Clinical trial NCT04109976: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis
PsA
Auto-Injector
Bimekizumab
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2019-10-01
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 start and 4 weeks after training in self-injection technique using the bimekizumab safety syringe (SS) or the bimekizumab auto-injector (AI).


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Week 4
Secondary outcomes:
measure: 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
timeFrame: Baseline
Other outcomes:
Locations:
city: Boise
country: United States
facility: Dv0004 50024
state: Idaho
city: Lexington
country: United States
facility: Dv0004 50028
state: Kentucky
city: Baton Rouge
country: United States
facility: Dv0004 50023
state: Louisiana
city: Hagerstown
country: United States
facility: Dv0004 50015
state: Maryland
city: Wheaton
country: United States
facility: Dv0004 50026
state: Maryland
city: Lansing
country: United States
facility: Dv0004 50019
state: Michigan
city: Saint Louis
country: United States
facility: Dv0004 50016
state: Missouri
city: Freehold
country: United States
facility: Dv0004 50005
state: New Jersey
city: Albuquerque
country: United States
facility: Dv0004 50029
state: New Mexico
city: Brooklyn
country: United States
facility: Dv0004 50010
state: New York
city: Charlotte
country: United States
facility: Dv0004 50125
state: North Carolina
city: Salisbury
country: United States
facility: Dv0004 50031
state: North Carolina
city: Dayton
country: United States
facility: Dv0004 50040
state: Ohio
city: Duncansville
country: United States
facility: Dv0004 50020
state: Pennsylvania
city: Wyomissing
country: United States
facility: Dv0004 50006
state: Pennsylvania
city: Johnston
country: United States
facility: Dv0004 50008
state: Rhode Island
city: Jackson
country: United States
facility: Dv0004 50001
state: Tennessee
city: Mesquite
country: United States
facility: Dv0004 50036
state: Texas
city: Waco
country: United States
facility: Dv0004 50009
state: Texas
city: Beckley
country: United States
facility: Dv0004 50050
state: West Virginia
city: Brno
country: Czechia
facility: Dv0004 40061
city: Pardubice
country: Czechia
facility: Dv0004 40009
city: Praha 2
country: Czechia
facility: Dv0004 40066
city: Praha 5
country: Czechia
facility: Dv0004 40063
city: Uherské Hradiště
country: Czechia
facility: Dv0004 40010
city: Zlín
country: Czechia
facility: Dv0004 40012
city: Hamburg
country: Germany
facility: Dv0004 40029
city: Szentes
country: Hungary
facility: Dv0004 40079
city: Elbląg
country: Poland
facility: Dv0004 40038
city: Elbląg
country: Poland
facility: Dv0004 40088
city: Gdynia
country: Poland
facility: Dv0004 40096
city: Kraków
country: Poland
facility: Dv0004 40042
city: Kraków
country: Poland
facility: Dv0004 40092
city: Lublin
country: Poland
facility: Dv0004 40037
city: Nowa Sól
country: Poland
facility: Dv0004 40091
city: Poznań
country: Poland
facility: Dv0004 40044
city: Toruń
country: Poland
facility: Dv0004 40118
city: Warsaw
country: Poland
facility: Dv0004 40041
city: Warsaw
country: Poland
facility: Dv0004 40097
city: Warszawa
country: Poland
facility: Dv0004 40098
city: Wrocław
country: Poland
facility: Dv0004 40039
city: Wrocław
country: Poland
facility: Dv0004 40043
city: Moscow
country: Russian Federation
facility: Dv0004 20005
city: Petrozavodsk
country: Russian Federation
facility: Dv0004 20013
city: Saint Petersburg
country: Russian Federation
facility: Dv0004 20004
city: Ulyanovsk
country: Russian Federation
facility: Dv0004 20014
city: Yaroslavl
country: Russian Federation
facility: Dv0004 20015
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: