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Be Part of Research - Trial Details - A Safety and Tolerability Study of Otelixizumab in Thyroid Eye Disease

A Safety and Tolerability Study of Otelixizumab in Thyroid Eye Disease

Stopped

Open to: ALL

Age: 18.0 - 75.0

Medical Conditions

Eye Diseases
Graves Ophthalmopathy


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jul 2010 Aug 2012

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : 8 day dose rising intravenous infusions of a low dose of otelixizumab

Intervention Arm Group : Part A;

Intervention Type : DRUG
Intervention Description : 8 day dose rising intravenous infusions of a medium low dose of otelixizumab

Intervention Arm Group : Part A;

Intervention Type : DRUG
Intervention Description : 8 day dose rising intravenous infusions of a medium high dose of otelixizumab

Intervention Arm Group : Part A;

Intervention Type : DRUG
Intervention Description : 8 day dose rising intravenous infusions of a high dose of otelixizumab

Intervention Arm Group : Part A;

Intervention Type : DRUG
Intervention Description : 8 day dose rising intravenous infusions of otelixizumab administered at a dose decided upon results from Part A.

Intervention Arm Group : Part B - Otelixizumab;

Intervention Type : DRUG
Intervention Description : Weekly intravenous infusions of methylprednisolone administered as 500 mg per week for 6 weeks and then 250 mg per week for 6 weeks

Intervention Arm Group : Part B - Methylprednisolone;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • GSK Investigational Site
    Newcastle upon Tyne
    NE1 3BZ


The study is sponsored by GlaxoSmithKline




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Read full details for Trial ID: NCT01114503
Last updated 08 October 2020

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