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Monoclonal Antibodies
Ocrelizumab for Pediatric Multiple Sclerosis
Phase 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female participants of childbearing potential must agree to either remain completely abstinent or to use reliable means of contraception
Children and adolescents must have received all childhood required vaccinations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, up to 5 years
Awards & highlights
Study Summary
This trial will study the effects of a new MS drug in children and adolescents. The goal is to see if it is safe and works well in this age group.
Who is the study for?
This trial is for children and adolescents aged ≥10 to ≤18 with relapsing-remitting multiple sclerosis (RRMS). They must weigh at least 25 kg, be new to disease-modifying therapy, have up-to-date vaccinations, agree to use contraception if applicable, and show neurologic stability for 30 days prior. Participants should not have other neurological disorders that mimic MS or a history of severe infections or cancer.Check my eligibility
What is being tested?
The study tests Ocrelizumab's safety and effects in young patients with RRMS over two years. It aims to find the right dosing regimen for further research. The participants will receive Ocrelizumab while being monitored for how their body absorbs and responds to it.See study design
What are the potential side effects?
Ocrelizumab may cause infusion reactions like itching or rash, infections due to weakened immune response, potential liver issues indicated by blood tests, and possibly an increased risk of some types of cancers based on adult studies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use birth control or remain abstinent.
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My child has received all required vaccinations.
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I have been diagnosed with relapsing-remitting multiple sclerosis.
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I have not taken any disease-modifying treatments before.
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My disability level allows me to walk without aid or rest for 200 meters.
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My body weight is at least 25 kg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months, up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Levels of CD19+ B-cell Count in Blood
Serum Concentration of Ocrelizumab
Secondary outcome measures
Antibody Titers Against Standard Vaccines
Developmental Milestones - Growth velocity: Height. Change in height measured in centimeters (cm)
Developmental Milestones: Age at menarche, related with the female reproductive status
+7 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 4 (optional)Experimental Treatment1 Intervention
Based on PK, PD, safety, and tolerability data analyses of Cohorts 1 and 2, additional participants with a body weight >/= 40 kg may be enrolled and receive another dose level of ocrelizumab
Group II: Cohort 3 (optional)Experimental Treatment1 Intervention
Based on PK, PD, safety, and tolerability data analyses of Cohorts 1 and 2, additional participants with a body weight from >/= 25 kg to < 40 kg may be enrolled and receive another dose level of ocrelizumab
Group III: Cohort 2Experimental Treatment1 Intervention
Participants with a body weight >/= 40 kg (with at least 2 participants with a body weight >/= 40 kg but </= 50 kg) will receive 600 mg ocrelizumab
Group IV: Cohort 1Experimental Treatment1 Intervention
Participants with a body weight from >/= 25 kg to < 40 kg (with at least 2 participants with a body weight from >/= 25 kg to </= 35 kg) will receive 300 milligram (mg) ocrelizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ocrelizumab
2016
Completed Phase 3
~5730
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,089,850 Total Patients Enrolled
34 Trials studying Multiple Sclerosis
24,931 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,567 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
18,258 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use birth control or remain abstinent.I've had MS treatment for 6 months but my condition worsened after.I do not have other neurological conditions that could be confused with MS.You have had a severe allergic reaction to a specific type of medication called monoclonal antibodies, or you are allergic to any part of the ocrelizumab solution.My child has received all required vaccinations.Your CD4 cell count is less than 30%.I have been diagnosed with relapsing-remitting multiple sclerosis.You have a history or test results showing blood clotting problems.You cannot undergo a magnetic resonance imaging (MRI) scan.I have been treated with therapies targeting B-cells.Your body has too few infection-fighting white blood cells.My neurological condition has been stable for at least 30 days.I have not taken any disease-modifying treatments before.My disability level allows me to walk without aid or rest for 200 meters.I had a second MS attack with clear symptoms after an initial ADEM-like episode.My lymphocyte count is below the normal range for my age and sex.I have a history of or currently have a chronic infection like HIV.I have had cancer before, including any type of solid tumor, blood cancer, or early-stage cancer.I have not received a live vaccine in the last 6 weeks.My body weight is at least 25 kg.I do not have aquaporin 4 or MOG antibodies.I have an infection that needed hospital care or IV antibiotics.You are unable to receive medication or have blood drawn through a vein in your arm.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 4 (optional)
- Group 3: Cohort 2
- Group 4: Cohort 3 (optional)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many facilities are coordinating this trial?
"There are 8 sites currently enrolling patients in this trial, which are located in San Francisco, Boston, Philadelphia, and 5 other cities."
Answered by AI
Will patients who take Ocrelizumab experience any adverse effects?
"Ocrelizumab is still in Phase 2 clinical trials, meaning that while there is some data supporting its safety, there is currently no data to suggest that the medication is effective."
Answered by AI
Could I possibly sign up for this research project?
"This study is meant for 36 participants that have multiple sclerosis and are aged 10 to 18. Candidates must meet the following requirements: Expanded Disability Status Scale (EDSS) at screening: 0-5.5, inclusive, Participants who have had at least 6 contiguous months of DMT within the past 1 year must have evidence of disease activity occurring after the full 6-month course of treatment, that is, at least one relapse or >/= 1 Gd-enhancing lesion(s) on a T1-weighted brain MRI, Body weight >/= 25 kg, Children and adolescents must have received"
Answered by AI
What is the precedent for using Ocrelizumab in medical research?
"The research for ocrelizumab started in 2008 at the Legacy Health System; Clinical Research & Tech Ctr. So far, 10 studies have been completed with 29 more currently underway. The majority of these live studies are based in San Francisco, California."
Answered by AI
Is this a new or innovative type of research?
"First researched in 2008, Ocrelizumab was approved for Phase 2 clinical trials after an initial study of 220 people. 29 studies are currently underway across 321 cities and 60 countries."
Answered by AI
Is this research only available to those who are 55 and older?
"Children aged 10 to 18 years old may be eligible for this clinical trial. Out of the 44 trials searching for participants in this age group, this is the only one that414 trials are searching for participants over the age of 65."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Boston Childrens Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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