Rheumatoid Arthritis (RA)Phase 3NCT06596772
A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [Proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis
A Phase 3 study testing MB04 (proposed biosimilar to etanercept) and Enbrel (etanercept) in people with Rheumatoid Arthritis (RA), run by mAbxience Research S.L. at 60 sites in 6 countries.
Trial summary
A study to compare efficacy, pharmacokinetics, safety and immunogenicity of MB04 [proposed etanercept biosimilar] to Enbrel® [EU-sourced] in rheumatoid arthritis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- MB04 (proposed biosimilar to etanercept) and Enbrel (etanercept)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 501 participants
- Where
- 60 sitesin 6 countries
- Study dates
- 3 Oct 2024to 20 Feb 2026
- 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
- Documented history of RA diagnosis consistent with the 2010 ACR/EULAR classification criteria ≥6 months prior to randomization (but not exceeding 15 years prior to screening).
- Moderately to severe RA despite appropriate MTX at baseline therapy defined as having more than or equal to six swollen joints and more than or equal to six tender joints and either erythrocyte sedimentation rate (ESR, Westergren) ≥ 28 mm/h or serum C-reactive protein \> 5.0 mg/dL and positive rheumatoid factor and/or CCP at screening
- Stable dose MTX between 10 to 25 mg weekly during ≥12 weeks, since ≥8 weeks prior to randomization
- Stable dose of NSAID and/or other analgesics for at least 4 weeks prior to randomization, when used
- Stable dose ≤10 mg prednisone daily or equivalent for ≥4 weeks prior to randomization, when used
- Patients who are otherwise medically stable according to investigator's discretion
Show all 16Show fewer
- Agree to use highly effective contraceptive methods up to 6 months after last dose Exclusion
- Previously treated with any biologic or targeted synthetic DMARD
- Previously treated with any monoclonal antibody for a condition other than RA
- Hypersensitivity to any component of study drug and/or prefilled syringe components
- Arthritis with onset prior to age 16 years or current diagnosis of inflammatory joint disease other than RA
- Systemic manifestations of RA other than rheumatoid nodules or secondary Sjogren's syndrome
- Active infection or potentially relapsing infections that could have a severe outcome. Latent tuberculosis infection detected during screening should start an approved treatment regimen according to standard of care and rescreened
- Solid or hematologic malignancy within the past 5 years
- Pregnant and breastfeeding women
- Any medical condition in the opinion of the investigator that would be a risk for safety, cooperation in the study or interferes with the interpretation of the study results
Who cannot join
None listed.
Trial locations and contacts
60 sites in 6 countries.
60 sites in 6 countries
Poland29 sites
Research Site 1603
Bialystok
Research Site 1614
Bialystok
Research site 1616
Bialystok
Research site 1613
Bydgoszcz
Research site 1623
Bytom
Research Site 1615
Elblag
Research Site 1627
Elblag
Research Site 1606
Gdynia
Research Site 1611
Katowice
Research Site 1617
Krakow
Research Site 1622
Lublin
Research site 1605
Nowa Sól
Research Site 1618
Opole
Research site 1628
Piotrkow Trybunalski
Research Site 1624
Poniatowa
Research Site 1601
Poznan
Research Site 1602
Poznan
Research Site 1608
Poznan
Research Site 1619
Poznan
Research Site 1621
Poznan
Research Site 1612
Siedlce
Research Site 1610
Sochaczew
Research site 1629
Stalowa Wola
Research Site 1620
Torun
Research Site 1604
Warsaw
Research Site 1607
Warsaw
Research Site 1609
Warsaw
Research Site 1625
Wroclaw
Research Site 1626
Zamość
Georgia9 sites
Research site 7004
Batumi
Research site 7010
Batumi
Research site 7001
Tbilisi
Research site 7002
Tbilisi
Research site 7003
Tbilisi
Research site 7005
Tbilisi
Research site 7006
Tbilisi
Research site 7007
Tbilisi
Research site 7009
Tbilisi
Bulgaria8 sites
Research site 2007
Haskovo
Research site 2005
Plovdiv
Research Site 2002
Rousse
Research site 2001
Sofia
Research Site 2003
Sofia
Research Site 2008
Sofia
Research site 2004
Vidin
Research site 2006
Vratsa
Romania6 sites
Research Site 1803
Bacau
Research Site 1805
Brasov
Research Site 1801
Bucharest
Research site 1802
Bucharest
Research site 1804
Bucharest
Research site 1806
Râmnicu Vâlcea
Serbia5 sites
Research site 1903
Belgrade
Research site 1904
Belgrade
Research site 1905
Belgrade
Research Site 1902
Novi Sad
Research site 1901
Zrenjanin
Moldova3 sites
Research Site 1301
Chisinau, MD-2068
Research site 1302
Chisinau, MD2025
Research site 1303
Chisinau
About this study
Official title: A Prospective, Randomized, Double-blind, Parallel-group Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of MB04 and EU-sourced Enbrel® in Patients With Moderate to Severe Rheumatoid Arthritis
A study to compare efficacy, pharmacokinetics, safety and immunogenicity of MB04 [proposed etanercept biosimilar] to Enbrel® [EU-sourced] in rheumatoid arthritis
Read the detailed description
The study will randomize approximately 458 patients aged between 18 and 75 years with active Rheumatoid Arthritis despite methotrexate therapy.
All patients shall receive methotrexate for ≥12 weeks and on a stable dose (10 to 25 mg/week) for ≥8 weeks prior to randomization, and folic acid (≥5 mg/week) from 4 weeks prior to screening until the end of the treatment period (Week 36).
Screening evaluations will be completed within 28 days prior to randomization. There will be 2 periods in the study: Main Treatment Period and Transition Period.
During the Main Treatment Period, eligible patients will be randomized, at a 1:1 ratio, to administer a 50 mg weekly dose of MB04 or EU- sourced Enbrel® subcutaneously (SC) using an Interactive Response System (IRT). After completing Week 24 assessment, patients will continue to receive the study treatment up to Week 36. Those patients who were originally assigned to EU-sourced Enbrel® will be randomized, at a 1:1 ratio, to receive either MB04 or EU-sourced Enbrel® SC, while patients originally assigned to MB04 will continue with the same treatment until Week 36.
After treatment discontinuation, patients will undergo a Safety Follow-up Period for 4 weeks, up to Week 40.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- MB04 (proposed biosimilar to etanercept), Enbrel (etanercept)
- Keywords
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB04 (proposed biosimilar to etanercept)Drug
MB04 50 mg/week via subcutaneous injection
Enbrel (etanercept)Drug
Enbrel 50 mg/week via subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| MB04 (proposed etanercept biosimilar) | Experimental | MB04 50 mg/week via subcutaneous injection Receives: Drug: MB04 (proposed biosimilar to etanercept) |
| Enbrel (etanercept) | Active comparator | Enbrel 50 mg/week via subcutaneous injection Receives: Drug: Enbrel (etanercept) |
What is being measured
The primary outcome is the main question the study is designed to answer.
American College of Rheumatology 20% Response Criteria (ACR20)
Measured: Week 24
Secondary outcomes (3)
ACR20
Measured: Weeks 36
American College of Rheumatology 50% Response Criteria (ACR50)
Measured: Weeks 24 and 36
American College of Rheumatology 70% Response Criteria (ACR70)
Measured: Weeks 24 and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 Oct 2024
- Primary completion20 Feb 2026
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies 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
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- mAbxience Research S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596772
- Sponsor's protocol ID
- MB04-C-01-23
- Status last verified
- Oct 2026
- First submitted
- 11 Sep 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Parallel-group Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of MB04 and EU-sourced Enbrel® in Patients With Moderate to Severe Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06596772
- Acronym / sponsor ID
- MB04-C-01-23
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- mAbxience Research S.L.Industry (pharma, biotech, devices)
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 19 Sep 2024 (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.
A study to compare efficacy, pharmacokinetics, safety and immunogenicity of MB04 [proposed etanercept biosimilar] to Enbrel® [EU-sourced] in rheumatoid arthritis
Detailed description
The study will randomize approximately 458 patients aged between 18 and 75 years with active Rheumatoid Arthritis despite methotrexate therapy.
All patients shall receive methotrexate for ≥12 weeks and on a stable dose (10 to 25 mg/week) for ≥8 weeks prior to randomization, and folic acid (≥5 mg/week) from 4 weeks prior to screening until the end of the treatment period (Week 36).
Screening evaluations will be completed within 28 days prior to randomization. There will be 2 periods in the study: Main Treatment Period and Transition Period.
During the Main Treatment Period, eligible patients will be randomized, at a 1:1 ratio, to administer a 50 mg weekly dose of MB04 or EU- sourced Enbrel® subcutaneously (SC) using an Interactive Response System (IRT). After completing Week 24 assessment, patients will continue to receive the study treatment up to Week 36. Those patients who were originally assigned to EU-sourced Enbrel® will be randomized, at a 1:1 ratio, to receive either MB04 or EU-sourced Enbrel® SC, while patients originally assigned to MB04 will continue with the same treatment until Week 36.
After treatment discontinuation, patients will undergo a Safety Follow-up Period for 4 weeks, up to Week 40.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| MB04 (proposed etanercept biosimilar) | Experimental | Drug: MB04 (proposed biosimilar to etanercept)MB04 50 mg/week via subcutaneous injection |
| Enbrel (etanercept) | Active comparator | Drug: Enbrel (etanercept)Enbrel 50 mg/week via subcutaneous injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Documented history of RA diagnosis consistent with the 2010 ACR/EULAR classification criteria ≥6 months prior to randomization (but not exceeding 15 years prior to screening).
- Moderately to severe RA despite appropriate MTX at baseline therapy defined as having more than or equal to six swollen joints and more than or equal to six tender joints and either erythrocyte sedimentation rate (ESR, Westergren) ≥ 28 mm/h or serum C-reactive protein \> 5.0 mg/dL and positive rheumatoid factor and/or CCP at screening
- Stable dose MTX between 10 to 25 mg weekly during ≥12 weeks, since ≥8 weeks prior to randomization
- Stable dose of NSAID and/or other analgesics for at least 4 weeks prior to randomization, when used
- Stable dose ≤10 mg prednisone daily or equivalent for ≥4 weeks prior to randomization, when used
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MB04 (proposed biosimilar to etanercept)MB04 50 mg/week via subcutaneous injection | Drug | MB04 (proposed etanercept biosimilar) |
| Enbrel (etanercept)Enbrel 50 mg/week via subcutaneous injection | Drug | Enbrel (etanercept) |
Primary outcome
American College of Rheumatology 20% Response Criteria (ACR20)
Time frame: Week 24
3 secondary outcomes
ACR20
Time frame: Weeks 36
American College of Rheumatology 50% Response Criteria (ACR50)
Time frame: Weeks 24 and 36
American College of Rheumatology 70% Response Criteria (ACR70)
Time frame: Weeks 24 and 36
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 8 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
60 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MB04 (proposed biosimilar to etanercept) and Enbrel (etanercept) in people with Rheumatoid Arthritis (RA), run by mAbxience Research S.L. at 60 sites in 6 countries.
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 16 inclusion and 0 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 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in Poland, Georgia, Bulgaria, Romania, Serbia and 1 more country. 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?
American College of Rheumatology 20% Response Criteria (ACR20) (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2026.