18 and older, any sex, with Thyroid Eye Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Thyroid Eye Disease Clinical Activity ScorePrimary· 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
Baseline
Group
Value
95% CI
Celecoxib
0
Celecoxib
0
Celecoxib
1
Celecoxib
0
1 month
Group
Value
95% CI
Celecoxib
0
Celecoxib
0
Celecoxib
1
Celecoxib
0
3 months
Group
Value
95% CI
Celecoxib
0
Celecoxib
0
Celecoxib
1
Celecoxib
0
6 months
Group
Value
95% CI
Celecoxib
0
Celecoxib
0
Celecoxib
1
Celecoxib
0
Proptosis as Measured in Millimeters With an Exophthalmometer (Right Eye)Secondary· At baseline, 1, 3 and 6 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.
Baseline
Group
Value
95% CI
Celecoxib
20.5
1 month
Group
Value
95% CI
Celecoxib
20.5
3 months
Group
Value
95% CI
Celecoxib
20.5
6 months
Group
Value
95% CI
Celecoxib
20.5
Proptosis as Measured in Millimeters With an Exophthalmometer (Left Eye)Secondary· At baseline, 1, 3 and 6 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.
Baseline
Group
Value
95% CI
Celecoxib
21.5
1 month
Group
Value
95% CI
Celecoxib
21.5
3 months
Group
Value
95% CI
Celecoxib
21.5
6 months
Group
Value
95% CI
Celecoxib
21.5
Number of Participants With Ocular MisalignmentSecondary· At baseline
Presence or absence of ocular misalignment measured in prism diopters.
Present
Group
Value
95% CI
Celecoxib
0
Absent
Group
Value
95% CI
Celecoxib
1
Number of Participants With Ocular MisalignmentSecondary· At 1 month
Presence or absence of ocular misalignment measured in prism diopters.
Present
Group
Value
95% CI
Celecoxib
0
Absent
Group
Value
95% CI
Celecoxib
1
Number of Participants With Ocular MisalignmentSecondary· At 3 months
Presence or absence of ocular misalignment measured in prism diopters.
Present
Group
Value
95% CI
Celecoxib
0
Absent
Group
Value
95% CI
Celecoxib
1
Number of Participants With Ocular MisalignmentSecondary· At 6 months
Presence or absence of ocular misalignment measured in prism diopters.
Present
Group
Value
95% CI
Celecoxib
0
Absent
Group
Value
95% CI
Celecoxib
1
Eyelid Retraction as Measured in Millimeters (Right Eye)Secondary· At baseline, 1, 3 and 6 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.
Baseline
Group
Value
95% CI
Celecoxib
0.5
1 month
Group
Value
95% CI
Celecoxib
0.5
3 months
Group
Value
95% CI
Celecoxib
0.5
6 months
Group
Value
95% CI
Celecoxib
0.5
Eyelid Retraction as Measured in Millimeters (Left Eye)Secondary· At baseline, 1, 3 and 6 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.
Baseline
Group
Value
95% CI
Celecoxib
2
1 month
Group
Value
95% CI
Celecoxib
2
3 months
Group
Value
95% CI
Celecoxib
2
6 months
Group
Value
95% CI
Celecoxib
2
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Currently open trials in the same condition.
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Trials by the same sponsor.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
Last refreshed: 31 July 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02845336.