Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis, ALVOFLEX

Alvotech

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Biological: Simponi (Golimumab); Biological: AVT05 (proposed biosimilar to golimumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05842213

AVT05-GL-C01

Details and patient eligibility

About

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.

Enrollment: 502 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 factor, positive anti-citrullinated peptide antibodies and/or evidence of 1 joint erosion of hands, wrist of dominant hand or feet at screening
• Subjects must have taken methotrexate for ≥12 weeks

Exclusion criteria

• Prior treatment with biologics or Janus kinase inhibitors that may be used as disease-modifying anti-rheumatic drugs
• Any past or concurrent medical conditions that could potentially increase the subject's risks or that would interfere with the study evaluation, procedures or study completion
• Major chronic inflammatory disease or connective tissue disease other than RA or any active autoimmune disease
• Presence of chronic obstructive pulmonary disease
• Presence of chronic heart failure NYHA class III or IV

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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502 participants in 2 patient groups

AVT05

Experimental group

Description:

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

Treatment:

Biological: AVT05 (proposed biosimilar to golimumab)

Simponi

Active Comparator group

Description:

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

Treatment:

Biological: AVT05 (proposed biosimilar to golimumab)

Biological: Simponi (Golimumab)