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NCT00488631 · OUTCOME

Number of Participants in Clinical Response Through Week 54

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
Induction Baseline, Week 0 through Week 54

What was measured

Clinical response is defined as decrease from induction baseline in Mayo score by greater than or equal to (\>=) 30 percent and \>= 3, with either decrease from induction baseline in rectal bleeding subscore of \>= 1 or rectal bleeding subscore of 0 or 1. Participants who lost clinical response prior to Week 54 were considered not to meet endpoint. Mayo score is sum of 4 subscores (ie, stool frequency, rectal bleeding, endoscopic findings, physician's global assessment); each rated on scale from 0 to 3, with higher scores indicating more severe disease. Total Mayo score value ranges from 0 to 12.

Analysis population: Primary analysis population included randomly assigned participants in clinical response 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 Maintenance154
GLM-I-Rsp-Golimumab 50 mg Maintenance151
GLM-I-Rsp-Golimumab 100 mg Maintenance151

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance48Not reportedNot reportedNot reportedNot reported
GLM-I-Rsp-Golimumab 50 mg Maintenance71Not reportedNot reportedNot reportedNot reported
GLM-I-Rsp-Golimumab 100 mg Maintenance75Not 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 in clinical response through Week 54 were summarized using the Cochran-Mantel-Haenszel (CMH) test stratified by clinical remission status at Week 0 and the induction dose factor.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.010
    p Value Comment
    A fixed sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level (i.e., testing golimumab 100 mg vs. placebo first, then, if positive, testing 50 mg vs. placebo).
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
  2. group Description
    Statistical analysis for number of participants in clinical response through Week 54 were summarized using the Cochran-Mantel-Haenszel (CMH) test stratified by clinical remission status at Week 0 and the induction dose factor.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    p Value Comment
    A fixed sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level (i.e., testing golimumab 100 mg vs. placebo first, then, if positive, testing 50 mg vs. placebo).
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
Complete source fields
analyses
  1. group Description
    Statistical analysis for number of participants in clinical response through Week 54 were summarized using the Cochran-Mantel-Haenszel (CMH) test stratified by clinical remission status at Week 0 and the induction dose factor.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.010
    p Value Comment
    A fixed sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level (i.e., testing golimumab 100 mg vs. placebo first, then, if positive, testing 50 mg vs. placebo).
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
  2. group Description
    Statistical analysis for number of participants in clinical response through Week 54 were summarized using the Cochran-Mantel-Haenszel (CMH) test stratified by clinical remission status at Week 0 and the induction dose factor.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    p Value Comment
    A fixed sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level (i.e., testing golimumab 100 mg vs. placebo first, then, if positive, testing 50 mg vs. placebo).
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        48
      2. group Id
        OG001
        value
        71
      3. group Id
        OG002
        value
        75
denoms
  1. counts
    1. group Id
      OG000
      value
      154
    2. group Id
      OG001
      value
      151
    3. group Id
      OG002
      value
      151
    units
    Participants
description
Clinical response is defined as decrease from induction baseline in Mayo score by greater than or equal to (\>=) 30 percent and \>= 3, with either decrease from induction baseline in rectal bleeding subscore of \>= 1 or rectal bleeding subscore of 0 or 1. Participants who lost clinical response prior to Week 54 were considered not to meet endpoint. Mayo score is sum of 4 subscores (ie, stool frequency, rectal bleeding, endoscopic findings, physician's global assessment); each rated on scale from 0 to 3, with higher scores indicating more severe disease. Total Mayo score value ranges from 0 to 12.
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
Primary analysis population included randomly assigned participants in clinical response 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
Induction Baseline, Week 0 through Week 54
title
Number of Participants in Clinical Response Through Week 54
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice