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Celecoxib for Thyroid Eye Disease

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ClinicalTrials.gov Identifier: NCT02845336
Recruitment Status : Recruiting
First Posted : July 27, 2016
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.


Condition or disease Intervention/treatment Phase
Thyroid Eye Disease Drug: Celecoxib Drug: artificial tears Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Trial of Celecoxib in the Treatment of Mild Thyroid Eye Disease
Actual Study Start Date : March 5, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: Celecoxib
celecoxib 100mg PO twice per day for 3 months
Other Name: Celebrex

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

Active Comparator: Control
Patients who are randomized to standard treatment (requiring no prescription medication, but standard recommendations such as artificial tears, avoiding cigarette smoke)
Drug: artificial tears
Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke.




Primary Outcome Measures :
  1. Thyroid Eye Disease Clinical Activity Score [ Time Frame: 12 months ]
    A clinical score based on examination findings at each clinic visit


Secondary Outcome Measures :
  1. Change in proptosis as measured in millimeters with an exophthalmometer [ Time Frame: 12 months ]
    A clinical measure of how prominent the eyes are and any change in this measure over the duration of the study, as measured in millimeters with an exophthalmometer

  2. Change in ocular misalignment as measured in prism diopters [ Time Frame: 12 months ]
    Double vision resulting from thyroid eye disease (presence/absence and change with time over the duration of the study, and if present, measures of ocular misalignment in prism diopters)

  3. Change in eyelid retraction as measured in millimeters [ Time Frame: 12 months ]
    A clinical measure of the most common manifestation of thyroid eye disease--change in eyelid retraction as measured in millimeters at each visit over the duration of the study

  4. Quality of Life [ Time Frame: 12 months ]
    Thyroid eye disease specific survey of quality of life will be administered, and change in quality of life score over the duration of the study will be measured



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02845336


Contacts
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Contact: Nickisa Hodgson, MD 410-955-3577 nhodgso2@jhmi.edu
Contact: Jessica R Chang, MD 3154206045 jchang72@jhmi.edu

Locations
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United States, Maryland
Wilmer Eye Institute, Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Nickisa Hodgson, MD    410-955-1112    nhodgso2@jhmi.edu   
Principal Investigator: Timothy J McCulley, MD         
Sub-Investigator: Nicholas R Mahoney, MD         
Sub-Investigator: Fatemeh Rajaii, MD PhD         
Sub-Investigator: Jessica Chang, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Timothy J McCulley, MD Wilmer Eye Institute, Johns Hopkins School of Medicine
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02845336     History of Changes
Other Study ID Numbers: IRB00094787
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Graves Ophthalmopathy
Thyroid Diseases
Eye Diseases
Endocrine System Diseases
Eye Diseases, Hereditary
Graves Disease
Orbital Diseases
Genetic Diseases, Inborn
Autoimmune Diseases
Immune System Diseases
Exophthalmos
Goiter
Hyperthyroidism
Celecoxib
Lubricant Eye Drops
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Ophthalmic Solutions
Pharmaceutical Solutions