Clinical Trials in Germany / NCT04991116
Active, not recruiting
Phase 3
Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis
NCT04991116 · tracked via the Priya Life Science Germany tracker
Condition(s) studied
Psoriatic Arthritis
Investigational drug(s) / intervention(s)
TILD sub-cutaneous (SC) injection
TILD sub-cutaneous (SC) injection: 1 mL injection of study medication
Study summary
An open label phase 3 study
Eligibility
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.
Primary outcome measure(s)
- Incidence and intensity of Adverse Events (AEs) recorded through the study period — Week 124
- Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 — Week 124
ACR20 response is an aggregate of: 1\. at least 20% reduction in tender joint count and swollen joint count and at least 3 of the following 5 assessments: 1. physician's global assessment of disease activity 2. patient's global assessment of disease activity 3. patient's assessment of pain 4. patient's self-assessed disability based on health assessment questionnaire 5. c-reactive protein - Proportion of Subjects Who Reached (American College of Rheumatology Score of 50) ACR50 — Week 124
ACR50 response is an aggregate of: 1\. at least 50% reduction in tender joint count and swollen joint count and at least 3 of the following 5 assessments: 1. physician's global assessment of disease activity 2. patient's global assessment of disease activity 3. patient's assessment of pain 4. patient's self-assessed disability based on health assessment questionnaire 5. c-reactive protein - Proportion of Subjects Who Reached (American College of Rheumatology Score of 70) ACR70 — Week 124
ACR70 response is an aggregate of: 1\. at least 70% reduction in tender joint count and swollen joint count and at least 3 of the following 5 assessments: 1. physician's global assessment of disease activity 2. patient's global assessment of disease activity 3. patient's assessment of pain 4. patient's self-assessed disability based on health assessment questionnaire 5. c-reactive protein
Trial sites (99)
| Facility | City | Region | Status |
|---|---|---|---|
| Sunpharma site no 50 | Dothan | Alabama | |
| Sunpharma site no 80 | Gilbert | Arizona | |
| Sunpharma site no 65 | Mesa | Arizona | |
| Sunpharma site no 105 | Phoenix | Arizona | |
| Sunpharma site no. 30 | Covina | California | |
| Sunpharma site no 110 | Encino | California | |
| Sunpharma site no. 17 | Fountain Valley | California | |
| Sunpharma site no. 15 | Thousand Oaks | California | |
| Sunpharma site no 113 | Avon Park | Florida | |
| Sunpharma site no. 21 | Clearwater | Florida | |
| Sunpharma site no. 02 | Hialeah | Florida | |
| Sunpharma site no 71 | Kissimmee | Florida | |
| Sunpharma site no 107 | Margate | Florida | |
| Sunpharma site no. 05 | New Port Richey | Florida | |
| Sunpharma site no 32 | Ocoee | Florida | |
| SunPharma Site no 22 | Tamarac | Florida | |
| Sunpharma site no 52 | Gainesville | Georgia | |
| Sunpharma site no 51 | Orland Park | Illinois | |
| Sunpharma site no 49 | Schaumburg | Illinois | |
| Sunpharma site no 47 | Skokie | Illinois | |
| Sunpharma site no. 20 | Wichita | Kansas | |
| Sunpharma site no. 14 | Springfield | Missouri | |
| Sunpharma site no 104 | St Louis | Missouri | |
| Sunpharma site no 48 | Kalispell | Montana | |
| Sunpharma Site no 27 | Lincoln | Nebraska | |
| Sunpharma site no 33 | Voorhees Township | New Jersey | |
| Sunpharma site no 34 | Charlotte | North Carolina | |
| Sunpharma site no 111 | Leland | North Carolina | |
| Sunpharma site no 53 | Wilmington | North Carolina | |
| Sunpharma site no 35 | Minot | North Dakota | |
| Sunpharma site no. 11 | Middleburg Heights | Ohio | |
| Sunpharma site no 31 | Greenville | South Carolina | |
| Sunpharma site no. 08 | Baytown | Texas | |
| Sunpharma site no. 13 | Baytown | Texas | |
| Sunpharma Site no 28 | Lubbock | Texas | |
| Sunpharma site no 109 | Mesquite | Texas | |
| Sunpharma site no. 03 | San Antonio | Texas | |
| Sunpharma site no. 16 | San Antonio | Texas | |
| Sunpharma site no. 01 | Tomball | Texas | |
| Sunpharma site no 96 | Salt Lake City | Utah |
+ 59 more sites — see the full list on the official registry below.
More Sun Pharmaceutical Industries Limited trials in Germany
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04991116 on ClinicalTrials.gov ↗ ← All trials in Germany