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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05199103
Other study ID # KNW-1-075/N/8/K
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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