Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis

Launched by SUN PHARMACEUTICAL INDUSTRIES LIMITED · Aug 4, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at the long-term safety and effectiveness of a medication called Tildrakizumab for people with Psoriatic Arthritis, a condition that causes joint pain and skin problems. The study is currently recruiting participants aged between 65 and 74 years, and it is open to both men and women. To join, participants must be able to understand the study's requirements and provide written consent. They should also have completed a previous related study without any issues that would prevent them from continuing.

Participants in this trial can expect to receive regular treatments and attend scheduled check-ups to monitor their health. It's important to note that women who are pregnant, breastfeeding, or planning to become pregnant during the study are not eligible. Additionally, those who have already participated in this long-term study cannot join again. Overall, this research aims to learn more about how Tildrakizumab can help manage Psoriatic Arthritis over an extended period.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects possess the ability to understand the requirements of the study.
• • Subject has provided written informed consent as evidenced by signature on an informed consent form approved by an institutional review board/EC.
• • Agree to abide by the study restrictions, scheduled treatment, laboratory assessments, other study procedures and return to the site for the required assessments.
• • 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.
• Exclusion Criteria:
• • Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception.
• • 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.
• • Subject has previously been enrolled in this long-term extension study.
• • 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.