Auto-injector Real Life Handling in Patients

RA Clinical Trial

Official title: Assessment of Real-life Patient Handling Experience of AVT02 Administered Subcutaneous With an Auto-Injector in Patients With Moderate to Severe Active RA

Status Completed

Clinical Trial Summary

To assess the real-life patient handling experience with the use of an autoinjector in patients with moderate to severe active Rheumatoid Arthritis (RA) who self-inject AVT02 subcutaneously (SC).

Clinical Trial Description

This is an autoinjector handling study to assess the ability of patients to self-inject AVT02 with the proposed autoinjector in the normal standard of care setting, and to assess the reliability of the proposed autoinjector for AVT02.

On Week 0 (Day 0) eligible patients will be trained by qualified study site personnel (Investigator-led trained injection) following the first injection. The patient will return to the clinic on Week 2 (Day 14) and will be asked to selfinject the second dose (trained self-injection). The injection will be observed by the study personnel and the patient provided any assistance necessary to complete an acceptable injection.

On Week 4 (Day 28), Week 6 (Day 42), and Week 8 (Day 56), the patient will return to clinic and will be asked to self-inject the dose without assistance but under observation of qualified trial staff (observed self-injection).

Observations of autoinjector handling events are recorded independently by both trial site staff and patients using standardized questionnaires.

Any failures to inject will be investigated to determine if they are mechanical failures of the device or due to use error of the patient.

All failures will be further investigated to determine the root cause, and where necessary, appropriate mitigation will be developed and implemented.

In the Extension period (Weeks 9 to 56), AVT02 40 mg will be administered every other week via prefilled syringe (PFS) starting from Week 10 and ending at week 54. The final efficacy evaluation is expected at Week 56.

The clinical study report (CSR) will include the data from the 8week active period. The extension phase CSR will include the data from the 48-week extension period (Weeks 9 to 56). ;

Related Conditions & MeSH terms

• RA

• NCT number: NCT04224194
• Study type: Interventional
• Source: Alvotech Swiss AG
• Status: Completed
• Phase: Phase 3
• Start date: November 4, 2019
• Completion date: February 26, 2021