Time-point | Methotrexate add-on study dosing group | Monotherapy study dosing group | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Once daily (q.d.) | Twice daily (b.i.d.) | Once daily (q.d.) | |||||||||
Placebo | 50 | 100 | 200 | 25 | 50 | 100 | Placebo | 50 | 100 | 200 | |
Health Assessment Questionnaire-Disability Index (HAQ-DI), points | |||||||||||
Week 12 | −0.38 | −0.58 | −0.65* | −0.75*** | −0.59 | −0.58 | −0.84*** | −0.23 | −0.66*** | −0.68*** | −0.74*** |
Week 24 | −0.37 | −0.63 | −0.78*** | −0.82*** | −0.62** | −0.66** | −0.90*** | NAa | −0.69 | −0.79 | −0.85 |
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale, points | |||||||||||
Week 12 | 5.6 | 7.6 | 9.5* | 11.4*** | 6.9 | 8.4 | 11.3*** | 3.9 | 9.5*** | 10.2*** | 11.2*** |
Week 24 | 6.0 | 7.9 | 11.1*** | 11.6** | 7.7 | 9.0 | 12.8*** | NAa | 10.0 | 11.3 | 13.7 |
Patient global assessment of disease activity (Patient Global), mm | |||||||||||
Week 12 | −16.7 | −25.2 | −29.1* | −34.2*** | −25.2* | −27.0* | −35.6*** | −11.5 | −27.5*** | −30.0*** | −28.2*** |
Week 24 | −17.9 | −29.4* | −34.4* | −34.9* | −27.3* | −28.1* | −39.1*** | NAa | −29.1 | −32.2 | −35.1 |
Pain, mm | |||||||||||
Week 12 | −16.9 | −24.8 | −27.4* | −31.4** | −24.2 | − 28.3* | −37.9*** | −13.3 | −29.2*** | −31.5*** | −31.3*** |
Week 24 | −17.0 | −27.1* | −32.7*** | −34.6*** | −26.9* | −27.7* | −37.9*** | NAa | −29.1 | −35.1 | −37.7 |
Short Form-36: Physical component score (PCS), points | |||||||||||
Week 12 | 3.2 | 6.7** | 8.4*** | 8.9*** | 7.5** | 7.1** | 10.5*** | 3.0 | 7.1** | 7.8*** | 8.6*** |
Week 24 | 2.8 | 7.3*** | 9.9*** | 9.7*** | 7.8*** | 7.9*** | 11.6*** | NAa | 6.9 | 10.0 | 9.7 |
Short Form-36: Mental component score (MCS), points | |||||||||||
Week 12 | 4.3 | 4.4 | 5.1 | 8.1 | 3.5 | 3.1 | 6.2 | 2.7 | 4.9* | 6.9** | 6.8** |
Week 24 | 4.7 | 4.3 | 6.7 | 7.2 | 3.8 | 3.5 | 7.1 | NAa | 5.1 | 7.7 | 8.5 |