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Comparative, Multicenter Study in Subjects With Rheumatoid Arthritis, ALVOFLEX (ALVOFLEX)

Primary Purpose

Rheumatoid Arthritis

Status
Active
Phase
Phase 3
Locations
Bulgaria
Study Type
Interventional
Intervention
AVT05 (proposed biosimilar to golimumab)
Simponi (Golimumab)
Sponsored by
Alvotech Swiss AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rheumatology clinic, University Multiprofile Hospital for Active Treatment Kaspela

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AVT05

Simponi

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
April 24, 2023
Last Updated
September 20, 2023
Sponsor
Alvotech Swiss AG
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1. Study Identification

Unique Protocol Identification Number
NCT05842213
Brief Title
Comparative, Multicenter Study in Subjects With Rheumatoid Arthritis, ALVOFLEX
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alvotech Swiss AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
502 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AVT05
Arm Type
Experimental
Arm Description
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
Arm Title
Simponi
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
AVT05 (proposed biosimilar to golimumab)
Intervention Description
AVT05 is a recombinant human IgG1қ mAb developed as a subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
Simponi (Golimumab)
Intervention Description
Simponi (Golimumab) is a recombinant human IgG1қ mAb developed as a subcutaneous injection
Primary Outcome Measure Information:
Title
Demonstrate comparative efficacy of AVT05 with EU-approved Simponi as measured by DAS28-CRP at week 16.
Description
Change from baseline in DAS28-CRP response criteria at week 16
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Assess additional efficacy measures of AVT05 and EU-Simponi in terms of DAS28-CRP
Description
Change from baseline in DAS28-CRP response criteria at weeks 4, 8, 12, 24, 32, 40, 48 and 52
Time Frame
Weeks 4, 8, 12, 24, 32, 40, 48 and 52
Title
Assess additional efficacy measures of AVT05 and EU-Simponi in terms of ACR20/50/70 and its individual components throughout the study
Description
Percentage of subjects achieving ACR20/50/70 at weeks 4, 8, 12, 16, 24, 32, 40, 48 and 52
Time Frame
Weeks 4, 8, 12, 16, 24, 32, 40, 48 and 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Bucknall
Organizational Affiliation
Alvotech Swiss AG
Official's Role
Study Director
Facility Information:
Facility Name
Rheumatology clinic, University Multiprofile Hospital for Active Treatment Kaspela
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria

12. IPD Sharing Statement

Learn more about this trial

Comparative, Multicenter Study in Subjects With Rheumatoid Arthritis, ALVOFLEX

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