Phase 3 N=208 Randomized Double-blind Treatment

A Study of Golimumab in Participants With Active Ankylosing Spondylitis

Ankylosing Spondylitis

Bottom Line

View on ClinicalTrials.gov: NCT02186873 ↗

Enrolled (actual)

208

Serious AEs

2.3%

Results posted

Nov 2017

Primary outcome: Primary: Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16 — 26.2; 73.3 Percentage of Participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Placebo (Drug); Golimumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Janssen Research & Development, LLC
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16	26.2; 73.3	<0.001 sig
SECONDARY Percentage of Participants Who Achieved at Least 40 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 40) at Week 16	8.7; 47.6	—
SECONDARY Percentage of Participants Who Achieved at Least 50 Percent Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 16	14.6; 41.0	—
SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 16	-0.471; -2.386	—
SECONDARY Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16	2.86; 8.52	—
SECONDARY Change From Baseline in Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 16	0.78; 6.47	—
SECONDARY Percentage of Participants With Low Level of Disease Activity (ASAS Partial Remission) at Week 16	3.9; 16.2	—
SECONDARY Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16	-1.8; -5.4	—
SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16	-0.15; -0.73	—

Summary

The purpose of this study is to evaluate the efficacy of intravenously (administration of a fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants with active ankylosing spondylitis (chronic inflammatory disease of unknown etiology that involves the sacroiliac joints, and often the axial skeleton, entheses, and peripheral joints).

Eligibility Criteria

Inclusion Criteria

Participants with diagnosis of definite ankylosing spondylitis for at least 3 months based on modified New York radiographic and clinical criteria
Participants with symptoms of active disease at screening and at baseline
Participant has either an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAID) over a 4 week period in total with maximal recommended doses of NSAIDs, or is unable to receive a full 4 weeks of maximal NSAID therapy because of intolerance, toxicity, or contraindications to NSAIDs
Participants with C- reactive protein (CRP) level of greater than or equal to (>=) 0.3 milligram per deciliter (mg/dL) at screening
Additional protocol-defined inclusion criteria apply

Exclusion Criteria

Participant with other inflammatory diseases that might confound the evaluations of benefit from the golimumab therapy
Pregnant or lactating females
Participants with chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis
Participants who had a serious infection (including but not limited to, hepatitis, pneumonia, sepsis, or pyelonephritis), or have been hospitalized for an infection, or have been treated with intravenous (IV) antibiotics for an infection within 2 months prior to first administration of study agent
Additional protocol-defined exclusion criteria apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02186873). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.