An Open Label Trial of Celecoxib in the Treatment of Mild Thyroid Eye Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Thyroid Eye Disease Clinical Activity Score
研究概览
简要总结
Thyroid eye disease (TED) is an autoimmune disorder in which the immune system attacks orbital tissues, resulting in characteristic changes in eyelid position, globe position in the orbit, extraocular muscle balance, and optic nerve function. TED is a potentially blinding disease, and current treatments largely consist of nonspecific reduction of inflammation using corticosteroids or radiation therapy. Regardless of treatment, once TED progresses from its inflammatory phase to a more fibrotic, resolution phase, the orbital changes become fixed and can be modified only by surgery.
The investigators propose to treat a cohort of patients with active TED using a selective COX-2 inhibitor, celecoxib, and to compare these patients to an observational control group. The investigators hypothesize that celecoxib will reduce the severity of disease and/or prevent progression to proptosis, diplopia, and corneal exposure or compressive optic neuropathy.
详细描述
The investigators intend to use celecoxib, a non-steroidal anti-inflammatory drug approved by the Food and Drug Administration (FDA) for the treatment of pain, osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, as a treatment for active TED. In vitro data have shown that transformation of orbital fibroblasts into adipocytes is mediated by cyclooxygenase-2 (COX-2), and a case report suggests that COX-2 inhibition can improve TED in the acute phase. Thus, the investigators intend to evaluate the efficacy of COX-2 inhibition in the treatment of active TED and its ability to improve both the acute inflammatory signs and more permanent fibrotic changes of quiescent disease. The investigators will enroll patients with active TED and treat them for 3 months (a characteristic period of disease activity) and compare this to standard treatments for mild active TED (observation, with over the counter interventions such as lubrication with artificial tears) to assess efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recent diagnosis of thyroid eye disease (within the past 3 months)
- •Have ocular symptoms or signs of TED with a clinical activity score (CAS) of at least 3
排除标准
- •Pregnancy
- •Previous treatment with corticosteroid for TED for >2wks
- •Previous treatment with orbital radiation for TED
- •Impaired renal function
- •Impaired hepatic function
- •Treatment with antihypertensive medications except beta-blockers
- •History of congestive heart failure, cardiac valvular disease, or coronary artery disease
- •Allergy to NSAID or previous adverse reaction (ie. GI bleeding)
- •Vision loss due to compressive optic neuropathy
研究组 & 干预措施
Celecoxib
Patients who are randomized to treatment with celecoxib 100mg pills by mouth twice a day for 3 months, in addition to standard of care treatment as described under the Control arm
干预措施: Celecoxib (Drug)
Celecoxib
Patients who are randomized to treatment with celecoxib 100mg pills by mouth twice a day for 3 months, in addition to standard of care treatment as described under the Control arm
干预措施: artificial tears (Drug)
Control
Patients who are randomized to standard treatment (requiring no prescription medication, but standard recommendations such as artificial tears, avoiding cigarette smoke)
干预措施: artificial tears (Drug)
结局指标
主要结局
Thyroid Eye Disease Clinical Activity Score
时间窗: At baseline, 1, 3 and 6 months
A clinical score based on examination findings at each clinic visit. Clinical Activity Scores ranged from 0 to 10; 0 = Normal 1-3 = Mild 4-6 = Moderate 7-10 = Severe
次要结局
- Proptosis as Measured in Millimeters With an Exophthalmometer (Right Eye)(At baseline, 1, 3 and 6 months)
- Proptosis as Measured in Millimeters With an Exophthalmometer (Left Eye)(At baseline, 1, 3 and 6 months)
- Number of Participants With Ocular Misalignment(At 6 months)
- Eyelid Retraction as Measured in Millimeters (Right Eye)(At baseline, 1, 3 and 6 months)
- Eyelid Retraction as Measured in Millimeters (Left Eye)(At baseline, 1, 3 and 6 months)
- Quality of Life as Assessed by a Thyroid Eye Disease Specific Survey of Quality of Life(6 months)