Psoriatic Arthritis Clinical Trial
Official title:
A Multicenter, Randomized, Open-Label Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or Auto-Injector for the Subcutaneous Self-Injection of Bimekizumab Solution by Subjects With Active Psoriatic Arthritis
Verified date | November 2023 |
Source | UCB Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 start and 4 weeks after training in self-injection technique using the bimekizumab safety syringe (SS) or the bimekizumab auto-injector (AI).
Status | Completed |
Enrollment | 214 |
Est. completion date | November 13, 2020 |
Est. primary completion date | November 5, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: -Subjects are not permitted to enroll in DV0004 if any of the PA0012 [NCT04009499] study exclusion criteria are met |
Country | Name | City | State |
---|---|---|---|
Czechia | Dv0004 40061 | Brno | |
Czechia | Dv0004 40009 | Pardubice | |
Czechia | Dv0004 40066 | Praha 2 | |
Czechia | Dv0004 40063 | Praha 5 | |
Czechia | Dv0004 40010 | Uherské Hradište | |
Czechia | Dv0004 40012 | Zlín | |
Germany | Dv0004 40029 | Hamburg | |
Hungary | Dv0004 40079 | Szentes | |
Poland | Dv0004 40038 | Elblag | |
Poland | Dv0004 40088 | Elblag | |
Poland | Dv0004 40096 | Gdynia | |
Poland | Dv0004 40042 | Kraków | |
Poland | Dv0004 40092 | Kraków | |
Poland | Dv0004 40037 | Lublin | |
Poland | Dv0004 40091 | Nowa Sól | |
Poland | Dv0004 40044 | Poznan | |
Poland | Dv0004 40118 | Torun | |
Poland | Dv0004 40041 | Warsaw | |
Poland | Dv0004 40097 | Warsaw | |
Poland | Dv0004 40098 | Warszawa | |
Poland | Dv0004 40039 | Wroclaw | |
Poland | Dv0004 40043 | Wroclaw | |
Russian Federation | Dv0004 20005 | Moscow | |
Russian Federation | Dv0004 20013 | Petrozavodsk | |
Russian Federation | Dv0004 20004 | Saint Petersburg | |
Russian Federation | Dv0004 20014 | Ulyanovsk | |
Russian Federation | Dv0004 20015 | Yaroslavl | |
United States | Dv0004 50029 | Albuquerque | New Mexico |
United States | Dv0004 50023 | Baton Rouge | Louisiana |
United States | Dv0004 50050 | Beckley | West Virginia |
United States | Dv0004 50024 | Boise | Idaho |
United States | Dv0004 50010 | Brooklyn | New York |
United States | Dv0004 50125 | Charlotte | North Carolina |
United States | Dv0004 50040 | Dayton | Ohio |
United States | Dv0004 50020 | Duncansville | Pennsylvania |
United States | Dv0004 50005 | Freehold | New Jersey |
United States | Dv0004 50015 | Hagerstown | Maryland |
United States | Dv0004 50001 | Jackson | Tennessee |
United States | Dv0004 50008 | Johnston | Rhode Island |
United States | Dv0004 50019 | Lansing | Michigan |
United States | Dv0004 50028 | Lexington | Kentucky |
United States | Dv0004 50036 | Mesquite | Texas |
United States | Dv0004 50016 | Saint Louis | Missouri |
United States | Dv0004 50031 | Salisbury | North Carolina |
United States | Dv0004 50009 | Waco | Texas |
United States | Dv0004 50026 | Wheaton | Maryland |
United States | Dv0004 50006 | Wyomissing | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
UCB Biopharma SRL |
United States, Czechia, Germany, Hungary, Poland, Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab Safety Syringe (BKZ-SS) or the Bimekizumab Auto-injector (BKZ-AI) at Week 4 | Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-safety syringe (SS) or the bimekizumab-auto-injector (AI) which shows that the investigational medicinal product (IMP) was delivered completely (ie, container is empty), and - No Adverse Device Effects (ADEs) that would preclude continued use of the device for self-injection (ie, no serious ADEs (SADEs) and/or ADEs leading to withdrawal). | Week 4 | |
Secondary | Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab Safety Syringe (BKZ-SS) or the Bimekizumab Auto-injector (BKZ-AI) at Baseline | Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which shows that the IMP is delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs and/or ADEs leading to withdrawal). | Baseline |
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