Table 2 Protocol-defined flare [25]
Flare core variable | Range of scores | Clinically meaningful change |
|---|---|---|
1. Caregiver/patient assessment of overall well-being VAS | 0–10 (0=maximal well-being) | ≥2 |
2. Physician assessment of disease activity VAS | 0–10 (0=no disease activity) | ≥2 |
3. Caregiver/patient assessment of pain VAS | 0–10 (0=no pain) | ≥2 |
4. Function (PROMIS mobility and upper extremity) | Mean T-score=50 (SD 10) | ≥3 |
5. Active joint count | 0–10 | ≥1 |