Antithymocyte Globulin as a Second Line Therapy in Graves Orbitopathy

January 14, 2022 updated by: Gabriela Handzlik, Medical University of Silesia

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
    • Silesia
      • Katowice, Silesia, Poland, 40-029
        • Recruiting
        • Department of Internal Medicine and Oncological Chemotherapy, Medical Faculty in Katowice, Medical University of Silesia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rabbit antithymocyte globulin (rATG)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
≥2 point change in Clinical Activity Score from baseline
Time Frame: Week 6, 12, 24, 48
Week 6, 12, 24, 48
change in proptosis
Time Frame: 48 weeks
48 weeks
a diplopia response
Time Frame: 48 weeks
48 weeks
change of distant best-corrected visual acuity
Time Frame: Week 6, 12, 24, 48
Week 6, 12, 24, 48
change of mean retinal sensitivity
Time Frame: Week 6, 12, 24, 48
Week 6, 12, 24, 48

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in CD4/CD8 ratio
Time Frame: Week 6, 12, 24, 48
Week 6, 12, 24, 48
changes in TSH-receptor antibodies level
Time Frame: Week 6, 12, 24, 48
Week 6, 12, 24, 48
increase in 1 degree amplitude in Pattern visual evoked potential (VEP) by 1 µV
Time Frame: Week 6, 12, 24, 48
Week 6, 12, 24, 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Investigators

  • Principal Investigator: Jerzy Chudek, Prof., Medical University of Silesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

December 27, 2021

First Submitted That Met QC Criteria

January 14, 2022

First Posted (Actual)

January 20, 2022

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 14, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KNW-1-075/N/8/K

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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