A Randomized Clinical Trial of Intravenous Methylprednisolone With 2 Protocols in Patients With Graves Orbitopathy

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThird Affiliated Hospital, Sun Yat-Sen University

About this trial

Intravenous glucocorticoid (IVGC) is an accessible and effective therapy for Graves orbitopathy (GO); the 4.5-g weekly protocol is well studied, but many details of treatment protocols need to be clarified. The goal of this trial is to compare the efficacy and safety of weekly and daily protocol of IVGC in GO. Researchers will compare daily protocol to weekly protocol to see if daily protocol works to treat GO.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-65 years old;

diagnosed as thyroid associated ophthalmopathy by using Bartley criteria,Moderate to severe (EUGOGO grade), with CAS≥3 points;

Thyroid function normally lasts for more than 2 months, with oral antithyroid drugs or thyroid surgery, or six months after iodine-131 treatment;

without receiving immunosuppressive therapy for thyroid eye disease before.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • methylprednisolone(daily scheme)

    Drug

    0.5 g methylprednisolone i.v. daily for 5 consecutive days, followed by oral prednisone for 6 months. Oral prednisone started at 40 mg/day for 4 weeks and then the dose was tapered by 5 mg/day every 2-4 weeks.

  • methylprednisolone(weekly scheme)

    Drug

    0.5 g methylprednisolone i.v. weekly for 6 weeks and then the dose was tapered by 0.25 g/week over the following 6 weeks.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

the overall response rate at 24 week

"Response" was defined as an improvement in at least two of the following four criteria were present, and the contralateral eye disease did not worsen: (1) the width of the eyelid was reduced by ≥2 mm; (2) The five scores of eyelid congestion, eyelid edema, conjunctival congestion, conjunctival edema and carunculae lacrimalis swelling in CAS decreased by ≥1 point; (3) The regression of exophthalmos ≥2 mm; (4) Increased eye movement ≥8° or improved diplopia ≥ grade I (continuous to interrupted, interrupted to brief, brief to none).

Time frame
24 week

Secondary outcomes

1

Changes of clinical activity score (CAS) from baseline to 24 week

changes of clinical activity score (CAS) from baseline to 24 week

Time frame
24 week
2

changes of quality of life score (QoF-s) from baseline to 24 week

changes of quality of life score (QoF-s )

Time frame
24 week
3

changes of exophthalmos from baseline to 24 week

changes of exophthalmos from baseline to 24 week

Time frame
24 week
4

changes of width of the eyelid from baseline to 24 week

changes of width of the eyelid from baseline to 24 week

Time frame
24 week

Other outcomes

1

Changes of blood pressure from baseline to 24 week

Changes of blood pressure from baseline to 24 week

Time frame
24 week
2

Changes of weight from baseline to 24 week

Changes of weight from baseline to 24 week

Time frame
24 week
3

Changes of fasting blood glucose from baseline to 24 week

Changes of fasting blood glucose from baseline to 24 week

Time frame
24 week
4

Changes of serum low density lipoprotein cholesterol

Changes of low density lipoprotein cholesterol from baseline to 24 week

Time frame
24 week

Locations

This trial has no locations.

Sponsors and contacts

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