NCT06596772 A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis
| NCT ID | NCT06596772 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | mAbxience Research S.L. |
| Condition | Rheumatoid Arthritis (RA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 458 participants |
| Start Date | 2024-10-03 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 458 participants in total. It began in 2024-10-03 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A study to compare efficacy, pharmacokinetics, safety and immunogenicity of MB04 \[proposed etanercept biosimilar\] to Enbrel® \[EU-sourced\] in rheumatoid arthritis
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06596772 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Rheumatoid Arthritis (RA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06596772 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 458 participants.
Is NCT06596772 currently recruiting?
Yes, NCT06596772 is actively recruiting participants. Contact the research team at Susana.Millan@mabxience.com for enrollment information.
Where is the NCT06596772 trial being conducted?
This trial is being conducted at Haskovo, Bulgaria, Plovdiv, Bulgaria, Rousse, Bulgaria, Sofia, Bulgaria and 11 additional locations.
Who is sponsoring the NCT06596772 clinical trial?
NCT06596772 is sponsored by mAbxience Research S.L.. The trial plans to enroll 458 participants.
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