Exploring a novel outcome measure of symptom progression in knee osteoarthritis utilizing a large randomized trial
Authors' conclusion
The symptom progression endpoint discriminated between placebo and treatment responses in a post hoc analysis of a Phase 2 investigational DMOAD KOA trial.
Study context
- Population
- FORWARD trial participants with knee OA442 completed Year 3
- Participants
- 549 participants
- Comparison
- Sprifermin vs placebo
- Primary endpoint
- Time to symptom progression: first occurrence of WOMAC Pain worsening ≥10 points with no improvement (≤9 point decrease) in WOMAC Function (0-100 scale)
- Follow-up
- Year 3
Methodological detailsintent-to-treat, Phase 2
- Intent-to-treat
- Phase 2
Primary result
As reported in the abstract
Time to symptom progression
Each group vs placeboHazard ratio (95% CI)
100 μg Q6M
0.51(0.28–0.93)
100 μg Q12M
0.69(0.40–1.20)
30 μg Q6M
0.89(0.53–1.50)
30 μg Q12M
0.80(0.47–1.35)
Further findings
Knee replacements, symptom progressors vs non-progressors
Time to symptom progression through Year 5 and in subgroup meeting modern trial inclusion criteria
- Similar findings
- 378 (68.9%) completed Year 5
Original publication
Exploring a novel outcome measure of symptom progression in knee osteoarthritis utilizing a large randomized trial. Osteoarthritis Cartilage. Published 28 December 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →