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NCT02181673 · OUTCOME

Change From Baseline in Dactylitis Scores at Week 14 in Participants With Dactylitis at Baseline

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 Deviation
Time frame
Baseline and Week 14

What was measured

Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness.

Analysis population: Population included all Randomized participants With Dactylitis (Score \>0) at Baseline. Here "N" (number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure.

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
Placebo115
Golimumab130

Reported measurements

Source class 1
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-2.87.03Not reportedNot reportedNot reported
Golimumab-7.88.57Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.03
        value
        -2.8
      2. group Id
        OG001
        spread
        8.57
        value
        -7.8
denoms
  1. counts
    1. group Id
      OG000
      value
      115
    2. group Id
      OG001
      value
      130
    units
    Participants
description
Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness.
dispersion Type
Standard Deviation
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
Population included all Randomized participants With Dactylitis (Score \>0) at Baseline. Here "N" (number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Baseline and Week 14
title
Change From Baseline in Dactylitis Scores at Week 14 in Participants With Dactylitis at Baseline
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice