Study comparing MB04 (etanercept biosimilar) with Enbrel in patients with moderate to severe rheumatoid arthritis who are taking methotrexate

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What is this study about?

This study focuses on patients with moderate to severe Rheumatoid Arthritis, a chronic condition that causes joint inflammation, pain, and stiffness. The research compares two medications: MB04 (a proposed new medication) and Enbrel (also known as etanercept). Both medications belong to a group of drugs called tumor necrosis factor alpha inhibitors, which help reduce inflammation in the body.

The purpose of this study is to determine if MB04 works as effectively as Enbrel in treating rheumatoid arthritis. Both medications are given as injections under the skin using pre-filled syringes. During the study, patients will also continue taking methotrexate, which is a standard medication for rheumatoid arthritis treatment.

The treatment period lasts 36 weeks, during which patients receive injections of either MB04 or Enbrel. The maximum daily dose is 50 mg, and the total amount of medication received during the study will not exceed 1800 mg. Throughout the study, doctors will monitor how well the medications work by checking joint symptoms and overall disease activity.

1 Initial treatment phase

You will receive subcutaneous injections of either MB04 or Enbrel® (50 mg solution). The specific medication will be randomly assigned.

You will continue taking your current dose of methotrexate (between 10 to 25 mg weekly).

If you are taking other medications such as NSAIDs, pain relievers, or prednisone (up to 10 mg daily), you will maintain your current doses.

2 Follow-up visits – weeks 4, 8, and 12

Your response to treatment will be evaluated during clinic visits.

The doctor will assess your joint symptoms and overall disease activity using standardized measurements.

Blood samples may be collected to monitor your response to treatment.

3 Main assessment – week 24

A comprehensive evaluation of your treatment response will be performed.

The doctor will measure improvements in your joint symptoms and daily activities.

This is the primary timepoint for comparing the effectiveness of the treatments.

4 Extended follow-up – week 36

Final evaluation to assess the long-term effectiveness of the treatment.

The doctor will perform the same assessments as in previous visits.

This visit marks the end of the active treatment phase.

5 Safety monitoring

Throughout the study, your health will be monitored for any side effects.

You must use effective contraception during the study and for 6 months after the last dose.

The total duration of your participation will be approximately 36 weeks.

Who Can Join the Study?

  • Age between 18 to 75 years old (male or female)
  • Diagnosed with Rheumatoid Arthritis for at least 6 months but less than 15 years
  • Have moderate to severe Rheumatoid Arthritis despite taking methotrexate (a medication that reduces inflammation)
  • Taking a stable dose of methotrexate between 10 to 25 mg weekly for at least 12 weeks, with no changes in the last 8 weeks
  • If taking pain medications (NSAIDs – anti-inflammatory drugs like ibuprofen), the dose must be stable for at least 4 weeks
  • If taking prednisone (a steroid medication), the dose must be 10 mg or less per day and stable for at least 4 weeks
  • Be in generally stable health, as determined by the study doctor
  • Willing to use reliable birth control methods during the study and for 6 months after the last dose of study medication

Who Cannot Join the Study?

  • History of severe allergic reactions or anaphylaxis (life-threatening allergic reaction)
  • Active or chronic infections, including tuberculosis (TB) or hepatitis B
  • History of cancer within the past 5 years (except successfully treated non-melanoma skin cancer)
  • Severe heart conditions, including congestive heart failure (when heart cannot pump blood effectively)
  • Significant kidney or liver disease
  • Nervous system disorders, including multiple sclerosis or lupus
  • Pregnant or breastfeeding women
  • Current treatment with other biological medications (specialized drugs that target specific parts of immune system)
  • Blood disorders or significant abnormalities in blood tests
  • Uncontrolled high blood pressure or diabetes
  • Recent live vaccines (within 4 weeks before starting the study)
  • Participation in other clinical trials within the past 3 months
  • Alcohol or drug abuse within the past 6 months
  • Mental health conditions that could interfere with study participation

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centrul Medical Sana S.R.L. Bucharest Romania
Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik Bialystok Poland
CENTRUM MEDYCZNE REUMA PARK Warsaw Poland
Vasarhelyi Sarkanyfu Kft. Hodmezovasarhely Hungary
Reumedika s.c. Poznan Poland
Twoja Przychodnia Opolskie Centrum Medyczne Opole Poland

Other Sites

Site Name City Country Status
Diagnostic Consulting Center XVII Sofia Ltd. Sofia Bulgaria
Saint Maria Hospital Bucharest Romania
Lukmed 2 Sp. z o.o. Siedlce Poland
Rcmed Oddzial Sochaczew Sochaczew Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Nowa Sol Poland
Silmedic Sp. z o.o. Katowice Poland
Clinicmed Daniluk Nowak Sp. k. Bialystok Poland
Qualiclinic Kft. Budapest Hungary
Medical Center Teodora EOOD Ruse Bulgaria
Solumed Sp. z o.o. sp.k. Poznan Poland
Centrum Medyczne All-Med Badania Kliniczne Cracow Poland
Medaudio-Optica S.R.L. Ramnicu Valcea Romania
Mbal Lyulin EAD Sofia Bulgaria
Meditsinski Tsentar-N.I Pirogov EOOD Sofia Bulgaria
Revita Kft. Budapest Hungary
Complex Rendelo Med Zrt. Szekesfehervar Hungary
Ambulatorium Sp. z o.o. Elblag Poland
Ai Centrum Medyczne Sp. z o.o. Poznan Poland
Wromedica I Bielicka A Strzalkowska s.c. Wroclaw Poland
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Etg Neuroscience Sp. z o.o. Warsaw Poland
Pratia S.A. Skorzewo Poland
University Multiprophy Hospital For Active Treatment – Plovdiv AD Plovdiv Bulgaria
Spitalul Judetean De Urgenta Bacau Bacau Romania
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet Szolnok Hungary
NIEPUBLICZNY ZAKŁAD OPIEKI ZDROWOTNEJ BIF-MED S.C. A. Wawiernia,M. Roykiewicz,R. Roykiewicz Bytom Poland
INTER CLINIC Piotr Adrian Klimiuk Bialystok Poland
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o. Poznan Poland
Vital Medical Center Veszprem Hungary
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p. Elblag Poland
Mztqsdrsf Ijkckepwtl Cjxhwzee Sqmxoaxi Sau z oaoz Warsaw Poland
Ciizdmj Mhdddtb Dq Dsfkusmmnr So Tgewjnneh Afoglglbe Ndlxnd Sbkmjy Brasov Romania
Mehntqatjba Tmhqxvv Seceiob M Ejie Vidin Bulgaria
Srmaz Sxipjgh Spahxgtbfisbkma Svy z omej Stalowa Wola Poland
Tjeovqjm Sog z oiby Piotrkow Trybunalski Poland
Pwxckwy Mvzxmd Szy z Orwt Egr Pjxpfiuwc Poniatowa Poland
Mozmynl Csriid Stndbi Exht Vratsa Bulgaria
Pontcwlj Pbofzvfo Lpxsdijo Pcsp Dr Hvg Mdg Pamcl Hcemlh Poznan Poland
Doancnyarv Cecsaoaxfe Ckzebo 1 Vxucqqgey Eeue Velingrad Bulgaria
Moprltbu Srfmqx Bucharest Romania
Jriydf Boi Kalocsa Hungary

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
30.10.2024
Hungary Hungary
Not yet recruiting
30.10.2024
Poland Poland
Not recruiting
30.10.2024
Romania Romania
Not recruiting
30.10.2024

Trial locations

Investigated drugs:

MB04 is a biosimilar medication being studied for treating rheumatoid arthritis. It is designed to work similarly to Enbrel in reducing joint inflammation and managing arthritis symptoms.

Enbrel (etanercept) is a medication used to treat rheumatoid arthritis by reducing inflammation in the joints. It works by blocking a substance in the body that causes inflammation.

Methotrexate is a medication commonly used to treat rheumatoid arthritis. It helps reduce pain, swelling, and stiffness in the joints by suppressing the immune system’s inflammatory response.

Investigated diseases:

Rheumatoid Arthritis – A chronic inflammatory disease that primarily affects the joints throughout the body. The condition causes the immune system to mistakenly attack the body’s own tissues, particularly the lining of joint capsules, leading to inflammation and swelling. Over time, this ongoing inflammation can cause thickening of the joint lining, destruction of cartilage and bone within the joint, and gradual loss of joint function. The disease typically affects multiple joints symmetrically, meaning if one hand is affected, the other usually is too. Rheumatoid arthritis commonly begins in the small joints of the hands and feet, but can spread to larger joints like knees, hips, and shoulders. The condition often develops gradually, with symptoms including joint pain, stiffness (especially in the morning), swelling, and warmth in affected areas.

Trial ID:
2024-510826-16-00
Protocol code:
MB04-C-01-23
Trial Phase:
Therapeutic confirmatory (Phase III)

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