Status:
COMPLETED
A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Active Psoriatic Arthritis
Lead Sponsor:
UCB Biopharma SRL
Conditions:
Psoriatic Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate for each self-injecting device presentation the ability of subjects with psoriatic arthritis (PsA) to safely and effectively self-inject bimekizumab at study st...
Eligibility Criteria
Inclusion
- Subject fulfills all inclusion criteria for the PA0012 \[NCT04009499\] study
- Subject is considered reliable and capable of adhering to the DV0004 protocol (eg, able to understand and complete questionnaires, able to use investigational self-injecting device presentations according to the instructions for use (IFU), and able to adhere to the visit schedule) according to the judgment of the Investigator
- Subject is willing to self-inject
Exclusion
- Subjects are not permitted to enroll in DV0004 if any of the PA0012 \[NCT04009499\] study exclusion criteria are met
Key Trial Info
Start Date :
August 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2020
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT04109976
Start Date
August 13 2019
End Date
November 13 2020
Last Update
November 30 2023
Active Locations (47)
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1
Dv0004 50024
Boise, Idaho, United States, 83702
2
Dv0004 50028
Lexington, Kentucky, United States, 40504
3
Dv0004 50023
Baton Rouge, Louisiana, United States, 70836
4
Dv0004 50015
Hagerstown, Maryland, United States, 21742