Antithymocyte Globulin as a Second Line Therapy in Graves Orbitopathy

Graves Orbitopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05199103
• Other study ID #: KNW-1-075/N/8/K
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2022
• Source: Medical University of Silesia
• Contact: Gabriela Handzlik, Ph.D.
• Phone: 322591202
• Email: ghandzlik[@]sum.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Graves Ophthalmopathy
• Graves Orbitopathy

Intervention

Drug:
• rabbit anti-thymocyte globulin
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.

Locations

Country	Name	City	State
Poland	Department of Internal Medicine and Oncological Chemotherapy, Medical Faculty in Katowice, Medical University of Silesia	Katowice	Silesia

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Silesia

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	=2 point change in Clinical Activity Score from baseline		Week 6, 12, 24, 48
Primary	change in proptosis		48 weeks
Primary	a diplopia response		48 weeks
Primary	change of distant best-corrected visual acuity		Week 6, 12, 24, 48
Primary	change of mean retinal sensitivity		Week 6, 12, 24, 48
Secondary	changes in CD4/CD8 ratio		Week 6, 12, 24, 48
Secondary	changes in TSH-receptor antibodies level		Week 6, 12, 24, 48
Secondary	increase in 1 degree amplitude in Pattern visual evoked potential (VEP) by 1 µV		Week 6, 12, 24, 48