TriangleNCT02065557 · OUTCOME
Ranked Secondary Endpoint 1: Percentage of Participants With Clinical Response Per FMS at Week 52 in Week 8 Responders Per PMS - Maintenance Period
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Week 52
What was measured
The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those with a decrease in PMS ≥ 2 points and ≥ 30% from Baseline. Clinical response per FMS is defined as a decrease in FMS ≥ 3 points and ≥ 30% from Baseline.
Analysis population: Modified intent-to-treat (mITT): all Week 8 PMS responders who were re-randomized at Week 8 and received at least 1 dose of study drug during the Maintenance period; analyzed as randomized at the beginning of the Maintenance phase. NRI: missing data is imputed as not having met the endpoint.
Groups in this outcome
Main Study: M-PL
(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.
Main Study: M-SD
Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \[maximum dose of 40 mg\] eow). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.
Main Study: M-HD
Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \[maximum dose of 40 mg\] ew). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.
Main Study: M-SD + M-HD
Combined M-SD + M-HD arms (see above).
Integrated Study (Main + Japan Sub-Study): M-PL
(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.
Integrated Study (Main + Japan Sub-Study): M-SD
Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \[maximum dose of 40 mg\] eow). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.
Integrated Study (Main + Japan Sub-Study): M-HD
Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \[maximum dose of 40 mg\] ew). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.
Integrated Study (Main + Japan Sub-Study): M-SD + M-HD
Combined M-SD + M-HD arms (see above).
| Group | Source count |
|---|---|
| Main Study: M-PL | 12 |
| Main Study: M-SD | 31 |
| Main Study: M-HD | 31 |
| Main Study: M-SD + M-HD | 62 |
| Integrated Study (Main + Japan Sub-Study): M-PL | 12 |
| Integrated Study (Main + Japan Sub-Study): M-SD | 33 |
| Integrated Study (Main + Japan Sub-Study): M-HD | 35 |
| Integrated Study (Main + Japan Sub-Study): M-SD + M-HD | 68 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study: M-PL | 33.3 | Not reported | 9.92 | 65.11 | Not reported |
| Main Study: M-SD | 61.3 | Not reported | 42.19 | 78.15 | Not reported |
| Main Study: M-HD | 67.7 | Not reported | 48.63 | 83.32 | Not reported |
| Main Study: M-SD + M-HD | 64.5 | Not reported | 51.34 | 76.26 | Not reported |
| Integrated Study (Main + Japan Sub-Study): M-PL | 33.3 | Not reported | 9.92 | 65.11 | Not reported |
| Integrated Study (Main + Japan Sub-Study): M-SD | 57.6 | Not reported | 39.22 | 74.52 | Not reported |
| Integrated Study (Main + Japan Sub-Study): M-HD | 65.7 | Not reported | 47.79 | 80.87 | Not reported |
| Integrated Study (Main + Japan Sub-Study): M-SD + M-HD | 61.8 | Not reported | 49.18 | 73.29 | Not reported |
Source statistical analyses
- group Description
- Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.
- group Ids
- OG003
- non Inferiority Comment
- one-sample two-sided Chi-square test
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.001
- p Value Comment
- Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)
- statistical Comment
- controlling familywise Type I error of 5% in a strong sense
- statistical Method
- rejective multiple test procedure
- group Description
- Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.
- group Ids
- OG002
- non Inferiority Comment
- one-sample two-sided Chi-square test
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.001
- p Value Comment
- Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)
- statistical Comment
- controlling familywise Type I error of 5% in a strong sense
- statistical Method
- Chi-squared
- group Description
- Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.
- group Ids
- OG001
- non Inferiority Comment
- one-sample two-sided Chi-square test
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.008
- p Value Comment
- Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)
- statistical Comment
- controlling familywise Type I error of 5% in a strong sense
- statistical Method
- Chi-squared
- group Description
- Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.
- group Ids
- OG007
- non Inferiority Comment
- one-sample two-sided Chi-square test
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.001
- p Value Comment
- Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)
- statistical Comment
- controlling familywise Type I error of 5% in a strong sense
- statistical Method
- rejective multiple test procedure
- group Description
- Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.
- group Ids
- OG006
- non Inferiority Comment
- one-sample two-sided Chi-square test
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.001
- p Value Comment
- Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)
- statistical Comment
- controlling familywise Type I error of 5% in a strong sense
- statistical Method
- rejective multiple test procedure
- group Description
- Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.
- group Ids
- OG005
- non Inferiority Comment
- one-sample two-sided Chi-square test
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.038
- p Value Comment
- Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)
- statistical Comment
- controlling familywise Type I error of 5% in a strong sense
- statistical Method
- rejective multiple test procedure
Complete source fields
- analyses
- group Description
- Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.
- group Ids
- OG003
- non Inferiority Comment
- one-sample two-sided Chi-square test
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.001
- p Value Comment
- Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)
- statistical Comment
- controlling familywise Type I error of 5% in a strong sense
- statistical Method
- rejective multiple test procedure
- group Description
- Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.
- group Ids
- OG002
- non Inferiority Comment
- one-sample two-sided Chi-square test
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.001
- p Value Comment
- Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)
- statistical Comment
- controlling familywise Type I error of 5% in a strong sense
- statistical Method
- Chi-squared
- group Description
- Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.
- group Ids
- OG001
- non Inferiority Comment
- one-sample two-sided Chi-square test
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.008
- p Value Comment
- Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)
- statistical Comment
- controlling familywise Type I error of 5% in a strong sense
- statistical Method
- Chi-squared
- group Description
- Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.
- group Ids
- OG007
- non Inferiority Comment
- one-sample two-sided Chi-square test
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.001
- p Value Comment
- Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)
- statistical Comment
- controlling familywise Type I error of 5% in a strong sense
- statistical Method
- rejective multiple test procedure
- group Description
- Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.
- group Ids
- OG006
- non Inferiority Comment
- one-sample two-sided Chi-square test
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.001
- p Value Comment
- Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)
- statistical Comment
- controlling familywise Type I error of 5% in a strong sense
- statistical Method
- rejective multiple test procedure
- group Description
- Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.
- group Ids
- OG005
- non Inferiority Comment
- one-sample two-sided Chi-square test
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.038
- p Value Comment
- Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)
- statistical Comment
- controlling familywise Type I error of 5% in a strong sense
- statistical Method
- rejective multiple test procedure
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.92
- upper Limit
- 65.11
- value
- 33.3
- group Id
- OG001
- lower Limit
- 42.19
- upper Limit
- 78.15
- value
- 61.3
- group Id
- OG002
- lower Limit
- 48.63
- upper Limit
- 83.32
- value
- 67.7
- group Id
- OG003
- lower Limit
- 51.34
- upper Limit
- 76.26
- value
- 64.5
- group Id
- OG004
- lower Limit
- 9.92
- upper Limit
- 65.11
- value
- 33.3
- group Id
- OG005
- lower Limit
- 39.22
- upper Limit
- 74.52
- value
- 57.6
- group Id
- OG006
- lower Limit
- 47.79
- upper Limit
- 80.87
- value
- 65.7
- group Id
- OG007
- lower Limit
- 49.18
- upper Limit
- 73.29
- value
- 61.8
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 31
- group Id
- OG003
- value
- 62
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 33
- group Id
- OG006
- value
- 35
- group Id
- OG007
- value
- 68
- units
- Participants
- description
- The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those with a decrease in PMS ≥ 2 points and ≥ 30% from Baseline. Clinical response per FMS is defined as a decrease in FMS ≥ 3 points and ≥ 30% from Baseline.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- (Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.
- id
- OG000
- title
- Main Study: M-PL
- description
- Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \[maximum dose of 40 mg\] eow). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.
- id
- OG001
- title
- Main Study: M-SD
- description
- Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \[maximum dose of 40 mg\] ew). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.
- id
- OG002
- title
- Main Study: M-HD
- description
- Combined M-SD + M-HD arms (see above).
- id
- OG003
- title
- Main Study: M-SD + M-HD
- description
- (Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.
- id
- OG004
- title
- Integrated Study (Main + Japan Sub-Study): M-PL
- description
- Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \[maximum dose of 40 mg\] eow). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.
- id
- OG005
- title
- Integrated Study (Main + Japan Sub-Study): M-SD
- description
- Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \[maximum dose of 40 mg\] ew). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.
- id
- OG006
- title
- Integrated Study (Main + Japan Sub-Study): M-HD
- description
- Combined M-SD + M-HD arms (see above).
- id
- OG007
- title
- Integrated Study (Main + Japan Sub-Study): M-SD + M-HD
- param Type
- NUMBER
- population Description
- Modified intent-to-treat (mITT): all Week 8 PMS responders who were re-randomized at Week 8 and received at least 1 dose of study drug during the Maintenance period; analyzed as randomized at the beginning of the Maintenance phase. NRI: missing data is imputed as not having met the endpoint.
- reporting Status
- POSTED
- time Frame
- Week 52
- title
- Ranked Secondary Endpoint 1: Percentage of Participants With Clinical Response Per FMS at Week 52 in Week 8 Responders Per PMS - Maintenance Period
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice