Summary of Phase 2 results and subsequent modifications
| Exact (0−100) | Rescaled (0−10) | Rounded to 0.5 (0−10) | |
|---|---|---|---|
| Joint involvement* | |||
| 1 large | 0 | 0 | 0 |
| >1−10 large, asymmetric | 10.2 | 1.02 | 1 |
| >1−10 large, symmetric | 16.1 | 1.61 | 1.5 |
| 1−3 small | 21.2 | 2.12 | 2 |
| 4−10 small | 28.8 | 2.88 | 3 |
| >10, including at least 1 small joint | 50.8 | 5.08 | 5 |
| Serology† | |||
| Negative RF and negative ACPA | 0 | 0 | 0 |
| Low-positive RF or low-positive ACPA | 22.0 | 2.20 | 2 |
| High-positive RF or high-positive ACPA | 33.9 | 3.39 | 3.5 |
| Acute-phase reactants‡ | |||
| Normal CRP and normal ESR | 0 | 0 | 0 |
| Abnormal CRP or abnormal ESR | 5.9 | 0.59 | 0.5 |
| Duration of symptoms§ | |||
| <6 weeks | 0 | 0 | 0 |
| ≥6 weeks | 9.3 | 0.93 | 1 |
↵* Joint involvement refers to any swollen or tender joint on examination. Distal interphalangeal joints, first carpometacarpal joints and first metatarsophalangeal (MTP) joints are excluded from assessment. Categories of joint distribution are classified according to the location and number of the involved joints, with placement into the highest category possible based on the pattern of joint involvement. ‘Large joints’ refers to shoulders, elbows, hips, knees and ankles. ‘Small joints’ refers to the MTP joints, proximal interphalangeal joints, second to fifth MTP joints, thumb interphalangeal joints and wrists. ‘Symmetric’ is defined as bilateral involvement of at least one region. In the category ‘>10 joints,’ at least one of the involved joints must be a small joint; the other joints can include any combination of large and additional small joints, as well as other joints not specifically listed elsewhere (eg, temporomandibular, acromioclavicular, sternoclavicular, etc).
↵† Negative refers to international unit (IU) values that are less than or equal to the upper limit of normal (ULN) for the laboratory and assay; low-positive refers to IU values that are higher than the ULN but three of less times the ULN for the laboratory and assay; high-positive refers to IU values that are more than three times the ULN for the laboratory and assay. When rheumatoid factor (RF) information is only available as positive or negative, a positive result should be scored as low-positive for RF.
↵‡ Normal/abnormal is determined by local laboratory standards.
↵§ Duration of symptoms refers to patient self-report of the duration of signs or symptoms of synovitis (eg, pain, swelling, tenderness) of joints that are clinically involved at the time of assessment, regardless of treatment status.
ACPA, anti-citrullinated protein antibody; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate.