NCT05199103

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

4 years

First QC Date

December 27, 2021

Last Update Submit

January 14, 2022

Conditions

Graves Orbitopathy

Keywords

Graves diseaseproptosisantithymocyte globulin

Outcome Measures

Primary Outcomes (5)

  • ≥2 point change in Clinical Activity Score from baseline

    Week 6, 12, 24, 48

  • change in proptosis

    48 weeks

  • a diplopia response

    48 weeks

  • change of distant best-corrected visual acuity

    Week 6, 12, 24, 48

  • change of mean retinal sensitivity

    Week 6, 12, 24, 48

Secondary Outcomes (3)

  • changes in CD4/CD8 ratio

    Week 6, 12, 24, 48

  • changes in TSH-receptor antibodies level

    Week 6, 12, 24, 48

  • increase in 1 degree amplitude in Pattern visual evoked potential (VEP) by 1 µV

    Week 6, 12, 24, 48

Study Arms (1)

Rabbit antithymocyte globulin (rATG)

EXPERIMENTAL
Drug: rabbit anti-thymocyte globulin

Interventions

rabbit anti-thymocyte globulinDRUG

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.

Rabbit antithymocyte globulin (rATG)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine and Oncological Chemotherapy, Medical Faculty in Katowice, Medical University of Silesia

Katowice, Silesian Voivodeship, 40-029, Poland

RECRUITING

Related Publications (1)

  • Sarnat-Kucharczyk M, Swierkot M, Handzlik G, Kulawik G, Jagoda K, Grochola-Malecka I, Fryzewska J, Mrukwa-Kominek E, Chudek J. Antithymocyte Globulin as Second-Line Therapy in Graves Orbitopathy-Preliminary Results From a Prospective Single-Center Study. Front Endocrinol (Lausanne). 2022 May 9;13:871009. doi: 10.3389/fendo.2022.871009. eCollection 2022.

    PMID: 35615718DERIVED

MeSH Terms

Conditions

Graves OphthalmopathyGraves DiseaseExophthalmos

Interventions

Antilymphocyte Serum

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesOrbital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex Mixtures

Study Officials

  • Jerzy Chudek, Prof.

    Medical University of Silesia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriela Handzlik, Ph.D.

CONTACT

322591202ghandzlik@sum.edu.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 27, 2021

First Posted

January 20, 2022

Study Start

January 1, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

January 20, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)