drugset / Trial / NCT01114503
A Safety and Tolerability Study of Otelixizumab in Thyroid Eye Disease
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Methylprednisolone | Other / unclassified | 250 mg | Intravenous |
| Subject | Otelixizumab | Monoclonal antibody | — | Intravenous |