Celecoxib for Thyroid Eye Disease

NCT02845336 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: IRB00094787
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Eye Disease

Outcome Measures

Primary Outcomes (1)

• Thyroid Eye Disease Clinical Activity Score

  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

  At baseline, 1, 3 and 6 months

Secondary Outcomes (9)

• 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 baseline

• Number of Participants With Ocular Misalignment

  At 1 month

• Number of Participants With Ocular Misalignment

  At 3 months

Study Arms (2)

Celecoxib

EXPERIMENTAL

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; Drug: artificial tears

Control

ACTIVE COMPARATOR

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

Drug: artificial tears

Interventions

Celecoxib DRUG

celecoxib 100mg PO twice per day for 3 months

Also known as: Celebrex

Celecoxib

artificial tears DRUG

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

Celecoxib; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Wilmer Eye Institute, Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

Celecoxib; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Results Point of Contact

• Title: Timothy J McCulley, MD
• Organization: Johns Hopkins University

tmccull5@jhmi.edu

4105503000

Study Officials

• Timothy J McCulley, MD

  Wilmer Eye Institute, Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 27, 2016
• Study Start: March 5, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 31, 2020
• Results First Posted: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)