Long-Term Extension Trial of Tildrakizumab to Prove Its Safety in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 540
Summary
- Conditions
- Psoriatic Arthritis
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Masking Description: Subjects will be not be randomized and will enter the long-term extension study with one fixed dose regimen of tildrakizumab, low dose regimen at Week 52 of the parent study. Study continued to be double blind until wk 52 and there after open label. Subjects continue to assigned treatment from parent study up to week 52 in the Long term extension and there after all subjects began migrating to receive low dose injection Q12 weeks in an open-label fashion for up to an additional 4 years..Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Subjects have rolled over from parent study, i.e., CLR_16_23, into the long-term extension study CLR_18_07. The study has been open label post 1 year completion.
Subjects have rolled over from parent study, i.e., CLR_16_23, into the long-term extension study CLR_18_07. The study has been open label post 1 year completion.
Tracking Information
- NCT #
- NCT03552276
- Collaborators
- Not Provided
- Investigators
- Not Provided
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