ immunological disease such as rheumatoid arthritis, SLE, PSS, MCTD, Behcet syndrome or GPA\n- Concomitant florid active immune mediated disease (e.g. autoimmune hepatitis) that is untreated and/or requires immunosuppressive treatment\n- History of ongoing, chronic or recurrent infectious disease (Infection with HIV, HBV or HCV) or evidence of tuberculosis infection as defined by a positive QuantiFERON Tb-Gold test. If presence of latent tuberculosis is established then treatment according to local country guidelines must have been initiated but patient cannot take part in the study\n- History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed), treated or untreated within the past 5 years prior to enrolment\n- History or evidence of ongoing alcohol or drug abuse, within the last six months prior to enrolment\n- Contraindication for Guselkumab treatment according to their SmPCs\n- Use of any inadmissible medication (e.g. drugs under development or bDMARDs approved for PsA other than Guselkumab) List of admitted drugs alongside IMP: • csDMARD - Leflunomide (e.g. Arava), Sulfasalazine (e.g. Azulfidine RA, Pleon RA), Methotrexate (e.g. Lantarel, Metex) and/or • systemic glucocorticoids with a stable dose of ≤ 7,5 mg of prednisolone equivalents within the last 12 weeks of screening\n- Nursing mother or pregnant woman"}

Primary endpoints

• {"endpoint_text":"- Resolution of enthesitis (SPARCC = 0) at week 24","definition_or_measurement_approach":"Resolution defined as SPARCC enthesitis score equal to 0 at Week 24 (ultrasound-confirmed enthesitis assessed using the SPARCC instrument; endpoint measured at week 24)"}

Germany

Earliest CTIS Part Ii Submission Date

19-05-2024

Latest Decision Or Authorization Date

01-04-2025

Processing Time Days

317

Number Of Sites

4

Number Of Participants

129

Primary sponsor

Full Name

Universitaetsklinikum Erlangen AöR

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany