drugset / Trial / NCT02270632

A Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of F8IL10 (Dekavil) in Patients With Active RA Receiving MTX

NCT02270632

Phase 2 Terminated 27 enrolled Philogen S.p.A.
RandomizedParallel-groupTriple-blindTreatment

Summary

A multicenter, randomized, parallel assignment, double blind, placebo-controlled, safety/efficacy phase II study of two different dosages of subcutaneous F8IL10 in patients with active rheumatoid arthritis receiving MTX.

Timeline

Start
2014-10-01
Primary completion
2019-04
Completion
2023-06-08

Drugs

EvaluationDrugModalityDoseRoute
Subject F8IL10 Monoclonal antibody 30 ug/kg Subcutaneous
Subject F8IL10 Monoclonal antibody 160 ug/kg Subcutaneous
Background MTX Unknown

Indications