TriangleNCT02346240 · OUTCOME
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48 for Those Achieving PASI75 at Week 16
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
- Not reported
- Time frame
- Week 48
What was measured
The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Analysis population: The Week 16 Randomized Set (WK16RS) consisted of all participants who achieved a PASI75 response at Week 16 and were re-randomized into the double-blind, placebo-controlled Maintenance Treatment Period. Missing data were handled using non-response imputation (NRI) methods.
Groups in this outcome
Placebo/Placebo Q2W (WK16RS)
This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI75 response at Week 16 and continued to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
Etanercept/Placebo Q2W (WK16RS)
This arm consisted of participants initially randomized in the Etanercept arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
Etanercept/CZP 200 mg Q2W (WK16RS)
This arm consisted of participants initially randomized in the Etanercept arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
CZP 200 mg Q2W/Placebo Q2W (WK16RS)
This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
CZP 200 mg Q2W/CZP 200 mg Q2W (WK16RS)
This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
CZP 200 mg Q2W/CZP 400 mg Q4W (WK16RS)
This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q4W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
CZP 400 mg Q2W/Placebo Q2W (WK16RS)
This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
CZP 400 mg Q2W/CZP 200 mg Q2W (WK16RS)
This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
CZP 400 mg Q2W/CZP 400 mg Q2W (WK16RS)
This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
| Group | Source count |
|---|---|
| Placebo/Placebo Q2W (WK16RS) | 2 |
| Etanercept/Placebo Q2W (WK16RS) | 24 |
| Etanercept/CZP 200 mg Q2W (WK16RS) | 50 |
| CZP 200 mg Q2W/Placebo Q2W (WK16RS) | 22 |
| CZP 200 mg Q2W/CZP 200 mg Q2W (WK16RS) | 44 |
| CZP 200 mg Q2W/CZP 400 mg Q4W (WK16RS) | 44 |
| CZP 400 mg Q2W/Placebo Q2W (WK16RS) | 25 |
| CZP 400 mg Q2W/CZP 200 mg Q2W (WK16RS) | 50 |
| CZP 400 mg Q2W/CZP 400 mg Q2W (WK16RS) | 49 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo/Placebo Q2W (WK16RS) | 100 | Not reported | Not reported | Not reported | Not reported |
| Etanercept/Placebo Q2W (WK16RS) | 8.3 | Not reported | Not reported | Not reported | Not reported |
| Etanercept/CZP 200 mg Q2W (WK16RS) | 82.0 | Not reported | Not reported | Not reported | Not reported |
| CZP 200 mg Q2W/Placebo Q2W (WK16RS) | 45.5 | Not reported | Not reported | Not reported | Not reported |
| CZP 200 mg Q2W/CZP 200 mg Q2W (WK16RS) | 79.5 | Not reported | Not reported | Not reported | Not reported |
| CZP 200 mg Q2W/CZP 400 mg Q4W (WK16RS) | 88.6 | Not reported | Not reported | Not reported | Not reported |
| CZP 400 mg Q2W/Placebo Q2W (WK16RS) | 36.0 | Not reported | Not reported | Not reported | Not reported |
| CZP 400 mg Q2W/CZP 200 mg Q2W (WK16RS) | 80.0 | Not reported | Not reported | Not reported | Not reported |
| CZP 400 mg Q2W/CZP 400 mg Q2W (WK16RS) | 98.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 100
- group Id
- OG001
- value
- 8.3
- group Id
- OG002
- value
- 82.0
- group Id
- OG003
- value
- 45.5
- group Id
- OG004
- value
- 79.5
- group Id
- OG005
- value
- 88.6
- group Id
- OG006
- value
- 36.0
- group Id
- OG007
- value
- 80.0
- group Id
- OG008
- value
- 98.0
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 50
- group Id
- OG003
- value
- 22
- group Id
- OG004
- value
- 44
- group Id
- OG005
- value
- 44
- group Id
- OG006
- value
- 25
- group Id
- OG007
- value
- 50
- group Id
- OG008
- value
- 49
- units
- Participants
- description
- The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
- groups
- description
- This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI75 response at Week 16 and continued to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
- id
- OG000
- title
- Placebo/Placebo Q2W (WK16RS)
- description
- This arm consisted of participants initially randomized in the Etanercept arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
- id
- OG001
- title
- Etanercept/Placebo Q2W (WK16RS)
- description
- This arm consisted of participants initially randomized in the Etanercept arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
- id
- OG002
- title
- Etanercept/CZP 200 mg Q2W (WK16RS)
- description
- This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
- id
- OG003
- title
- CZP 200 mg Q2W/Placebo Q2W (WK16RS)
- description
- This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
- id
- OG004
- title
- CZP 200 mg Q2W/CZP 200 mg Q2W (WK16RS)
- description
- This arm consisted of participants initially randomized in the CZP 200 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q4W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
- id
- OG005
- title
- CZP 200 mg Q2W/CZP 400 mg Q4W (WK16RS)
- description
- This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded Placebo in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
- id
- OG006
- title
- CZP 400 mg Q2W/Placebo Q2W (WK16RS)
- description
- This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 200 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
- id
- OG007
- title
- CZP 400 mg Q2W/CZP 200 mg Q2W (WK16RS)
- description
- This arm consisted of participants initially randomized in the CZP 400 mg arm, who achieved a PASI75 response at Week 16 and were re-randomized to receive blinded CZP 400 mg Q2W in the Maintenance Period (Week 16 to Week 48). Participants formed the Week 16 Randomized Set (WK16RS).
- id
- OG008
- title
- CZP 400 mg Q2W/CZP 400 mg Q2W (WK16RS)
- param Type
- NUMBER
- population Description
- The Week 16 Randomized Set (WK16RS) consisted of all participants who achieved a PASI75 response at Week 16 and were re-randomized into the double-blind, placebo-controlled Maintenance Treatment Period. Missing data were handled using non-response imputation (NRI) methods.
- reporting Status
- POSTED
- time Frame
- Week 48
- title
- Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48 for Those Achieving PASI75 at Week 16
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice