Comparative, Multicenter Study in Subjects With Rheumatoid Arthritis, ALVOFLEX

Rheumatoid Arthritis Clinical Trial

— ALVOFLEX  

Official title:

Randomized, Double-blind, 2-arm Multicenter Study to Investigate the Efficacy, Safety and Immunogenicity Between Subcutaneous AVT05 and EU-approved Simponi® in Subjects With Moderate to Severe Rheumatoid Arthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05842213
• Other study ID #: AVT05-GL-C01
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 30, 2023
• Est. completion date: August 2024

Study information

• Verified date: September 2023
• Source: Alvotech Swiss AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 502
• Est. completion date: August 2024
• Est. primary completion date: March 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• AVT05 (proposed biosimilar to golimumab)
AVT05 is a recombinant human IgG1? mAb developed as a subcutaneous injection
• Simponi (Golimumab)
Simponi (Golimumab) is a recombinant human IgG1? mAb developed as a subcutaneous injection

Locations

Country	Name	City	State
Bulgaria	Rheumatology clinic, University Multiprofile Hospital for Active Treatment Kaspela	Plovdiv

Sponsors (1)

Lead Sponsor	Collaborator
Alvotech Swiss AG

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Week 16
Secondary	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	Weeks 4, 8, 12, 24, 32, 40, 48 and 52
Secondary	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	Weeks 4, 8, 12, 16, 24, 32, 40, 48 and 52