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NCT02181673 · OUTCOME

Percentage of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 14

A Study of Golimumab in Participants With Active Psoriatic Arthritis · Source last updated 2017-12-21

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Placebo198
Golimumab196

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo13.6Not reportedNot reportedNot reportedNot reported
Golimumab59.2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13.6
      2. group Id
        OG001
        value
        59.2
denoms
  1. counts
    1. group Id
      OG000
      value
      198
    2. 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
  1. description
    Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
    id
    OG000
    title
    Placebo
  2. 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