Psoriatic Arthritis
Conditions
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).
Interventions
DRUGTILD sub-cutaneous (SC) injection
1 mL injection of study medication
Sponsors
Sun Pharmaceutical Industries Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Australia, Canada, Czechia, Estonia, Germany, India, Italy, Japan, Poland, Slovakia, South Korea, Spain, Taiwan, United States
Outcome results
None listed