Rheumatoid ArthritisPhase 3ALVOFLEXNCT05842213
Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis, ALVOFLEX
A Phase 3 study testing AVT05 (proposed biosimilar to golimumab) and Simponi (Golimumab) in people with Rheumatoid Arthritis, run by Alvotech Swiss AG at 1 site in Bulgaria.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- AVT05 (proposed biosimilar to golimumab) and Simponi (Golimumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 502 participants
- Where
- 1 siteBulgaria
- Study dates
- 30 Mar 2023to 24 Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Rheumatology clinic, University Multiprofile Hospital for Active Treatment Kaspela
Plovdiv, 4001
About this study
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
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
- Rheumatoid Arthritis
- Being tested
- AVT05 (proposed biosimilar to golimumab), Simponi (Golimumab)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Biological: AVT05 (proposed biosimilar to golimumab); Biological: Simponi (Golimumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 16
Secondary outcomes (2)
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
Measured: 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
Measured: Weeks 4, 8, 12, 16, 24, 32, 40, 48 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start30 Mar 2023
- Primary completion4 Mar 2024
- Study completion24 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvotech Swiss AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Bucknall, Study director, Alvotech Swiss AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842213
- Sponsor's protocol ID
- AVT05-GL-C01
- Acronym
- ALVOFLEX
- Status last verified
- Oct 2024
- First submitted
- 24 Apr 2023
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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. 2026 Jan;40(1):135-149. doi: 10.1007/s40259-025-00748-8. Epub 2025 Nov 3.
PubMed 41182658
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05842213
- Acronym / sponsor ID
- ALVOFLEX / AVT05-GL-C01
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- Alvotech Swiss AGIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AVT05 | Experimental | Biological: AVT05 (proposed biosimilar to golimumab)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 |
| Simponi | Active comparator | Biological: AVT05 (proposed biosimilar to golimumab), Biological: Simponi (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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVT05 (proposed biosimilar to golimumab)AVT05 is a recombinant human IgG1қ mAb developed as a subcutaneous injection | Biological | AVT05, Simponi |
| Simponi (Golimumab)Simponi (Golimumab) is a recombinant human IgG1қ mAb developed as a subcutaneous injection | Biological | Simponi |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Derived from this study: PubMed 41182658Luque 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. 2026 Jan;40(1):135-149. doi: 10.1007/s40259-025-00748-8. Epub 2025 Nov 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Bucknall study director
Alvotech Swiss AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AVT05 (proposed biosimilar to golimumab) and Simponi (Golimumab) in people with Rheumatoid Arthritis, run by Alvotech Swiss AG at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate comparative efficacy of AVT05 with EU-approved Simponi as measured by DAS28-CRP at week 16. (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05842213, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.