Antithymocyte Globulin as a Second Line Therapy in Graves Orbitopathy

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Silesia
• Treatments: Antilymphocyte Serum; Thymoglobulin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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