NCT01750697 · OUTCOME

Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Rituximab

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: mcg/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: From Day 1 to Day 180

What was measured

Cmax is the maximum observed plasma rituximab concentration. Cmax was assessed at each visit following 1st, 2nd, 3rd, and 4th IV dose of rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. Cmax was calculated in micrograms per millilitre (mcg/mL).

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

Group	Source count
Rituximab (Experimental)	25

Reported measurements

1st Dose

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Rituximab (Experimental)	230	0.166	Not reported	Not reported	Not reported

2nd Dose

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Rituximab (Experimental)	305	0.181	Not reported	Not reported	Not reported

3rd Dose

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Rituximab (Experimental)	353	0.183	Not reported	Not reported	Not reported

4th Dose

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Rituximab (Experimental)	378	0.174	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.166
value
230
title
1st Dose
categories
measurements
group Id
OG000
spread
0.181
value
305
title
2nd Dose
categories
measurements
group Id
OG000
spread
0.183
value
353
title
3rd Dose
categories
measurements
group Id
OG000
spread
0.174
value
378
title
4th Dose

denoms

counts
group Id
OG000
value
25
units
Participants

description

dispersion Type

Geometric Coefficient of Variation

groups

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: Maximum Plasma Concentration (Cmax) of Rituximab

type

SECONDARY

unit Of Measure

mcg/mL

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

Preserved source evidence · Not medical advice