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Compares treatment options for Rheumatoid Arthritis (RA)
Official title A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT06596772
What this study is testing
What is MB04 (proposed biosimilar to etanercept)?
MB04 (proposed biosimilar to etanercept) is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for rheumatoid arthritis (ra).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A study to compare efficacy, pharmacokinetics, safety and immunogenicity of MB04 [proposed etanercept biosimilar] to Enbrel® [EU-sourced] in rheumatoid arthritis
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Inclusion
- Documented history of RA diagnosis consistent with the 2010 ACR/EULAR classification criteria ≥6 months prior to randomization (but not exceeding 15...
- 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...
- 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
See the full 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...
- 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...
- 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
- Haskovo, Bulgaria
- Plovdiv, Bulgaria
- Rousse, Bulgaria
- Sofia, Bulgaria
- Vidin, Bulgaria
- Vratsa, Bulgaria
- Batumi, Georgia
- Tbilisi, Georgia
- Chisinau, Moldova
- Bialystok, Poland
- Bydgoszcz, Poland
- Bytom, Poland
- Elblag, Poland
- Gdynia, Poland
- Katowice, Poland
- Krakow, Poland
- Lublin, Poland
- Nowa Sól, Poland
- Opole, Poland
- Piotrkow Trybunalski, Poland
+ 17 more site(s).
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 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Haskovo, Bulgaria; Plovdiv, Bulgaria; Rousse, Bulgaria; Sofia, Bulgaria; Vidin, Bulgaria; Vratsa, Bulgaria and 31 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.