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NCT01750697 · OUTCOME

Pharmacokinetics: Rituximab Clearance (CL)

A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis · Source last updated 2019-06-26

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
GEOMETRIC_MEAN
Unit
mL/day
Interval / dispersion
Geometric Coefficient of Variation
Time frame
From Day 1 to Day 180

What was measured

CL is a quantitative measure of the rate at which a drug substance is removed from the body. The following allometric scaling equation was used for the estimation of CL in children: CL= qCL X (BSA/1.9) 0.92 X 1.31\*ADA where qCL is a typical value of clearance in millilitres per day (mL/day) for a typical participant (i.e., Body Surface Area (BSA) of 1.9 m\^2 and absence of anti-rituximab antibodies (ADA)) and is equal to 258 mL/day; BSA is in m\^2 and ADA is 1 when anti-rituximab antibodies are present (0 otherwise). The allometric scaling factor was 0.92. CL was calculated in millilitres per day (mL/day).

Analysis population: The PK analysis population included all participants in the safety population who provided at least one evaluable PK sample.

Groups in this outcome

Rituximab (Experimental)

Participants received rituximab as an intravenous (IV) infusion of 375 milligrams per meter squared (mg/m\^2) once a week on Days 1, 8, 15 and 22 during the Remission Induction Phase (Day 1 (baseline) to Month 6) and were followed for a minimum of 18 months (maximum 4.5yrs) during the Follow-up Phase until the Common-closeout (CCO))

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Rituximab (Experimental)25

Reported measurements

Source class 1
Values in mL/day · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Rituximab (Experimental)2040.414Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.414
        value
        204
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
CL is a quantitative measure of the rate at which a drug substance is removed from the body. The following allometric scaling equation was used for the estimation of CL in children: CL= qCL X (BSA/1.9) 0.92 X 1.31\*ADA where qCL is a typical value of clearance in millilitres per day (mL/day) for a typical participant (i.e., Body Surface Area (BSA) of 1.9 m\^2 and absence of anti-rituximab antibodies (ADA)) and is equal to 258 mL/day; BSA is in m\^2 and ADA is 1 when anti-rituximab antibodies are present (0 otherwise). The allometric scaling factor was 0.92. CL was calculated in millilitres per day (mL/day).
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received rituximab as an intravenous (IV) infusion of 375 milligrams per meter squared (mg/m\^2) once a week on Days 1, 8, 15 and 22 during the Remission Induction Phase (Day 1 (baseline) to Month 6) and were followed for a minimum of 18 months (maximum 4.5yrs) during the Follow-up Phase until the Common-closeout (CCO))
    id
    OG000
    title
    Rituximab (Experimental)
param Type
GEOMETRIC_MEAN
population Description
The PK analysis population included all participants in the safety population who provided at least one evaluable PK sample.
reporting Status
POSTED
time Frame
From Day 1 to Day 180
title
Pharmacokinetics: Rituximab Clearance (CL)
type
PRIMARY
unit Of Measure
mL/day

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice