NCT01550003 · OUTCOME

Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16

Pediatric Arthritis Study of Certolizumab Pegol · Source last updated 2024-10-23

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

Measure: GEOMETRIC_MEAN
Unit: ug/ml
Interval / dispersion: 95% Confidence Interval
Time frame: Week 16

What was measured

Certolizumab Pegol (CZP) plasma concentration level was measured in micrograms per milliliter (ug/ml).

Analysis population: The Pharmacokinetic Per-Protocol (PK-PP) Set was a subset of the SS consisting of those study participants who took at least 1 dose of study medication, provided measurable plasma CZP concentration samples (with recorded sampling date/time or for which date/time can be reasonably assumed). Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Groups in this outcome

Reduced CZP Dose -Weight Group: 10 - <20 kg

Participants received CZP 50 milligrams (mg) sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 50 mg sc Q4W (maintenance dose) from Week 8 onwards.

Reduced CZP Dose - Weight Group: 20 - <40 kg

Participants received CZP 100 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 50 mg sc Q2W (maintenance dose) from Week 6 onwards.

Reduced CZP Dose - Weight Group: >=40 kg

Participants received CZP 200 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 100 mg sc Q2W (maintenance dose) from Week 6 onwards.

Original CZP Dose - Weight Group: 10 - <20 kg

Participants received CZP 100 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 50 mg sc Q2W (maintenance dose) from Week 6 onwards.

Original CZP Dose - Weight Group: 20 - <40 kg

Participants received CZP 200 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 100 mg sc Q2W (maintenance dose) from Week 6 onwards.

Original CZP Dose - Weight Group: >=40 kg

Participants received CZP 400 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 200 mg sc Q2W (maintenance dose) from Week 6 onwards.

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
Reduced CZP Dose -Weight Group: 10 - <20 kg	10
Reduced CZP Dose - Weight Group: 20 - <40 kg	24
Reduced CZP Dose - Weight Group: >=40 kg	36
Original CZP Dose - Weight Group: 10 - <20 kg	5
Original CZP Dose - Weight Group: 20 - <40 kg	29
Original CZP Dose - Weight Group: >=40 kg	49

Reported measurements

Source class 1

Values in ug/ml · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Reduced CZP Dose -Weight Group: 10 - <20 kg	1.6166	Not reported	0.4720	5.5368	Not reported
Reduced CZP Dose - Weight Group: 20 - <40 kg	9.2277	Not reported	5.1453	16.5491	Not reported
Reduced CZP Dose - Weight Group: >=40 kg	13.8928	Not reported	11.0030	17.5416	Not reported
Original CZP Dose - Weight Group: 10 - <20 kg	22.9060	Not reported	13.3380	39.3374	Not reported
Original CZP Dose - Weight Group: 20 - <40 kg	25.7752	Not reported	16.9024	39.3058	Not reported
Original CZP Dose - Weight Group: >=40 kg	33.5680	Not reported	25.7883	43.6945	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.4720
upper Limit
5.5368
value
1.6166
group Id
OG001
lower Limit
5.1453
upper Limit
16.5491
value
9.2277
group Id
OG002
lower Limit
11.0030
upper Limit
17.5416
value
13.8928
group Id
OG003
lower Limit
13.3380
upper Limit
39.3374
value
22.9060
group Id
OG004
lower Limit
16.9024
upper Limit
39.3058
value
25.7752
group Id
OG005
lower Limit
25.7883
upper Limit
43.6945
value
33.5680

denoms

counts
group Id
OG000
value
10
group Id
OG001
value
24
group Id
OG002
value
36
group Id
OG003
value
5
group Id
OG004
value
29
group Id
OG005
value
49
units
Participants

description

Certolizumab Pegol (CZP) plasma concentration level was measured in micrograms per milliliter (ug/ml).

dispersion Type

95% Confidence Interval

groups

description
Participants received CZP 50 milligrams (mg) sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 50 mg sc Q4W (maintenance dose) from Week 8 onwards.
id
OG000
title
Reduced CZP Dose -Weight Group: 10 - <20 kg
description
Participants received CZP 100 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 50 mg sc Q2W (maintenance dose) from Week 6 onwards.
id
OG001
title
Reduced CZP Dose - Weight Group: 20 - <40 kg
description
Participants received CZP 200 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 100 mg sc Q2W (maintenance dose) from Week 6 onwards.
id
OG002
title
Reduced CZP Dose - Weight Group: >=40 kg
description
Participants received CZP 100 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 50 mg sc Q2W (maintenance dose) from Week 6 onwards.
id
OG003
title
Original CZP Dose - Weight Group: 10 - <20 kg
description
Participants received CZP 200 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 100 mg sc Q2W (maintenance dose) from Week 6 onwards.
id
OG004
title
Original CZP Dose - Weight Group: 20 - <40 kg
description
Participants received CZP 400 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 200 mg sc Q2W (maintenance dose) from Week 6 onwards.
id
OG005
title
Original CZP Dose - Weight Group: >=40 kg

param Type

GEOMETRIC_MEAN

population Description

The Pharmacokinetic Per-Protocol (PK-PP) Set was a subset of the SS consisting of those study participants who took at least 1 dose of study medication, provided measurable plasma CZP concentration samples (with recorded sampling date/time or for which date/time can be reasonably assumed). Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

reporting Status

POSTED

time Frame

Week 16

title

Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16

type

PRIMARY

unit Of Measure

ug/ml

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Preserved source evidence · Not medical advice