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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Arthritis, Rheumatoid

Treatments: Drug: BI 695501 Prefilled syringe; Drug: BI 695501 Autoinjector

Study type: Interventional

Funder types: Industry

Identifiers

NCT02636907

1297.11

2015-003030-27 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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77 participants in 1 patient group

BI 695501

Experimental group

Treatment:

Drug: BI 695501 Prefilled syringe

Drug: BI 695501 Autoinjector