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NCT02186873 · OUTCOME

Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16

A Study of Golimumab in Participants With Active Ankylosing Spondylitis · Source last updated 2025-10-30

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 16

What was measured

ASAS 20 defined as 20 percent (%) improvement compared to baseline in the ASAS Working Group criteria: that is, greater than or equal to (\>=)20% improvement from baseline in at least 3 of the 4 domains: patient's global assessment of disease activity (0=very well,10 =very poor), total back pain (0=no pain,10=most severe pain), function (self-assessment using BASFI \[0=no functional impairment to 10= maximal impairment\]), inflammation (0=none,10=very severe) with an absolute improvement of at least 1 (0-10 centimeter (cm) visual analogue scale \[VAS\]), and an absence of deterioration (defined as \>=20% worsening and absolute worsening of at least 1 on a 0-10 cm scale) in the potential remaining domain.

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

Groups in this outcome

Group 1: Placebo Then Golimumab

Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.

Group 2: Golimumab

Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment 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
Group 1: Placebo Then Golimumab103
Group 2: Golimumab105

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group 1: Placebo Then Golimumab26.2Not reportedNot reportedNot reportedNot reported
Group 2: Golimumab73.3Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    35.18
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    58.99
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.001
    param Type
    Difference in Percentage
    param Value
    47.1
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    35.18
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    58.99
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.001
    param Type
    Difference in Percentage
    param Value
    47.1
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        26.2
      2. group Id
        OG001
        value
        73.3
denoms
  1. counts
    1. group Id
      OG000
      value
      103
    2. group Id
      OG001
      value
      105
    units
    Participants
description
ASAS 20 defined as 20 percent (%) improvement compared to baseline in the ASAS Working Group criteria: that is, greater than or equal to (\>=)20% improvement from baseline in at least 3 of the 4 domains: patient's global assessment of disease activity (0=very well,10 =very poor), total back pain (0=no pain,10=most severe pain), function (self-assessment using BASFI \[0=no functional impairment to 10= maximal impairment\]), inflammation (0=none,10=very severe) with an absolute improvement of at least 1 (0-10 centimeter (cm) visual analogue scale \[VAS\]), and an absence of deterioration (defined as \>=20% worsening and absolute worsening of at least 1 on a 0-10 cm scale) in the potential remaining domain.
groups
  1. description
    Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
    id
    OG000
    title
    Group 1: Placebo Then Golimumab
  2. description
    Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
    id
    OG001
    title
    Group 2: Golimumab
param Type
NUMBER
population Description
The full analysis set (FAS) included all participants who were randomized in the study.
reporting Status
POSTED
time Frame
Week 16
title
Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16
type
PRIMARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice