A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis

March 21, 2025 updated by: mAbxience Research S.L.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

458

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Bulgaria
      • Haskovo, Bulgaria
        • Recruiting
        • Research site 2007
      • Plovdiv, Bulgaria
        • Recruiting
        • Research site 2005
      • Ruse, Bulgaria
        • Recruiting
        • Research Site 2002
      • Sofia, Bulgaria
        • Recruiting
        • Research Site 2003
      • Sofia, Bulgaria
        • Recruiting
        • Research Site 2008
      • Sofia, Bulgaria
        • Recruiting
        • Research site 2001
      • Vidin, Bulgaria
        • Recruiting
        • Research site 2004
      • Vratsa, Bulgaria
        • Recruiting
        • Research site 2006
  • Georgia
      • Batumi, Georgia
        • Recruiting
        • Research site 7004
      • Batumi, Georgia
        • Recruiting
        • Research site 7010
      • Tbilisi, Georgia
        • Recruiting
        • Research site 7001
      • Tbilisi, Georgia
        • Recruiting
        • Research site 7002
      • Tbilisi, Georgia
        • Recruiting
        • Research site 7003
      • Tbilisi, Georgia
        • Recruiting
        • Research site 7005
      • Tbilisi, Georgia
        • Recruiting
        • Research site 7009
      • Tbilisi, Georgia
        • Recruiting
        • Research site 7006
      • Tbilisi, Georgia
        • Recruiting
        • Research site 7007
  • Moldova, Republic of
      • Chișinău, Moldova, Republic of, MD2025
        • Recruiting
        • Research Site 1302
      • Chișinău, Moldova, Republic of, MD-2068
        • Recruiting
        • Research Site 1301
  • Poland
      • Bialystok, Poland
        • Recruiting
        • Research Site 1614
      • Białystok, Poland
        • Recruiting
        • Research Site 1603
      • Białystok, Poland
        • Recruiting
        • Research site 1616
      • Bydgoszcz, Poland
        • Recruiting
        • Research site 1613
      • Bytom, Poland
        • Recruiting
        • Research site 1623
      • Elblag, Poland
        • Recruiting
        • Research Site 1615
      • Elblag, Poland
        • Recruiting
        • Research Site 1627
      • Gdynia, Poland
        • Recruiting
        • Research Site 1606
      • Katowice, Poland
        • Recruiting
        • Research Site 1611
      • Krakow, Poland
        • Recruiting
        • Research Site 1617
      • Lublin, Poland
        • Recruiting
        • Research Site 1622
      • Nowa Sól, Poland
        • Recruiting
        • Research site 1605
      • Opole, Poland
        • Recruiting
        • Research Site 1618
      • Piotrków Trybunalski, Poland
        • Recruiting
        • Research site 1628
      • Poniatowa, Poland
        • Recruiting
        • Research Site 1624
      • Poznan, Poland
        • Recruiting
        • Resarch Site 1619
      • Poznan, Poland
        • Recruiting
        • Research Site 1601
      • Poznan, Poland
        • Recruiting
        • Research Site 1602
      • Poznan, Poland
        • Recruiting
        • Research Site 1608
      • Poznan, Poland
        • Recruiting
        • Research Site 1621
      • Siedlce, Poland
        • Recruiting
        • Research Site 1612
      • Sochaczew, Poland
        • Recruiting
        • Research Site 1610
      • Stalowa Wola, Poland
        • Recruiting
        • Research site 1629
      • Torun, Poland
        • Recruiting
        • Research Site 1620
      • Warszawa, Poland
        • Recruiting
        • Research Site 1604
      • Warszawa, Poland
        • Recruiting
        • Research Site 1607
      • Warszawa, Poland
        • Recruiting
        • Research Site 1609
      • Wroclaw, Poland
        • Recruiting
        • Research Site 1625
      • Zamość, Poland
        • Recruiting
        • Research Site 1626
  • Romania
      • Bacau, Romania
        • Recruiting
        • Research Site 1803
      • Brasov, Romania
        • Recruiting
        • Research Site 1805
      • Bucuresti, Romania
        • Recruiting
        • Resarch Site 1801
      • Bucuresti, Romania
        • Recruiting
        • Research site 1804
      • Bucuresti, Romania
        • Recruiting
        • Research site 1802
      • Chisináu, Romania
        • Recruiting
        • Research Site 1303
      • Râmnicu Vâlcea, Romania
        • Recruiting
        • Research site 1806
  • Serbia
      • Belgrade, Serbia
        • Recruiting
        • Research site 1903
      • Belgrade, Serbia
        • Recruiting
        • Research site 1904
      • Belgrade, Serbia
        • Recruiting
        • Research site 1905
      • Novi Sad, Serbia
        • Recruiting
        • Research Site 1902
      • Zrenjanin, Serbia
        • Recruiting
        • Research site 1901

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion

  • 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
  • Agree to use highly effective contraceptive methods up to 6 months after las dose Exclusion
  • Previously treated with any biologic or targeted synthetic DMARD
  • Previously treated with any monoclonal antibody for other condition 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 that 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Enbrel (etanercept)
Enbrel 50 mg/week via subcutaneous injection
Drug: Enbrel (etanercept)
Enbrel 50 mg/week via subcutaneous injection
Experimental: MB04 (proposed etanercept biosimilar)
MB04 50 mg/week via subcutaneous injection
Drug: MB04 (proposed biosimilar to etanercept)
MB04 50 mg/week via subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
American College of Rheumatology 20% Response Criteria (ACR20)
Time Frame: Week 24
Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
ACR20
Time Frame: Weeks 36
Weeks 36
American College of Rheumatology 50% Response Criteria (ACR50)
Time Frame: Weeks 24 and 36
Weeks 24 and 36
American College of Rheumatology 70% Response Criteria (ACR70)
Time Frame: Weeks 24 and 36
Weeks 24 and 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

mAbxience Research S.L.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

September 11, 2024

First Submitted That Met QC Criteria

September 16, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB04-C-01-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis (RA)

Clinical Trials on MB04 (proposed biosimilar to etanercept)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe