Summary
Infliximab 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trials linking Infliximab to Ankylosing Spondylitis / Axial Spondyloarthropathy: 4 have completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00778869). The largest enrolment is 800 participants (NCT03729674). Registration activity spans 2002 to 2018. The literature layer holds 16 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 1 systematic review, 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2016 to 2025. 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 | 69.5 (trials 19.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 4 completed, 4 other |
| Linked publications | 16 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 2 randomised controlled trial publications, 1 systematic review) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00778869 | Analysis of the Peripheral Blood Mononuclear Cells of Patients With Ankylosing Spondylitis During Infliximab Treatment (Study P04465)(COMPLETED) 2005 | completed | Phase 4 | 10 |
| NCT00686894 | Enthesitis With Ultra Sonography Doppler in Spondyloarthropathies Treated With Infliximab (Study P04440) 2008 | terminated | Phase 4 | 7 |
| NCT00844805 | Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1) 2009 | completed | Phase 3 | 158 |
| NCT01571206 | An Extension Study to Demonstrate the Equivalence of Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 1.1 2012 | completed | Phase 1 | 174 |
| NCT00591201 | Efficacy, Safety, and Tolerability Study of Infliximab in Juvenile Spondyloarthropathies 2002 | completed | PHASE2, PHASE3 | 26 |
| NCT02557308 | An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis 2015 | terminated | Not applicable | 329 |
| NCT00237419 | Examination of Radiographic Progression, Efficacy and Safety of Long-Term Treatment With Infliximab in Patients With Ankylosing Spondylitis 2005 | status unknown | Not applicable | 149 |
| NCT03729674 | Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs 2018 | status unknown | Not applicable | 800 |
Published literature
- Cochrane review Comparative efficacy, safety and immunogenicity of biosimilars and their reference biologic drugs in ankylosing spondylitis: a systematic review and meta-analysis of randomized controlled trialsYiu CH, Or CH, Almutairi K et al. · Expert opinion on biological therapy · 2025 · PMID 40418343
- 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
- Cochrane review Anti-TNF-α induced paradoxical psoriasis in patients with ankylosing spondylitis: a systematic reviewSagonas I, Iliopoulos G, Baraliakos X et al. · Clinical and experimental rheumatology · 2024 · PMID 37812484
- 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 Do fatty lesions explain the effect of inflammation on new syndesmophytes in patients with radiographic axial spondyloarthritis? Results from the SIAS cohort and ASSERT trialStal R, Ramiro S, van der Heijde D et al. · RMD open · 2023 · PMID 37407237
- Clinical trial publication A randomized, double-blind, placebo-controlled 12-week trial of infliximab in patients with juvenile-onset spondyloarthritisBurgos-Vargas R, Loyola-Sanchez A, Ramiro S et al. · Arthritis research & therapy · 2022 · PMID 35941676
- Cochrane review Optimal Biologic Drugs for the Treatment of Ankylosing Spondylitis: Results from a Network Meta-Analysis and Network MetaregressionCao Z, Guo J, Li Q et al. · BioMed research international · 2022 · PMID 35845959
- 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
- Clinical trial publication Increased Induction Infliximab Clearance Predicts Early Antidrug Antibody DetectionEser A, Reinisch W, Schreiber S et al. · Journal of clinical pharmacology · 2021 · PMID 32905628
- 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 Infliximab treatment reduces depressive symptoms in patients with ankylosing spondylitis: an ancillary study to a randomized controlled trial (ASSERT)Webers C, Stolwijk C, Schiepers O et al. · Arthritis research & therapy · 2020 · PMID 32993799
- Clinical trial publication Bone changes and curative effect of infliximab in patients with ankylosing spondylitisLi L, Chen B, Zhao H et al. · Journal of musculoskeletal & neuronal interactions · 2020 · PMID 32877981
- 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 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
- Randomized controlled trial Physical Function and Spinal Mobility Remain Stable Despite Radiographic Spinal Progression in Patients with Ankylosing Spondylitis Treated with TNF-α Inhibitors for Up to 10 YearsPoddubnyy D, Fedorova A, Listing J et al. · The Journal of rheumatology · 2016 · PMID 27803139
- Randomized controlled trial Partial remission in ankylosing spondylitis and non-radiographic axial spondyloarthritis in treatment with infliximab plus naproxen or naproxen alone: associations between partial remission and baseline disease characteristicsSieper J, Rudwaleit M, Lenaerts J et al. · Rheumatology (Oxford, England) · 2016 · PMID 27411482
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 Infliximab approved for Ankylosing Spondylitis / Axial Spondyloarthropathy?
Infliximab 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 Infliximab in clinical trials for Ankylosing Spondylitis / Axial Spondyloarthropathy?
ClinicalTrials.gov lists 8 registered trials linking Infliximab to Ankylosing Spondylitis / Axial Spondyloarthropathy: 4 have completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00778869). The largest enrolment is 800 participants (NCT03729674). Registration activity spans 2002 to 2018.
What does the evidence show for Infliximab in Ankylosing Spondylitis / Axial Spondyloarthropathy?
Infliximab 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.