Single-centre, Safety and Efficacy, Open-label Study Evaluating Antithymocyte Globulin Treatment in Subjects With Graves Orbitopathy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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 doses of glucocorticoids.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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)

Locations
Other Locations
Poland
Department of Internal Medicine and Oncological Chemotherapy, Medical Faculty in Katowice, Medical University of Silesia
Recruiting
Katowice
Contact Information
Primary
Gabriela Handzlik, Ph.D.
ghandzlik@sum.edu.pl
322591202
Time Frame
Start Date: January 1, 2020
Estimated Completion Date: December 31, 2023
Participants
Target number of participants: 20
Treatments
Experimental: Rabbit antithymocyte globulin (rATG)
Related Therapeutic Areas
Sponsors
Leads: Medical University of Silesia

This content was sourced from clinicaltrials.gov

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