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Antithymocyte Globulin as a Second Line Therapy in Graves Orbitopathy

Sponsor
Medical University of Silesia (Other)
Overall Status
Recruiting
CT.gov ID
NCT05199103
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
48
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: rabbit anti-thymocyte globulin
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Single-centre, Safety and Efficacy, Open-label Study Evaluating Antithymocyte Globulin Treatment in Subjects With Graves Orbitopathy
Actual Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. ≥2 point change in Clinical Activity Score from baseline [Week 6, 12, 24, 48]

  2. change in proptosis [48 weeks]

  3. a diplopia response [48 weeks]

  4. change of distant best-corrected visual acuity [Week 6, 12, 24, 48]

  5. change of mean retinal sensitivity [Week 6, 12, 24, 48]

Secondary Outcome Measures

  1. changes in CD4/CD8 ratio [Week 6, 12, 24, 48]

  2. changes in TSH-receptor antibodies level [Week 6, 12, 24, 48]

  3. increase in 1 degree amplitude in Pattern visual evoked potential (VEP) by 1 µV [Week 6, 12, 24, 48]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Internal Medicine and Oncological Chemotherapy, Medical Faculty in Katowice, Medical University of Silesia Katowice Silesia Poland 40-029

Sponsors and Collaborators

  • Medical University of Silesia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gabriela Handzlik, Principal Investigator, Medical University of Silesia
ClinicalTrials.gov Identifier:
NCT05199103
Other Study ID Numbers:
  • KNW-1-075/N/8/K
First Posted:
Jan 20, 2022
Last Update Posted:
Jan 20, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gabriela Handzlik, Principal Investigator, Medical University of Silesia
Graves disease
proptosis
antithymocyte globulin
Additional relevant MeSH terms:
Graves Ophthalmopathy
Antilymphocyte Serum
Thymoglobulin

Study Results

No Results Posted as of Jan 20, 2022