Active and moderate to severe Graves’ Orbitopathy
Conditions
Interventions
Trade Name: ATG-Fresenius S
Product Name: ATG-Fresenius
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
Fresenius Biotech GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be enrolled in this study only if they meet all of the following criteria: • Signed and dated informed consent form. • Active and moderate to severe GO. • Age: 18 – 70 years. • Patients able to comply with all study related requirements. • Patients able to receive oral medication. • Women of childbearing age with a safe contraceptive method throughout the study. 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: Patients will not be enrolled in this study if they meet any of the following criteria: • Women who are pregnant or breast feeding, or with positive urine pregnancy test • Known Human Immunodeficiency Virus (HIV) infection. • Unable or unwilling to comply fully with the protocol. • Confirmed optic neuropathy with major deterioration of visual acuity. • Patients with anamnestically known hypersensitivity to rabbit immunoglobulin antibodies. • Patients with major organ dysfunctions (> threefold of normal values). • Serious psychiatric or psychological disorders. • Severe actual viral, bacterial or fungal infection not adequately controlled. • Thrombocytopenia: < 80,000 thrombocytes/µl. • Leukopenia: < 4,000 leukocytes/µl. • Concurrent or previous malignancy. • Participation in another study of an investigational medicinal product concurrently or within the last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to investigate whether add-on treatment of ATG-Fresenius S to standard steroid therapy has a beneficial effect on response to therapy defined as Clinical Activity Score (CAS) and Clinical Severity Score (CSS).;Secondary Objective: The secondary objectives of the study are the assessment of the safety and further efficacy parameters in terms of T-cell subpopulations, cytokines, specific and unspecific autoantibodies, thyroid-related hormones, thyroid sonography, glycosaminoglycans, quality of life and requirement of additional treatment for GO.;Primary end point(s): The primary endpoint is the response to therapy at Week 12 vs. Week 0 after commencement of therapy. Response to treatment is defined as clinically relevant improvement of major objective ophthalmic evaluation parameters in at least one eye, which are: • Decrease in Clinical Activity Score (CAS) by >= 2 points at Week 12 compared to Week 0. • Decrease in Clinical Severity Score (CSS) by >= 2 points at Week 12 compared to Week 0. | — |
Countries
Germany
Outcome results
None listed