Thyroid Associated Opthalmopathies | Prednisone Versus Doxycycline in the Treatment of Graves' Orbitopathy
Thyroid Associated Opthalmopathies research study
What is the primary objective of this study?
The aim of this study is to compare the efficacy and safety of prednisone versus sub-antimicrobial dose doxycycline (50 mg/d) in the treatment of active moderate-severe Graves' Orbitopathy (GO).
Who is eligible to participate?
Inclusion Criteria: - Confirmed diagnosis of Graves' Orbitopathy (as defined by Bartley and Gorman) - Eyelid retraction (upper eyelid margin at or above the superior corneoscleral limbus in primary gaze without frontalis muscle contraction) in association with any one of the following: - Thyroid dysfunction or abnormal regulation (increased serum thyroxine or triiodothyronine level, decreased serum thyroid stimulating hormone level, absence of thyroid radioiodine uptake suppression after administration of triiodothyronine, or the presence of thyroid stimulating immunoglobulins in serum) - Exophthalmos - Extraocular muscle involvement (restrictive myopathy or objective evidence of enlarged muscles) - Optic nerve dysfunction (abnormal visual acuity, color vision, pupillary reaction or perimetry not attributable to other causes) OR - Thyroid dysfunction or abnormal regulation in association with any one of the following: - Exophthalmos - Extraocular muscle involvement - Optic nerve dysfunction - Moderate-severe GO According to EUGOGO statement, patients with moderate-severe GO usually have any one or more of the following：lid retraction≥2mm, moderate or severe soft tissue involvement, exophthalmos≥3mm above normal for race and gender, inconstant, or constant diplopia. - Clinical activity score ≥ 3 - Being euthyroid for at least 1 months before the date of inclusion - Must be able to swallow tablets - Written informed consent is obtained Exclusion Criteria: - Mild Graves' Orbitopathy - Sight-threatening Graves' Orbitopathy - Clinical activity score ＜ 3 - Previous treatment for GO Oral steroids, intravenous steroids, radiotherapy - Pregnant females as determined by positive (serum or urine) human chorionic gonadotrophin (hCG) test at screening or prior to dosing, or lactating females - Uncontrolled diabetes or hypertension - History of mental / psychiatric disorder - Hepatic dysfunction (Albumin (Alb) , Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline phosphates levels must be within normal range for eligibility) - Renal impairment (Urea and Creatinine levels must be within normal range) - Doxycycline or Prednisone allergy or intolerance
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Thyroid Associated Opthalmopathies
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Prednisone+placebo of DoxycyclinePrednisone: 50 mg/d for 14 day, tailed by 40 mg/d for 14 day, 30 mg/d for 28 day, 20 mg/d for 28 day, 15 mg/d for 14 day, 10 mg/d for 14 day, in total 16 weeks; Placebo of doxycycline: administered for 16 weeks
Drug:Doxycycline+placebo of PrednisoneDoxycycline: 50 mg PO per day for 12 weeks, and placebo for another 4 weeks; Placebo of prednisone: administered for 16 weeks.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Prednisone+placebo of DoxycyclinePrednisone: 50 mg/d for 14 day, tailed by 40 mg/d for 14 day, 30 mg/d for 28 day, 20 mg/d for 28 day, 15 mg/d for 14 day, 10 mg/d for 14 day, in total 16 weeks; Placebo of doxycycline: administered for 16 weeks.
Doxycycline+placebo of PrednisoneDoxycycline: 50 mg/d for 12 weeks, and placebo for another 4 weeks; Placebo of prednisone: administered for 16 weeks.
Start Date: November 2012
Completed Date: January 2016
Phase: Phase 2/Phase 3
Primary Outcome: Overall treatment response
Secondary Outcome: • Health related quality of life questionnaires (GO-QoL)
Study sponsors, principal investigator, and references
Principal Investigator: Dan Liang, MD
Lead Sponsor: Sun Yat-sen University