Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis
- Conditions
- Psoriatic Arthritis
- Interventions
- Drug: TILD sub-cutaneous (SC) injection
- Registration Number
- NCT04991116
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief Summary
An open label phase 3 study
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 650
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TILD q12 weeks TILD sub-cutaneous (SC) injection -
- Primary Outcome Measures
Name Time Method 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 proteinProportion 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 proteinProportion 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 proteinIncidence and intensity of Adverse Events (AEs) recorded through the study period Week 124
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (93)
Sunpharma site no 36
🇨🇿Brno, Czechia
Sunpharma site no 67
🇨🇿Praha 2, Czechia
Sunpharma site no 89
🇨🇿Praha 4, Czechia
Sunpharma site no 82
🇨🇿Zlin, Czechia
Sunpharma site no 44
🇪🇪Tallinn, Estonia
Sunpharma site no 39
🇪🇪Tartu, Estonia
Sunpharma site no 40
🇪🇪Tartu, Estonia
Sunpharma site no 37
🇩🇪Berlin, Germany
Sunpharma site no 83
🇩🇪Herne, Germany
Sunpharma site no 55
🇵🇱Nadarzyn, Poland
Sunpharma site no 60
🇵🇱Torun, Poland
Sunpharma site no 61
🇵🇱Warszawa, Poland
Sunpharma site no 74
🇸🇰Martin, Slovakia
Sunpharma site no 57
🇪🇸La Coruña, Spain
Sunpharma site no 62
🇪🇸Sevilla, Spain
Sunpharma site no 75
🇨🇳Tainan, Taiwan
Sunpharma site no 77
🇨🇳Taipei, Taiwan
Sunpharma site no 50
🇺🇸Dothan, Alabama, United States
Sunpharma site no 73
🇯🇵Shinjuku-ku, Tokyo, Japan
Sunpharma site no 45
🇯🇵Fukuoka, Japan
Sunpharma site no 84
🇯🇵Itabashi-ku, Japan
Sunpharma site no 46
🇯🇵Kumamoto-shi, Japan
Sunpharma site no 72
🇯🇵Mitaka, Japan
Sunpharma site no 79
🇯🇵Miyazaki, Japan
Sunpharma site no 78
🇯🇵Nagoya, Japan
Sunpharma site no 64
🇯🇵Sendai-shi, Japan
Sunpharma site no 63
🇯🇵Sendai-shi, Japan
Sunpharma site no 87
🇯🇵Tsu, Japan
Sunpharma site no 98
🇰🇷Seoul, Korea, Republic of
Sunpharma site no 70
🇰🇷Seoul, Korea, Republic of
Sunpharma site no 43
🇵🇱Bialystok, Poland
Sunpharma site no 69
🇵🇱Bialystok, Poland
Sunpharma site no 56
🇵🇱Krakow, Poland
Sunpharma site no 81
🇵🇱Lublin, Poland
Sunpharma site no 85
🇵🇱Poznan, Poland
Sunpharma site no 68
🇵🇱Poznan, Poland
Sunpharma site no 42
🇸🇰Nové Mesto Nad Váhom, Slovakia
Sunpharma site no 41
🇸🇰Rimavska Sobota, Slovakia
Sunpharma site no 38
🇪🇸Cordoba, Spain
SunPharma Site No 23
🇪🇸Córdoba, Spain
Sunpharma site no 86
🇪🇸Malaga, Spain
Sunpharma site no 80
🇺🇸Gilbert, Arizona, United States
Sunpharma site no 65
🇺🇸Mesa, Arizona, United States
Sunpharma site no. 30
🇺🇸Covina, California, United States
Sunpharma site no. 17
🇺🇸Fountain Valley, California, United States
Sunpharma site no. 15
🇺🇸Thousand Oaks, California, United States
Sunpharma site no. 21
🇺🇸Clearwater, Florida, United States
Sunpharma site no. 02
🇺🇸Hialeah, Florida, United States
Sunpharma site no 71
🇺🇸Kissimmee, Florida, United States
Sunpharma site no. 05
🇺🇸New Port Richey, Florida, United States
Sunpharma site no 32
🇺🇸Ocoee, Florida, United States
SunPharma Site no 22
🇺🇸Tamarac, Florida, United States
Sunpharma site no 52
🇺🇸Gainesville, Georgia, United States
Sunpharma site no 51
🇺🇸Orland Park, Illinois, United States
Sunpharma site no 49
🇺🇸Schaumburg, Illinois, United States
Sunpharma site no 47
🇺🇸Skokie, Illinois, United States
Sunpharma site no. 20
🇺🇸Wichita, Kansas, United States
Sunpharma site no 104
🇺🇸Saint Louis, Missouri, United States
Sunpharma site no. 14
🇺🇸Springfield, Missouri, United States
Sunpharma site no 48
🇺🇸Kalispell, Montana, United States
Sunpharma Site no 27
🇺🇸Lincoln, Nebraska, United States
Sunpharma site no 33
🇺🇸Voorhees, New Jersey, United States
Sunpharma site no 34
🇺🇸Charlotte, North Carolina, United States
Sunpharma site no 53
🇺🇸Wilmington, North Carolina, United States
Sunpharma site no 35
🇺🇸Minot, North Dakota, United States
Sunpharma site no. 11
🇺🇸Middleburg Heights, Ohio, United States
Sunpharma site no 31
🇺🇸Greenville, South Carolina, United States
Sunpharma site no. 08
🇺🇸Baytown, Texas, United States
Sunpharma site no. 13
🇺🇸Baytown, Texas, United States
Sunpharma Site no 28
🇺🇸Lubbock, Texas, United States
Sunpharma site no. 03
🇺🇸San Antonio, Texas, United States
Sunpharma site no. 16
🇺🇸San Antonio, Texas, United States
Sunpharma site no. 01
🇺🇸Tomball, Texas, United States
Sunpharma site no 96
🇺🇸Salt Lake City, Utah, United States
Sunpharma site no 66
🇺🇸Spokane, Washington, United States
Sunpharma site no 59
🇦🇺Phillip, Australian Capital Territory, Australia
Sunpharma site no 58
🇦🇺Maroochydore, Queensland, Australia
Sunpharma site no. 24
🇦🇺Hobart, Tasmania, Australia
Sunpharma site no 95
🇨🇦Trois-Rivières, Canada
Sunpharma site no 92
🇮🇳Surat, Gujrat, India
Sunpharma site no 101
🇮🇳Belgaum, Karnataka, India
Sunpharma site no 91
🇮🇳Hubli, Karnataka, India
Sunpharma site no 93
🇮🇳Chennai, Tamil Nadu, India
Sunpharma site no 100
🇮🇳Bangalore, TN, India
Sunpharma site no 103
🇮🇳Chennai, TN, India
Sunpharma site no 102
🇮🇳Secunderabad, India
Sunpharma site no 94
🇮🇳Sevilla, India
Sunpharma site no 90
🇮🇹Verona, Italy
Sunpharma site no 88
🇪🇸Santiago De Compostela, Spain
Sunpharma site no 97
🇪🇸Valencia, Spain
Sunpharma site no 76
🇨🇳Kaohsiung, Taiwan
Sunpharma site no 54
🇨🇳Taichung, Taiwan
Sunpharma site no 99
🇨🇳Taichung, Taiwan