Mycophenolate sodium in Graves’ orbitopathy - MINGO

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-002123-93-DE

Enrollment

150

Registered

2009-04-16

Start date

2009-07-30

Completion date

Unknown

Last updated

2015-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graves' orbitopathy MedDRA version: 9.1 Level: LLT Classification code 10065624 Term: Graves-Basedow disease

Interventions

Trade Name: Myfortic Product Name: Mycophenolate Sodium Product Code: ERL080 Pharmaceutical Form: Tablet INN or Proposed INN: Mycophenolate Sodium CAS Number: 37415-62-6 Current Sponsor code: ERL080 O

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: - Response rate at week 12: comparison of the combination treatment vs. steroid monotherapy - 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 - Relapse rate at weeks 24 and 36 in both groups	—

Measure

Time frame

Main Objective: - Response rate at week 12: comparison of the combination treatment vs. steroid monotherapy - 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 - Relapse rate at weeks 24 and 36 in both groups

—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026