Graves OphthalmopathyNCT05793359
Comparison of the Effectiveness of Two Glucocorticoid Regimens for Treatment of Graves' Orbitopathy
An observational study of Graves Ophthalmopathy, run by Medical University of Sofia at 1 site in Bulgaria.
Trial summary
The goal of this interventional study is to compare the effectiveness of two different glucocorticoid regimens for treatment of active moderate-to-severe Graves' orbitopathy. The main questions it aims to answer are: 1. Are the two glucocorticoid regimens similarly effective? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graves Ophthalmopathy
- What is being tested?
- Methylprednisolone
- Type of treatment
- Injection or infusion
- How many people
- 62 participants
- Where
- 1 siteBulgaria
- Study dates
- 25 Jul 2017to 25 Feb 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
Study population: Sixty-two patients with untreated active moderate-to-severe Graves' orbitopathy in euthyroid state under treatment.
Who may be able to join
- Active moderate-to-severe Graves' orbitopathy
- Without previous treatment with glucocorticoids or orbital radiotherapy
- Euthyroid state
Who cannot join
- Uncontrolled hyper- or hypothyroidism
- Previously treated Graves' orbitopathy
- Mild or sight-threatening form of Graves' orbitopathy
- Inactive moderate-to-severe Graves' orbitopathy
- Contraindications for glucocorticoid treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of Two Different Glucocorticoid Regimens for Treatment of Active Moderate-to-severe Graves' Orbitopathy
The goal of this interventional study is to compare the effectiveness of two different glucocorticoid regimens for treatment of active moderate-to-severe Graves' orbitopathy. The main questions it aims to answer are:
- Are the two glucocorticoid regimens similarly effective?
- Do the two glucocorticoid regimens have similar safety profile? The patients involved are treated with one of the two glucocorticoid regimens. Their ocular status, therapeutic response and quality of life reassessed during the treatment, at its end, and 3 month later.
Read the detailed description
Systemic glucocorticoids are the mainstay of treatment for active moderate-to-severe Graves' orbitopathy. However, there are a number of different glucocorticoid regimens with different total dosage, schemes of administration and duration. The goal of this interventional study is to compare the effectiveness of two different glucocorticoid regimens for treatment of active moderate-to-severe Graves' orbitopathy. The main questions it aims to answer are:
- Are the two glucocorticoid regimens similarly effective?
- Do the two glucocorticoid regimens have similar safety profile? The patients involved are treated with one of the two glucocorticoid regimens. The first group is treated with modified monthly regimen, including 3 pulses of 3 infusions of 500 mg methylprednisolone administered in three consecutive months, with application of 125 mg methylprednisolone intramuscularly once per week between the pulses. Total cumulative dose - 5.5. g., duration - 3 months. After completion of the venous infusions, a low dose peroral glucocorticoid therapy is prescribed for the next 3 months. The second group is treated with weekly glucocorticoid regimen: 6 infusions of 500 mg methylprednisolone during the first 6 weeks followed by 6 infusions of 250 mg methylprednisolone during the next 6 weeks. Total cumulative dose - 4.5 g., duration - 3 months. Patients' ocular status and therapeutic response are assessed at 1st, 3rd and 6th months; quality of life - at 3rd and 6th month.
- Conditions
- Graves Ophthalmopathy
- Being tested
- Methylprednisolone
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Urbason
methylprednisolone applied as intravenous infusions or intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| Modified monthly regimen | Treatment with 3 pulses of 3 infusions of 500 mg methylprednisolone on 3 consecutive months with intramuscular administration of 125 mg methylprednisolone per week between the pulses. Additional low dose peroral treatment after completion of the pulses. Receives: Drug: Methylprednisolone | |
| Weekly regimen | Treatment with 6 infusions of 500 mg methylprednisolone during the first 6 weeks, followed by 6 infusions of 250 mg methylprednisolone during the next 6 weeks. Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the changes in the overall therapeutic response assessed using Bartalena's criteria during the treatment with the two glucocorticoid regimens
Comparison of the changes in the overall therapeutic response assessed using Bartalena's criteria and classified as full, partial and no response during the treatment with the two glucocorticoid regimens
Measured: 6 months
Comparison of the changes in clinical activity score, assessed using a 7- or 10-point scale and expressed in points during the treatment with the two glucocorticoid regimens
Comparison of the changes in clinical activity score, assessed using a 7-point scale at baseline or 10-point scale during the follow-up and expressed in points as recommended by European Thyroid Association and European Group on Graves' orbitopathy during the treatment with the two glucocorticoid regimens
Measured: 6 months
Comparison of the changes in lid aperture expressed in mm during the treatment with the two glucocorticoid regimens
Comparison of the changes in lid aperture measured by ruler and expressed in mm during the treatment with the two glucocorticoid regimens
Measured: 6 months
Comparison of the changes in proptosis expressed in mm during the treatment with the two glucocorticoid regimens
Comparison of the changes in proptosis measured by Hertel's exophthalmometer and expressed in mm during the treatment with the two glucocorticoid regimens
Measured: 6 months
Comparison of the changes in visual acuity expressed in decimals during the treatment with the two glucocorticoid regimens
Comparison of the changes in visual acuity measured by Snellen chart and expressed in decimals during the treatment with the two glucocorticoid regimens
Measured: 6 months
Comparison of the changes in diplopia assessed using Gorman's classification system during the treatment with the two glucocorticoid regimens
Comparison of the changes in diplopia assessed using Gorman's classification system and classified as gr. 0 absent, gr. I intermittent, gr. II inconstant, gr. III constant during the treatment with the two glucocorticoid regimens
Measured: 6 months
Comparison of the changes in soft tissue involvement evaluated using the colour atlas proposed by European Group on Graves' orbitopathy during the treatment with the two glucocorticoid regimens
Comparison of the changes in soft tissue involvement evaluated using the colour atlas proposed by European Group on Graves' orbitopathy and categorized as gr. 0-I absent or mild, gr. II-III moderate or severe during the treatment with the two glucocorticoid regimens
Measured: 6 months
Comparison of the changes in subjective symptoms whose severity was reported by patients themselves using subjective scale during the treatment with the two glucocorticoid regimens
Comparison of the changes in subjective symptoms whose severity was reported by patients themselves and were graded as 0-I absent or mild, gr. II-III moderate or severe during the treatment with the two glucocorticoid regimens
Measured: 6 months
Comparison of the changes in quality of life assessed by disease-specific questionnaire recommended by European Group on Graves' orbitopathy (GO-QoL) аnd expressed as percentages during the treatment with the two glucocorticoid regimens
Comparison of the changes in quality of life during the treatment with the two glucocorticoid regimens assessed by disease-specific questionnaire recommended by European Group on Graves' orbitopathy (GO-QoL) аnd expressed as percentages, which includes two subscales - one evaluating the impact of Graves' orbitopathy on patients' visual functioning (QoL-VF) and the other related to the changes of physical appearance as a result of the disease (QoL-AP)
Measured: 6 months
Incidence of treatment-emerged adverse events in the two glucocorticoid regimens groups
Number and type of adverse reactions in the study groups reported by patients themselves or found by the laboratory tests or during clinical examination.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start25 Jul 2017
- Primary completion25 Feb 2021
- Study completion25 Feb 2021
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 OphthalmopathyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Medical University of Sofia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariya Stoynova, Medical University of Sofia
- Investigators
- Mariya D Stoynova, PhD, Principal investigator, Medical University of Sofia: Medicinski universitet-Sofia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793359
- Sponsor's protocol ID
- 21A /25.07.2017
- Status last verified
- Mar 2023
- First submitted
- 7 Mar 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stoynova MA, Shinkov AD, Dimitrova ID, Yankova IA, Kovatcheva RD. Comparison of the efficacy of two different glucocorticoid regimens for treatment of active moderate-to-severe Graves' orbitopathy. Int Ophthalmol. 2023 Dec;43(12):4747-4757. doi: 10.1007/s10792-023-02875-z. Epub 2023 Sep 12.
PubMed 37698660
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Two Different Glucocorticoid Regimens for Treatment of Active Moderate-to-severe Graves' Orbitopathy
- ClinicalTrials.gov ID
- NCT05793359
- Acronym / sponsor ID
- 21A /25.07.2017
- Conditions
- Graves Ophthalmopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Medical University of SofiaUniversity, hospital or other
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 31 Mar 2023 (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 goal of this interventional study is to compare the effectiveness of two different glucocorticoid regimens for treatment of active moderate-to-severe Graves' orbitopathy. The main questions it aims to answer are:
- Are the two glucocorticoid regimens similarly effective?
- Do the two glucocorticoid regimens have similar safety profile? The patients involved are treated with one of the two glucocorticoid regimens. Their ocular status, therapeutic response and quality of life reassessed during the treatment, at its end, and 3 month later.
Detailed description
Systemic glucocorticoids are the mainstay of treatment for active moderate-to-severe Graves' orbitopathy. However, there are a number of different glucocorticoid regimens with different total dosage, schemes of administration and duration. The goal of this interventional study is to compare the effectiveness of two different glucocorticoid regimens for treatment of active moderate-to-severe Graves' orbitopathy. The main questions it aims to answer are:
- Are the two glucocorticoid regimens similarly effective?
- Do the two glucocorticoid regimens have similar safety profile? The patients involved are treated with one of the two glucocorticoid regimens. The first group is treated with modified monthly regimen, including 3 pulses of 3 infusions of 500 mg methylprednisolone administered in three consecutive months, with application of 125 mg methylprednisolone intramuscularly once per week between the pulses. Total cumulative dose - 5.5. g., duration - 3 months. After completion of the venous infusions, a low dose peroral glucocorticoid therapy is prescribed for the next 3 months. The second group is treated with weekly glucocorticoid regimen: 6 infusions of 500 mg methylprednisolone during the first 6 weeks followed by 6 infusions of 250 mg methylprednisolone during the next 6 weeks. Total cumulative dose - 4.5 g., duration - 3 months. Patients' ocular status and therapeutic response are assessed at 1st, 3rd and 6th months; quality of life - at 3rd and 6th month.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified monthly regimen | – | Drug: MethylprednisoloneTreatment with 3 pulses of 3 infusions of 500 mg methylprednisolone on 3 consecutive months with intramuscular administration of 125 mg methylprednisolone per week between the pulses. Additional low dose peroral treatment after completion of the pulses. |
| Weekly regimen | – | Drug: MethylprednisoloneTreatment with 6 infusions of 500 mg methylprednisolone during the first 6 weeks, followed by 6 infusions of 250 mg methylprednisolone during the next 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sixty-two patients with untreated active moderate-to-severe Graves' orbitopathy in euthyroid state under treatment.
Key inclusion criteria (3 listed)
- Active moderate-to-severe Graves' orbitopathy
- Without previous treatment with glucocorticoids or orbital radiotherapy
- Euthyroid state
Key exclusion criteria (5 listed)
- Uncontrolled hyper- or hypothyroidism
- Previously treated Graves' orbitopathy
- Mild or sight-threatening form of Graves' orbitopathy
- Inactive moderate-to-severe Graves' orbitopathy
- Contraindications for glucocorticoid treatment
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 |
|---|---|---|
| MethylprednisoloneAlso: Urbasonmethylprednisolone applied as intravenous infusions or intramuscularly | Drug | Modified monthly regimen, Weekly regimen |
Primary outcome
Comparison of the changes in the overall therapeutic response assessed using Bartalena's criteria during the treatment with the two glucocorticoid regimens
Time frame: 6 months
Comparison of the changes in the overall therapeutic response assessed using Bartalena's criteria and classified as full, partial and no response during the treatment with the two glucocorticoid regimens
Comparison of the changes in clinical activity score, assessed using a 7- or 10-point scale and expressed in points during the treatment with the two glucocorticoid regimens
Time frame: 6 months
Comparison of the changes in clinical activity score, assessed using a 7-point scale at baseline or 10-point scale during the follow-up and expressed in points as recommended by European Thyroid Association and European Group on Graves' orbitopathy during the treatment with the two glucocorticoid regimens
Comparison of the changes in lid aperture expressed in mm during the treatment with the two glucocorticoid regimens
Time frame: 6 months
Comparison of the changes in lid aperture measured by ruler and expressed in mm during the treatment with the two glucocorticoid regimens
Comparison of the changes in proptosis expressed in mm during the treatment with the two glucocorticoid regimens
Time frame: 6 months
Comparison of the changes in proptosis measured by Hertel's exophthalmometer and expressed in mm during the treatment with the two glucocorticoid regimens
Comparison of the changes in visual acuity expressed in decimals during the treatment with the two glucocorticoid regimens
Time frame: 6 months
Comparison of the changes in visual acuity measured by Snellen chart and expressed in decimals during the treatment with the two glucocorticoid regimens
Comparison of the changes in diplopia assessed using Gorman's classification system during the treatment with the two glucocorticoid regimens
Time frame: 6 months
Comparison of the changes in diplopia assessed using Gorman's classification system and classified as gr. 0 absent, gr. I intermittent, gr. II inconstant, gr. III constant during the treatment with the two glucocorticoid regimens
Comparison of the changes in soft tissue involvement evaluated using the colour atlas proposed by European Group on Graves' orbitopathy during the treatment with the two glucocorticoid regimens
Time frame: 6 months
Comparison of the changes in soft tissue involvement evaluated using the colour atlas proposed by European Group on Graves' orbitopathy and categorized as gr. 0-I absent or mild, gr. II-III moderate or severe during the treatment with the two glucocorticoid regimens
Comparison of the changes in subjective symptoms whose severity was reported by patients themselves using subjective scale during the treatment with the two glucocorticoid regimens
Time frame: 6 months
Comparison of the changes in subjective symptoms whose severity was reported by patients themselves and were graded as 0-I absent or mild, gr. II-III moderate or severe during the treatment with the two glucocorticoid regimens
Comparison of the changes in quality of life assessed by disease-specific questionnaire recommended by European Group on Graves' orbitopathy (GO-QoL) аnd expressed as percentages during the treatment with the two glucocorticoid regimens
Time frame: 6 months
Comparison of the changes in quality of life during the treatment with the two glucocorticoid regimens assessed by disease-specific questionnaire recommended by European Group on Graves' orbitopathy (GO-QoL) аnd expressed as percentages, which includes two subscales - one evaluating the impact of Graves' orbitopathy on patients' visual functioning (QoL-VF) and the other related to the changes of physical appearance as a result of the disease (QoL-AP)
Incidence of treatment-emerged adverse events in the two glucocorticoid regimens groups
Time frame: 6 months
Number and type of adverse reactions in the study groups reported by patients themselves or found by the laboratory tests or during clinical examination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Derived from this study: PubMed 37698660Stoynova MA, Shinkov AD, Dimitrova ID, Yankova IA, Kovatcheva RD. Comparison of the efficacy of two different glucocorticoid regimens for treatment of active moderate-to-severe Graves' orbitopathy. Int Ophthalmol. 2023 Dec;43(12):4747-4757. doi: 10.1007/s10792-023-02875-z. Epub 2023 Sep 12.
- Individual participant dataSharing planned: No
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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.
Mariya D Stoynova, PhD principal investigator
Medical University of Sofia: Medicinski universitet-Sofia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graves Ophthalmopathy, run by Medical University of Sofia at 1 site in Bulgaria.
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 5 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: finished, as of the sponsor's last update on 31 Mar 2023. 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 Bulgaria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the changes in the overall therapeutic response assessed using Bartalena's criteria during the treatment with the two glucocorticoid regimens (time frame: 6 months). The study lists 10 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 NCT05793359, 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 31 Mar 2023.