Psoriatic arthritis MedDRA version: 21.0 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, having completed the 16 weeks of treatment in the qualifying core study GLPG0634-CL-224 and who may benefit from filgotinib long-term treatment according to the investigator’s judgment. • Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to continue to use highly effective methods of contraception as described in the protocol. • Able and willing to sign the informed consent form (ICF), as approved by the Independent Ethics Committee (IEC) and agree to the schedule of assessments. 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 95 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • Subjects who are deemed not to be benefitting from the study drug based upon lack of improvement or worsening of their symptoms. Local guidelines for subject treatment need to be followed. • Persistent abnormal laboratory values associated with the use of the study drug (including and not limited to hematology, liver and renal function values), according to the investigator’s clinical judgment. • Subjects who discontinued the qualifying core study GLPG0634-CL-224 due to safety or tolerability issues. • Subjects who require immunization with live/live attenuated vaccine. • Diagnosis of rheumatic autoimmune disease or inflammatory joint disease other than psoriatic arthritis, except for Sjögren’s syndrome. • Subjects with symptoms suggestive of uncontrolled hypertension, congestive heart failure, uncontrolled diabetes, cerebrovascular accident, myocardial infarction, unstable angina, unstable arrhythmia or any other cardiovascular condition since the inclusion to the GLPG0634-CL-224 study. • Subjects with symptoms suggestive of gastrointestinal tract ulceration and/or active diverticulitis since the inclusion to the GLPG0634-CL-224 study. • Subjects with symptoms suggestive of possible lymphoproliferative disease including lymphadenopathy or splenomegaly since the inclusion to the GLPG0634-CL-224 study. • Subjects with symptoms suggestive of malignancy since the inclusion to the GLPG0634-CL-224 study. Reference is made to the protocol for a complete overview of the exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and tolerability of filgotinib in patients with psoriatic arthritis (PsA).;Secondary Objective: - To evaluate the long-term efficacy of filgotinib in patients with PsA. - To evaluate the long-term effects of filgotinib administration on disability, fatigue and quality of life in patients with PsA.;Primary end point(s): Incidence of AEs, SAEs, and discontinuations due to AEs, as well as changes in laboratory results, ECGs, body weight and vital signs over time;Timepoint(s) of evaluation of this end point: Various timepoints throughout the trial as specified in the protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Signs and symptoms of PsA: - Proportion of subjects achieving MDA. - Proportion of subjects with PASDAS low disease activity (LDA, i.e. PASDAS = 3.2) and proportion of subjects with PASDAS VLDA (Very Low Disease Activity, i.e. PASDAS = 1.9). • Signs and symptoms of peripheral arthritis: - Proportion of subjects achieving ACR20, ACR50 and ACR70 response rates. - Percentage of patients with Psoriatic Arthritis Disease Activity Score (PASDAS) low disease activity (LDA, i.e. PASDAS =3.2) - Percentage of patients with PASDAS VLDA (Very Low Disease Activity, i.e. PASDAS=1.9) - Change from core baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) - Proportion of subjects with DAPSA remission/LDA (DAPSA = 14) and proportion of subjects with DAPSA remission (DAPSA = 4) • Psoriasis in those subjects with psoriasis involving =3% Body Surface Area (BSA), or with psoriatic nail involvement (only for mNAPSI), at core baseline: - Change from core baseline in PASI and proportions of subjects with PASI50, PASI75, PASI90, and PASI100. - Change from core baseline in Physician's Global Assessment of psoriasis. - Change from core baseline in Patient's Global Assessment of psoriasis. - Change from core baseline in mNAPSI. - Change from core baseline in pruritus NRS. - Proportion of subjects achieving a pruritus NRS response (improvement in pruritus NRS score of =3). • Enthesitis in those subjects with enthesitis at core baseline: - Change from core baseline in the SPARCC Enthesitis Index. • Dactylitis in those subjects with dactylitis at core baseline: - Change from core baseline in LDI. • Physical function: - Change from core baseline in HAQ-DI. • Fatigue and general quality of life: - Change from core baseline in FACIT-Fatigue, SF-36, and PsAID scores. • Signs and symptoms of peripheral arthritis and physical function: - Change from core baseline in individual components of the ACR response criteria;Timepoint | — |
Countries
Belgium, Bulgaria, Czech Republic, Estonia, Germany, Poland, Spain, Ukraine
Contacts
Public ContactClinical Trial Information Desk
Galapagos NV
Outcome results
None listed