NCT05842213

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
502

participants targeted

Target at P50-P75 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Mar 2023

Shorter than P25 for phase_3 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2024

Completed
Last Updated

October 2, 2024

Status Verified

October 1, 2024

Enrollment Period

11 months

First QC Date

April 24, 2023

Last Update Submit

October 1, 2024

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    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

    Weeks 4, 8, 12, 16, 24, 32, 40, 48 and 52

Study Arms (2)

AVT05

EXPERIMENTAL

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

Biological: AVT05 (proposed biosimilar to golimumab)

Simponi

ACTIVE COMPARATOR

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

Biological: AVT05 (proposed biosimilar to golimumab)Biological: Simponi (Golimumab)

Interventions

AVT05 (proposed biosimilar to golimumab)BIOLOGICAL

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

AVT05Simponi
Simponi (Golimumab)BIOLOGICAL

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

Simponi

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology clinic, University Multiprofile Hospital for Active Treatment Kaspela

Plovdiv, 4001, Bulgaria

Location

Related Publications (1)

  • Luque M, Zhelyazkova K, Vashishta L, Rai M, Sattar A, Petrovic K, Bucknall R, Leutz S, Berti F. Efficacy and Safety of Biosimilar AVT05 Versus Reference Product Golimumab in Combination with Methotrexate in Moderate-to-Severe Rheumatoid Arthritis: 52-Week Results of a Randomized, Parallel-Group, Double-Blind Study. BioDrugs. 2025 Nov 3. doi: 10.1007/s40259-025-00748-8. Online ahead of print.

    PMID: 41182658DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

golimumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Richard Bucknall

    Alvotech Swiss AG

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2023

First Posted

May 3, 2023

Study Start

March 30, 2023

Primary Completion

March 4, 2024

Study Completion

September 24, 2024

Last Updated

October 2, 2024

Record last verified: 2024-10

Locations

BU(1)