TriangleNCT02065557 · OUTCOME
Co-Primary Endpoint 1: Percentage of Participants Who Achieved Clinical Remission as Measured by Partial Mayo Score (PMS) at Week 8 - Induction 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 8
What was measured
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. 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 sub scores (stool frequency, rectal bleeding and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in PMS indicates improvement. Clinical remission was defined as a PMS ≤ 2 and no individual subscore \> 1.
Analysis population: Intent-to-Treat (ITT): all participants who received at least 1 dose of study drug during the Induction period; analyzed as enrolled/randomized. Non-responder imputation (NRI): missing data is imputed as not having met the endpoint.
Groups in this outcome
Main Study: I-SD
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
Main Study: I-HD
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
Main Study: I-SD + I-HD
Combined I-SD + I-HD arms (see above).
Main Study: I-HD-OL
(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
Integrated Study (Main + Japan Sub-Study): I-SD
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
Integrated Study (Main + Japan Sub-Study): I-HD
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
Integrated Study (Main + Japan Sub-Study): I-SD + I-HD
Combined I-SD + I-HD arms (see above).
Integrated Study (Main + Japan Sub-Study): I-HD-OL
(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
| Group | Source count |
|---|---|
| Main Study: I-SD | 30 |
| Main Study: I-HD | 47 |
| Main Study: I-SD + I-HD | 77 |
| Main Study: I-HD-OL | 16 |
| Integrated Study (Main + Japan Sub-Study): I-SD | 32 |
| Integrated Study (Main + Japan Sub-Study): I-HD | 51 |
| Integrated Study (Main + Japan Sub-Study): I-SD + I-HD | 83 |
| Integrated Study (Main + Japan Sub-Study): I-HD-OL | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study: I-SD | 43.3 | Not reported | 25.46 | 62.57 | Not reported |
| Main Study: I-HD | 59.6 | Not reported | 44.27 | 73.63 | Not reported |
| Main Study: I-SD + I-HD | 53.2 | Not reported | 41.52 | 64.71 | Not reported |
| Main Study: I-HD-OL | 68.8 | Not reported | 41.34 | 88.98 | Not reported |
| Integrated Study (Main + Japan Sub-Study): I-SD | 40.6 | Not reported | 23.70 | 59.36 | Not reported |
| Integrated Study (Main + Japan Sub-Study): I-HD | 58.8 | Not reported | 44.17 | 72.42 | Not reported |
| Integrated Study (Main + Japan Sub-Study): I-SD + I-HD | 51.8 | Not reported | 40.56 | 62.92 | Not reported |
| Integrated Study (Main + Japan Sub-Study): I-HD-OL | 66.7 | Not reported | 40.99 | 86.66 | Not reported |
Source statistical analyses
- group Description
- Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.
- 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 I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)
- 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 Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.
- group Ids
- OG001
- 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 I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)
- 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 Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.
- group Ids
- OG000
- 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 I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)
- 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 Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.
- 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 I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)
- 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 Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.
- group Ids
- OG005
- 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 I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)
- 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 Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.
- group Ids
- OG004
- 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 I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)
- 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 Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.
- 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 I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)
- 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 Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.
- group Ids
- OG001
- 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 I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)
- 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 Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.
- group Ids
- OG000
- 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 I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)
- 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 Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.
- 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 I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)
- 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 Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.
- group Ids
- OG005
- 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 I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)
- 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 Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.
- group Ids
- OG004
- 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 I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)
- 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
- 25.46
- upper Limit
- 62.57
- value
- 43.3
- group Id
- OG001
- lower Limit
- 44.27
- upper Limit
- 73.63
- value
- 59.6
- group Id
- OG002
- lower Limit
- 41.52
- upper Limit
- 64.71
- value
- 53.2
- group Id
- OG003
- lower Limit
- 41.34
- upper Limit
- 88.98
- value
- 68.8
- group Id
- OG004
- lower Limit
- 23.70
- upper Limit
- 59.36
- value
- 40.6
- group Id
- OG005
- lower Limit
- 44.17
- upper Limit
- 72.42
- value
- 58.8
- group Id
- OG006
- lower Limit
- 40.56
- upper Limit
- 62.92
- value
- 51.8
- group Id
- OG007
- lower Limit
- 40.99
- upper Limit
- 86.66
- value
- 66.7
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 47
- group Id
- OG002
- value
- 77
- group Id
- OG003
- value
- 16
- group Id
- OG004
- value
- 32
- group Id
- OG005
- value
- 51
- group Id
- OG006
- value
- 83
- group Id
- OG007
- value
- 18
- units
- Participants
- description
- The Mayo score is a tool designed to measure disease activity for ulcerative colitis. 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 sub scores (stool frequency, rectal bleeding and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in PMS indicates improvement. Clinical remission was defined as a PMS ≤ 2 and no individual subscore \> 1.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
- id
- OG000
- title
- Main Study: I-SD
- description
- Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
- id
- OG001
- title
- Main Study: I-HD
- description
- Combined I-SD + I-HD arms (see above).
- id
- OG002
- title
- Main Study: I-SD + I-HD
- description
- (After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
- id
- OG003
- title
- Main Study: I-HD-OL
- description
- Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
- id
- OG004
- title
- Integrated Study (Main + Japan Sub-Study): I-SD
- description
- Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
- id
- OG005
- title
- Integrated Study (Main + Japan Sub-Study): I-HD
- description
- Combined I-SD + I-HD arms (see above).
- id
- OG006
- title
- Integrated Study (Main + Japan Sub-Study): I-SD + I-HD
- description
- (After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
- id
- OG007
- title
- Integrated Study (Main + Japan Sub-Study): I-HD-OL
- param Type
- NUMBER
- population Description
- Intent-to-Treat (ITT): all participants who received at least 1 dose of study drug during the Induction period; analyzed as enrolled/randomized. Non-responder imputation (NRI): missing data is imputed as not having met the endpoint.
- reporting Status
- POSTED
- time Frame
- Week 8
- title
- Co-Primary Endpoint 1: Percentage of Participants Who Achieved Clinical Remission as Measured by Partial Mayo Score (PMS) at Week 8 - Induction Period
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice