NCT02636907

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	BI 695501 Autoinjector
DRUG	BI 695501 Prefilled syringe

Timeline

• Start date: 2016-01-06
• Primary completion: 2016-06-21
• Completion: 2017-06-29
• First posted: 2015-12-22
• Last updated: 2018-07-10
• Results posted: 2017-10-06

Locations

19 sites across 2 countries: United States, Poland