Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis, ALVOFLEX

Sponsor
Alvotech Swiss AG
Study ID
NCT05842213
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a study to compare the efficacy, safety and immunogenicity of AVT05 versus EU-Simponi® in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA). The study will consist of up to 4-week Screening Period, a 48-week Treatment Period, and a 4-week Safety Follow-up Period.

Key Dates

Start date
Mar 30, 2023
Status verified
Oct 2024
Primary completion
Mar 4, 2024
Completion
Sep 24, 2024

Study Design

Enrollment
502 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AVT05
    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
  • Active Comparator: Simponi
    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

Primary Outcome Measure

Demonstrate comparative efficacy of AVT05 with EU-approved Simponi as measured by DAS28-CRP at week 16. [ Time Frame: Week 16 ]

Related Studies