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
NCT ID: NCT02636907
Last Updated: 2018-07-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
77 participants
INTERVENTIONAL
2016-01-06
2017-06-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BI 695501
BI 695501 Autoinjector
BI 695501 Prefilled syringe
Interventions
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BI 695501 Autoinjector
BI 695501 Prefilled syringe
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* American College of Rheumatology functional Class IV or wheelchair/ bed bound.
* Primary or secondary immunodeficiency.
18 Years
80 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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Inland Rheumatology Clinical Trials, Inc.
Upland, California, United States
Lovelace Scientific Resources, Incorporated
Venice, Florida, United States
Klein and Associates, M.D., P.A.
Cumberland, Maryland, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Albuquerque Center For Rheumatology
Albuquerque, New Mexico, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Rheumatology Clinic Of Houston, P.A.
Houston, Texas, United States
Arthritis & Osteoporosis Associates LLP
Lubbock, Texas, United States
Heartland Research Associates, LLC
Nassau Bay, Texas, United States
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
Bialystok, , Poland
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz, , Poland
Wojewodzki Szpital Zespolony w Elblagu
Elblag, , Poland
Medica Pro Familia Spolka Akcyjna, Oddzial w Gdyni
Gdynia, , Poland
Medical Centre Pratia Katowice I
Katowice, , Poland
Medical Centre Pratia Krakow
Krakow, , Poland
Specialist Center ALL-MED, Krakow
Krakow, , Poland
Niepubliczny ZOZ, "Nasz Lekarz", Lekarzy Rodzinnych z
Torun, , Poland
Medical Centre Pratia Warszawa
Warsaw, , Poland
Wojewodzki Szpital Specjalistyczny we Wroclawiu
Wroclaw, , Poland
Countries
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References
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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.
Other Identifiers
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2015-003030-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1297.11
Identifier Type: -
Identifier Source: org_study_id
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