drugset / Trial / NCT01791842

TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE

NCT01791842

Phase 2 Completed 19 enrolled Hospices Civils de Lyon
RandomizedCrossoverQuadruple-blindTreatment

Summary

Bone pain due to fibrous dysplasia of bone is usually treated with bisphosphonates. A small proportion of patients fail to respond adequately. Mutated bone cells produce large amounts of Interleukin-6 (IL-6), with increased bone resorption as a result. Inhibition of IL-6 may be of interest to reduce bone resorption and therefore bone pain. TOCIDYS is a placebo-controlled randomized cross-over trial to test the hypothesis that tocilizumab can reduce bone resorption in those patients with fibrous dysplasia who have already received bisphosphonates.

Timeline

Start
2013-05-05
Primary completion
2015-05
Completion
2018-06-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Tocilizumab Monoclonal antibody 8 mg/kg Intravenous

Indications