Clinical Trials Logo
  1. Home
  2. Graves Ophthalmopathy
  3. NCT05793359

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

Graves Ophthalmopathy Clinical Trial

Official title:
Comparison of the Efficacy of Two Different Glucocorticoid Regimens for Treatment of Active Moderate-to-severe Graves' Orbitopathy

Clinical 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. 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.

Clinical Trial 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: 1. Are the two glucocorticoid regimens similarly effective? 2. 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05793359
Study type Observational [Patient Registry]
Source Medical University of Sofia
Contact
Status Completed
Phase
Start date July 25, 2017
Completion date February 25, 2021
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05532072 - Rapamycin Plus Methylprednisolone Versus Methylprednisolone Alone in Active, Moderate-to-severe Graves' Orbitopathy. Early Phase 1
Completed NCT01727973 - Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy Phase 1/Phase 2
Recruiting NCT06112340 - A Phase 2b Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED) Phase 2/Phase 3
Recruiting NCT05678374 - Exploring Immunological Markers Associated With Mental Fatigue in Graves' Disease
Recruiting NCT03708627 - Bimatoprost as a Treatment for Graves' Orbitopathy Early Phase 1
Withdrawn NCT01379196 - Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy Phase 1/Phase 2
Recruiting NCT06275373 - The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction
Recruiting NCT06226545 - A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease Phase 2
Recruiting NCT05126147 - Hydroxychloroquine in Mild Graves' Orbitopathy Phase 4
Recruiting NCT01999790 - Comparison Study Between Two Techniques for Correction of Upper Lid Retraction in Patients With Grave's Orbitopathy N/A
Recruiting NCT03066076 - Total Thyroidectomy Versus Thionamides in Patients With Moderate-to-Severe Graves' Ophthalmopathy Phase 3
Active, not recruiting NCT03122847 - Glucocorticoids and Bone in Graves' Ophthalmopathy
Terminated NCT01893450 - Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment N/A
Completed NCT00348413 - Thyroid Treatment Trial N/A
Completed NCT03498417 - Anti-insulin-like Growth Factor-1 Receptor (IGF-1R) Antibodies in Graves' Disease and Graves' Orbitopathy
Not yet recruiting NCT04598815 - Sirolimus for Graves' Orbitopathy (GO) Phase 2
Terminated NCT01114503 - A Safety and Tolerability Study of Otelixizumab in Thyroid Eye Disease Phase 2
Completed NCT05775185 - Therapeutic Efficacy of Orbital Radiotherapy in Patients With Graves' Orbitopathy
Recruiting NCT02203682 - Doxycycline Treatment in Mild Thyroid-Associated Ophthalmopathy Phase 2
Recruiting NCT05276063 - A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED) Phase 2/Phase 3