Comparison of the Effectiveness of Two Glucocorticoid Regimens for Treatment of Graves' Orbitopathy

NCT05793359 | Completed

• 1 other identifier: 21A /25.07.2017
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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. 1.Are the two glucocorticoid regimens similarly effective?
2. 2.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.

Conditions

Graves Ophthalmopathy

Outcome Measures

Primary Outcomes (10)

• 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

  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

  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

  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

  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

  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

  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

  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

  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)

  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.

  6 months

Study Arms (2)

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.

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.

Drug: Methylprednisolone

Interventions

Methylprednisolone DRUG

methylprednisolone applied as intravenous infusions or intramuscularly

Also known as: Urbason

Modified monthly regimen; Weekly regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sixty-two patients with untreated active moderate-to-severe Graves' orbitopathy in euthyroid state under treatment.

You may qualify if:

• Active moderate-to-severe Graves' orbitopathy
• Without previous treatment with glucocorticoids or orbital radiotherapy
• Euthyroid state

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Sofia: lead

Study Sites (1)

University Hospital of Endocrinology

Sofia, 1000, Bulgaria

Location

Related Publications (1)

• 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.

  PMID: 37698660 DERIVED

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mariya D Stoynova, PhD

  Medical University of Sofia: Medicinski universitet-Sofia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 31, 2023
• Study Start: July 25, 2017
• Primary Completion: February 25, 2021
• Study Completion: February 25, 2021
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)