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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
502
AVT05 is a recombinant human IgG1қ mAb developed as a subcutaneous injection
Simponi (Golimumab) is a recombinant human IgG1қ mAb developed as a subcutaneous injection
Rheumatology clinic, University Multiprofile Hospital for Active Treatment Kaspela
Plovdiv, Bulgaria
Demonstrate comparative efficacy of AVT05 with EU-approved Simponi as measured by DAS28-CRP at week 16.
Change from baseline in DAS28-CRP response criteria at week 16
Time frame: Week 16
Assess additional efficacy measures of AVT05 and EU-Simponi in terms of DAS28-CRP
Change from baseline in DAS28-CRP response criteria at weeks 4, 8, 12, 24, 32, 40, 48 and 52
Time frame: Weeks 4, 8, 12, 24, 32, 40, 48 and 52
Assess additional efficacy measures of AVT05 and EU-Simponi in terms of ACR20/50/70 and its individual components throughout the study
Percentage of subjects achieving ACR20/50/70 at weeks 4, 8, 12, 16, 24, 32, 40, 48 and 52
Time frame: Weeks 4, 8, 12, 16, 24, 32, 40, 48 and 52
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