Summary
Adalimumab 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trials linking Adalimumab to Ankylosing Spondylitis / Axial Spondyloarthropathy: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00133315). The largest enrolment is 1250 participants (NCT00478660). Registration activity spans 2004 to 2018. The literature layer holds 16 publications for this pair: 5 Cochrane reviews, 4 meta-analyses, 1 systematic review, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2017 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 | 78.0 (trials 28.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 7 completed, 1 other |
| Linked publications | 16 (5 Cochrane reviews, 5 clinical trial publications, 4 meta-analyses, 1 systematic review, 1 randomised controlled trial publication) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01174186 | Intestinal Inflammation in Ankylosing Spondylitis and the Effects of Adalimumab on Mucosal Healing 2010 | completed | Phase 4 | 30 |
| NCT00133315 | TNFalfa Blocking Treatment of Spondylarthropathies 2004 | completed | Phase 4 | 50 |
| NCT00972218 | Effectiveness and Safety of Spondylitis Related to Inflammatory Bowel Disease 2009 | withdrawn | Phase 4 | — |
| NCT04135508 | A Phase III Study Evaluate the Efficacy and Safety of BAT1406 and Humira 2016 | completed | Phase 3 | 554 |
| NCT00478660 | An Open-Label Study to Evaluate the Response to Adalimumab in Patients With Active Ankylosing Spondylitis Who Have Failed Standard Therapy or TNF-Alpha Inhibitors (RHAPSODY) 2006 | completed | Phase 3 | 1,250 |
| NCT02750800 | Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE) 2016 | completed | Not applicable | 427 |
| NCT01387802 | Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis 2011 | completed | Not applicable | 722 |
| NCT03339089 | Real-world Effectiveness of Adalimumab on Health Outcomes in Chinese Patients With Immune-Mediated Inflammatory Diseases 2018 | completed | Not applicable | 224 |
Published literature
- Clinical trial publication Comparison of the Efficacy and Safety of Biosimilar Adalimumab Injection with Innovator Adalimumab in Subjects with Active Ankylosing SpondylitisChandrashekara S, Parida JR, Sonawale A et al. · The Journal of the Association of Physicians of India · 2025 · PMID 40955932
- 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
- Clinical trial publication Identification of patient endotypes and adalimumab treatment responders in axial spondyloarthritis using blood-derived extracellular matrix biomarkersPort H, Christiansen F, Nielsen SH et al. · RMD open · 2024 · PMID 38199849
- Cochrane review Approaches and outcomes of adalimumab discontinuation in patients with well-controlled inflammatory arthritis: a systematic search and reviewBalay-Dustrude E, Fennell J, Baszis K et al. · Pediatric rheumatology online journal · 2024 · PMID 39734203
- 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
- Systematic review An Overview of Adalimumab Therapy for Ankylosing SpondylitisSukhanova AM, Gilavian MA, Melnik EV et al. · Current rheumatology reviews · 2024 · PMID 38415452
- Clinical trial publication The effects of supervision on the outcomes of exercise training in patients with ankylosing spondylitis: A single-blind randomized controlled trialHosseini M, Rahimibarghani S, Ghorbanpour S et al. · International journal of rheumatic diseases · 2023 · PMID 37096931
- Clinical trial publication Efficacy and safety of upadacitinib in patients with active psoriatic arthritis and axial involvement: results from two phase 3 studiesBaraliakos X, Ranza R, Östör A et al. · Arthritis research & therapy · 2023 · PMID 37038159
- Clinical trial publication Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitisBurmester GR, Cohen SB, Winthrop KL et al. · RMD open · 2023 · PMID 36754548
- Meta-analysis Work productivity in patients with axial spondyloarthritis initiating biological or targeted synthetic disease-modifying antirheumatic drugs: a systematic literature review and meta-analysisRudwaleit M, Mørup MF, Humphries B et al. · RMD open · 2023 · PMID 38035757
- 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 Comparison of the efficacy and safety of the adalimumab biosimilar TQ-Z2301 and adalimumab for the treatment of Chinese patients with active ankylosing spondylitis: a multi-center, randomized, double-blind, phase III clinical trialLi J, Xue Z, Wu Z et al. · Clinical rheumatology · 2022 · PMID 35676450
- 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
- Cochrane review Is secukinumab a safe alternative treatment for ankylosing spondylitis with Guillain Barré syndrome after anti-TNF-α treatment? Case report and literature reviewPsarelis S, Hajineocli APD, Hadjicosta E et al. · Clinical rheumatology · 2017 · PMID 28233109
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 Adalimumab approved for Ankylosing Spondylitis / Axial Spondyloarthropathy?
Adalimumab 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 Adalimumab in clinical trials for Ankylosing Spondylitis / Axial Spondyloarthropathy?
ClinicalTrials.gov lists 8 registered trials linking Adalimumab to Ankylosing Spondylitis / Axial Spondyloarthropathy: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00133315). The largest enrolment is 1250 participants (NCT00478660). Registration activity spans 2004 to 2018.
What does the evidence show for Adalimumab in Ankylosing Spondylitis / Axial Spondyloarthropathy?
Adalimumab 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.