Summary
Golimumab has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Ankylosing Spondylitis / Axial Spondyloarthropathy would be drug repurposing rather than first-in-human development. This does not mean it is approved for Ankylosing Spondylitis / Axial Spondyloarthropathy. ClinicalTrials.gov lists 8 registered trials linking Golimumab to Ankylosing Spondylitis / Axial Spondyloarthropathy: 1 is currently recruiting; 1 is active or not yet recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01668004). The largest enrolment is 10000 participants (NCT01965132). Registration activity spans 2009 to 2025. The literature layer holds 17 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 2 systematic reviews, 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2016 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Ankylosing Spondylitis ranks 151 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Progressive structural damage (sacroiliac fusion, syndesmophytes) in majority without treatment; spontaneous radiographic remission essentially zero; ~10% achieve clinical remission without anti-inflammatory therapy.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 74.5 (trials 24.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 1 active / not yet recruiting, 4 completed, 2 other |
| Linked publications | 17 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 2 systematic reviews, 2 randomised controlled trial publications) |
| Agent type | Biologic |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT01718951 | Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Trial 2012 | completed | Phase 4 | 30 |
| NCT01668004 | The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012) 2012 | completed | Phase 4 | 101 |
| NCT02438787 | A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Participants With Active Radiographic Axial Spondyloarthritis 2015 | terminated | Phase 3 | 315 |
| NCT07138898 | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty 2025 | not yet recruiting | Phase 2 | 80 |
| NCT02456363 | Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis 2009 | status unknown | Phase 2 | 300 |
| NCT01313858 | A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554) 2010 | completed | Not applicable | 1,613 |
| NCT03557853 | Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Golimumab 2016 | completed | Not applicable | 39 |
| NCT01965132 | Korean College of Rheumatology Biologics and Targeted Therapy Registry 2012 | recruiting | Not applicable | 10,000 |
Published literature
- Cochrane review Impact of Biologics on Cardiovascular Events in Ankylosing Spondylitis: A Meta-AnalysisYin H, Wang Y, Chen Z et al. · International journal of rheumatic diseases · 2026 · PMID 41672949
- Meta-analysis Risk of new-onset and recurrent uveitis with different biologics for ankylosing spondylitis: a network meta-analysisZhao X, Xie Q, He X et al. · Frontiers in immunology · 2025 · PMID 40621455
- Clinical trial publication Safety and Efficacy of Golimumab in Indian Patients with Active Spondyloarthritis of Ankylosing Spondylitis or Psoriatic Arthritis: A Multicenter, Noncomparative, Open-Label, Real-World StudyUpadhyaya S, Kumar U, Chandrashekara S et al. · The Journal of the Association of Physicians of India · 2024 · PMID 38736116
- Clinical trial publication Comparison of the effect of treatment with NSAIDs added to anti-TNF therapy versus anti-TNF therapy alone on the progression of structural damage in the spine over 2 years in patients with radiographic axial spondyloarthritis from the randomised-controlled CONSUL trialProft F, Torgutalp M, Muche B et al. · Annals of the rheumatic diseases · 2024 · PMID 38228361
- Meta-analysis Targeted therapies and conventional care for the treatment of ankylosing spondylitis in China: a cost-effectiveness analysis based on the network-meta analysisShi J, Zhou W, Lin T et al. · Journal of orthopaedic surgery and research · 2024 · PMID 39155381
- Clinical trial publication Long-term golimumab persistence: Five-year treatment retention data pooled from pivotal Phase III clinical trials in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitisWeinstein CLJ, Meehan AG, Lin J et al. · Clinical rheumatology · 2023 · PMID 37751000
- Systematic review Efficacy and safety of biological DMARDs: a systematic literature review informing the 2022 update of the ASAS-EULAR recommendations for the management of axial spondyloarthritisWebers C, Ortolan A, Sepriano A et al. · Annals of the rheumatic diseases · 2023 · PMID 36270657
- Clinical trial publication Efficacy and Safety of Intravenous Golimumab in Ankylosing Spondylitis Patients With Early and Late Disease Through One Year of the GO-ALIVE StudyDeodhar AA, Shiff NJ, Gong C et al. · Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases · 2022 · PMID 35653615
- Meta-analysis Impact of biologics on health-related quality of life in patients with Ankylosing spondylitis: A systematic review and meta-analysis of randomized controlled trialsHo A, Younis I, Le QA · Seminars in arthritis and rheumatism · 2022 · PMID 35339841
- Randomized controlled trial 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 trialReveille JD, Hwang MC, Danve A et al. · Clinical rheumatology · 2021 · PMID 32926247
- Systematic review Differences in biologics for treating ankylosing spondylitis: the contribution of network meta-analysisMigliore A, Gigliucci G, Integlia D et al. · European review for medical and pharmacological sciences · 2021 · PMID 33506892
- Clinical trial publication Effects of Intravenous Golimumab on Health-Related Quality of Life in Patients with Ankylosing Spondylitis: 28-Week Results of the GO-ALIVE TrialReveille JD, Deodhar A, Ince A et al. · Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2020 · PMID 33032770
- Cochrane review Drug Survival of Biologics in Treating Ankylosing Spondylitis: A Systematic Review and Meta-analysis of Real-World EvidenceYu CL, Yang CH, Chi CC · BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020 · PMID 32946076
- Cochrane review Patients with ankylosing spondylitis treatment by golimumab: a systematic review and meta-analysisSayed Abdulla J, Shi J, Roy BS et al. · European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2020 · PMID 32447529
- Randomized controlled trial Spinal mobility in the cervical and lumbar spine correlates with magnetic resonance imaging findings for inflammatory and structural changes in patients with active ankylosing spondylitisBaraliakos X, Hermann KA, Xu S et al. · Clinical and experimental rheumatology · 2020 · PMID 32242806
- Cochrane review Risk of serious infections in biological treatment of patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis: a meta-analysisWang S, He Q, Shuai Z · Clinical rheumatology · 2018 · PMID 29290076
- Cochrane review Risk of infections using anti-TNF agents in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: a systematic review and meta-analysisMinozzi S, Bonovas S, Lytras T et al. · Expert opinion on drug safety · 2016 · PMID 27924643
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Golimumab approved for Ankylosing Spondylitis / Axial Spondyloarthropathy?
Golimumab has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Ankylosing Spondylitis / Axial Spondyloarthropathy would be drug repurposing rather than first-in-human development. This does not mean it is approved for Ankylosing Spondylitis / Axial Spondyloarthropathy. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Golimumab in clinical trials for Ankylosing Spondylitis / Axial Spondyloarthropathy?
ClinicalTrials.gov lists 8 registered trials linking Golimumab to Ankylosing Spondylitis / Axial Spondyloarthropathy: 1 is currently recruiting; 1 is active or not yet recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01668004). The largest enrolment is 10000 participants (NCT01965132). Registration activity spans 2009 to 2025.
What does the evidence show for Golimumab in Ankylosing Spondylitis / Axial Spondyloarthropathy?
Golimumab has both completed registered trials and synthesis-level publications linked to Ankylosing Spondylitis / Axial Spondyloarthropathy. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.