NCT02186873 · OUTCOME

Change From Baseline in Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) Score 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: MEAN
Unit: Units on a Scale
Interval / dispersion: Standard Deviation
Time frame: Baseline and Week 16

What was measured

The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score(vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10.

Analysis population: FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

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

Group	Source count
Group 1: Placebo Then Golimumab	98
Group 2: Golimumab	104

Reported measurements

Source class 1

Values in Units on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Group 1: Placebo Then Golimumab	0.78	10.004	Not reported	Not reported	Not reported
Group 2: Golimumab	6.47	9.122	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
10.004
value
0.78
group Id
OG001
spread
9.122
value
6.47

denoms

counts
group Id
OG000
value
98
group Id
OG001
value
104
units
Participants

description

dispersion Type

Standard Deviation

groups

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
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

MEAN

population Description

FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

reporting Status

POSTED

time Frame

Baseline and Week 16

title

Change From Baseline in Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 16

type

SECONDARY

unit Of Measure

Units on a Scale

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

Preserved source evidence · Not medical advice