TriangleNCT02065557 · OUTCOME
Ranked Secondary Endpoint 4: Percentage of Participants With Corticosteroid-Free Clinical Remission 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. Among participants receiving systemic corticosteroids at Baseline, corticosteroid-free clinical remission per FMS at Week 52 is defined as having discontinued systemic corticosteroids prior to Week 52 and being in FMS clinical remission at Week 52 (defined as Mayo Score ≤ 2 and no individual subscore \> 1).
Analysis population: 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. Participants receiving systemic corticosteroids at baseline. 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 | 5 |
| Main Study: M-SD | 13 |
| Main Study: M-HD | 16 |
| Main Study: M-SD + M-HD | 29 |
| Integrated Study (Main + Japan Sub-Study): M-PL | 5 |
| Integrated Study (Main + Japan Sub-Study): M-SD | 15 |
| Integrated Study (Main + Japan Sub-Study): M-HD | 17 |
| Integrated Study (Main + Japan Sub-Study): M-SD + M-HD | 32 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study: M-PL | 40.0 | Not reported | 5.27 | 85.34 | Not reported |
| Main Study: M-SD | 30.8 | Not reported | 9.09 | 61.43 | Not reported |
| Main Study: M-HD | 31.3 | Not reported | 11.02 | 58.66 | Not reported |
| Main Study: M-SD + M-HD | 31.0 | Not reported | 15.28 | 50.83 | Not reported |
| Integrated Study (Main + Japan Sub-Study): M-PL | 40.0 | Not reported | 5.27 | 85.34 | Not reported |
| Integrated Study (Main + Japan Sub-Study): M-SD | 26.7 | Not reported | 7.79 | 55.10 | Not reported |
| Integrated Study (Main + Japan Sub-Study): M-HD | 35.3 | Not reported | 14.21 | 61.67 | Not reported |
| Integrated Study (Main + Japan Sub-Study): M-SD + M-HD | 31.3 | Not reported | 16.12 | 50.01 | 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
- 0.382
- 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 (24.08%)
- 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
- 1.000
- 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 (24.08%)
- 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
- OG001
- non Inferiority Comment
- one-sample two-sided Chi-square test
- non Inferiority Type
- SUPERIORITY
- p Value
- 1.000
- 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 (24.08%)
- 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
- OG007
- non Inferiority Comment
- one-sample two-sided Chi-square test
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.344
- 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 (24.08%)
- 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
- 0.559
- 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 (24.08%)
- 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
- 0.815
- 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 (24.08%)
- 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
- 0.382
- 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 (24.08%)
- 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
- 1.000
- 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 (24.08%)
- 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
- OG001
- non Inferiority Comment
- one-sample two-sided Chi-square test
- non Inferiority Type
- SUPERIORITY
- p Value
- 1.000
- 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 (24.08%)
- 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
- OG007
- non Inferiority Comment
- one-sample two-sided Chi-square test
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.344
- 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 (24.08%)
- 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
- 0.559
- 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 (24.08%)
- 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
- 0.815
- 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 (24.08%)
- 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
- 5.27
- upper Limit
- 85.34
- value
- 40.0
- group Id
- OG001
- lower Limit
- 9.09
- upper Limit
- 61.43
- value
- 30.8
- group Id
- OG002
- lower Limit
- 11.02
- upper Limit
- 58.66
- value
- 31.3
- group Id
- OG003
- lower Limit
- 15.28
- upper Limit
- 50.83
- value
- 31.0
- group Id
- OG004
- lower Limit
- 5.27
- upper Limit
- 85.34
- value
- 40.0
- group Id
- OG005
- lower Limit
- 7.79
- upper Limit
- 55.10
- value
- 26.7
- group Id
- OG006
- lower Limit
- 14.21
- upper Limit
- 61.67
- value
- 35.3
- group Id
- OG007
- lower Limit
- 16.12
- upper Limit
- 50.01
- value
- 31.3
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 16
- group Id
- OG003
- value
- 29
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 15
- group Id
- OG006
- value
- 17
- group Id
- OG007
- value
- 32
- 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. Among participants receiving systemic corticosteroids at Baseline, corticosteroid-free clinical remission per FMS at Week 52 is defined as having discontinued systemic corticosteroids prior to Week 52 and being in FMS clinical remission at Week 52 (defined as Mayo Score ≤ 2 and no individual subscore \> 1).
- 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
- 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. Participants receiving systemic corticosteroids at baseline. NRI: missing data is imputed as not having met the endpoint.
- reporting Status
- POSTED
- time Frame
- Week 52
- title
- Ranked Secondary Endpoint 4: Percentage of Participants With Corticosteroid-Free Clinical Remission 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