Status:
UNKNOWN
Antithymocyte Globulin as a Second Line Therapy in Graves Orbitopathy
Lead Sponsor:
Medical University of Silesia
Conditions:
Graves Orbitopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The overall objective of the study is to evaluate the safety and efficacy of rabbit antithymocyte globulin in the treatment of Graves orbitopathy (GO) after ineffective treatment with moderate-to-high...
Detailed Description
This is a prospective interventional, single-center study examining the safety and efficacy of rabbit antithymocyte globulin (rATG) in adult patients with active moderate-to-severe GO after ineffectiv...
Eligibility Criteria
Inclusion
- Clinical diagnosis of Graves' disease associated with active thyroid eye disease and a clinical activity score of ≥ 3
- Euthyroid or with mild hypo- or hyperthyroidism defined as free thyroxine (FT4) and free triiodothyronine (FT3) levels less than 50% above or below the normal limits
- previous ineffective treatment (partial response, recurrence or progression of symptoms) with moderate-to-high doses of glucocorticoids (at least 4.5 g of methylprednisolone)
Exclusion
- hypersensitivity to rabbit proteins or to any product excipients
- active acute or chronic infections
- latent tuberculosis
- leucopenia below 3000/μl
- lymphopenia below 400/μl
- thrombocytopenia below 75000/μl
- coagulation disorders
- active malignancy and pregnancy
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05199103
Start Date
January 1 2020
End Date
December 31 2023
Last Update
January 20 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Internal Medicine and Oncological Chemotherapy, Medical Faculty in Katowice, Medical University of Silesia
Katowice, Silesian Voivodeship, Poland, 40-029