Study on the Effectiveness and Safety of Tocilizumab and Methotrexate for Adults 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 two treatments: a proposed biosimilar called DRL_Tocilizumab and a reference product known as RoActemra. Both treatments are given as a solution for injection under the skin and are used alongside another medication called methotrexate, which is commonly used to treat rheumatoid arthritis.

The purpose of the study is to evaluate how effective and safe these treatments are for patients with moderate to severe rheumatoid arthritis. Participants will receive either the biosimilar or the reference product, and some may receive a placebo. The study will last for several weeks, during which participants will have regular check-ups to monitor their condition and any changes in their symptoms. The main goal is to see how the treatments affect the disease activity score, which measures the severity of rheumatoid arthritis symptoms.

Throughout the study, participants will be closely monitored for any side effects or reactions to the treatments. The study aims to provide valuable information on the potential benefits and risks of using the biosimilar compared to the reference product, helping to improve treatment options for people living with rheumatoid arthritis.

1 joining the study

Upon joining the study, the patient will be assessed to ensure they meet the eligibility criteria. This includes having moderate to severe rheumatoid arthritis for at least 6 months and being on a stable dose of methotrexate (MTX) for at least 8 weeks prior to the study.

2 randomization and treatment initiation

The patient will be randomly assigned to receive either the proposed tocilizumab biosimilar (DRL_TC) or the reference product (RoActemra®).

Both medications are administered as a subcutaneous injection.

The patient will continue their current dose of MTX and folic acid throughout the study.

3 treatment administration

The patient will receive the assigned medication as an add-on to their existing MTX treatment. The specific dosage and frequency will be determined by the study protocol and the healthcare provider.

4 monitoring and assessments

The patient’s response to the treatment will be monitored through regular assessments. These include measuring changes in disease activity using the DAS28-ESR score at various time points: baseline, week 5, week 9, week 13, week 17, week 21, and week 25.

Safety assessments will also be conducted to monitor any adverse effects or reactions to the treatment.

5 completion of the study

The study is expected to conclude by March 31, 2025. Upon completion, the patient’s overall response to the treatment will be evaluated, and any necessary follow-up care will be provided.

Who Can Join the Study?

  • Must be a male or female aged between 18 and 80 years old.
  • Must be willing to provide informed consent to participate in the study.
  • Must have active moderate to severe rheumatoid arthritis for at least 6 months.
  • Must have at least 6 swollen joints and 8 tender joints.
  • Must have an erythrocyte sedimentation rate (ESR) of at least 28 mm/hour. ESR is a blood test that can show inflammation in the body.
  • Must have been on stable doses of methotrexate (MTX) for at least 8 weeks before joining the study. MTX is a medication used to treat rheumatoid arthritis.
  • Must be taking a stable dose of folic acid for at least 4 weeks before joining the study. Folic acid is a type of vitamin B that helps reduce side effects of MTX.
  • If taking other medications for rheumatoid arthritis, must have stopped them for a certain period before starting the study.
  • If taking glucocorticoids, must not be taking more than 10 mg per day and must be on a stable dose for at least 6 weeks before joining the study. Glucocorticoids are a type of steroid medication.
  • If taking NSAIDs (non-steroidal anti-inflammatory drugs), must be on a stable dose for at least 4 weeks before joining the study. NSAIDs are medications that reduce pain and inflammation.
  • Women who can have children must have a negative pregnancy test and agree to use reliable birth control during the study and for 6 months after. Men must agree to use birth control or be permanently sterile.
  • Must be able to self-administer the study treatment or have help from a caregiver.
  • Must be able to follow all study requirements according to the study doctor’s opinion.

Who Cannot Join the Study?

  • Patients who have been previously exposed to JAK pathway inhibitors cannot participate. These are medications that affect certain proteins involved in the immune response.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Futuremeds Sp. z o.o. Wroclaw Poland
Futuremeds Łódź Lodz Poland
CENTRUM MEDYCZNE REUMA PARK Warsaw Poland
NZOZ LECZNICA MAK-MED s.c. Nadarzyn Poland

Other Sites

Site Name City Country Status
Respublikine Siauliu ligonine VšĮ Siauliai Lithuania
Pratia Pardubice a.s. Pardubice Czechia
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o. Poznan Poland
MediTrials OÜ Tartu Estonia
Revmatologicky Ustav Prague Czechia
Revita Kft. Budapest Hungary
Dkc Fokus-5 Lzip OOD Sofia Bulgaria
Obudai Egeszsegugyi Centrum Kft. Zalaegerszeg Hungary
Clintrial s.r.o. Prague Czechia
Kistarcsai Flor Ferenc Korhaz Kistarcsa Hungary
Kliiniliste Uuringute Keskus OÜ Tartu Estonia
RK MedCenter SRL Iasi Romania
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Mcm Polimedica 2 Sp. z o.o. Warsaw Poland
Pratia S.A. Skorzewo Poland
Klaipedos universiteto ligonine VšĮ Klaipeda Lithuania
Saint Maria Hospital Bucharest Romania
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Spitalul Clinic Judetean De Urgenta Craiova Craiova Romania
Medical Centre Synexus Sofia EOOD Sofia Bulgaria
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A. Olsztyn Poland
Revmaclinic s.r.o. Brno-Stred Czechia
Reumed Sp. z o.o. Lublin Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Nowa Sol Poland
University Multiprofile Hospital For Active Treatment Kaspela EOOD Plovdiv Bulgaria
Clinicmed Daniluk Nowak Sp. k. Bialystok Poland
Centrum Medyczne Oporow Wroclaw Poland
Spitalul Municipal Ploiesti Ploiesti Romania
Rheuma Medicus Sp. z o.o. Warsaw Poland
Medical Center Zara-Med EOOD Stara Zagora Bulgaria
Kaunas city polyclinic Public institution Kaunas Lithuania
Complex Rendelo Med Zrt. Szekesfehervar Hungary
L.K.N. Arthrocentrum s.r.o. Hlucin Czechia
REUMA CENTRUM Specjalistyczna Praktyka Lekarska Dr n. med. Jakub Trefler Warsaw Poland
Medical Center 1 Sevlievo EOOD Sevlievo Bulgaria
DRC Kft. Szekesfehervar Hungary
Mzdskkvzo Ijahpxgkgw Ctmvsrky Sqazlual Ssi z onyd Warsaw Poland
Ozwjxl Enmvfczydhwei Cmkpcmw Kkxy Kaposvar Hungary
Pdscjevp Pzmknzte Ljtmkzkh Puai Dm Hss Mzg Pruki Hasewy Poznan Poland
Mfbhwvmr Mdtgtrs Ajjhwrz Pleven Bulgaria
Rjjbgjodlyqv spfxbe Brno-Sever Czechia
Ijzlarqu Utr Kaunas Lithuania
Msyfiir Cagzzw Myxntvcwwp Porhdd Osf Pleven Bulgaria
Eavo Tlzqbqp Czhcsjr Hsdfakyk Tallin Estonia

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not yet recruiting
25.09.2023
Czechia Czechia
Not yet recruiting
25.09.2023
Estonia Estonia
Not yet recruiting
25.09.2023
Hungary Hungary
Not yet recruiting
25.09.2023
Lithuania Lithuania
Not yet recruiting
25.09.2023
Poland Poland
Not yet recruiting
25.09.2023
Romania Romania
Not yet recruiting
25.09.2023

Trial locations

Investigated drugs:

DRL_Tocilizumab is a proposed biosimilar medication being tested for its effectiveness, safety, and ability to trigger an immune response in patients. It is used in the treatment of moderate to severe rheumatoid arthritis. This medication is administered by injection under the skin and is being compared to an existing treatment to see if it works just as well.

RoActemra is a reference medication already used to treat moderate to severe rheumatoid arthritis. It is also given by injection under the skin. This medication helps reduce inflammation and pain in the joints by targeting specific proteins in the body that cause these symptoms.

Methotrexate is a medication commonly used in combination with other treatments for rheumatoid arthritis. It helps to reduce inflammation and slow down the progression of the disease. Methotrexate is taken regularly to help manage symptoms and improve joint function.

Investigated diseases:

Rheumatoid Arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically causes pain, swelling, and stiffness in the joints, often starting in the hands and feet. Over time, it can lead to joint damage and deformities. The disease progresses through periods of flares and remissions, where symptoms can worsen or improve. It can also affect other parts of the body, including the skin, eyes, lungs, and blood vessels. The exact cause is unknown, but it involves the immune system attacking the body’s own tissues.

Trial ID:
2022-501361-44-00
Protocol code:
TC-01-003
Trial Phase:
Therapeutic confirmatory (Phase III)

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