NCT01114503 - A Safety and Tolerability Study of Otelixizumab in Thyroid Eye Disease | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 7, 2010

Primary Completion Date

August 29, 2012

Study Completion Date

August 29, 2012

Conditions

Graves Ophthalmopathy

Interventions

DRUG

Otelixizumab - low dose

8 day dose rising intravenous infusions of a low dose of otelixizumab

DRUG

Otelixizumab - medium low dose

8 day dose rising intravenous infusions of a medium low dose of otelixizumab

DRUG

Otelixizumab - medium high dose

8 day dose rising intravenous infusions of a medium high dose of otelixizumab

DRUG

Otelixizumab - high dose

8 day dose rising intravenous infusions of a high dose of otelixizumab

DRUG

Otelixizumab

8 day dose rising intravenous infusions of otelixizumab administered at a dose decided upon results from Part A.

DRUG

Methylprednisolone

Weekly intravenous infusions of methylprednisolone administered as 500 mg per week for 6 weeks and then 250 mg per week for 6 weeks

Trial Locations (1)

GSK Investigational Site, Newcastle upon Tyne