Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lakefront Biotherapeutics NV
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female subjects who are ≥18 years of age, on the day of signing informed consent.
Diagnosis of psoriatic arthritis meeting Classification Criteria for Psoriatic Arthritis (CASPAR)
Have active psoriatic arthritis defined as ≥5 swollen joints (from a 66 swollen joint count \[SJC\]) and ≥5 tender joints (from a 68 tender joint count \[TJC\]) at Screening and Baseline (measurable dactylitis of a digit counts as a single swollen joint and if tender, then also a single tender joint).
Have had a history of documented plaque psoriasis or currently active plaque psoriasis
If using cDMARD therapy, subjects must have been on it for 12 weeks prior to screening, with a stable dose (including stable route of administration) for at least 4 weeks prior to baseline.
If using non-drug therapies (including physical therapies), thse should be kept sable during screening
Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use highly effective methods of contraception as described in the protocol
You may not be if
Use of JAK inhibitors, investigational or approved, at any time, including filgotinib;
Prior use of more than one TNF inhibitor, at any time.
Use of oral steroids at a dose \>10 mg/day of prednisone or prednisone equivalent or at a dose that hasn't been stable for at least 4 weeks prior to Baseline;
Any therapy by intra-articular injections (e.g. corticosteroid, hyaluronate) within 4 weeks prior to screening;
Use of more than 1 NSAID or cyclooxygenase-2 (COX-2) inhibitor.
Have undergone surgical treatment for psoriatic arthritis including synovectomy and arthroplasty in more than 3 joints and/or within the last 12 weeks prior to screening
Presence of very poor functional status or unable to perform self-care.
Administration of a live or attenuated vaccine within 12 weeks prior to baseline
