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A study to compare efficacy, pharmacokinetics, safety and immunogenicity of MB04 [proposed etanercept biosimilar] to Enbrel® [EU-sourced] in rheumatoid arthritis
EU CTIS ID: 2024-510826-16-00
What this study is testing
To compare the efficacy of MB04 with European Union (EU)-sourced Enbrel® at Week 24 in terms of American College of Rheumatology 20% response criteria (ACR20) in patients with moderate to severe rheumatoid arthritis (RA) on methotrexate (MTX) therapy
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult (male or female) between 18 to 75 years
- Rheumatoid Arthritis (RA) diagnosis ≥6 months prior to randomization (time from diagnosis <15 years)
- Moderately to severe RA despite appropriate MTX at baseline therapy
- 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
You likely can't join if
- 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
See the full eligibility criteria
- Adult (male or female) between 18 to 75 years
- Rheumatoid Arthritis (RA) diagnosis ≥6 months prior to randomization (time from diagnosis <15 years)
- Moderately to severe RA despite appropriate MTX at baseline therapy
- 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 last dose
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Georgia
- Serbia
- Moldova, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Georgia; Serbia; Moldova, Republic of. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.