Combination Therapy of F8IL10 and Methotrexate in Rheumatoid Arthritis Patients

"Weekly administration of F8IL10 (from 6 to 600 μg/kg), starting from 6 μg/kg cohort 1. The cohort 10 represents the last dose-level of the study.~F8IL10 will be administered as subcutaneous (s.c.) injections. Patients will receive 4 cycles of treatment unless there is unacceptable toxicity or withdrawal of consent."

"Methotrexate will be administered at a fixed dose of 10-15 mg on Day 1, orally (p.o.), subcutaneously (s.c.) or intramuscularly (i.m.).~Patients will receive 4 cycles of treatment unless there is unacceptable toxicity or withdrawal of consent."