Phase 3
Completed N=208
A Study of Golimumab in Participants With Active Ankylosing Spondylitis
Source: ClinicalTrials.gov NCT02186873 ↗Enrolled (actual)
208
Serious AEs
2.3%
Results posted
Nov 2017
Primary outcomePrimary: 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
◆ Published Evidence
Established
69citations · ~9 / year
Safety and Efficacy of Golimumab Administered Intravenously in Adults with Ankylosing Spondylitis: Results through Week 28 of the GO-ALIVE Study.
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).
Linked Publications (5)
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Safety and Efficacy of Golimumab Administered Intravenously in Adults with Ankylosing Spondylitis: Results through Week 28 of the GO-ALIVE Study.
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The effect of intravenous golimumab on health-related quality of life and work productivity in adult patients with active ankylosing spondylitis: results of the phase 3 GO-ALIVE trial.
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Pooled safety results across phase 3 randomized trials of intravenous golimumab in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
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Efficacy and Safety of Intravenous Golimumab in Ankylosing Spondylitis Patients With Early and Late Disease Through One Year of the GO-ALIVE Study.
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Effect of Intravenous Golimumab on Fatigue and the Relationship with Clinical Response in Adults with Active Ankylosing Spondylitis in the Phase 3 GO-ALIVE Study.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT02186873) and the linked publication. 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. Informational only — not medical advice.