Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis
Study Details
Study Description
Brief Summary
An open label phase 3 study
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed 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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TILD q12 weeks
|
Drug: TILD sub-cutaneous (SC) injection
1 mL injection of study medication
|
Outcome Measures
Primary Outcome Measures
- 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: physician's global assessment of disease activity patient's global assessment of disease activity patient's assessment of pain patient's self-assessed disability based on health assessment questionnaire 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: physician's global assessment of disease activity patient's global assessment of disease activity patient's assessment of pain patient's self-assessed disability based on health assessment questionnaire 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: physician's global assessment of disease activity patient's global assessment of disease activity patient's assessment of pain patient's self-assessed disability based on health assessment questionnaire c-reactive protein
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sunpharma site no. 30 | Covina | California | United States | 91722 |
| 2 | Sunpharma site no. 17 | Fountain Valley | California | United States | 92708 |
| 3 | Sunpharma site no. 15 | Thousand Oaks | California | United States | 91320 |
| 4 | Sunpharma site no. 21 | Clearwater | Florida | United States | 33765 |
| 5 | Sunpharma site no. 02 | Hialeah | Florida | United States | 33016 |
| 6 | Sunpharma site no. 19 | Miami | Florida | United States | 33135 |
| 7 | Sunpharma site no. 05 | New Port Richey | Florida | United States | 34652 |
| 8 | SunPharma Site no 22 | Tamarac | Florida | United States | 33321 |
| 9 | Sunpharma site no. 29 | Decatur | Georgia | United States | 30033 |
| 10 | Sunpharma site no. 20 | Wichita | Kansas | United States | 67207 |
| 11 | Sunpharma Site no 26 | Lake Charles | Louisiana | United States | 70605 |
| 12 | Sunpharma site no. 07 | Worcester | Massachusetts | United States | 01605 |
| 13 | Sunpharma site no. 10 | Lansing | Michigan | United States | 48910 |
| 14 | Sunpharma site no. 14 | Springfield | Missouri | United States | 65810 |
| 15 | Sunpharma Site no 27 | Lincoln | Nebraska | United States | 68516 |
| 16 | Sunpharma site no. 09 | Rochester | New York | United States | 14623 |
| 17 | Sunpharma site no. 18 | Cincinnati | Ohio | United States | 45242 |
| 18 | Sunpharma site no. 11 | Middleburg Heights | Ohio | United States | 44130 |
| 19 | Sunpharma site no. 25 | Wyomissing | Pennsylvania | United States | 19610 |
| 20 | Sunpharma site no 31 | Greenville | South Carolina | United States | 29601 |
| 21 | Sunpharma site no. 13 | Baytown | Texas | United States | 77521 |
| 22 | Sunpharma site no. 06 | Houston | Texas | United States | 77004 |
| 23 | Sunpharma site no. 08 | Houston | Texas | United States | 77521 |
| 24 | Sunpharma site no. 04 | League City | Texas | United States | 77573 |
| 25 | Sunpharma Site no 28 | Lubbock | Texas | United States | 79410 |
| 26 | Sunpharma site no. 03 | San Antonio | Texas | United States | 78229 |
| 27 | Sunpharma site no. 16 | San Antonio | Texas | United States | 78229 |
| 28 | Sunpharma site no. 01 | Tomball | Texas | United States | 77375 |
| 29 | Sunpharma site no. 12 | Spokane | Washington | United States | 99204 |
| 30 | Sunpharma site no. 24 | Hobart | Tasmania | Australia | 7000 |
| 31 | SunPharma Site No 23 | Córdoba | Spain | 14004 |
Sponsors and Collaborators
- Sun Pharmaceutical Industries Limited
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TILD-21-01