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

Completed · Phase 2

Conditions studied: Arthritis, Rheumatoid

In brief

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.

Key facts

Study ID

NCT02636907

Run by

Boehringer Ingelheim

People needed

77

Starts

2016-01-06

Expected to finish

2017-06-29

Last updated by the study team

2018-07-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.
• Patients must be able and willing to self-inject BI 695501. Further inclusion criteria apply.

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.
• History of tuberculosis (TB). Further exclusion criteria apply.

Where it is running

• 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

Full record on ClinicalTrials.gov

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