Microsoft PowerPoint - Roche IR Event EULAR Final.ppt
Microsoft PowerPoint - Roche IR Event EULAR Final.ppt
Microsoft PowerPoint - Roche IR Event EULAR Final.ppt
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Study design<br />
Open-label extension study of rituximab in RA<br />
Phase II/III<br />
Open-label extension study of rituximab treatment<br />
Course 1 of rituximab Course Repeated 2 courses Course 3<br />
Phase IIa<br />
Placebo<br />
Rituximab<br />
2 x 1000 mg<br />
Rituximab 2 x 1000 mg<br />
+ cyclophosphamide<br />
Rituximab<br />
2 x 1000 mg<br />
Timing of repeat treatment<br />
courses was variable,<br />
depending on clinical need<br />
Rituximab 2 x 1000 mg<br />
+ methotrexate<br />
Placebo<br />
Rituximab<br />
2 x 1000 mg<br />
Long-term<br />
follow-up<br />
Phase IIb<br />
DANCER<br />
Rituximab 2 x 500 mg<br />
+ methotrexate<br />
Rituximab 2 x 1000 mg<br />
+ methotrexate<br />
Phase III<br />
REFLEX<br />
Placebo<br />
Rituximab 2 x 1000 mg<br />
+ methotrexate<br />
All patients in the open-label extension study received weekly methotrexate (10–25 mg) and methylprednisolone 100 mg iv on<br />
Days 1 and 15 plus oral prednisone 60 mg/day on Days 2–7 and 30 mg/day on Days 8–14<br />
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