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
• Trial end date: 2017-06-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim

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.