Adults 18 to 45, any sex, with Spondyloarthritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Without a Disease Activity Flare During Period 2Primary· Up to 12 months
Disease flare is defined as an Ankylosing Spondylitis Disease Activity Score (ASDAS) at two consecutive visits that both show either absolute score ≥2.1 or a post-withdrawal increase of ≥1.1 relative to baseline prior to the first dose of double-blind treatment in Period 2. The ASDAS is a composite index assessing disease activity in axial spondyloarthropathies that consists of 4 self-assessed parameters and 1 laboratory parameter. The self-assessed parameters of back pain, duration of morning stiffness, Patient Global Disease Assessment (PGDn), and peripheral pain/swelling are individually sc
Group
Value
95% CI
Golimumab QM (Full Treatment Regimen)
84.1
Golimumab Q2M (Reduced Treatment Regimen)
68.3
Placebo (Treatment Withdrawal Regimen)
33.9
Percentage of Participants With a Flare Who Show a Clinical Response Within 3 Months of Open-Label Golimumab RetreatmentSecondary· Up to 3 months following start of retreatment
Clinical response is defined as Bath Ankylosing Spondylitis Disease Assessment Index (BASDAI) score improvement of ≥2.0 or ≥50% improvement within 3 months of the start of retreatment, relative to the mean of the two consecutive BASDAI scores that defined the flare. Sustained clinical response refers to participants who attained clinical response and maintained BASDAI criteria throughout the 3-month retreatment period. Response data was collected throughout Period 2 (12 months) and censored to include only the first 3 months after retreatment for a disease flare. The BASDAI is a summary of 6 p
Within 1 month of retreatment
Group
Value
95% CI
Open-Label Retreatment
90.6
79.3 – 96.9
Within 2 months of retreatment
Group
Value
95% CI
Open-Label Retreatment
96.2
87.0 – 99.5
Within 3 months of retreatment
Group
Value
95% CI
Open-Label Retreatment
96.2
87.0 – 99.5
Sustained clinical response
Group
Value
95% CI
Open-Label Retreatment
71.7
57.7 – 83.2
Time to First Disease FlareSecondary· Month 3, Month 6, Month 9, and Month 12
The Kaplan-Meier analysis of time to first "flare" in Period 2 is represented by the percentage of participants who experienced a disease flare relative to baseline prior to the first dose of double-blind treatment in Period 2. Disease flare is defined as ASDAS at two consecutive visits that both show either absolute score ≥2.1 or a post-withdrawal increase of ≥1.1.
Month 3
Group
Value
95% CI
Golimumab QM (Full Treatment Regimen)
14.3
Golimumab Q2M (Reduced Treatment Regimen)
7.9
Placebo (Treatment Withdrawal Regimen)
41.9
Month 6
Group
Value
95% CI
Golimumab QM (Full Treatment Regimen)
14.3
Golimumab Q2M (Reduced Treatment Regimen)
17.5
Placebo (Treatment Withdrawal Regimen)
58.1
Month 9
Group
Value
95% CI
Golimumab QM (Full Treatment Regimen)
14.3
Golimumab Q2M (Reduced Treatment Regimen)
20.6
Placebo (Treatment Withdrawal Regimen)
61.3
Month 12
Group
Value
95% CI
Golimumab QM (Full Treatment Regimen)
15.9
Golimumab Q2M (Reduced Treatment Regimen)
23.8
Placebo (Treatment Withdrawal Regimen)
61.3
Percentage of Participants Achieving ASAS20 (Assessment in SpondyloArthritis International Society) Response (Double-blind Treatment)Secondary· Up to 12 months
ASAS20 is a 20% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of ≥20% from Baseline and an absolute improvement from Baseline of ≥1.0 in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a ≥20% worsening and an absolute worsening of ≥1.0) in the potential remaining domain. Baseline for ASAS20 analysis is defined as the last ASAS score prior to the first dose of double-blind treatment in Period 2. The ASAS consists of 4 domains: the Patient Global Disease Assess
Group
Value
95% CI
Golimumab QM (Full Treatment Regimen)
9.5
Golimumab Q2M (Reduced Treatment Regimen)
3.2
Placebo (Treatment Withdrawal Regimen)
0.0
Percentage of Participants Achieving ASAS20 Response (Open-label Retreatment)Secondary· Up to 12 months
ASAS20 is a 20% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of ≥20% from Baseline and an absolute improvement from Baseline of ≥1.0 in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a ≥20% worsening and an absolute worsening of ≥1.0) in the potential remaining domain. Baseline for ASAS20 analysis is defined as the last ASAS score prior to the first dose of open-label retreatment in Period 2. The ASAS consists of 4 domains: the Patient Global Disease Assess
Group
Value
95% CI
Open-Label Retreatment
94.3
84.3 – 98.8
Percentage of Participants Achieving ASAS40 Response (Double-blind Treatment)Secondary· Up to 12 months
ASAS40 is a 40% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of ≥40% from Baseline and an absolute improvement from Baseline of ≥2.0 in at least 3 of 4 domains, and 2) No deterioration from Baseline in the potential remaining domain. Baseline for ASAS40 analysis is defined as the last ASAS score prior to the first dose of double-blind treatment in Period 2. The ASAS consists of 4 domains: the Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Func
Group
Value
95% CI
Golimumab QM (Full Treatment Regimen)
0
Golimumab Q2M (Reduced Treatment Regimen)
0
Placebo (Treatment Withdrawal Regimen)
0
Percentage of Participants Achieving ASAS40 Response (Open-label Retreatment)Secondary· Up to 12 months
ASAS40 is a 40% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of ≥40% from Baseline and an absolute improvement from Baseline of ≥2.0 in at least 3 of 4 domains, and 2) No deterioration from Baseline in the potential remaining domain. Baseline for ASAS40 analysis is defined as the last ASAS score prior to the first dose of open-label retreatment in Period 2. The ASAS consists of 4 domains: the Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Func
Group
Value
95% CI
Open-Label Retreatment
90.6
79.3 – 96.9
Percentage of Participants Achieving ASAS Partial Remission (Double-blind Treatment)Secondary· Up to 12 months
ASAS partial remission is defined as a score of ≤2 in all 4 ASAS domains. Baseline for this analysis is defined as the ASAS score prior to the first dose of double-blind treatment in Period 2. The ASAS consists of 4 domains: Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]), and morning stiffness (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]). Each domain is measured on a 10-point numeric scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact, with a h
Group
Value
95% CI
Golimumab QM (Full Treatment Regimen)
85.7
Golimumab Q2M (Reduced Treatment Regimen)
85.7
Placebo (Treatment Withdrawal Regimen)
71.0
Percentage of Participants Achieving ASAS Partial Remission (Open-label Retreatment)Secondary· Up to 12 months
ASAS partial remission is defined as a score of ≤2 in all 4 ASAS domains. Baseline for this analysis is defined as the ASAS score prior to the first dose of open-label retreatment in Period 2. The ASAS consists of 4 domains: Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]), and morning stiffness (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]). Each domain is measured on a 10-point numeric scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact, with a h
Group
Value
95% CI
Open-Label Retreatment
92.5
81.8 – 97.9
Percentage of Participants Achieving BASDAI50 Response (Double-blind Treatment)Secondary· Up to 12 months
BASDAI50 is defined as ≥50% improvement from baseline in the Bath Ankylosing Spondylitis Disease Assessment Index (BASDAI) score. Baseline for BASDAI50 analysis is defined as the last BASDAI score prior to the first dose of double-blind treatment in Period 2. The BASDAI is a summary of 6 participant-assessed measures rated on scales of 0 (none) to 10 (very severe): fatigue, spinal pain, joint pain/swelling, tenderness, morning stiffness, and duration of morning stiffness \[0 (zero) to 10 (2 or more hours)\]. The BASDAI score is the mean of responses to the 6 questions with a minimum of 0 and a
Group
Value
95% CI
Golimumab QM (Full Treatment Regimen)
49.2
Golimumab Q2M (Reduced Treatment Regimen)
30.2
Placebo (Treatment Withdrawal Regimen)
24.2
Percentage of Participants Achieving BASDAI50 Response (Open-label Retreatment)Secondary· Up to 12 months
BASDAI50 is defined as ≥50% improvement from baseline in the Bath Ankylosing Spondylitis Disease Assessment Index (BASDAI) score. Baseline for BASDAI50 analysis is defined as the last BASDAI score prior to the first dose of open-label retreatment in Period 2. The BASDAI is a summary of 6 participant-assessed measures rated on scales of 0 (none) to 10 (very severe): fatigue, spinal pain, joint pain/swelling, tenderness, morning stiffness, and duration of morning stiffness \[0 (zero) to 10 (2 or more hours)\]. The BASDAI score is the mean of responses to the 6 questions with a minimum of 0 and a
Group
Value
95% CI
Open-Label Retreatment
98.1
89.9 – 100.0
Percentage of Participants Achieving Inactive Disease Status (Double-Blind Treatment)Secondary· Up to 12 months
Inactive disease status is defined as an ASDAS score \<1.3. The ASDAS is a composite index assessing disease activity in axial spondyloarthropathies that consists of 4 self-assessed parameters and 1 laboratory parameter. The self-assessed parameters of back pain, duration of morning stiffness, Patient Global Disease Assessment (PGDn), and peripheral pain/swelling are individually scored on a numeric scale of 0 to 10, with 0 being low activity/impact and 10 being high activity/impact. The self-assessed criteria and the laboratory value of CRP are combined to provide the total ASDAS score, which
Group
Value
95% CI
Golimumab QM (Full Treatment Regimen)
85.7
Golimumab Q2M (Reduced Treatment Regimen)
84.1
Placebo (Treatment Withdrawal Regimen)
61.3
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to evaluate the effect of treatment withdrawal compared to continued treatment with golimumab (GLM) administered by subcutaneous (SC) injection on the incidence of a "flare" in non-radiographic axial spondyloarthritis over up to 12 months. The primary hypothesis is that continued treatment with golimumab is superior to treatment withdrawal, based on the percentage of subjects without a "flare" during up to 12 months of blinded therapy.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 28 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03253796.