Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis, ALVOFLEX
Phase 3
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Biological: AVT05 (proposed biosimilar to golimumab)
- Registration Number
- NCT05842213
- Lead Sponsor
- Alvotech Swiss AG
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 502
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Simponi Simponi (Golimumab) 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 Simponi AVT05 (proposed biosimilar to golimumab) 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 AVT05 AVT05 (proposed biosimilar to golimumab) 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
- Primary Outcome Measures
Name Time Method Demonstrate comparative efficacy of AVT05 with EU-approved Simponi as measured by DAS28-CRP at week 16. Week 16 Change from baseline in DAS28-CRP response criteria at week 16
- Secondary Outcome Measures
Name Time Method Assess additional efficacy measures of AVT05 and EU-Simponi in terms of ACR20/50/70 and its individual components throughout the study Weeks 4, 8, 12, 16, 24, 32, 40, 48 and 52 Percentage of subjects achieving ACR20/50/70 at weeks 4, 8, 12, 16, 24, 32, 40, 48 and 52
Assess additional efficacy measures of AVT05 and EU-Simponi in terms of DAS28-CRP Weeks 4, 8, 12, 24, 32, 40, 48 and 52 Change from baseline in DAS28-CRP response criteria at weeks 4, 8, 12, 24, 32, 40, 48 and 52
Trial Locations
- Locations (1)
Rheumatology clinic, University Multiprofile Hospital for Active Treatment Kaspela
🇧🇬Plovdiv, Bulgaria