RECRUITING

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

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Conditions

Psoriatic Arthritis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

An open label phase 3 study

Official Title

An Open-Label Extension Study to Evaluate Long Term Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis.

Quick Facts

Study Start:2022-06-30
Study Completion:2029-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04991116

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  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.
  1. * Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception.
  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.

Contacts and Locations

Study Contact

Head, Clinical Developement
CONTACT
9122 66455645
Clinical.Trial@sunpharma.com

Study Locations (Sites)

Sunpharma site no 50
Dothan, Alabama, 36305
United States
Sunpharma site no 80
Gilbert, Arizona, 85297
United States
Sunpharma site no 65
Mesa, Arizona, 85210
United States
Sunpharma site no. 30
Covina, California, 91722
United States
Sunpharma site no. 17
Fountain Valley, California, 92708
United States
Sunpharma site no. 15
Thousand Oaks, California, 91320
United States
Sunpharma site no. 21
Clearwater, Florida, 33765
United States
Sunpharma site no. 02
Hialeah, Florida, 33016
United States
Sunpharma site no 71
Kissimmee, Florida, 34744
United States
Sunpharma site no. 05
New Port Richey, Florida, 34652
United States
Sunpharma site no 32
Ocoee, Florida, 34751
United States
SunPharma Site no 22
Tamarac, Florida, 33321
United States
Sunpharma site no 52
Gainesville, Georgia, 30501
United States
Sunpharma site no 51
Orland Park, Illinois, 60467
United States
Sunpharma site no 49
Schaumburg, Illinois, 60195
United States
Sunpharma site no 47
Skokie, Illinois, 60076
United States
Sunpharma site no. 20
Wichita, Kansas, 67207
United States
Sunpharma site no. 14
Springfield, Missouri, 65807
United States
Sunpharma site no 48
Kalispell, Montana, 59901
United States
Sunpharma Site no 27
Lincoln, Nebraska, 68516
United States
Sunpharma site no 33
Voorhees, New Jersey, 08043
United States
Sunpharma site no 34
Charlotte, North Carolina, 28204
United States
Sunpharma site no 53
Wilmington, North Carolina, 28401
United States
Sunpharma site no 35
Minot, North Dakota, 58701
United States
Sunpharma site no. 11
Middleburg Heights, Ohio, 44130
United States
Sunpharma site no 31
Greenville, South Carolina, 29601
United States
Sunpharma site no. 08
Baytown, Texas, 77521
United States
Sunpharma site no. 13
Baytown, Texas, 77521
United States
Sunpharma Site no 28
Lubbock, Texas, 79410
United States
Sunpharma site no. 03
San Antonio, Texas, 78229
United States
Sunpharma site no. 16
San Antonio, Texas, 78229
United States
Sunpharma site no. 01
Tomball, Texas, 77375
United States
Sunpharma site no 66
Spokane, Washington, 99204
United States

Collaborators and Investigators

Sponsor: Sun Pharmaceutical Industries Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-30
Study Completion Date2029-04

Study Record Updates

Study Start Date2022-06-30
Study Completion Date2029-04

Terms related to this study

Additional Relevant MeSH Terms

  • Psoriatic Arthritis