At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 77 enrolled
Drug / intervention
BI 695501 Autoinjector +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating BI 695501 Autoinjector and BI 695501 Prefilled syringe for Arthritis, Rheumatoid. Completed, enrolled 77 participants across 19 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
CountriesPoland, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2015
Enrollment StartJan 2016
Primary CompletionJun 2016
Study CompletionJun 2017
TodayJul 2026
First PostedDec 22, 2015
Enrollment StartJan 6, 2016
Primary CompletionJun 21, 2016
Study CompletionJun 29, 2017
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 10.5 years ago
Interventions
BI 695501 Autoinjectordrug
BI 695501 Prefilled syringedrug