18 and older, any sex, with Spondylitis, Ankylosing or Arthritis, Psoriatic. 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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)Primary· Up to Week 32
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. Any AE that occurred at or after the initial administration of study drug through the day of last dose plus 8 weeks was considered to be TEAE.
Ankylosing Spondylitis (AS)
Group
Value
95% CI
Golimumab (Simponi)
10
Psoriatic Arthritis (PsA)
Group
Value
95% CI
Golimumab (Simponi)
18
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs)Primary· Up to Week 32
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolo
AS
Group
Value
95% CI
Golimumab (Simponi)
2
PsA
Group
Value
95% CI
Golimumab (Simponi)
2
Percentage of Ankylosing Spondylitis (AS) Participants With at Least 20 Percent (%) Improvement in the Assessment of SpondyloArthritis International Society (ASAS20) Criteria at Week 14Secondary· Week 14
ASAS 20 response criteria was defined as an improvement from baseline of greater than (\>)20% and \>1 unit in at least 3 of following 4 ASAS domains on scale of 0-10 units and no worsening from baseline of \>20% and \>1 unit in the remaining ASAS domain on a scale of 0-10 units. The 4 ASAS domains were as follows (0-10 units numerical rating scale \[NRS\]): Patient's global assessment (PGA) of disease:0=not active spondylitis, 10=very active spondylitis; total and night Spinal pain: 0=no pain, 10=most severe pain; bath ankylosing spondylitis functional index (BASFI, self-assessment of particip
Group
Value
95% CI
Golimumab (Simponi)
74.5
Percentage of Psoriatic Arthritis (PsA) Participants Meeting the American College of Rheumatology 20% Improvement Criteria (ACR20) at Week 14Secondary· Week 14
ACR20 was is defined as greater than or equal to (\>=) 20% improvement in swollen and tender joint count and \>=20% improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 centimeter \[cm\], 0 cm=no pain and 10 cm=worst possible pain), PGA of disease activity by using VAS (the scale ranges from 0 cm to 10 cm, \[0 cm=no pain to 10 cm=worst possible pain\]), physician's global assessment of disease activity using VAS (scale ranges from 0 cm to 10 cm; \[0 cm=very well and 10 cm=very poor\]), participant's assessment of physical function measu
Group
Value
95% CI
Golimumab (Simponi)
84.6
Percentage of AS Participants With ASAS20 Criteria at Week 24Secondary· Week 24
ASAS 20 response criteria was defined as an improvement from baseline of greater than (\>) 20% and \>1 unit in at least 3 of following 4 ASAS domains on scale of 0 to 10 units and no worsening from baseline of \>20% and \>1 unit in the remaining ASAS domain on a scale of 0 to 10 units. The 4 ASAS domains were as follows (0 to 10 units NRS): PGA of disease:0=not active spondylitis, 10=very active spondylitis; total and night Spinal pain: 0=no pain, 10=most severe pain; BASFI, self-assessment of participant's degree of mobility and functional ability represented as mean of 10 questions \[8 of wh
Group
Value
95% CI
Golimumab (Simponi)
66.0
Percentage of PsA Participants Meeting the ACR20 Criteria at Week 24Secondary· Week 24
ACR20 was is defined as \>=20% improvement in swollen and tender joint count and \>=20% improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 centimeter \[cm\], 0 cm=no pain and 10 cm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 cm to 10 cm, \[0 cm=no pain to 10 cm=worst possible pain\]), PGA of disease activity using VAS (scale ranges from 0 cm to 10 cm; \[0=very well and 10 cm=very poor\]), participant's assessment of physical function measured by HAQ-DI, defined as a 20-qu
Group
Value
95% CI
Golimumab (Simponi)
93.2
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to Week 32.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to assess the safety of subcutaneous (SC) golimumab in participants with active Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) over 24 weeks.
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 Johnson & Johnson Private Limited
Last refreshed: 4 February 2025
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/NCT03733925.