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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis

Study Purpose

This 2-year study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic (PD) effects of ocrelizumab in children and adolescents ages ≥ 10 to ≤ 18 years with relapsing-remitting multiple sclerosis (RRMS). The data from this study will serve to determine the dosing regimen of ocrelizumab to be further investigated in the subsequent Phase III study in children and adolescents.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 10 Years - 18 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Body weight >/= 25 kg.
  • - Children and adolescents must have received all childhood required vaccinations.
  • - Female participants of childbearing potential must agree to either remain completely abstinent or to use reliable means of contraception.
  • - Diagnosis of relapsing-remitting multiple sclerosis (RRMS) - Expanded Disability Status Scale (EDSS) at screening: 0-5.5, inclusive.
  • - Neurologic stability for >/= 30 days prior to screening, and between screening and baseline.
  • - Participants naive to prior disease-modifying therapy (DMT) - 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.

Exclusion Criteria:

  • - Known presence or suspicion of other neurologic disorders that may mimic MS, including, but not limited to, acute disseminated encephalomyelitis, neuromyelitis optica or neuromyelitis optica spectrum disorders and any neurologic, somatic, or metabolic condition that could interfere with brain function or normal cognitive or neurological development.
  • - Patients that are aquaporin 4 positive and myelin oligodendrocyte glycoprotein (MOG) antibody positive are not eligible to participate in the study.
  • - In case of an ADEM-like appearance of the first MS attack, a second attack with clear MS-like features is required.
  • - Infection requiring hospitalization or treatment with IV anti-infective agents.
  • - History or known presence of recurrent or chronic infection (e.g., HIV, syphilis, tuberculosis) - Receipt of a live or live-attenuated vaccine within 6 weeks prior to treatment allocation.
  • - History or laboratory evidence of coagulation disorders.
  • - Peripheral venous access that precludes IV administration and venous blood sampling.
  • - Inability to complete a magnetic resonance imaging (MRI) scan.
  • - History of cancer, including solid tumors, hematologic malignancies, and carcinoma in situ.
  • - History of a severe allergic or anaphylactic reaction to humanized or murine monoclonal antibody (mAbs) or known hypersensitivity to any component of ocrelizumab solution.
  • - Previous treatment with B-cell-targeted therapies.
  • - Percentage of CD4 < 30% - Absolute Neutrophil Count < 1.5x1000/microliter.
- Lymphocyte count below the lower limit of normal (LLN) for age- and sex-specific reference range

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04075266
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hoffmann-La Roche
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Trials
Principal Investigator Affiliation Hoffmann-La Roche
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Italy, Mexico, Poland, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Sclerosis
Arms & Interventions

Arms

Experimental: Cohort 1

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

Experimental: Cohort 2

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

Experimental: Cohort 3 (optional)

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

Experimental: Cohort 4 (optional)

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

Interventions

Drug: - Ocrelizumab

Ocrelizumab is administered as two infusions of half the dose given 14 days apart for the first dose, then subsequent doses are administered as a single infusion every 24 weeks. Cohort 1: total dose of 300 mg Cohort 2: total dose of 600 mg Cohort 3 and 4: additional dose level(s) may be lower than 300 mg, between 300 mg and 600 mg, or higher than 600 mg, but will be no higher than 1200 mg

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Loma Linda University health, Loma Linda, California

Status

Withdrawn

Address

Loma Linda University health

Loma Linda, California, 92354

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

University of California San Francisco, San Francisco, California

Status

Withdrawn

Address

University of California San Francisco

San Francisco, California, 94117

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Aurora, Colorado

Status

Active, not recruiting

Address

University of Colorado Denver Childrens Hospital Rocky Mountain MS Center

Aurora, Colorado, 80045

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Childrens National Health Center, Washington, District of Columbia

Status

Recruiting

Address

Childrens National Health Center

Washington, District of Columbia, 20010

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

University of Louisville Physicians, Louisville, Kentucky

Status

Withdrawn

Address

University of Louisville Physicians

Louisville, Kentucky, 40202

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Boston Childrens Hospital, Boston, Massachusetts

Status

Recruiting

Address

Boston Childrens Hospital

Boston, Massachusetts, 02115

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Washington Universtiy school of Medicine, Saint Louis, Missouri

Status

Active, not recruiting

Address

Washington Universtiy school of Medicine

Saint Louis, Missouri, 63110

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

New York, New York

Status

Withdrawn

Address

Pediatric MS Center at New York University Langone Medical Center

New York, New York, 10016

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Stony Brook University Medical Center, Stony Brook, New York

Status

Withdrawn

Address

Stony Brook University Medical Center

Stony Brook, New York, 11794

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Akron Childrens Hospital, Akron, Ohio

Status

Withdrawn

Address

Akron Childrens Hospital

Akron, Ohio, 44308

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Cleveland Clinic, Cleveland, Ohio

Status

Active, not recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44106

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Withdrawn

Address

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

International Sites

Roma, Lazio, Italy

Status

Active, not recruiting

Address

Ospedale Pediatrico Bambino Gesù; Divisione di Neurologia

Roma, Lazio, 00165

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Roma, Lazio, Italy

Status

Active, not recruiting

Address

Azienda Ospedaliera Sant'Andrea; UOC Neurologia

Roma, Lazio, 00189

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Irccs A.O.U.San Martino Ist; Dinogmi, Genova, Liguria, Italy

Status

Withdrawn

Address

Irccs A.O.U.San Martino Ist; Dinogmi

Genova, Liguria, 16132

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Gallarate, Lombardia, Italy

Status

Withdrawn

Address

Ospedale S.Antonio Abate; Neurologia 2 ? Sclerosi Multipla e Recupero Neurologico

Gallarate, Lombardia, 21013

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Milano, Lombardia, Italy

Status

Withdrawn

Address

IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla

Milano, Lombardia, 20132

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Catania, Sicilia, Italy

Status

Active, not recruiting

Address

AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla

Catania, Sicilia, 95123

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Clinstile S.A de C.V., Mexico City, Mexico CITY (federal District), Mexico

Status

Withdrawn

Address

Clinstile S.A de C.V.

Mexico City, Mexico CITY (federal District), 06700

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

?ód?, Poland

Status

Withdrawn

Address

Instytut Centrum Zdrowia Matki Polki; Klinika Neurologii

?ód?, , 93-338

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Gda?sk, Poland

Status

Active, not recruiting

Address

Uniwersyteckie Centrum Kliniczne; Klinika Neurologii Rozwojowej

Gda?sk, , 80-952

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Pozna?, Poland

Status

Active, not recruiting

Address

Uniwersytecki Szpital Kliniczny w Poznaniu; Od. Kliniczny Neurologii Dzieci i M?odziezy

Pozna?, , 60-355

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Warszawa, Poland

Status

Active, not recruiting

Address

Dzieci?cy Szpital Kliniczny im. Józefa Polikarpa Brudzi?skiego; Klinika Neurologii Dzieciecej

Warszawa, , 02-091

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Warszawa, Poland

Status

Active, not recruiting

Address

Instytut Pomnik Centrum Zdrowia Dziecka; Klinika Neurologii i Epileptologii

Warszawa, , 04-730

Site Contact

[email protected]

888-662-6728 (U.S. and Canada)

Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

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If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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