Summary
Prednisolone 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 3 registered trials linking Prednisolone to Ankylosing Spondylitis / Axial Spondyloarthropathy: 1 has completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT01790022). The largest enrolment is 75 participants (NCT00244166). Registration activity spans 2002 to 2023. The literature layer holds 5 publications for this pair: 5 clinical trial publications. Publication years run from 1975 to 2014. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
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 | 35.5 (trials 5.5, literature 10.0, tier 15, approved bonus 5.0) |
| Registered trials | 3 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 2 other |
| Linked publications | 5 (5 clinical trial publications) |
| Agent type | Drug (Small molecule) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01790022 | Efficacy and Safety of MEthylprednisolone Administered Intravenously for the Treatment of Patients With Active AnkyLosing spondyLitis (METALL) 2012 | status unknown | Phase 2 | 20 |
| NCT07113834 | Characteristics of Ankylosing Spondylitis Associated Uveitis 2023 | completed | Not applicable | 22 |
| NCT00244166 | Prednisolone in Active Ankylosing Spondylitis (AS) 2002 | status unknown | PHASE2, PHASE3 | 75 |
Published literature
- Clinical trial publication Etanercept therapy in Behçet's disease. The tight control strategy in refractory diseaseMohammed RH · Zeitschrift fur Rheumatologie · 2014 · PMID 24549921
- Clinical trial publication Efficacy of oral prednisolone in active ankylosing spondylitis: results of a double-blind, randomised, placebo-controlled short-term trialHaibel H, Fendler C, Listing J et al. · Annals of the rheumatic diseases · 2014 · PMID 23625982
- Clinical trial publication Population pharmacokinetics of infliximab in patients with ankylosing spondylitisXu Z, Seitz K, Fasanmade A et al. · Journal of clinical pharmacology · 2008 · PMID 18401017
- Clinical trial publication Low dose of infliximab is inadequate in most patients with spondylarthropathiesSidiropoulos P, Kritikos HD, Siakka P et al. · Clinical and experimental rheumatology · 2005 · PMID 16095121
- Clinical trial publication [Practical experiences in the intra-articular treatment of chronic rheumatic diseases]Häntzschel H, Reinelt D, Otto W · Zeitschrift fur die gesamte innere Medizin und ihre Grenzgebiete · 1975 · PMID 1210468
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 Prednisolone approved for Ankylosing Spondylitis / Axial Spondyloarthropathy?
Prednisolone 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 Prednisolone in clinical trials for Ankylosing Spondylitis / Axial Spondyloarthropathy?
ClinicalTrials.gov lists 3 registered trials linking Prednisolone to Ankylosing Spondylitis / Axial Spondyloarthropathy: 1 has completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT01790022). The largest enrolment is 75 participants (NCT00244166). Registration activity spans 2002 to 2023.
What does the evidence show for Prednisolone in Ankylosing Spondylitis / Axial Spondyloarthropathy?
Prednisolone has 1 completed trial and 5 linked publications for Ankylosing Spondylitis / Axial Spondyloarthropathy. Completed trials may or may not have posted results; follow the NCT links to check. 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.