Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT04224194
Status:
COMPLETED
Last Update Posted:
2022-05-05
First Post:
2019-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Auto-injector Real Life Handling in Patients
Sponsor:
Alvotech Swiss AG
Organization:
Study Overview
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
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
Detailed 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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: