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NCT02552212 · OUTCOME

Percentage of Subjects With Adverse Events Leading to Withdrawal From Investigational Medicinal Product (IMP) During the Study

Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS · Source last updated 2022-08-18

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

Measure
NUMBER
Unit
percentage of subjects
Interval / dispersion
Not reported
Time frame
From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)

What was measured

An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Analysis population: The SS consisted of all subjects who received at least 1 dose of study treatment.

Groups in this outcome

Placebo (SS)

Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Safety Set (SS).

CZP 200 mg Q2W (SS)

Certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards. Subjects formed the SS.

Placebo->OL CZP (SS)

Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.

CZP->OL CZP (SS)

Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.

SFE OL CZP 200 mg Q2W (SS)

Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).

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

Analysis denominator · Participants

GroupSource count
Placebo (SS)158
CZP 200 mg Q2W (SS)159
Placebo->OL CZP (SS)96
CZP->OL CZP (SS)20
SFE OL CZP 200 mg Q2W (SS)243

Reported measurements

Source class 1
Values in percentage of subjects · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo (SS)1.9Not reportedNot reportedNot reportedNot reported
CZP 200 mg Q2W (SS)1.9Not reportedNot reportedNot reportedNot reported
Placebo->OL CZP (SS)3.1Not reportedNot reportedNot reportedNot reported
CZP->OL CZP (SS)0Not reportedNot reportedNot reportedNot reported
SFE OL CZP 200 mg Q2W (SS)2.5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1.9
      2. group Id
        OG001
        value
        1.9
      3. group Id
        OG002
        value
        3.1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        2.5
denoms
  1. counts
    1. group Id
      OG000
      value
      158
    2. group Id
      OG001
      value
      159
    3. group Id
      OG002
      value
      96
    4. group Id
      OG003
      value
      20
    5. group Id
      OG004
      value
      243
    units
    Participants
description
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
groups
  1. description
    Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Safety Set (SS).
    id
    OG000
    title
    Placebo (SS)
  2. description
    Certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards. Subjects formed the SS.
    id
    OG001
    title
    CZP 200 mg Q2W (SS)
  3. description
    Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.
    id
    OG002
    title
    Placebo->OL CZP (SS)
  4. description
    Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.
    id
    OG003
    title
    CZP->OL CZP (SS)
  5. description
    Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
    id
    OG004
    title
    SFE OL CZP 200 mg Q2W (SS)
param Type
NUMBER
population Description
The SS consisted of all subjects who received at least 1 dose of study treatment.
reporting Status
POSTED
time Frame
From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)
title
Percentage of Subjects With Adverse Events Leading to Withdrawal From Investigational Medicinal Product (IMP) During the Study
type
SECONDARY
unit Of Measure
percentage of subjects

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

Preserved source evidence · Not medical advice