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
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
2 other identifiers
interventional
77
2 countries
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2016
Shorter than P25 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2015
CompletedFirst Posted
Study publicly available on registry
December 22, 2015
CompletedStudy Start
First participant enrolled
January 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2017
CompletedResults Posted
Study results publicly available
October 6, 2017
CompletedJuly 10, 2018
June 1, 2018
6 months
December 18, 2015
September 11, 2017
June 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
The percentage of successful self-injections as reported in the questionnaires completed by both the trial site personnel and the patient during the Autoinjector Assessment Period analyzing all self-injections occurring after the training self-injection up to the EoT Visit. Successful self-injections were based on the response to Question 2 (Q2) on the questionnaire, which queried whether the full content of the autoinjector was injected into the body. An injection was considered successful when both the patient and the qualified trial site personnel responded yes to the Q2 on their respective questionnaires. If they responded no to Q2, patients and trial site personnel were instructed to also answer Question 3, which asked what prevented the patient for injecting the full contents of the autoinjector. Planned injections after discontinuation from the trial were not included in the analysis. Percentage of injections calculated relative to the total number of first injections.
Up to Day 50.
Secondary Outcomes (5)
Autoinjector Assessment Period: Percentage of Any Autoinjector Handling Events
Up to Day 50.
Autoinjector Assessment Period: The Percentage of Patients With Local Injection Site Reactions
Up to 17 weeks.
Autoinjector Assessment Period: The Percentage of Patients With Drug-related Adverse Events Per Investigator Assessment
Up to 17 weeks.
Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Local Injection Site Reactions
up to Week 60
Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Drug-related Adverse Events as Per Investigator Assessment
up to Week 60
Study Arms (1)
BI 695501
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Inland Rheumatology Clinical Trials, Inc.
Upland, California, 91786, United States
Lovelace Scientific Resources, Incorporated
Venice, Florida, 34292, United States
Klein and Associates, M.D., P.A.
Cumberland, Maryland, 21502, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01605, United States
Albuquerque Center For Rheumatology
Albuquerque, New Mexico, 87102, United States
Metroplex Clinical Research Center
Dallas, Texas, 75231, United States
Rheumatology Clinic Of Houston, P.A.
Houston, Texas, 77065, United States
Arthritis & Osteoporosis Associates LLP
Lubbock, Texas, 79424, United States
Heartland Research Associates, LLC
Nassau Bay, Texas, 77058, United States
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
Bialystok, 15-099, Poland
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz, 85-168, Poland
Wojewodzki Szpital Zespolony w Elblagu
Elblag, 82-300, Poland
Medica Pro Familia Spolka Akcyjna, Oddzial w Gdyni
Gdynia, 81-338, Poland
Medical Centre Pratia Katowice I
Katowice, 40-954, Poland
Medical Centre Pratia Krakow
Krakow, 30-002, Poland
Specialist Center ALL-MED, Krakow
Krakow, 31-023, Poland
Niepubliczny ZOZ, "Nasz Lekarz", Lekarzy Rodzinnych z
Torun, 87-100, Poland
Medical Centre Pratia Warszawa
Warsaw, 01-868, Poland
Wojewodzki Szpital Specjalistyczny we Wroclawiu
Wroclaw, 51-128, Poland
Related Publications (1)
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.
PMID: 29764238DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2015
First Posted
December 22, 2015
Study Start
January 6, 2016
Primary Completion
June 21, 2016
Study Completion
June 29, 2017
Last Updated
July 10, 2018
Results First Posted
October 6, 2017
Record last verified: 2018-06