Clinical, laboratory and ultrasound markers for the prediction of the response on the pulse-dose treatment by intravenous glucocorticoids in patients with endocrine orbitopathy

Phase 1

• Conditions: MedDRA version: 12.1Level: LLTClassification code 10066617Term: Graves' ophthalmopathy worsened; MedDRA version: 12.1Level: LLTClassification code 10014702Term: Endocrine exophthalmos; MedDRA version: 12.1Level: LLTClassification code 10015684Term: Exophthalmos endocrine; MedDRA version: 12.1Level: LLTClassification code 10057889Term: Graves' ophthalmopathy; active severe endocrine orbitopathy; MedDRA version: 12.1Level: LLTClassification code 10043787Term: Thyrotoxic exophthalmos

• Registration Number: EUCTR2010-018289-21-CZ
• Lead Sponsor: Insitute of Endocrinology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-26
• Last Update Posted: 14 November 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Pacients with active and moderate to severe or sight threatening endocrine orbitopathy (EO), age more than 18 years, laboratory positivity of autoantibodies against TSH receptor, patological monitored parameters for the ultrasonographical examination of the orbit.
Activity is maesured on the classical features on inflamantion: clinical activity score (CAS). CAS more tahn 4 indicates active EO.
Moderate to severe EO: Patients usualy have any one or more of the following: lid retraciton more than 2 mm, moderate or severe soft tissue involvement, exophthalmos more than 3 mm above normal for race and gender, inconstant, or constant diplopia.
Sight threatening EO: Patients with dysthyroid optic neuropathy and/or corneal breakdown.
Monitored parameters for the ultrasonographic examination of the orbit: thickness of the medial, lateral and inferior direct eye muscle and thickness of the upper muscle group - superior direct with eyelid levator - lateral and inferior, according to an arbitrary scale established by us the muscle echogenicity - I to IV, where I is a normal orbital muscle, i.e. deeply hypoechogeneic, IV is of the echogenicity as high that it is barely undistinguishable from surrounding connective tissue. Measurement of the flow rates especially in the arteria centralis retinae, artheries cilliares breves and in artheria ophthalmica.

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

hypersensitivity, TBC (patients with active disease and latent disease, including positive tuberculin test, which need careful monitoring for possibility of reactivation of disease and requirements of chemoprophylaxis), systemic mycosis, active peptic ulcer, fresh intestinal anastomoses, decompensated diabetes mellitus, severe heart insuficiency, severe uncorrected hypertension, psychosis (acute or in medical history), severe impairment of renal function, active hepatitis, gravidity, lactation, inability to sign the informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Aim of the project is to find laboratory, clinical and ultrasonographic markers usable for the prediction of the response on intravenous GC administration in severe endocrine orbitopathy and to elucidate the differences in the treatment effect among individual patients.;Secondary Objective: To improve the efficiency of the treatment and diagnostics in patients with severe endocrine orbitopathy ;Primary end point(s): The characteristics of particular clinical, laboratory and ultrasonographic markers for prediction of response to iv glucocorticoid administration