Patient demographics and baseline disease characteristics
| Characteristic* | Patients (N=171) | Patients entered in long-term extension (n=128) |
|---|---|---|
| Age, years | 11.3 (3.5) | 11.3 (3.6) |
| Disease duration, years | 3.8 (3.9)† | 3.7 (3.6)‡ |
| Female, n (%) | 135 (78.9) | 98 (76.6) |
| White, n§ (%) | 157 (95.2) | 121 (96.0) |
| Body weight, kg | 42.2 (18.8) | 43.5 (19.5) |
| Rheumatoid factor positive, n¶ (%) | 37 (22.0) | 27 (21.6) |
| Prior DMARDs not including methotrexate, n (%) | 44 (25.7) | 36 (28.1) |
| Prior methotrexate use, n (%) | 103 (60.2) | 83 (64.8) |
| Tender joint count | 11.4 (12.4) | 12.0 (12.8) |
| Swollen joint count | 14.8 (9.4) | 14.9 (9.1) |
| Pain on passive motion joint count | 10.3 (11.7) | 9.5 (10.4) |
| Limitation of passive motion joint count | 13.5 (9.2) | 13.4 (9.4) |
| Active joint count | 17.2 (10.4) | 17.2 (10.3) |
| CRP, mg/dL | 2.6 (4.1)§ | 2.4 (4.1)¶ |
| Elevated CRP||, n (%) | 112 (65.9)§ | 79 (62.2)¶ |
| Physician Global Assessment of disease activity# | 5.9 (1.8) | 5.8 (1.8) |
| Patient or Parent Global Assessment of overall well-being** | 4.8 (2.3)§ | 4.8 (2.3)¶ |
| Patient or Parent Global Assessment of pain†† | 5.0 (2.5) | 4.9 (2.5) |
| Childhood Health Assessment Questionnaire Disability Index‡‡ | 1.1 (0.7) | 1.0 (0.7) |
Tender joint count, pain on passive motion joint count and limitation of passive motion joint count based on 75 joints; swollen joint count based on 66 joints.
*Data are mean (SD) unless otherwise noted.
†n=170.
‡n=127.
§n=165 and n=126.
¶n=168 and n=125.
||Elevated CRP defined as >0.0287 mg/dL.
#0–10 cm visual analogue scale (0=inactive; 10=maximum activity).
**0–10 cm visual analogue scale (0=very good; 10=very poor).
††0–10 cm visual analogue scale (0=no pain; 10=very severe pain).
‡‡Mean rating of 8 category scores (0=no difficulty to perform activity; 3=complete inability to perform activity).
CRP, C reactive protein; DMARDs, disease-modifying antirheumatic drugs.