drugset / Trial / NCT01636817

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

NCT01636817

Phase 2 Terminated 239 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 s.c. (subcutaneous, under the skin) injections to patients with active rheumatoid arthritis (RA) who are inadequate responders to anti-TNFa biologics and are on a stable background of methotrexate (MTX) therapy.

Timeline

Start
2012-08
Primary completion
2014-11
Completion
2014-11

Drugs

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

Indications