Summary
Certolizumab Pegol 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 Certolizumab Pegol to Ankylosing Spondylitis / Axial Spondyloarthropathy: 2 are active or not yet recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02132234). The largest enrolment is 925 participants (NCT01797224). Registration activity spans 2012 to 2025. The literature layer holds 12 publications for this pair: 1 Cochrane review, 3 meta-analyses, 3 systematic reviews and 5 clinical trial publications. Publication years run from 2014 to 2022. 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 | 73.0 (trials 23.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 2 active / not yet recruiting, 4 completed, 2 other |
| Linked publications | 12 (5 clinical trial publications, 3 meta-analyses, 3 systematic reviews, 1 Cochrane 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT02132234 | Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis 2013 | status unknown | Phase 4 | 100 |
| NCT02505542 | Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo 2015 | completed | Phase 3 | 736 |
| NCT03215277 | A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis 2017 | completed | Phase 2 | 76 |
| NCT07138898 | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty 2025 | not yet recruiting | Phase 2 | 80 |
| NCT02154425 | A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers 2014 | completed | Phase 1 | 17 |
| NCT01797224 | OTIS Cimzia Pregnancy Registry 2012 | active, not recruiting | Not applicable | 925 |
| NCT02354105 | A Study to Assess the Effectiveness of Certolizumab Pegol in Patients With Axial Spondyloarthritis in Daily Life 2015 | completed | Not applicable | 680 |
| NCT02775656 | UCB Cimzia Pregnancy Follow-up Study 2016 | terminated | Not applicable | 1 |
Published literature
- 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 Predictors of long-term clinical response in patients with non-radiographic axial spondyloarthritis receiving certolizumab pegolMaksymowych WP, Kumke T, Auteri SE et al. · Arthritis research & therapy · 2021 · PMID 34715908
- 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
- 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
- Clinical trial publication Associations between certolizumab pegol serum levels, anti-drug antibodies and treatment response in patients with inflammatory joint diseases: data from the NOR-DMARD studyGehin JE, Goll GL, Warren DJ et al. · Arthritis research & therapy · 2019 · PMID 31783773
- Meta-analysis The Comparative Safety of TNF Inhibitors in Ankylosing Spondylitis-a Meta-Analysis Update of 14 Randomized Controlled TrialsHou LQ, Jiang GX, Chen YF et al. · Clinical reviews in allergy & immunology · 2018 · PMID 28717941
- Systematic review Comparative Efficacy of Tumor Necrosis Factor-α Inhibitors in Ankylosing Spondylitis: A Systematic Review and Bayesian Network MetaanalysisWang R, Dasgupta A, Ward MM · The Journal of rheumatology · 2018 · PMID 29335342
- Clinical trial publication Sustained efficacy, safety and patient-reported outcomes of certolizumab pegol in axial spondyloarthritis: 4-year outcomes from RAPID-axSpAvan der Heijde D, Dougados M, Landewé R et al. · Rheumatology (Oxford, England) · 2017 · PMID 28498975
- Systematic review Tumour necrosis factor-α inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis: a systematic review and economic evaluationCorbett M, Soares M, Jhuti G et al. · Health technology assessment (Winchester, England) · 2016 · PMID 26847392
- Meta-analysis Indirect comparison between subcutaneous biologic agents in ankylosing spondylitisMigliore A, Bizzi E, Bernardi M et al. · Clinical drug investigation · 2015 · PMID 25388909
- Clinical trial publication Discriminant validity, responsiveness and reliability of the arthritis-specific Work Productivity Survey assessing workplace and household productivity within and outside the home in patients with axial spondyloarthritis, including nonradiographic axial spondyloarthritis and ankylosing spondylitisOsterhaus JT, Purcaru O · Arthritis research & therapy · 2014 · PMID 25099160
- Clinical trial publication Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 studyLandewé R, Braun J, Deodhar A et al. · Annals of the rheumatic diseases · 2014 · PMID 24013647
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 Certolizumab Pegol approved for Ankylosing Spondylitis / Axial Spondyloarthropathy?
Certolizumab Pegol 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 Certolizumab Pegol in clinical trials for Ankylosing Spondylitis / Axial Spondyloarthropathy?
ClinicalTrials.gov lists 8 registered trials linking Certolizumab Pegol to Ankylosing Spondylitis / Axial Spondyloarthropathy: 2 are active or not yet recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02132234). The largest enrolment is 925 participants (NCT01797224). Registration activity spans 2012 to 2025.
What does the evidence show for Certolizumab Pegol in Ankylosing Spondylitis / Axial Spondyloarthropathy?
Certolizumab Pegol 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.