drugset / Trial / NCT01023256

Safety and Preliminary Efficacy of MOR103 in Patients With Active Rheumatoid Arthritis

NCT01023256

Phase 1/2 Completed 96 enrolled MorphoSys AG
RandomizedSingle-groupDouble-blindTreatment

Summary

GM-CSF is considered to have a key role in the initiation and progression of arthritic inflammation. The purpose of this study is to evaluate the safety, preliminary efficacy, pharmacokinetics, and immunogenicity of multiple doses of MOR103, a human antibody to GM-CSF, in patients with active rheumatoid arthritis.

Timeline

Start
2009-12
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Otilimab Monoclonal antibody 0.3 mg/kg Intravenous
Subject Otilimab Monoclonal antibody 1 mg/kg Intravenous
Subject Otilimab Monoclonal antibody 1.5 mg/kg Intravenous

Indications