Study on the Safety and Effectiveness of Ocrelizumab vs. Fingolimod for Children and Adolescents 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 Relapsing-Remitting Multiple Sclerosis, which is a type of multiple sclerosis characterized by periods of new or increasing symptoms followed by periods of partial or complete recovery. The study is comparing two treatments: Ocrelizumab and Fingolimod. Ocrelizumab is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein, while Fingolimod is taken orally in the form of hard capsules. The trial also includes a placebo, which is a substance with no active medication, to help understand the effects of the treatments better.

The purpose of the study is to evaluate the safety and effectiveness of Ocrelizumab compared to Fingolimod in children and adolescents with Relapsing-Remitting Multiple Sclerosis. Participants in the study will receive either Ocrelizumab or Fingolimod, and their health will be monitored over a period of time to observe any changes in their condition. The study aims to determine if Ocrelizumab is not inferior to Fingolimod in terms of reducing the annualized relapse rate, which is a measure of how often relapses occur over a year.

Throughout the study, participants will undergo various assessments, including MRI scans, to check for changes in the brain and to monitor the number of new or enlarging lesions. The study will also track any side effects or adverse events that may occur. This research is important for understanding how these treatments can help manage Relapsing-Remitting Multiple Sclerosis in younger patients and to ensure their safety and effectiveness.

1 randomization

Upon joining the study, participants are randomly assigned to receive either ocrelizumab or fingolimod. This process ensures that each participant has an equal chance of receiving either treatment.

2 treatment administration

Participants receiving fingolimod will take Gilenya 0.5 mg hard capsules orally. The dosage and frequency are determined by the study protocol.

Participants receiving ocrelizumab will receive Ocrevus 300 mg as an intravenous infusion. The frequency and duration of administration are specified in the study protocol.

3 monitoring and assessments

Throughout the study, participants undergo regular monitoring to assess the safety and effectiveness of the treatment. This includes brain MRI scans to detect new or enlarging lesions, and assessments of any adverse events.

Blood tests are conducted to measure levels of CD19 B-cells and to check for the presence of anti-drug antibodies against ocrelizumab.

4 end of treatment

The study is estimated to conclude by September 17, 2029. At the end of the treatment period, participants will undergo final assessments to evaluate the overall impact of the treatment on their condition.

Who Can Join the Study?

  • Age between 10 to less than 18 years at the time of joining the study, with a body weight of at least 25 kilograms.
  • Must have had at least one episode of symptoms returning in the year before joining the study, or two episodes in the two years before joining, or must show signs of at least one area of brain inflammation on an MRI scan within 6 months before joining the study.
  • Must have a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS), which is a type of multiple sclerosis where symptoms come and go, confirmed by a special committee before joining the study.
  • Must have received all recommended childhood vaccinations according to local or national guidelines to protect against infectious diseases.
  • Must have a score between 0 and 5.5 on the Expanded Disability Status Scale (EDSS), which is a way to measure disability in people with multiple sclerosis.
  • Female participants who can have children must agree to either not have heterosexual intercourse or use birth control during the treatment period and for at least 24 weeks after the last dose of the study medication, and for 2 months after the last dose of another study medication.

Who Cannot Join the Study?

  • Patients with any other type of multiple sclerosis other than Relapsing-Remitting Multiple Sclerosis cannot participate. Relapsing-Remitting Multiple Sclerosis is a form of the disease where symptoms flare up and then improve.
  • Patients who have had a recent infection or illness that could affect their immune system are not eligible.
  • Individuals with a history of severe allergic reactions to medications or vaccines are excluded.
  • Patients who are currently pregnant or breastfeeding cannot take part in the study.
  • Anyone with a history of cancer, except for certain types of skin cancer, is not allowed to participate.
  • Patients with significant heart problems or uncontrolled high blood pressure are excluded.
  • Individuals who have participated in another clinical trial within the last 30 days are not eligible.
  • Patients who have received certain treatments for multiple sclerosis within a specific time frame before the study starts are excluded.
  • Anyone with a history of drug or alcohol abuse within the past year is not allowed to participate.
  • Patients with any other medical condition that the study doctors believe could interfere with the study results are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia Bucharest Romania
Medical University Of Vienna Vienna Austria

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Universitair Ziekenhuis Gent Gent Belgium
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD Sofia Bulgaria
University Of Debrecen Debrecen Hungary
Instytut Pomnik Centrum Zdrowia Dziecka Warsaw Poland
Tartu University Hospital Tartu Estonia
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire De Montpellier Montpellier France
Hospices Civils De Lyon Lyon France
St. Luke’s Hospital S.A. Thessaloniki Greece
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Rigshospitalet Copenhagen Denmark
KBC Split Split Croatia
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Clinic4U OÜ Tallin Estonia
Djecja bolnica Srebrnjak Zagreb Croatia
University Hospital Consorziale Policlinico Bari Italy
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Bicetre Hospital Le Kremlin-Bicetre France
Spitalul Clinic de Copii “Dr. Victor Gomoiu” Bucharest Romania
Università degli Studi “Gabriele d’Annunzio” – Center for Advanced Studies and Technology (CAST) Chieti Italy
Hcihtwas Uxnohclnwxvcg Dt Ld Pymkzzzk Madrid Spain
Blpcn Kwlfoifr Uobyijrudairf Stofhskj Vhza Riga Latvia
Uvdkkentmxe Wolhavzgmkwntpk &fnzcpr Vbnjnesjd Khssqxy utr Jzbimsovlkok Dpdwobd Datteln Germany
Eqszxpb Uewgxxjepuhq Mtjrquz Cfjzbkc Rsvgrrgwk (ashtxev Mga Rotterdam The Netherlands
Acgvbg Uovxezkdls Hgzxesfr Aarhus Denmark
Uoqhfpwjrnecat Cqlczeo Kfvzivukk Gdansk Poland
Hmziafbs Vefb dikhaddk Barcelona Spain
Hbwgiaeq Ufeepgkmijxlcf Sbrrbdmnzf &hdwhei Hiwwbeh dd Hxeejdjllwi STRASBOURG, Alsace France
Crifxp Hendlgruhh E Uqqvwlmtkkdkc Dc Ctrxbcq Eokeeq Coimbra Portugal

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
31.03.2022
Belgium Belgium
Not recruiting
31.03.2022
Bulgaria Bulgaria
Not recruiting
31.03.2022
Croatia Croatia
Not recruiting
31.03.2022
Denmark Denmark
Not recruiting
31.03.2022
Estonia Estonia
Not recruiting
31.03.2022
France France
Not recruiting
31.03.2022
Germany Germany
Not recruiting
31.03.2022
Greece Greece
Not recruiting
31.03.2022
Hungary Hungary
Not recruiting
31.03.2022
Italy Italy
Not recruiting
31.03.2022
Latvia Latvia
Not recruiting
31.03.2022
Poland Poland
Not recruiting
31.03.2022
Portugal Portugal
Not recruiting
31.03.2022
Romania Romania
Not recruiting
31.03.2022
Spain Spain
Not recruiting
31.03.2022
The Netherlands The Netherlands
Not recruiting
31.03.2022

Trial locations

Ocrelizumab is a medication used in this trial to treat children and adolescents with relapsing-remitting multiple sclerosis. It works by targeting specific cells in the immune system that are thought to play a role in the disease, helping to reduce the frequency of relapses.

Fingolimod is another medication being compared in this trial. It is also used to treat relapsing-remitting multiple sclerosis in children and adolescents. Fingolimod works by preventing certain immune cells from reaching the brain and spinal cord, which helps to reduce inflammation and the number of relapses.

Relapsing-Remitting Multiple Sclerosis – This is a form of multiple sclerosis characterized by episodes of new or increasing neurological symptoms, known as relapses, followed by periods of partial or complete recovery. During these relapses, the immune system mistakenly attacks the protective covering of nerve fibers, leading to communication problems between the brain and the rest of the body. The disease progresses with these unpredictable relapses, which can vary in severity and duration. Over time, some individuals may experience a gradual worsening of symptoms, even during periods of remission. The exact cause of the disease is unknown, but it involves a combination of genetic and environmental factors. Symptoms can include fatigue, numbness, vision problems, and difficulties with coordination and balance.

Trial ID:
2023-506516-40-00
Protocol code:
WN42086
Trial Phase:
Therapeutic confirmatory (Phase III)

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