Overview

This trial is active, not recruiting.

Condition arthritis, rheumatoid
Treatments bi 695501 autoinjector, bi 695501 prefilled syringe
Phase phase 2
Sponsor Boehringer Ingelheim
Start date January 2016
End date June 2016
Trial size 77 participants
Trial identifier NCT02636907, 1297.11, 2015-003030-27

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
bi 695501 autoinjector
bi 695501 prefilled syringe

Primary Outcomes

Measure
Autoinjector assessment period: Percentage of successful self-injections as reported in the questionnaires completed by both the trial site personnel and the patient analysing all self-injections.
time frame: 7 weeks

Secondary Outcomes

Measure
Frequency of any autoinjector handling events.
time frame: 7 weeks
The proportion of patients with local injection site reactions.
time frame: 7 weeks
The proportion of patients with drug-related adverse events per investigator assessment.
time frame: 7 weeks
The proportion of patients with local injection site reactions.
time frame: 60 weeks
The proportion of patients with drug-related adverse events per investigator assessments.
time frame: 60 weeks

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion criteria: - Moderately to severely active RA for at least 6 months, which is not adequately controlled by non-biologics DMARDs. - No contraindications to anti-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 TB. Further exclusion criteria apply.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.