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Completed

NCT Number: NCT05842213

Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis, ALVOFLEX

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rheumatology clinic, University Multiprofile Hospital for Active Treatment Kaspela

Plovdiv, 4001, Bulgaria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AVT05 (proposed biosimilar to golimumab)

Biological

AVT05 is a recombinant human IgG1қ mAb developed as a subcutaneous injection

Simponi (Golimumab)

Biological

Simponi (Golimumab) is a recombinant human IgG1қ mAb developed as a subcutaneous injection

Primary outcomes

  1. Demonstrate comparative efficacy of AVT05 with EU-approved Simponi as measured by DAS28-CRP at week 16.

    Time frame: Week 16

    Change from baseline in DAS28-CRP response criteria at week 16

Secondary outcomes

  1. Assess additional efficacy measures of AVT05 and EU-Simponi in terms of DAS28-CRP

    Time frame: 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

  2. Assess additional efficacy measures of AVT05 and EU-Simponi in terms of ACR20/50/70 and its individual components throughout the study

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Alvotech Swiss AG

Industry

Registry information

Official study 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

Acronym: ALVOFLEX

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 3, 2023
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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