SOM230 Graves Orbitopathy pilot trial.

Conditions: Graves Orbitopathy

Registration Number: NL-OMON26944

Lead Sponsor: Academic Medical Center Amsterdam

Brief Summary: Optimal management of Graves orbitopathy: a multidisciplinary approach. Soeters MR, van Zeijl CJJ, Boelen A, Kloos R, Saeed P, Vriesendorp TM, et al. The Netherlands journal of medicine. 69(7):302–8.<br> Efficacy and safety of three different cumulative doses of intravenous methylprednisolone for moderate to severe and active Graves' orbitopathy. Bartalena L, Krassas GE, Wiersinga W, Marcocci C, Salvi M, Daumerie C, Bournaud C, Stahl M, Sassi L, Veronesi G, Azzolini C, Boboridis KG, Mourits MP, Soeters MR, Baldeschi L, Nardi M, Currò N, Boschi A, Bernard M, von Arx G; European Group on Graves' Orbitopathy. J Clin Endocrinol Metab. 2012 Dec;97(12):4454-63.

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

1. Moderate – severe GO;

2. Corticosteroids contraindicated due to diabetes mellitus, severe osteoporosis, heart failure, psychosis, infectious diseases or other clinical relevant comorbidities;

Exclusion Criteria

1. Inability/refusal to give informed consent;

2. Pregnancy;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A validated overall ophthalmic/endocrine assessment at the CTEC with predefined criteria for success, no change and worsening of GO at 0, 4, 8 and 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Quality of life (Qol) assessed by the GO-QoL, a validated disease-specific quality-of-life questionnaire to be completed by the patient at 0, 4, 8 and 12 weeks.