RECRUITING

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

Description

An open label phase 3 study

Study Overview

Study Details

Study overview

An open label phase 3 study

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

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

Condition
Psoriatic Arthritis
Intervention / Treatment

-

Contacts and Locations

Dothan

Sunpharma site no 50, Dothan, Alabama, United States, 36305

Gilbert

Sunpharma site no 80, Gilbert, Arizona, United States, 85297

Mesa

Sunpharma site no 65, Mesa, Arizona, United States, 85210

Covina

Sunpharma site no. 30, Covina, California, United States, 91722

Fountain Valley

Sunpharma site no. 17, Fountain Valley, California, United States, 92708

Thousand Oaks

Sunpharma site no. 15, Thousand Oaks, California, United States, 91320

Clearwater

Sunpharma site no. 21, Clearwater, Florida, United States, 33765

Hialeah

Sunpharma site no. 02, Hialeah, Florida, United States, 33016

Kissimmee

Sunpharma site no 71, Kissimmee, Florida, United States, 34744

New Port Richey

Sunpharma site no. 05, New Port Richey, Florida, United States, 34652

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sun Pharmaceutical Industries Limited,

Study Record Dates

2029-04