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 75 Locations for this study
Dothan Alabama, 36305, United States
Gilbert Arizona, 85297, United States
Mesa Arizona, 85210, United States
Covina California, 91722, United States
Fountain Valley California, 92708, United States
Thousand Oaks California, 91320, United States
Clearwater Florida, 33765, United States
Hialeah Florida, 33016, United States
Kissimmee Florida, 34744, United States
New Port Richey Florida, 34652, United States
Ocoee Florida, 34751, United States
Tamarac Florida, 33321, United States
Gainesville Georgia, 30501, United States
Orland Park Illinois, 60467, United States
Schaumburg Illinois, 60195, United States
Skokie Illinois, 60076, United States
Wichita Kansas, 67207, United States
Springfield Missouri, 65807, United States
Kalispell Montana, 59901, United States
Lincoln Nebraska, 68516, 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
Middleburg Heights Ohio, 44130, United States
Greenville South Carolina, 29601, United States
Baytown Texas, 77521, United States
Baytown Texas, 77521, United States
Lubbock Texas, 79410, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78229, United States
Tomball Texas, 77375, United States
Spokane Washington, 99204, United States
Phillip Australian Capital Territory, 2606, Australia
Maroochydore Queensland, 4558, Australia
Hobart Tasmania, 7000, Australia
Brno , 638 0, Czechia
Praha 2 , 12800, Czechia
Praha 4 , 140 0, Czechia
Zlin , 760 0, Czechia
Tallinn , 10117, Estonia
Tartu , 50106, Estonia
Tartu , 50708, Estonia
Berlin , 12161, Germany
Herne , 44649, Germany
Verona , 37134, Italy
Shinjuku-ku Tokyo, 160-0, Japan
Fukuoka , 802-8, Japan
Itabashi-ku , 173-8, Japan
Kumamoto-shi , 860-8, Japan
Mitaka , 181-8, Japan
Miyazaki , 889-1, Japan
Nagoya , 467-8, Japan
Sendai-shi , 545-8, Japan
Sendai-shi , 980-8, Japan
Tsu , , Japan
Seoul , 3080, Korea, Republic of
Bialystok , 15-35, Poland
Bialystok , 15-87, Poland
Krakow , 30-03, Poland
Lublin , 20-60, Poland
Nadarzyn , 05-83, Poland
Poznan , 60-52, Poland
Poznan , 61-11, Poland
Torun , 87-10, Poland
Warszawa , 02-11, Poland
Martin , 036 0, Slovakia
Nové Mesto Nad Váhom , 915 0, Slovakia
Rimavska Sobota , 97901, Slovakia
Cordoba , 14004, Spain
Córdoba , 14004, Spain
La Coruña , 15006, Spain
Malaga , 29009, Spain
Santiago De Compostela , 15706, Spain
Sevilla , 41013, Spain
Kaohsiung , 833, Taiwan
Taichung , 402, Taiwan
Tainan , 710, Taiwan
Taipei , 112, Taiwan
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