drugset / Trial / NCT01636843

A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate

NCT01636843

Phase 2 Terminated 298 enrolled Novo Nordisk A/S
RandomizedParallel-groupDouble-blindTreatment

Summary

This trial is conducted in Europe, North America and South America. The aim of this trial is to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared to placebo when administered as weekly repeat subcutaneous (under the skin) injections in to patients with active rheumatoid arthritis (RA) with inadequate responses to methotrexate (MTX) while on a stable background of MTX therapy.

Timeline

Start
2012-10-30
Primary completion
2014-11-10
Completion
2014-11-10

Drugs

EvaluationDrugModalityDoseRoute
Subject FLETIKUMAB Monoclonal antibody 60 mg Subcutaneous
Subject FLETIKUMAB Monoclonal antibody 120 mg Subcutaneous
Subject FLETIKUMAB Monoclonal antibody 240 mg Subcutaneous

Indications