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

Condition(s) studied

Investigational drug(s) / intervention(s)

TILD sub-cutaneous (SC) injection: 1 mL injection of study medication

Study summary

An open label phase 3 study

Eligibility

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)

+ 59 more sites — see the full list on the official registry below.

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