ong-term open-label study of filgotinib in subjects with psoriatic arthritis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 105

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

• 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>- 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 Outcome Measures

Name	Time	Method

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