Study Comparing CT-P53 and Ocrelizumab for Patients with Relapsing-Remitting Multiple Sclerosis

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What is this study about?

This clinical trial is focused on studying a condition known as Multiple Sclerosis (MS), specifically a type called relapsing-remitting multiple sclerosis (RRMS). The study will compare the effects of two treatments: CT-P53 and Ocrevus. Both of these treatments involve a substance called ocrelizumab, which is used to help manage MS. The purpose of the study is to see if CT-P53 works as well as Ocrevus in treating patients with RRMS.

Participants in the study will receive either CT-P53 or Ocrevus through a method called intravenous infusion, which means the medication is given directly into a vein. The study will be conducted over a period of time, and participants will be monitored to see how their bodies respond to the treatment. This includes looking at how the medication moves through the body and its effects on the disease. Some participants may receive a placebo as part of the study.

The study aims to gather information on the safety and effectiveness of CT-P53 compared to Ocrevus. Participants will undergo regular check-ups and tests, such as MRI scans, to track the progress of their condition and any changes in their health. The study will help researchers understand if CT-P53 can be a reliable alternative to Ocrevus for people living with RRMS.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of multiple sclerosis according to specific criteria, recent activity of the condition, and neurological stability.

2 randomization

Participants are randomly assigned to receive either the investigational drug CT-P53 or the reference drug Ocrevus. This process ensures that the study is unbiased.

3 treatment initiation

Treatment begins with the administration of the assigned medication. Ocrevus is given as a 300 mg concentrate for solution for infusion, administered intravenously. CT-P53 is also administered as a solution for infusion.

4 ongoing treatment and monitoring

Participants receive regular doses of their assigned medication. The frequency and duration of these infusions are determined by the study protocol. Monitoring includes regular assessments to track the condition and any side effects.

5 follow-up assessments

Throughout the study, follow-up assessments are conducted to evaluate the effectiveness of the treatment. This includes measuring the number of new lesions in the brain using MRI scans and other health indicators.

6 completion of study

The study concludes with a final assessment to gather comprehensive data on the treatment’s impact. Participants may be asked to provide feedback on their experience.

Who Can Join the Study?

The patient must be a male or female aged between 18 and 55 years old, including both ages.
The patient must have been diagnosed with Multiple Sclerosis (MS), which is a condition affecting the brain and spinal cord, following specific guidelines known as the revised McDonald criteria from 2017.
The patient must show signs of recent MS activity, as described in the study details.
The patient must have stable neurological health for at least 30 days. Neurological health refers to the health of the nervous system, which includes the brain and nerves.
The patient must have a score between 0 and 6.0 on the EDSS score, which is a scale used to measure the level of disability in people with MS.

Who Cannot Join the Study?

Patients who do not have a diagnosis of Multiple Sclerosis cannot participate. Multiple Sclerosis is a condition that affects the brain and spinal cord.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
Patients who are part of a vulnerable population, such as those who may not be able to give informed consent, cannot participate.
Patients who are not able to follow the study procedures or attend all required visits cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have any other medical conditions that the study organizers believe would interfere with the study cannot participate.
Patients who are allergic to any of the study medications or their ingredients cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of certain infections or diseases that could affect the study results cannot participate.
Patients who have received certain treatments or medications recently that could interfere with the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland

Verified Sites

Site Name	City	Country
ClinHouse Centrum Medyczne	Zabrze	Poland
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Jihlava	Jihlava	Czechia
Poliklinika Vlatka Cavka d.o.o.	Zagreb	Croatia
Klinički bolnički centar Zagreb (University Hospital Center Zagreb)	Zagreb	Croatia
Neuro-Medic Sp. z o.o.	Katowice	Poland
Spitalul Clinic De Neuropsihiatrie Craiova	Craiova	Romania
Spitalul Clinic Judetean De Urgenta Cluj	Cluj Napoca	Romania
NZOZ Neuro- Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy	Poznan	Poland

Other Sites

Site Name	City	Country
University Hospital Ostrava	Ostrava	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria
Multiprofile Hospital For Active Treatment Elin Pelin EOOD	Elin Pelin	Bulgaria
Resmedica Sp. z o.o.	Kielce	Poland
Myqdail Cpwaio Hdpb Eeff	Sofia	Bulgaria
Hplmpbfh Vqft djebimcx	Barcelona	Spain
Dghnibflbtfkjxvoaslxjsv cnmyoo “akflbcxrlnncjqi Eqsp	Sofia	Bulgaria
Ptjolqrdims Sernet ddljlz	Zagreb	Croatia
Fuuiztncu Plna Lb Iwfmudexnvajs Brdgysbxa Dzw Hfwnuirw Umygkfrfycsti Lo Pak	Madrid	Spain
Soikomqrxvz Pxgfftgpb Spnyxqd Khzrvkjzo Ni 1 Iwehtcarytfdbvthlq Sjvkeut Swrxdcqfu Urxarlxqvqwk Mssnxzcqxx W Krxshqaxli	Zabrze	Poland
Kbs Zhmvzs	Zagreb	Croatia
Mrzvgfeiozqr Hbqkfnaa Ffb Asvcqq Tuochejbn Ir Nfwqrxgnv Ajh Plwgxzhoda Swm Ntbk Ekw	Sofia	Bulgaria
Mwmdowj Cpdasa Hnkl Ekod	Montana	Bulgaria
Mfm Pjziegb Srx z onec	Poznan	Poland
Nolbdkhy Zwrpfbqtp I Wvjltfaef Slh jw	Katowice	Poland
Mxqutsrzvfenukdzw Hgwkpiel Fcg Abglpr Tbhuxmixz Hhyfvk 2wnt Oqa	Sofia	Bulgaria
Crjvoqim Mmqhxdf Cfjchy Oyceoj	Osijek	Croatia
Azwbbcs Ctqgtfe Scvmwg	Bucharest	Romania
dqcx Mhdaw Rxobgqc Tpiuuh Craw	Hradec Kralove	Czechia
Nsdo „tundgieofzm Peiri Pckuy i iy Suxumh Jrxjb	Bedzin	Poland
Pfmbeuaf Cerlgyb Mwdurtcu	Zory	Poland
Mvhgerzjcp Cpefvu Skksnaf Lozt	Sofia	Bulgaria
Kxdicqze batbwfbv culdty Rkbaew (slpdlmjf Hbitkkqh Ciaqvo Rlesejh	Rijeka	Croatia
Uiyjyixunl Mfmekwifpmpx Hjzkcqkj fhq Axbzba Tanltxgso Sqdlr Myomjn &nrmzvi Pxqjkd	Pleven	Bulgaria
Smybc Mhehjt Pyxqqi Edul	Varna	Bulgaria
Cbmksgfqqf Pyqfhxe Lvbidebrl Sts z oagf	Gdansk	Poland
Cibumrm Maqumnfb Hbq Sbf z obcz	Poznan	Poland
Nfeemow sslhyp	Chocen	Czechia
Etiazgxye Stc z odvn	Szczecin	Poland
Movwhdsntejo Hnugemgx Fir Axebcj Tbkvmpdnopgax Hpsggsow Lvvu	Panagyurishte	Bulgaria
Pzuctgu Iscjw Sduzue	Oradea	Romania
Mflsmuplwwmf Hsjipdxc Fdl Azioey Tzxzgzidh Ajag Mdmaev Odh	Pleven	Bulgaria
Owcn Bysbeny Vdikrlxt	Varazdin	Croatia
Ngewqbkmljnn Ssq z olle	Warsaw	Poland
Cwtdtm Sfcetyvfc Sjseur	Campulung	Romania
Cybasao Ndfctkzqsv Kfelcaxzd Szjmjx	Lodz	Poland

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	01.12.2023
Croatia	Not recruiting	01.12.2023
Czechia	Not recruiting	01.12.2023
Poland	Not recruiting	01.12.2023
Romania	Not recruiting	01.12.2023
Spain	Not recruiting	01.12.2023

Trial locations

Investigated Drugs:

CT-P53 is an investigational medication being studied for its effectiveness and safety in treating patients with relapsing-remitting multiple sclerosis (RRMS). The trial aims to compare how well CT-P53 works and how it behaves in the body compared to an existing treatment.

Ocrevus is an approved medication used to treat patients with relapsing-remitting multiple sclerosis (RRMS). In this study, Ocrevus serves as the reference treatment to evaluate the effectiveness and safety of the investigational medication CT-P53. The trial includes both the EU-approved and US-licensed versions of Ocrevus to ensure comprehensive comparison.

Investigated Diseases:

Multiple sclerosis

Multiple Sclerosis – Multiple Sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It occurs when the immune system mistakenly attacks the protective sheath (myelin) that covers nerve fibers, leading to communication problems between the brain and the rest of the body. Over time, the disease can cause permanent damage or deterioration of the nerves themselves. Symptoms vary widely and can include fatigue, difficulty walking, numbness or tingling, muscle weakness, and problems with coordination and balance. The progression of the disease can be unpredictable, with periods of remission and relapses. The most common form is relapsing-remitting multiple sclerosis, where symptoms flare up and then improve for a time.

Trial ID:

2022-501622-37-00

Protocol code:

CT-P53 3.1

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing CT-P53 and Ocrelizumab for Patients with Relapsing-Remitting Multiple Sclerosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?