Ublituximab in Pediatric Participants with Relapsing forms of Multiple Sclerosis (RMS)

Conditions

Relapsing Multiple Sclerosis

Brief summary

(Part C) Safety a. Incidence and severity of AEs, with severity determined according to NCI CTCAE v5.0 b. Suicidal Ideation Columbia-Suicide Severity Rating Scale (C-SSRS), (Part A) Percentage of patients with CD19+ B cell at a defined level

Detailed description

Part A: Safety a. Incidence and severity of AEs, with severity determined according to NCI CTCAE v5.0 b. Suicidal ideation Columbia-Suicide Severity Rating Scale (C-SSRS), Part A: Pharmacology a. Serum concentrations of ublituximab b. Percentage of participants with anti-drug antibodies (ADAs) to ublituximab, Part B: Safety a. Incidence and severity of AEs, with severity determined according to NCI CTCAE v5.0 b. Suicidal ideation Columbia-Suicide Severity Rating Scale (C-SSRS), Part B: Pharmacology a. Calculated PK parameters of ublituximab b. CD19+ B cell counts c. Percentage of participants with Treatment Emergent Anti-Drug Antibody(TE-ADAs) to ublituximab

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGUblituximab Placebo

DRUGFINGOLIMOD

DRUGFingolimod placebo

DRUGublituximab

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
(Part C) Safety a. Incidence and severity of AEs, with severity determined according to NCI CTCAE v5.0 b. Suicidal Ideation Columbia-Suicide Severity Rating Scale (C-SSRS), (Part A) Percentage of patients with CD19+ B cell at a defined level	—

Secondary

Measure	Time frame
Part A: Safety a. Incidence and severity of AEs, with severity determined according to NCI CTCAE v5.0 b. Suicidal ideation Columbia-Suicide Severity Rating Scale (C-SSRS), Part A: Pharmacology a. Serum concentrations of ublituximab b. Percentage of participants with anti-drug antibodies (ADAs) to ublituximab, Part B: Safety a. Incidence and severity of AEs, with severity determined according to NCI CTCAE v5.0 b. Suicidal ideation Columbia-Suicide Severity Rating Scale (C-SSRS), Part B: Pharmacology a. Calculated PK parameters of ublituximab b. CD19+ B cell counts c. Percentage of participants with Treatment Emergent Anti-Drug Antibody(TE-ADAs) to ublituximab	—

Measure

Time frame

Part A: Safety a. Incidence and severity of AEs, with severity determined according to NCI CTCAE v5.0 b. Suicidal ideation Columbia-Suicide Severity Rating Scale (C-SSRS), Part A: Pharmacology a. Serum concentrations of ublituximab b. Percentage of participants with anti-drug antibodies (ADAs) to ublituximab, Part B: Safety a. Incidence and severity of AEs, with severity determined according to NCI CTCAE v5.0 b. Suicidal ideation Columbia-Suicide Severity Rating Scale (C-SSRS), Part B: Pharmacology a. Calculated PK parameters of ublituximab b. CD19+ B cell counts c. Percentage of participants with Treatment Emergent Anti-Drug Antibody(TE-ADAs) to ublituximab

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Countries

Poland

Outcome results

None listed