NCT00488631 · OUTCOME

Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids 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 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.

Analysis population: Analysis population included randomly assigned participants in clinical response to golimumab induction who were receiving concomitant corticosteroids at Week 0 of the 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

Group	Source count
Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance	87
GLM-I-Rsp-Golimumab 50 mg Maintenance	78
GLM-I-Rsp-Golimumab 100 mg Maintenance	82

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance	16	Not reported	Not reported	Not reported	Not reported
GLM-I-Rsp-Golimumab 50 mg Maintenance	22	Not reported	Not reported	Not reported	Not reported
GLM-I-Rsp-Golimumab 100 mg Maintenance	19	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

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

group Description
Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.279
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
group Description
Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.423
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

group Description
Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.279
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
group Description
Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.423
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

categories
measurements
group Id
OG000
value
16
group Id
OG001
value
22
group Id
OG002
value
19

denoms

counts
group Id
OG000
value
87
group Id
OG001
value
78
group Id
OG002
value
82
units
Participants

description

groups

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
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
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 in clinical response to golimumab induction who were receiving concomitant corticosteroids at Week 0 of the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

reporting Status

POSTED

time Frame

Week 54

title

Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study

type

SECONDARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice