Clinical trial NCT02636907: Assessment of the Handling Experience With the BI 695501 Autoinjector in Patients With Rheumatoid Arthritis Followed by an Extension Phase Using BI 695501 Prefilled Syringe
Official title: Assessment of Real-life Patient Handling Experience of BI 695501 Administered Subcutaneously With an Autoinjector in Patients With Rheumatoid Arthritis: an Open-label, Interventional Clinical Trial Followed by an Extension Phase of BI 695501 Administered With a Prefilled Syringe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthritis, Rheumatoid
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2015-12-22
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, phase II study of BI 695501 to assess handling experience of patients with Rheumatoid Arthritis using an autoinjector. The extension phase is to provide patients with additional exposure to BI 695501 and to enhance the safety database for this compound.


Eligibility criteria: Inclusion criteria:

* Moderately to severely active Rheumatoid arthritis (RA) for at least 6 months, which is not adequately controlled by non-biologics DMARDs.
* No contraindications to anti-Tumor necrosis factor (TNF) agents.
* Either biologics naive or biologics-experienced but with no experience of self-administration medication using autoinjector or pen.
* Patients must be able and willing to self-inject BI 695501. Further inclusion criteria apply.

Exclusion criteria:

* Experience with self-administration of medication using an autoinjector or pen.
* American College of Rheumatology functional Class IV or wheelchair/ bed bound.
* Primary or secondary immunodeficiency.
* History of tuberculosis (TB). Further exclusion criteria apply.

Primary outcomes:
measure: Autoinjector Assessment Period: Percentage of Successful Self-injections as Reported in the Questionnaires Completed by Both the Trial Site Personnel and the Patient Analysing All Self-injections
timeFrame: Up to Day 50.
Secondary outcomes:
measure: Autoinjector Assessment Period: Percentage of Any Autoinjector Handling Events
timeFrame: Up to Day 50.
measure: Autoinjector Assessment Period: The Percentage of Patients With Local Injection Site Reactions
timeFrame: Up to 17 weeks.
measure: Autoinjector Assessment Period: The Percentage of Patients With Drug-related Adverse Events Per Investigator Assessment
timeFrame: Up to 17 weeks.
measure: Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Local Injection Site Reactions
timeFrame: up to Week 60
measure: Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Drug-related Adverse Events as Per Investigator Assessment
timeFrame: up to Week 60
Other outcomes:
Locations:
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials, Inc.
state: California
city: Venice
country: United States
facility: Lovelace Scientific Resources, Incorporated
state: Florida
city: Cumberland
country: United States
facility: Klein and Associates, M.D., P.A.
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Albuquerque
country: United States
facility: Albuquerque Center For Rheumatology
state: New Mexico
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Rheumatology Clinic Of Houston, P.A.
state: Texas
city: Lubbock
country: United States
facility: Arthritis & Osteoporosis Associates LLP
state: Texas
city: Nassau Bay
country: United States
facility: Heartland Research Associates, LLC
state: Texas
city: Bialystok
country: Poland
facility: Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im.dr J. Biziela
city: Elblag
country: Poland
facility: Wojewodzki Szpital Zespolony w Elblagu
city: Gdynia
country: Poland
facility: Medica Pro Familia Spolka Akcyjna, Oddzial w Gdyni
city: Katowice
country: Poland
facility: Medical Centre Pratia Katowice I
city: Krakow
country: Poland
facility: Medical Centre Pratia Krakow
city: Krakow
country: Poland
facility: Specialist Center ALL-MED, Krakow
city: Torun
country: Poland
facility: Niepubliczny ZOZ, "Nasz Lekarz", Lekarzy Rodzinnych z
city: Warszawa
country: Poland
facility: Medical Centre Pratia Warszawa
city: Wroclaw
country: Poland
facility: Wojewodzki Szpital Specjalistyczny we Wroclawiu
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Cohen S, Klimiuk PA, Krahnke T, Assudani D. Successful administration of BI 695501, an adalimumab biosimilar, using an autoinjector (AI): results from a Phase II open-label clinical study (VOLTAIRE(R)-RL). Expert Opin Drug Deliv. 2018 Jun;15(6):545-548. doi: 10.1080/17425247.2018.1472572. Epub 2018 May 15.