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

Status:	Completed
Conditions:	Arthritis, Rheumatoid Arthritis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	18 - 80
Updated:	7/12/2018
Start Date:	January 6, 2016
End Date:	June 29, 2017

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

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.

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.

We found this trial at

sites

Clinical Pharmacology Study Group

Worcester, Massachusetts 01610

from

Worcester, MA