Mycophenolate sodium in Graves’ orbitopathy - MINGO

Conditions: Graves' orbitopathy
MedDRA version: 9.1Level: LLTClassification code 10065624Term: Graves-Basedow disease

Registration Number: EUCTR2008-002123-93-DE

Lead Sponsor: Johannes Gutenberg-Universität

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

1.Euthyroidism for at least 2 months with antithyroid drugs or following thyroidectomy, or 6 months following radioiodine administration
2.Active GO: Clinical Activity Score, CAS = 3 out of 7
3.Moderately severe GO: at least one of the following signs:
-Moderate to severe active soft tissue involvement, also according to color atlas evaluation
-Proptosis = 22 mm
-Eye muscle involvement with mono-ocular ductions in any direction of gaze of less than 30° or evident dismotility
-Diplopia according to Gorman score of grades a-c
4.No previous immunosuppressive treatment for GO
5.Age: 18-75 years
6.Effective method of contraception during the whole trial and at least six weeks after last intake of trial drugs
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.CAS <3
2.Optic neuropathy
3.Pregnancy, breast-feeding women
4.No informed consent
5.Acute or chronic viral hepatitis
6.Relevant Malignancy
7.Chronic renal failure (GFR < 30)
8.Corticosteroids or other immunosuppressive agents within last 3 months
9.Recent history of alcoholism or drug abuse

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - Response rate at week 12: comparison of the combination treatment vs. steroid monotherapy<br>- Relapse rate at weeks 24 and 36 in both groups;Secondary Objective: - Safty of the combination treatment Mycophenolate Sodium + Methylprednisolone i.v.;Primary end point(s): - Response rate at week 12: comparison of the combination treatment vs. steroid monotherapy<br>- Relapse rate at weeks 24 and 36 in both groups<br>

Secondary Outcome Measures