drugset / Trial / NCT01114503

A Safety and Tolerability Study of Otelixizumab in Thyroid Eye Disease

NCT01114503 ↗

Phase 2 Terminated 2 enrolled GlaxoSmithKline
RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to investigate the safety and tolerability of otelixizumab in patients with Graves' ophthalmopathy (thyroid eye disease). There is currently no alternative therapy available for this condition other than treatment with steroids, or radiotherapy and surgery. The study also includes a comparison of the current steroid treatment, methylprednisolone, with the proposed new otelixizumab treatment.

Timeline

Start
2010-07-07
Primary completion
2012-08-29
Completion
2012-08-29

Outcome

Outcome not reported

Stopped: “Clinical study in Graves' ophthalmopathy terminated until there is a better understanding of an efficacious dose with Otelixizumab from other clinical studies.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methylprednisolone Other / unclassified 250 mg Intravenous
Subject Otelixizumab Monoclonal antibody — Intravenous