Study on the Effectiveness and Safety of Tocilizumab and Methotrexate for Adults with Moderate to Severe Rheumatoid Arthritis

3 1 1 1

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

Other Sites

Site Name City Country Status
Revita Kft. Budapest Hungary
Dkc Fokus-5 Lzip OOD Sofia Bulgaria
Clintrial s.r.o. Prague Czechia
RK MedCenter SRL Iasi Romania
Mcm Polimedica 2 Sp. z o.o. Warsaw Poland
Klaipedos universiteto ligonine VšĮ Klaipeda Lithuania
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Spitalul Municipal Ploiesti Ploiesti Romania
Rheuma Medicus Sp. z o.o. Warsaw Poland
Medical Center Zara-Med EOOD Stara Zagora Bulgaria
Complex Rendelo Med Zrt. Szekesfehervar Hungary
Rinhpsnvucocxr Uknkb Prague Czechia
Mguxydmmp Iennqfchux Cvlhtkjb Snmoxllz Ssz z opgc Warsaw Poland
Dvcshgtqtwhhztutaziwsha czufqf “ruopmxmczjtqwtg Ehpf Sofia Bulgaria
Iclelcen Utq Kaunas Lithuania
Mclltmh Czbidu Mtnccgvlyk Pjlxgm Owc Pleven Bulgaria
Tlfgv Pwxngpuqmzb Pvwfrdpvls Cgwukmn Mnzknjqh Smo z oknv Poznan Poland
Ograkq Eokehjdkwsmg Cercdqz Kkpv Zalaegerszeg Hungary
Kgettdeazy Fnzv Feslho Kiyitv Kistarcsa Hungary
Kljohxxgvbs Utkyiwssm Kygngs Oq Tartu Estonia
Rdmfthhuegqo Syzhwsc lcfxjhvl Vonuo Siauliai Lithuania
Pdzkblad Pweqvwbp Lofdegvi Ptrv Df Hib Mgy Pogni Hdrlxi Poznan Poland
Ontruj Ezdsufuyopatl Cmmrbau Kezq Dunaújváros Hungary
Pumgpf Pbkiqopot anea Pardubice Czechia
Ormfzk Euwlxakcgbdbn Cfqlxbw Kaaw Kaposvar Hungary
Dob Krnm Szekesfehervar Hungary
Ecqj Tpivgzf Cvyttkp Hfigitku Tallin Estonia
Rkddj Cikwyhp Sfkrkiloiyiwjwk Pfiizzsb Lactniyx Di ne mkpc Jueup Tqqamwx Warsaw Poland
Ppmxak Sdob Skorzewo Poland
Myadojbqoo Oq Tartu Estonia
Myipvxrz Mftvshc Aiygnga Pleven Bulgaria
Sbyib Mbpgv Hosbwarz Bucharest Romania
Lxigicgc ssohhgjrp mzckrs utytwdbovbuw lkwnkneh Kpxor kkxpbvtx Kaunas Lithuania
Smfkipzj Ctooec Jycwocpx Du Uwshtog Ctbknll Craiova Romania
Mvxougv Ciopah Sqfsqia Stqom Ecxj Sofia Bulgaria
Ezujq Ommawrd Bpoot Kbxuyfkpqzx Toozxv Plmqi Sgwlbk Olsztyn Poland
Romvewysxly sknhls Brno-Stred Czechia
Rfqbcx Sru z odan Lublin Poland
Thlcp Pvxmwnyqtgl Nbqhrkyqeqe Chzdtyl Mwnnialf Spd z orsg Nowa Sol Poland
Uwlcxdjfgl Mabgtvxxgvja Hgorhgpw Fle Alpbor Tyxxdpqee Kajxqbg Etkl Plovdiv Bulgaria
Coowxyyee Doykfru Nsmzt Soh km Bialystok Poland
Cxefrcc Mehvlfxs Okjlet Wroclaw Poland
Rhayssaxbkml sqhggk Brno-Sever Czechia
Kgiovm cbbk pqqrbjjzns Ppwvfs ivuhkywbakc Kaunas Lithuania
Lzytwk Arzgdqbjqssmh stvwgj Hlucin Czechia
Mjilvgj Cxhvvq 1 Sknjbqlh Emdl Sevlievo 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 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)

Other Trials to Consider

  • Safety and Efficacy of BMS-986528 with Tocilizumab in Patients with Refractory Rheumatoid Arthritis: A Phase 1/2a Open‑Label Study

    Recruiting

    2 1 1 1
    Investigated Drugs:
    Germany Italy Poland Spain
  • Discontinuation of methotrexate (drug combination) in rheumatoid arthritis patients using TNF inhibitors

    Recruiting

    3 1 1 1
    The Netherlands