psoriatic arthritis MedDRA version: 19.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Sponsors
Galapagos NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female subjects who are =18 years of age, on the day of signing informed consent. • Diagnosis of psoriatic arthritis for at least 12 weeks prior to screening, and currently meet Classification Criteria for Psoriatic Arthritis (CASPAR) (see protocol). • 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 are only permitted to use one of the following drugs (methotrexate, leflunomide, sulfasalazine, hydroxychloroquine or chloroquine) and 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. • 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 105 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 19
Exclusion criteria
Exclusion criteria: • Use of JAK inhibitors, investigational or approved, at any time, including filgotinib; • Prior use of more than one TNF inhibitor (including proposed biosimilars with demonstrated equivalence to an approved TNF inhibitor for efficacy in a clinical study), at any time. Prior use of one TNF inhibitor is allowed, with the following minimum washout periods prior to screening: - Etanercept: 4 weeks - Adalimumab, certolizumab pegol, golimumab: 8 weeks - Infliximab: 12 weeks; • 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. If an NSAID or COX-2 inhibitor is used, it must not exceed maximum doses permitted as per local labeling and must have been used at a stable dose for at least 2 weeks prior to baseline. In addition, subjects are permitted to take acetylsalicylic acid at a dose of =325 mg q.d. for cardiac prophylaxis; • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the effect of filgotinib compared to placebo on the signs and symptoms of peripheral arthritis, as assessed by the ACR20 at Week 16.;Secondary Objective: Evaluate the effect of filgotinib compared to placebo on: - The signs and symptoms of psoriatic arthritis - The signs and symptoms of peripheral arthritis - Psoriasis - Enthesitis - Dactylitis - Physical function - Fatigue and general quality of life Evaluate the safety and tolerability of filgotinib. ;Primary end point(s): Percentage of patients achieving ACR20 at week 16;Timepoint(s) of evaluation of this end point: at week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: • The signs and symptoms of psoriatic arthritis, as assessed by the proportion of subjects achieving MDA. • The signs and symptoms of peripheral arthritis, as assessed by: - Proportion of subjects achieving ACR20, ACR50 and ACR70 response rates - Change from baseline in DAS28(CRP) - Proportion of subjects who achieve low disease activity (defined as DAS28[CRP] =3.2) and remission (defined as DAS28[CRP] <2.6) - Change from baseline in SDAI - Change from baseline in CDAI - EULAR response and remission rates - PsARC response rates • Psoriasis, as assessed by: - Change from baseline in PASI and proportions of subjects with PASI50, PASI75, PASI90, and PASI100 in those subjects with psoriasis involving =3% BSA at baseline - Change from baseline in Physician’s Global Assessment of psoriasis in those subjects with psoriasis involving =3% BSA at baseline - Change from baseline in Patient’s Global Assessment of psoriasis in those subjects with psoriasis involving =3% BSA at baseline - Change from baseline in mNAPSI in those subjects with psoriatic nail involvement at baseline - Change from baseline of pruritus NRS in those subjects with psoriasis involving =3% BSA at baseline - Proportion of subjects achieving a pruritus NRS response (improvement in pruritus NRS score of =3) • Enthesitis, as assessed by change from baseline in the SPARCC Enthesitis Index in those subjects with enthesitis at baseline • Dactylitis, as assessed by change from baseline in LDI in those subjects with dactylitis at baseline • Physical function, as assessed by change from baseline in HAQ-DI • Fatigue and general quality of life, as assessed by change from baseline in FACIT-Fatigue, SF-36, and PsAID scores • Signs and symptoms of peripheral arthritis and physical function, as assessed by change from baseline in individual components of the ACR response criteria Safety: Incidence of AEs, SAEs, and discontinuations due to AEs, as well as chang | — |
Countries
Belgium, Bulgaria, Czech Republic, Estonia, Germany, Poland, Spain, Ukraine
Contacts
Public ContactClinical Trial Information Desk
Galapagos NV
Outcome results
None listed