Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01550003 · OUTCOME

Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48

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 48

What was measured

Certolizumab Pegol (CZP) plasma concentration level was measured in 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

GroupSource count
Reduced CZP Dose -Weight Group: 10 - <20 kg9
Reduced CZP Dose - Weight Group: 20 - <40 kg24
Reduced CZP Dose - Weight Group: >=40 kg31
Original CZP Dose - Weight Group: 10 - <20 kg2
Original CZP Dose - Weight Group: 20 - <40 kg12
Original CZP Dose - Weight Group: >=40 kg25

Reported measurements

Source class 1
Values in ug/ml · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Reduced CZP Dose -Weight Group: 10 - <20 kg4.7404Not reported1.759612.7710Not reported
Reduced CZP Dose - Weight Group: 20 - <40 kg8.4459Not reported5.000214.2661Not reported
Reduced CZP Dose - Weight Group: >=40 kg12.2987Not reported8.695017.3962Not reported
Original CZP Dose - Weight Group: 10 - <20 kgNANot reportedNANAAs pre-specified in the SAP, Geometric Mean and 95% confidence interval (CI) were not calculated if less than 3 concentration were available or if the below the lower limit of quantification (LLOQ) was greater than (\>) 1/3.
Original CZP Dose - Weight Group: 20 - <40 kg20.7048Not reported11.174438.3636Not reported
Original CZP Dose - Weight Group: >=40 kg25.5940Not reported14.691344.5878Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.7596
        upper Limit
        12.7710
        value
        4.7404
      2. group Id
        OG001
        lower Limit
        5.0002
        upper Limit
        14.2661
        value
        8.4459
      3. group Id
        OG002
        lower Limit
        8.6950
        upper Limit
        17.3962
        value
        12.2987
      4. comment
        As pre-specified in the SAP, Geometric Mean and 95% confidence interval (CI) were not calculated if less than 3 concentration were available or if the below the lower limit of quantification (LLOQ) was greater than (\>) 1/3.
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      5. group Id
        OG004
        lower Limit
        11.1744
        upper Limit
        38.3636
        value
        20.7048
      6. group Id
        OG005
        lower Limit
        14.6913
        upper Limit
        44.5878
        value
        25.5940
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      24
    3. group Id
      OG002
      value
      31
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      12
    6. group Id
      OG005
      value
      25
    units
    Participants
description
Certolizumab Pegol (CZP) plasma concentration level was measured in ug/mL.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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 48
title
Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48
type
PRIMARY
unit Of Measure
ug/ml

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

Preserved source evidence · Not medical advice