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NCT02181673 · OUTCOME

Percentage of Participants Who Achieved an ACR 50 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 ACR 50 response is defined as: greater than or equal to (\>=) 50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and \>=50% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 cm scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).

Analysis population: The full analysis set (FAS) included all participants who were randomized.

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
Placebo239
Golimumab241

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo6.3Not reportedNot reportedNot reportedNot reported
Golimumab43.6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6.3
      2. group Id
        OG001
        value
        43.6
denoms
  1. counts
    1. group Id
      OG000
      value
      239
    2. group Id
      OG001
      value
      241
    units
    Participants
description
The ACR 50 response is defined as: greater than or equal to (\>=) 50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and \>=50% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 cm scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).
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 full analysis set (FAS) included all participants who were randomized.
reporting Status
POSTED
time Frame
Week 14
title
Percentage of Participants Who Achieved an ACR 50 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