Antithymocyte Globulin as a Second Line Therapy in Graves Orbitopathy

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    20
  • sponsor
    Medical University of Silesia
Updated on 25 March 2022

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.

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 ineffective treatment with moderate-to-high doses of glucocorticoids. All enrolled participants will receive 0.8 - 1.0 mg/kg of rATG (cumulative dose of 150-200 mg given intravenously in two or three divided doses, 24 hours apart) after premedication with methylprednisolone i.v. (in total dose of 375 mg), 1 mg of antihistaminic agent clemastine and 1000 mg paracetamol i.v.

In order to assess efficacy and safety of the treatment, patients will be evaluated at baseline and at 6, 12, 24 and 48 weeks. Baseline and subsequent evaluation will involve medical history, physical examination, including detailed eye examination, laboratory assessment (thyroid-stimulating hormone [TSH], flow cytometry, TSH-receptor antibodies, CBC) and orbital magnetic resonance imaging (MRI).

Details
Condition Graves Orbitopathy
Treatment Rabbit Anti-thymocyte Globulin
Clinical Study IdentifierNCT05199103
SponsorMedical University of Silesia
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

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
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