BridgeMD
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis
EU CTIS ID: 2023-507313-94-00
What this study is testing
To characterize the ocrelizumab pharmacokinetic (PK) profile in children and adolescents. To evaluate relationship between drug exposure and pharmacodynamic (PD) (cluster of differentiation 19 [CD19] + B-cell count) in children and adolescents.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1.Body weight >= 25 kg Note: enrollment of patients with a body weight >= 40 kg is closed
- 2.Children and adolescents must have received all childhood vaccinations as per local/national recommendations for childhood vaccination against infectious diseases
- 3.For female patients of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception including at least one method with a failure rate of < 1% per year, during the treatment period and for at least 24 weeks after the final dose of ocrelizumab. Adherence to local requirements, if more stringent, is required
- 4.Diagnosis of RRMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric multiple sclerosis (MS), Version 2012, and McDonald criteria 2017
- 5.Expanded disability status scale (EDSS) at screening: 0-5.5, inclusive
- 6.Patients who have had at least 6 continuous months of disease-modifying therapy (DMT) (e.g., any interferon [IFN] or glatiramer acetate [GA]) 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 gadolinium (Gd)-enhancing lesion(s) on a T1-weighted brain magnetic resonance imaging (MRI)
You likely can't join if
- 1.Known presence or suspicion (based on clinical or laboratory parameters) of other neurologic disorders that may mimic MS, including, but not limited to, acute disseminated encephalomyelitis (ADEM), neuromyelitis optica or neuromyelitis optica spectrum disorders; and any neurologic (other than MS), 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
- 2.Atypical MRI findings: ADEM-like presentation of lesions; lesions in atypical location for MS; bilateral soptic neuritis; extensive spinal cord lesions (>= 3 spinal segments)
- 3.Known active bacterial, viral, fungal, mycobacterial infection, or other infection, excluding fungal infection of nail beds
- 4.Receipt of a live or live-attenuated vaccine within 6 weeks prior to treatment allocation. The patient's vaccination record and a need for immunization should be carefully reviewed (scheduled vaccinations should be completed at least 6 weeks prior to receiving ocrelizumab, according to local guidelines)
- 5.History of a severe allergic or anaphylactic reaction to humanized or murine monoclonal antibodies (mAbs) or known hypersensitivity to any component of ocrelizumab solution
- 6.Positive screening tests for hepatitis B (hepatitis B surface antigen [HBsAg] positive, or positive hepatitis B core antibody [total HBcAb] confirmed by a positive viral deoxyribonucleic acid [DNA] polymerase chain reaction [PCR]) or hepatitis C antibody (HepCAb)
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.