NCT02181673 · OUTCOME
Percentage of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 14
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 14
What was measured
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.
Analysis population: The analysis set included randomized participants with greater than or equal to (\>=) 3 percent (%) body surface area (BSA) Psoriasis Skin Involvement at Baseline.
Groups in this outcome
Placebo
Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
Golimumab
Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
| Group | Source count |
|---|---|
| Placebo | 198 |
| Golimumab | 196 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 13.6 | Not reported | Not reported | Not reported | Not reported |
| Golimumab | 59.2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 13.6
- group Id
- OG001
- value
- 59.2
- denoms
- counts
- group Id
- OG000
- value
- 198
- group Id
- OG001
- value
- 196
- units
- Participants
- description
- The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.
- groups
- description
- Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
- id
- OG000
- title
- Placebo
- description
- Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
- id
- OG001
- title
- Golimumab
- param Type
- NUMBER
- population Description
- The analysis set included randomized participants with greater than or equal to (\>=) 3 percent (%) body surface area (BSA) Psoriasis Skin Involvement at Baseline.
- reporting Status
- POSTED
- time Frame
- Week 14
- title
- Percentage of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 14
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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