An Open-Label Extension Study to Evaluate Long Term Safety and Efficacy of Tildrakizumab in Patients with Psoriatic Arthritis
- Conditions
- Psoriatic Arthritis
- Registration Number
- JPRN-jRCT2031220622
- Lead Sponsor
- Oshima Satoe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 35
1.Subjects possess the ability to understand the requirements of the study.
2.Subject has provided written informed consent as evidenced by signature on an informed consent form approved by an institutional review board/EC.
3.Agree to abide by the study restrictions, scheduled treatment, laboratory assessments, other study procedures and return to the site for the required assessments.
4.Subject with PsA who had met all eligibility criteria for the parent study, had completed the parent study treatment period and has not developed any parent protocol criteria for premature discontinuation of treatment or withdrawal from the study.
5.Psoriatic Arthritis subjects who achieved ACR 20 response at study entry AND the subject has received sufficient clinical benefit, in the opinion of the Investigator, to support continued treatment with Tildrakizumab.
1.Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception, for example, a combination of the following: (1) oral contraceptive, depo progesterone, or intrauterine device; and (2) a barrier method (condom or diaphragm). Male subjects with female partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (e.g., condom) if not surgically sterile (i.e., vasectomy). Contraceptive methods must be practiced upon entering the study and through 17 weeks after the last dose of IMP. If a subject discontinues prematurely, the contraceptive method must be practiced for 17 weeks following final administration of IMP.
2.Female is pregnant or breastfeeding, or planning to become pregnant or initiate breastfeeding while enrolled in the study or up to 17 weeks after the last dose of IMP.
3.Subject has previously been enrolled in this long-term extension study.
4.Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for the subject.
5.Subject is currently suffering from non-plaque psoriasis e.g. erythrodermic, guttate or pustular. Nail psoriasis is allowed.
6.Subject has any concurrent medical condition or psychiatric condition or uncontrolled, clinically significant systemic disease (e.g., renal failure, heart failure, hypertension, liver disease, diabetes, or anaemia) that, in the opinion of the Investigator, could cause continued treatment to be detrimental to the subject.
7.Subject has any other laboratory anomaly that, in the judgement of the Principal Investigator, would make study entry inappropriate, or would interfere with interpretation of study results or could make continuation in the study harmful for the subject.
8.Subjects with a history of alcohol or drug abuse during the parent study.
9.Significant risk of suicidality at the Baseline assessment of this extension study based on the Investigator's judgment or, if appropriate, as indicated by a response of Yes since the last visit (of parent study) to question 4 or 5 in the suicidal ideation section, or any response of Yes in the behavioural section of the C SSRS.
10.Subject has a need for use of a live vaccine within 10 weeks of final anticipated dose of IMP for the long-term extension study.
11.Concomitant use of both leflunomide and methotrexate.
12.Concomitant use of prohibited medications or use of commercially available or investigational biologic therapies (other than Tildrakizumab) for PsO and/or PsA.
13.Subjects who are related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest may arise.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety:<br>-Incidence and intensity of Adverse Events (AEs) recorded through the study period<br>-Changes from baseline (of parent study) in laboratory parameters (Hematology, serum chemistry and urinalysis) at Week 24, Week 48, Week 72, Week 108/EoT and Week 124/EoS.<br>-The percentage of subjects with study treatment-related hypersensitivity reactions (e.g. anaphylaxis, urticaria, angioedema, etc.) at all time points<br>-The percentage of subjects with injection site reactions (e.g. pain, erythema, edema etc) at all time points<br>Efficacy:<br>-Proportion of subjects achieving ACR 20, ACR 50 and ACR 70 at Week 24, Week 48, Week 72, Week 108/EoT and Week 124/EoS.<br>-Change from baseline (of parent study) in the van der Heijde modified total Sharp score of X-ray of hands, wrists, and feet at Week 60 and Week 108/EoT.<br>-Change from baseline (of parent study) in ACR response criteria components score at Week 24, Week 48, Week 72, Week 108/EoT and Week 124/EoS
- Secondary Outcome Measures
Name Time Method