drugset / Trial / NCT02076659

Combination Therapy of F8IL10 and Methotrexate in Rheumatoid Arthritis Patients

NCT02076659

Phase 1 Completed 36 enrolled Philogen S.p.A.
NaSingle-groupOpen-labelTreatment

Summary

Phase I, multicenter, open-label, dose escalation study to test the efficacy and safety of F8IL10 and methotrexate when given as a combination in rheumatoid arthritis patients.

Timeline

Start
2011-09
Primary completion
2017-04
Completion
2017-04-13

Drugs

EvaluationDrugModalityDoseRoute
Subject F8IL10 Monoclonal antibody 6 ug/kg Subcutaneous
Subject F8IL10 Monoclonal antibody 600 ug/kg Subcutaneous
Background Methotrexate Small molecule 10 mg Oral
Background Methotrexate Small molecule 15 mg Oral

Indications