TriangleNCT03945019 · OUTCOME
Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Week 54
What was measured
Endoscopic response was defined as a 50% decrease in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score from the baseline value. The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder. Statistical testing for this outcome based on the colonoscopy (SES-CD) was conducted using the colonoscopy reading results of central level.
Analysis population: All-randomized population
Groups in this outcome
CT-P13 SC 120 mg
CT-P13 SC 120 mg
Placebo
Placebo
| Group | Source count |
|---|---|
| CT-P13 SC 120 mg | 231 |
| Placebo | 112 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CT-P13 SC 120 mg | 118 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 20 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- statistical Comment
- Stratified by Previous biologic agent and/or JAK inhibitors exposure, Use of oral corticosteroids treatment at Week 0, Clinical remission at Week 10.
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- statistical Comment
- Stratified by Previous biologic agent and/or JAK inhibitors exposure, Use of oral corticosteroids treatment at Week 0, Clinical remission at Week 10.
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- value
- 118
- group Id
- OG001
- value
- 20
- denoms
- counts
- group Id
- OG000
- value
- 231
- group Id
- OG001
- value
- 112
- units
- Participants
- description
- Endoscopic response was defined as a 50% decrease in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score from the baseline value. The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder. Statistical testing for this outcome based on the colonoscopy (SES-CD) was conducted using the colonoscopy reading results of central level.
- groups
- description
- CT-P13 SC 120 mg
- id
- OG000
- title
- CT-P13 SC 120 mg
- description
- Placebo
- id
- OG001
- title
- Placebo
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All-randomized population
- reporting Status
- POSTED
- time Frame
- Week 54
- title
- Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice