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Poor enrollment
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control | Active Comparator | Patients who are randomized to standard treatment (requiring no prescription medication, but standard recommendations such as artificial tears, avoiding cigarette smoke) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | celecoxib 100mg PO twice per day for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proptosis as Measured in Millimeters With an Exophthalmometer (Right Eye) | 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. | At baseline, 1, 3 and 6 months |
| Proptosis as Measured in Millimeters With an Exophthalmometer (Left Eye) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy J McCulley, MD | Wilmer Eye Institute, Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilmer Eye Institute, Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Celecoxib: celecoxib 100mg PO twice per day for 3 months artificial tears: Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke. |
| FG001 | Control | Patients who are randomized to standard treatment (requiring no prescription medication, but standard recommendations such as artificial tears, avoiding cigarette smoke) artificial tears: Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Celecoxib: celecoxib 100mg PO twice per day for 3 months artificial tears: Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | No participant in control arm was assessed for this outcome measure. | Posted | Count of Participants | Participants | At baseline, 1, 3 and 6 months |
|
6 months
No participant enrolled in the control arm was followed for adverse events. Only 1 participant in the treatment arm was followed for adverse events. The rest were either lost to follow up or didn't get medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Celecoxib: celecoxib 100mg PO twice per day for 3 months artificial tears: Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy J McCulley, MD | Johns Hopkins University | 4105503000 | tmccull5@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 21, 2017 | Jun 26, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D006111 | Graves Disease |
| D005094 | Exophthalmos |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| artificial tears | Drug | Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke. |
|
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. |
| At baseline, 1, 3 and 6 months |
| Number of Participants With Ocular Misalignment | Presence or absence of ocular misalignment measured in prism diopters. | At baseline |
| Number of Participants With Ocular Misalignment | Presence or absence of ocular misalignment measured in prism diopters. | At 1 month |
| Number of Participants With Ocular Misalignment | Presence or absence of ocular misalignment measured in prism diopters. | At 3 months |
| Number of Participants With Ocular Misalignment | Presence or absence of ocular misalignment measured in prism diopters. | At 6 months |
| Eyelid Retraction as Measured in Millimeters (Right Eye) | 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. | At baseline, 1, 3 and 6 months |
| Eyelid Retraction as Measured in Millimeters (Left Eye) | 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. | At baseline, 1, 3 and 6 months |
| Quality of Life as Assessed by a Thyroid Eye Disease Specific Survey of Quality of Life | 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. | 6 months |
| BG001 | Control | Patients who are randomized to standard treatment (requiring no prescription medication, but standard recommendations such as artificial tears, avoiding cigarette smoke) artificial tears: Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Control |
Patients who are randomized to standard treatment (requiring no prescription medication, but standard recommendations such as artificial tears, avoiding cigarette smoke) artificial tears: Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke. |
|
|
| Secondary | Proptosis as Measured in Millimeters With an Exophthalmometer (Right Eye) | 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. | No participant in control arm was assessed for this outcome measure. | Posted | Number | millimeters | At baseline, 1, 3 and 6 months |
|
|
|
| Secondary | Proptosis as Measured in Millimeters With an Exophthalmometer (Left Eye) | 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. | No participant in control arm was assessed for this outcome measure. | Posted | Number | millimeters | At baseline, 1, 3 and 6 months |
|
|
|
| Secondary | Number of Participants With Ocular Misalignment | Presence or absence of ocular misalignment measured in prism diopters. | No participant in control arm was assessed for this outcome measure. | Posted | Count of Participants | Participants | At baseline |
|
|
|
| Secondary | Number of Participants With Ocular Misalignment | Presence or absence of ocular misalignment measured in prism diopters. | No participant in control arm was assessed for this outcome measure. | Posted | Count of Participants | Participants | At 1 month |
|
|
|
| Secondary | Number of Participants With Ocular Misalignment | Presence or absence of ocular misalignment measured in prism diopters. | No participant in control arm was assessed for this outcome measure. | Posted | Count of Participants | Participants | At 3 months |
|
|
|
| Secondary | Number of Participants With Ocular Misalignment | Presence or absence of ocular misalignment measured in prism diopters. | No participant in control arm was assessed for this outcome measure. | Posted | Count of Participants | Participants | At 6 months |
|
|
|
| Secondary | Eyelid Retraction as Measured in Millimeters (Right Eye) | 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. | No participant in control arm was assessed for this outcome measure. | Posted | Number | millimeters | At baseline, 1, 3 and 6 months |
|
|
|
| Secondary | Eyelid Retraction as Measured in Millimeters (Left Eye) | 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. | No participant in control arm was assessed for this outcome measure. | Posted | Number | millimeters | At baseline, 1, 3 and 6 months |
|
|
|
| Secondary | Quality of Life as Assessed by a Thyroid Eye Disease Specific Survey of Quality of Life | 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. | This measure was not assessed. No data was collected. | Posted | 6 months |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Control | Patients who are randomized to standard treatment (requiring no prescription medication, but standard recommendations such as artificial tears, avoiding cigarette smoke) artificial tears: Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009916 |
| Orbital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |
|
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| Title | Measurements |
|---|---|
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| 6 months |
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| Title | Measurements |
|---|---|
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| 6 months |
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| Title | Measurements |
|---|
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| 6 months |
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| Title | Measurements |
|---|
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| 6 months |
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