Celecoxib for Thyroid Eye Disease

NCT ID: NCT02845336

Last Updated: 2020-07-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-05
• Study Completion Date: 2019-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Thyroid Eye Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Celecoxib

Intervention Type: DRUG

celecoxib 100mg PO twice per day for 3 months

artificial tears

Intervention Type: DRUG

Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke.

Control

Patients who are randomized to standard treatment (requiring no prescription medication, but standard recommendations such as artificial tears, avoiding cigarette smoke)

Group Type: ACTIVE_COMPARATOR

artificial tears

Intervention Type: DRUG

Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke.

Interventions

Celecoxib

celecoxib 100mg PO twice per day for 3 months

Intervention Type: DRUG

artificial tears

Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke.

Intervention Type: DRUG

Other Intervention Names

Celebrex

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy J McCulley, MD

Role: PRINCIPAL_INVESTIGATOR

Wilmer Eye Institute, Johns Hopkins School of Medicine

Locations

Wilmer Eye Institute, Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00094787

Identifier Type: -

Identifier Source: org_study_id