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NCT02181673 · OUTCOME

Change From Baseline in Total Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24

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
MEAN
Unit
units on a scale
Interval / dispersion
Standard Error
Time frame
Baseline and Week 24

What was measured

The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score and positive score changes indicate more radiographic damage and radiographic progression, respectively.

Analysis population: FAS for structural damage endpoints (FAS-SD) defined as participants in the FAS who were treated and had a non-missing baseline total modified vdH-S score for the analysis.

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
Placebo237
Golimumab237

Reported measurements

Source class 1
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo1.950.264Not reportedNot reportedNot reported
Golimumab-0.360.144Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.264
        value
        1.95
      2. group Id
        OG001
        spread
        0.144
        value
        -0.36
denoms
  1. counts
    1. group Id
      OG000
      value
      237
    2. group Id
      OG001
      value
      237
    units
    Participants
description
The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score and positive score changes indicate more radiographic damage and radiographic progression, respectively.
dispersion Type
Standard Error
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
MEAN
population Description
FAS for structural damage endpoints (FAS-SD) defined as participants in the FAS who were treated and had a non-missing baseline total modified vdH-S score for the analysis.
reporting Status
POSTED
time Frame
Baseline and Week 24
title
Change From Baseline in Total Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24
type
SECONDARY
unit Of Measure
units on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice