Graves OrbitopathyNCT05199103
Antithymocyte Globulin as a Second Line Therapy in Graves Orbitopathy
A study testing rabbit anti-thymocyte globulin in people with Graves Orbitopathy, run by Medical University of Silesia at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graves Orbitopathy
- What is being tested?
- rabbit anti-thymocyte globulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Internal Medicine and Oncological Chemotherapy, Medical Faculty in Katowice, Medical University of Silesia
Katowice, Silesian Voivodeship, 40-029
Gabriela Handzlik, 322591202 ext. 0048, ghandzlik@sum.edu.pl
About this study
Official title: 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.
Read the 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).
- Conditions
- Graves Orbitopathy
- Being tested
- rabbit anti-thymocyte globulin
- Keywords
- Graves disease, proptosis, antithymocyte globulin
- Medical subject headings
- Graves Ophthalmopathy, Graves Disease, Exophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Rabbit antithymocyte globulin (rATG) | Experimental | Not described Receives: Drug: rabbit anti-thymocyte globulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
≥2 point change in Clinical Activity Score from baseline
Measured: Week 6, 12, 24, 48
change in proptosis
Measured: 48 weeks
a diplopia response
Measured: 48 weeks
change of distant best-corrected visual acuity
Measured: Week 6, 12, 24, 48
change of mean retinal sensitivity
Measured: Week 6, 12, 24, 48
Secondary outcomes (3)
changes in CD4/CD8 ratio
Measured: Week 6, 12, 24, 48
changes in TSH-receptor antibodies level
Measured: Week 6, 12, 24, 48
increase in 1 degree amplitude in Pattern visual evoked potential (VEP) by 1 µV
Measured: Week 6, 12, 24, 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Jan 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graves OrbitopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela Handzlik, Medical University of Silesia
- Investigators
- Jerzy Chudek, Prof., Principal investigator, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199103
- Sponsor's protocol ID
- KNW-1-075/N/8/K
- Status last verified
- Jan 2022
- First submitted
- 27 Dec 2021
- Last updated
- 20 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35615718
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-centre, Safety and Efficacy, Open-label Study Evaluating Antithymocyte Globulin Treatment in Subjects With Graves Orbitopathy
- ClinicalTrials.gov ID
- NCT05199103
- Acronym / sponsor ID
- KNW-1-075/N/8/K
- Conditions
- Graves Orbitopathy
- Keywords
- Graves disease, proptosis, antithymocyte globulin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rabbit antithymocyte globulin (rATG) | Experimental | Drug: rabbit anti-thymocyte globulin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- hypersensitivity to rabbit proteins or to any product excipients
- active acute or chronic infections
- latent tuberculosis
- leucopenia below 3000/μl
- lymphopenia below 400/μl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rabbit anti-thymocyte globulin0.8 - 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. | Drug | Rabbit antithymocyte globulin (rATG) |
Primary outcome
≥2 point change in Clinical Activity Score from baseline
Time frame: Week 6, 12, 24, 48
change in proptosis
Time frame: 48 weeks
a diplopia response
Time frame: 48 weeks
change of distant best-corrected visual acuity
Time frame: Week 6, 12, 24, 48
change of mean retinal sensitivity
Time frame: Week 6, 12, 24, 48
3 secondary outcomes
changes in CD4/CD8 ratio
Time frame: Week 6, 12, 24, 48
changes in TSH-receptor antibodies level
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Derived from this study: PubMed 35615718Sarnat-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.
- Individual participant dataSharing planned: No
Related trials for Graves Orbitopathy
Active, not recruitingPhase 4
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Early Risk Stratification of Thyroid Eye Disease in Newly Diagnosed Graves' Disease
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RecruitingPhase 1
Evaluation of ETHY-001 for Safety, Tolerability, and Clinical Activity in Thyroid Eye Disease
Thyroid Eye Disease (TED), Graves' Disease
Not yet recruitingPhase 2
Prophylactic Treatment of Graves Ophthalmopathy (GO) in Newly Diagnosed Graves' Disease (GD) With Atorvastatin (ATORGO)
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RecruitingPhase 3
Study to Assess Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)
Thyroid Eye Disease, TED, Graves Orbitopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerzy Chudek, Prof. principal investigator
Medical University of Silesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rabbit anti-thymocyte globulin in people with Graves Orbitopathy, run by Medical University of Silesia at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriela Handzlik, Ph.D. (322591202 ext. 0048, ghandzlik@sum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
≥2 point change in Clinical Activity Score from baseline (time frame: Week 6, 12, 24, 48). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05199103, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022.