Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05842213 | Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis, ALVOFLEX | PHASE3 | COMPLETED | 502 | — | — | Mar 30, 2023 | Sep 24, 2024 | Oct 2, 2024 | 1 | Bulgaria |
Change from baseline in DAS28-CRP response criteria at week 16
| Arm | Type | Description |
|---|---|---|
| AVT05 | EXPERIMENTAL | AVT05 is the proposed biosimilar to Simponi. Subjects in this arm will receive AVT05 50mg s.c. every 4 weeks until week 48. Intervention: Biological: Golimumab |
| Simponi | ACTIVE_COMPARATOR | Subjects in this arm will receive EU Simponi 50mg s.c. every 4 weeks until week 12. At week 16 responders will be re-randomized in a 1:1 ratio to receive either: AVT05 50mg s.c. every 4 weeks until week 48 Simponi 50mg s.c. every 4 weeks until week 48 Intervention: Biological: Golimumab |
| Name | Type | Description |
|---|---|---|
| AVT05 (proposed biosimilar to golimumab) | BIOLOGICAL | AVT05 is a recombinant human IgG1қ mAb developed as a subcutaneous injection |
| Simponi (Golimumab) | BIOLOGICAL | Simponi (Golimumab) is a recombinant human IgG1қ mAb developed as a subcutaneous injection |
Inclusion Criteria: * Subjects diagnosed with active RA according to ACR/EULAR 2010 classification criteria * Subjects diagnosed with moderately to severe active RA as defined by ≥ 6 swollen (out of 66) and ≥6 tender (out of 68) joint counts, CRP \>1mg/l and with at least one of positive rheumatoid...