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NCT00488631 · OUTCOME

Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study

An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis · Source last updated 2016-04-26

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Week 30 and Week 54

What was measured

Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.

Analysis population: Analysis population included randomly assigned participants who were in clinical remission to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Groups in this outcome

Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance

Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.

GLM-I-Rsp-Golimumab 50 mg Maintenance

Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.

GLM-I-Rsp-Golimumab 100 mg Maintenance

Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.

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

Analysis denominator · Participants

GroupSource count
Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance54
GLM-I-Rsp-Golimumab 50 mg Maintenance52
GLM-I-Rsp-Golimumab 100 mg Maintenance54

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance13Not reportedNot reportedNot reportedNot reported
GLM-I-Rsp-Golimumab 50 mg Maintenance19Not reportedNot reportedNot reportedNot reported
GLM-I-Rsp-Golimumab 100 mg Maintenance21Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    Statistical analysis for number of participants with clinical remission at both Week 30 and 54 among participants with clinical remission at Week 0 of maintenance study were summarized using CMH test stratified by the induction dose factor.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.365
    p Value Comment
    Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
  2. group Description
    Statistical analysis for number of participants with clinical remission at both Week 30 and 54 among participants with clinical remission at Week 0 of maintenance study were summarized using CMH test stratified by the induction dose factor.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.098
    p Value Comment
    Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
Complete source fields
analyses
  1. group Description
    Statistical analysis for number of participants with clinical remission at both Week 30 and 54 among participants with clinical remission at Week 0 of maintenance study were summarized using CMH test stratified by the induction dose factor.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.365
    p Value Comment
    Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
  2. group Description
    Statistical analysis for number of participants with clinical remission at both Week 30 and 54 among participants with clinical remission at Week 0 of maintenance study were summarized using CMH test stratified by the induction dose factor.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.098
    p Value Comment
    Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        19
      3. group Id
        OG002
        value
        21
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    2. group Id
      OG001
      value
      52
    3. group Id
      OG002
      value
      54
    units
    Participants
description
Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.
groups
  1. description
    Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
    id
    OG000
    title
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance
  2. description
    Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
    id
    OG001
    title
    GLM-I-Rsp-Golimumab 50 mg Maintenance
  3. description
    Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
    id
    OG002
    title
    GLM-I-Rsp-Golimumab 100 mg Maintenance
param Type
NUMBER
population Description
Analysis population included randomly assigned participants who were in clinical remission to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
reporting Status
POSTED
time Frame
Week 30 and Week 54
title
Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice