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).
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
107
Combined product as Drug is delivered through an autoinjector pen on which real-life patient handling experience is assessed.
Aleksandre Aladashvili Clinic LLC
Tbilisi, Georgia
"National Institute of Endocrinology" LTD
Tbilisi, Georgia
JSC "EVEX Hospitals"
Tbilisi, Georgia
Tbilisi Heart and Vascular Clinic LTD
percentage of successful self-injections patient rated
The percentage of successful self-injections as reported in the questionnaires completed by the patients (Patient Assessment Tool, Question 1), analyzing all self-injections occurring after the trained self-injection. The higher the % the better the result.
Time frame: up to the Week 8
percentage of successful self-injections site staff rated
The percentage of successful self-injections as reported in the questionnaires completed by the trial site personnel (Observer Assessment Tool, Question 1) , analyzing all self-injections occurring after the trained self-injection. The higher the % the better the result.
Time frame: up to the Week 8
frequency of any autoinjector handling events during the self-injection process
An autoinjector handling event is any event preventing the patient from successfully, selfinjecting the full contents of the autoinjector and occurring after the training selfinjection with the autoinjector pen. The lower the number the better the result.
Time frame: Up to week 8
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Tbilisi, Georgia
Georgian Dutch Hospital LLC
Tbilisi, Georgia
Communal Noncommercial Enterprise "City Clinical Hospital 8" of Kharkiv City Council
Kharkiv, Ukraine
SI D. F. Chebotarev Institute of Gerontology NAMS Ukraine
Kyiv, Ukraine
Municipal Institution "Zaporozhye City Clinical hospital No.10"
Zaporizhzhya, Ukraine
CU "Zaporizhzhia Regional Clinical Hospital" ZRC
Zaporizhzhya, Ukraine