Study on the Effectiveness and Safety of Abatacept Biosimilar (DRL_AB) and Methotrexate for Patients with Moderate to Severe Rheumatoid Arthritis

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What is this study about?

This clinical trial is focused on studying the treatment of rheumatoid arthritis, a condition that causes pain and swelling in the joints. The study will compare the effects of a proposed biosimilar called DRL_AB with an existing medication known as Orencia, both of which are given through an intravenous infusion. These treatments will be used alongside another medication called methotrexate, which is commonly used to manage rheumatoid arthritis.

The purpose of the study is to evaluate how effective and safe these treatments are, as well as to understand their impact on the immune system. Participants will receive either the biosimilar or Orencia, in addition to methotrexate, over a period of time. The study will monitor changes in the participants’ condition, particularly focusing on improvements in joint pain and swelling, as well as any side effects that may occur.

Throughout the study, participants will have regular check-ups to assess their response to the treatment. The study aims to provide valuable information on whether the new biosimilar is as effective and safe as the existing treatment option, Orencia, for people with moderate to severe rheumatoid arthritis. This research could potentially offer more treatment choices for managing this chronic condition.

1 initial treatment phase

Upon joining the study, the patient will begin treatment with methotrexate tablets. The dosage will be at least 15 mg per week, adjusted based on tolerance and specific country guidelines. This medication is taken orally.

The patient will also receive Orencia (abatacept) through an intravenous infusion. This is a solution prepared from a powder concentrate. The infusion is administered at the study site.

2 comparison treatment phase

The patient will be randomly assigned to receive either the proposed Abatacept biosimilar (DRL_AB) or continue with Orencia. Both are administered via intravenous infusion.

This phase aims to compare the effectiveness and safety of the biosimilar with the original medication.

3 monitoring and assessment

Throughout the study, the patient’s condition will be monitored regularly. This includes assessing changes in disease activity using the DAS28-CRP score, which measures inflammation and joint symptoms.

Assessments will occur at baseline, Week 13, and Week 25 to evaluate the treatment’s impact.

4 safety evaluations

The study will monitor for any adverse effects, including allergic reactions, infections, and other potential side effects.

Blood tests will be conducted to check for the presence of antibodies that might affect the treatment’s effectiveness.

5 completion of study

The study is expected to conclude by January 2026. Upon completion, the patient’s overall response to the treatment will be evaluated.

The patient will receive information about the study’s findings and any implications for their ongoing treatment.

Who Can Join the Study?

  • Patients must provide a written informed consent, which means they agree to participate in the study after understanding all the details.
  • Patients should be able to follow all the study requirements.
  • Patients must be between 18 and 80 years old.
  • Patients should have had moderately to severely active Rheumatoid Arthritis for at least 6 months. This means they have swelling in at least 10 joints and tenderness in at least 12 joints, along with a specific level of a protein called CRP in their blood.
  • Patients must have been taking MTX (a medication) and folic acid for at least 3 months before starting the study. They should be on a stable dose of MTX for at least 4 weeks before joining the study.
  • Patients should not be taking other specific medications for Rheumatoid Arthritis, like cDMARDs, for at least 4 weeks before starting the study.
  • Patients should not be on bDMARDs (another type of medication) for at least 4 weeks before starting the study.
  • If patients are taking glucocorticoids (a type of steroid), they should not be taking more than 10 mg per day and should be on a stable dose for at least 6 weeks before joining the study.
  • If patients are taking NSAIDs (pain relief medications), they should be on a stable dose for at least 4 weeks before joining the study and not take them right before certain study visits.
  • Women who can have children must have a negative pregnancy test and agree to use effective birth control during the study and for 6 months after. Men must agree to use birth control methods and not donate sperm during the study and for 6 months after.

Who Cannot Join the Study?

  • Patients who have any other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have a history of allergic reactions to similar medications.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have been diagnosed with cancer in the past five years.
  • Patients who have received certain treatments for rheumatoid arthritis recently.
  • Patients who have a weakened immune system.
  • Patients who have had a recent surgery.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Ambulatories For Specialized Outpatient Medical Help Medical Center Kyuchuk Parizh OOD Plovdiv Bulgaria
CENTRUM MEDYCZNE REUMA PARK Warsaw Poland
Vasarhelyi Sarkanyfu Kft. Hodmezovasarhely Hungary
Futuremeds Sp. z o.o. Wroclaw Poland
NZOZ LECZNICA MAK-MED s.c. Nadarzyn Poland
Twoja Przychodnia Opolskie Centrum Medyczne Opole Poland
Innomedica OÜ Tallin Estonia

Other Sites

Site Name City Country Status
Revmatologicky Ustav Prague Czechia
SYNEXUS Magyarorszag Kft. Budapest Hungary
Saint Maria Hospital Bucharest Romania
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Spitalul Clinic Judetean De Urgenta Craiova Craiova Romania
Lukmed 2 Sp. z o.o. Siedlce Poland
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Reumed Sp. z o.o. Lublin Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Nowa Sol Poland
Daugavpils regionala slimnica SIA Daugavpils Latvia
University Multiprofile Hospital For Active Treatment Kaspela EOOD Plovdiv Bulgaria
Clinicmed Daniluk Nowak Sp. k. Bialystok Poland
Qualiclinic Kft. Budapest Hungary
Solumed Sp. z o.o. sp.k. Poznan Poland
Centrum Medyczne Oporow Wroclaw Poland
Centrum Medyczne All-Med Badania Kliniczne Cracow Poland
L.K.N. Arthrocentrum s.r.o. Hlucin Czechia
Diagnostic Consultative Center 1 Lom EOOD Lom Bulgaria
Revita Kft. Budapest Hungary
Complex Rendelo Med Zrt. Szekesfehervar Hungary
Orto klinika SIA Riga Latvia
Rheuma Medicus Sp. z o.o. Warsaw Poland
Malopolskie Centrum Kliniczne Cracow Poland
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A. Olsztyn Poland
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Clintrial s.r.o. Prague Czechia
Kliiniliste Uuringute Keskus OÜ Tartu Estonia
Respublikine Siauliu ligonine VšĮ Siauliai Lithuania
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Pratia Pardubice a.s. Pardubice Czechia
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Pratia S.A. Skorzewo Poland
Multiprofile Hospital For Active Treatment Dobrich AD Dobrich Bulgaria
MediTrials OÜ Tartu Estonia
Klaipedos universiteto ligonine VšĮ Klaipeda Lithuania
PV-Medical s.r.o. Zlin Czechia
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o. Poznan Poland
North Estonia Medical Centre Foundation Tallin Estonia
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne Promimed Sp. z o.o. sp.k. Cracow Poland
Vital Medical Center Veszprem Hungary
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p. Elblag Poland
Mqicyfigl Iwulyvshmw Ceseyblj Sulrjgna Swd z ornw Warsaw Poland
Rjjcmnuirmoc sagjjb Brno-Sever Czechia
Mnmaykg Czeifj Bpzfei 9o Esap Vidin Bulgaria
Cpiauwppc Snfrximh sbyjvr Butovice Czechia
Phdptku Meghhv Suu z Oxjq Efx Pizsszgse Poniatowa Poland
D Szwulkgv Ktknosfaou Prufmcg Pldmyusb Liepaja Latvia
Murasup Cphdlg Mzbahnwtkb Pnvepe Ouq Pleven Bulgaria

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
01.07.2024
Czechia Czechia
Not recruiting
01.07.2024
Estonia Estonia
Not recruiting
01.07.2024
Hungary Hungary
Not recruiting
01.07.2024
Latvia Latvia
Not recruiting
01.07.2024
Lithuania Lithuania
Not recruiting
01.07.2024
Poland Poland
Not recruiting
01.07.2024
Romania Romania
Not recruiting
01.07.2024

Trial locations

Investigated drugs:

DRL_AB is a proposed biosimilar medication being tested for its effectiveness, safety, and ability to trigger an immune response in patients with moderate to severe rheumatoid arthritis. It is administered through an intravenous route and is being compared to an existing medication to see if it works as well.

Orencia® is an existing medication used in the treatment of moderate to severe rheumatoid arthritis. It is given to patients through an intravenous route and is used in this study as a comparison to evaluate the new biosimilar medication.

Methotrexate is a medication commonly used to treat rheumatoid arthritis. In this study, it is used in combination with either DRL_AB or Orencia® to assess the overall effectiveness of the treatment in reducing the symptoms of the disease.

Investigated diseases:

Rheumatoid Arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It occurs when the immune system mistakenly attacks the body’s own tissues, leading to inflammation. Over time, this inflammation can cause damage to the joint tissues, resulting in pain, swelling, and stiffness. The disease often starts in smaller joints, such as those in the fingers and toes, and can progress to larger joints like the knees, hips, and shoulders. As the condition advances, it may lead to joint deformity and loss of function. Rheumatoid arthritis can also affect other parts of the body, including the skin, eyes, lungs, and blood vessels.

Trial ID:
2023-506664-14-00
Protocol code:
AB-01-004
Trial Phase:
Therapeutic confirmatory (Phase III)

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