Erosive hand osteoarthritis (EHOA)
Conditions
Brief summary
The primary endpoint is the difference in mean change of total erosion volume (mm3) of target joints (II, III, IV, V distal and proximal interphalangeal joints and II, III, IV, V metacarpal phalangeal joints) assessed with high resolution peripheral quantitative computed tomography (HRpQCT) using standardized approach between baseline (V1) and 12 months after baseline (V4)
Detailed description
The secondary endpoint will be the number and proportion of interphalangeal joints progressing from non‑erosive disease, defined as S/J phase at baseline, to erosive disease, defined as E phase at 48 weeks., The change from baseline to Month 12 in patient‑reported and functional outcomes, including AUSCAN (AUStralian CANadian Osteoarthritis Hand Index), FIHOA (Functional Index of Hand Osteoarthritis), and Pain VAS, reflecting pain, hand function, and disability from the patient perspective.
Interventions
DRUGObodence 60 mg solution for injection in pre-filled syringe
Sponsors
Azienda Ospedaliera Universitaria Integrata Verona
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the difference in mean change of total erosion volume (mm3) of target joints (II, III, IV, V distal and proximal interphalangeal joints and II, III, IV, V metacarpal phalangeal joints) assessed with high resolution peripheral quantitative computed tomography (HRpQCT) using standardized approach between baseline (V1) and 12 months after baseline (V4) | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint will be the number and proportion of interphalangeal joints progressing from non‑erosive disease, defined as S/J phase at baseline, to erosive disease, defined as E phase at 48 weeks., The change from baseline to Month 12 in patient‑reported and functional outcomes, including AUSCAN (AUStralian CANadian Osteoarthritis Hand Index), FIHOA (Functional Index of Hand Osteoarthritis), and Pain VAS, reflecting pain, hand function, and disability from the patient perspective. | — |
Outcome results
None listed