Psoriasis Clinical Trial
Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis
Summary
An open label phase 3 study
Full Description
Subjects from both INSPIRE 1 (TILD-19-07) and INSPIRE 2 (TILD-19-19) studies to roll over into this INSPIRE LTE study (TILD-21-01).
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.
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There are 51 Locations for this study
Dothan Alabama, 36305, United States
Covina California, 91722, United States
Hialeah Florida, 33016, United States
New Port Richey Florida, 34652, United States
Ocoee Florida, 34751, United States
Gainesville Georgia, 30501, United States
Orland Park Illinois, 60467, United States
Schaumburg Illinois, 60195, United States
Skokie Illinois, 60076, United States
Kalispell Montana, 59901, United States
Voorhees New Jersey, 08043, United States
Charlotte North Carolina, 28204, United States
Wilmington North Carolina, 28401, United States
Minot North Dakota, 58701, United States
Tomball Texas, 77375, United States
Phillip Australian Capital Territory, 2606, Australia
Maroochydore Queensland, 4558, Australia
Brno , 638 0, Czechia
Tallinn , 10117, Estonia
Tartu , 50106, Estonia
Tartu , 50708, Estonia
Berlin , 12161, Germany
Fukuoka , 802-8, Japan
Kumamoto-shi , 860-8, Japan
Sendai-shi , 545-8, Japan
Sendai-shi , 980-8, Japan
Bialystok , 15-35, Poland
Krakow , 30-03, Poland
Nadarzyn , 05-83, Poland
Torun , 87-10, Poland
Warszawa , 02-11, Poland
Nové Mesto Nad Váhom , 915 0, Slovakia
Rimavska Sobota , 97901, Slovakia
Cordoba , 14004, Spain
La Coruña , 15006, Spain
Sevilla , 41013, Spain
Taichung , 402, Taiwan
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