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Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis, ALVOFLEX

NCT05842213 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 502

Last updated 2024-10-02

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

AVT05 (proposed biosimilar to golimumab)

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

BIOLOGICAL

Simponi (Golimumab)

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

Sponsors & Collaborators

  • Alvotech Swiss AG

    lead INDUSTRY

Principal Investigators

  • Richard Bucknall · Alvotech Swiss AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-30
Primary Completion
2024-03-04
Completion
2024-09-24

Countries

  • Bulgaria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05842213 on ClinicalTrials.gov