TriangleNCT04205643 · OUTCOME
Percentage of Patients Achieving Clinical Remission 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
Clinical remission defined by modified Mayo score which ranges from 0 to 9, including Stool frequency subscore, Rectal bleeding subscore and Endoscopic subscore but excluding Physician's global assessment subscore from the Total Mayo score. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
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 | 294 |
| Placebo | 144 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CT-P13 SC 120 mg | 127 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 30 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 11.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 29.3
- estimate Comment
- The 95% stratified Newcombe CI with CMH weights
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- If the primary endpoint is significant, a fixed sequence procedure was employed to control the overall type I error rate of the key secondary endpoints.
- param Type
- Difference estimated using CMH weights
- param Value
- 21.1
- 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
- ci Lower Limit
- 11.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 29.3
- estimate Comment
- The 95% stratified Newcombe CI with CMH weights
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- If the primary endpoint is significant, a fixed sequence procedure was employed to control the overall type I error rate of the key secondary endpoints.
- param Type
- Difference estimated using CMH weights
- param Value
- 21.1
- 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
- 127
- group Id
- OG001
- value
- 30
- denoms
- counts
- group Id
- OG000
- value
- 294
- group Id
- OG001
- value
- 144
- units
- Participants
- description
- Clinical remission defined by modified Mayo score which ranges from 0 to 9, including Stool frequency subscore, Rectal bleeding subscore and Endoscopic subscore but excluding Physician's global assessment subscore from the Total Mayo score. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
- 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 Clinical Remission at Week 54
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice