drugset / Trial / NCT07486843
Preventing Structural Damage in Early Psoriatic Arthritis
RandomizedParallel-groupOpen-labelTreatment
Summary
Investigators hypothesize that TNFi is superior to SC MTX in preventing structural damage in early, treatment-naïve PsA, assessed using HR-pQCT. The study aims to ascertain: \- The effect of SC MTX and TNFi (adalimumab biosimilar) on erosion and enthesiophyte progression in early PsA by HR-pQCT. Participants will be: * Randomized in a 1:1 ratio to either the SC MTX group or the TNFi group. * HR-pQCT of MCPJ 2-4 will be performed at baseline, week 24, and one year. The primary outcome is the comparison of change in erosion volume over MCPJ 2-4 across 48 weeks between the SC MTX group (group 1) and the TNFi group (group 2), assessed by HR-pQCT.
Timeline
- Start
- 2026-03-16
- Primary completion
- 2027-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adalimumab | Monoclonal antibody | 40 mg | — |
| Comparator | Methotrexate | Small molecule | 7.5 mg | Subcutaneous |
| Comparator | Methotrexate | Small molecule | 10 mg | Subcutaneous |
| Comparator | Methotrexate | Small molecule | 15 mg | Subcutaneous |
| Comparator | Methotrexate | Small molecule | 20 mg | Subcutaneous |
| Comparator | Methotrexate | Small molecule | 25 mg | Subcutaneous |