Phase 2
Completed N=77
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
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT02636907 ↗
Enrolled (actual)
77
Serious AEs
11.7%
Results posted
Oct 2017
Primary outcomePrimary: 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 — 99.1 Percentage of injections
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
99.1 | — |
| SECONDARY Autoinjector Assessment Period: Percentage of Any Autoinjector Handling Events |
0.9; 99.1 | — |
| SECONDARY Autoinjector Assessment Period: The Percentage of Patients With Local Injection Site Reactions |
6.5 | — |
| SECONDARY Autoinjector Assessment Period: The Percentage of Patients With Drug-related Adverse Events Per Investigator Assessment |
11.7 | — |
| SECONDARY Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Local Injection Site Reactions |
23.4 | — |
| SECONDARY Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Drug-related Adverse Events as Per Investigator Assessment |
36.4 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02636907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.