Trial Outcomes & Findings for Celecoxib for Thyroid Eye Disease (NCT NCT02845336)

NCT ID: NCT02845336

Last Updated: 2020-07-31

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 7 participants
• Primary outcome timeframe: At baseline, 1, 3 and 6 months
• Results posted on: 2020-07-31

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	6	1
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Measure	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.	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.
Overall Study Lost to Follow-up	3	1
Overall Study Inability to get medication	2	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Celecoxib n=6 Participants 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.	Control n=1 Participants 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.	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=6 Participants	0 Participants n=1 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=6 Participants	1 Participants n=1 Participants	6 Participants n=7 Participants
Age, Categorical >=65 years	1 Participants n=6 Participants	0 Participants n=1 Participants	1 Participants n=7 Participants
Sex: Female, Male Female	4 Participants n=6 Participants	0 Participants n=1 Participants	4 Participants n=7 Participants
Sex: Female, Male Male	2 Participants n=6 Participants	1 Participants n=1 Participants	3 Participants n=7 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	6 Participants n=6 Participants	1 Participants n=1 Participants	7 Participants n=7 Participants

PRIMARY outcome

Timeframe: At baseline, 1, 3 and 6 months

Population: No participant in control arm was assessed for this outcome measure.

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

Outcome measures

Measure	Celecoxib n=1 Participants 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.	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.
Thyroid Eye Disease Clinical Activity Score Baseline · Normal	0 Participants	—
Thyroid Eye Disease Clinical Activity Score Baseline · Mild	0 Participants	—
Thyroid Eye Disease Clinical Activity Score Baseline · Moderate	1 Participants	—
Thyroid Eye Disease Clinical Activity Score Baseline · Severe	0 Participants	—
Thyroid Eye Disease Clinical Activity Score 1 month · Normal	0 Participants	—
Thyroid Eye Disease Clinical Activity Score 1 month · Mild	0 Participants	—
Thyroid Eye Disease Clinical Activity Score 1 month · Moderate	1 Participants	—
Thyroid Eye Disease Clinical Activity Score 1 month · Severe	0 Participants	—
Thyroid Eye Disease Clinical Activity Score 3 months · Normal	0 Participants	—
Thyroid Eye Disease Clinical Activity Score 3 months · Mild	0 Participants	—
Thyroid Eye Disease Clinical Activity Score 3 months · Moderate	1 Participants	—
Thyroid Eye Disease Clinical Activity Score 3 months · Severe	0 Participants	—
Thyroid Eye Disease Clinical Activity Score 6 months · Normal	0 Participants	—
Thyroid Eye Disease Clinical Activity Score 6 months · Mild	0 Participants	—
Thyroid Eye Disease Clinical Activity Score 6 months · Moderate	1 Participants	—
Thyroid Eye Disease Clinical Activity Score 6 months · Severe	0 Participants	—

SECONDARY outcome

Timeframe: At baseline, 1, 3 and 6 months

Population: No participant in control arm was assessed for this outcome measure.

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.

Outcome measures

Measure	Celecoxib n=1 Participants 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.	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.
Proptosis as Measured in Millimeters With an Exophthalmometer (Right Eye) Baseline	20.5 millimeters	—
Proptosis as Measured in Millimeters With an Exophthalmometer (Right Eye) 1 month	20.5 millimeters	—
Proptosis as Measured in Millimeters With an Exophthalmometer (Right Eye) 3 months	20.5 millimeters	—
Proptosis as Measured in Millimeters With an Exophthalmometer (Right Eye) 6 months	20.5 millimeters	—

SECONDARY outcome

Timeframe: At baseline, 1, 3 and 6 months

Population: No participant in control arm was assessed for this outcome measure.

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.

Outcome measures

Measure	Celecoxib n=1 Participants 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.	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.
Proptosis as Measured in Millimeters With an Exophthalmometer (Left Eye) Baseline	21.5 millimeters	—
Proptosis as Measured in Millimeters With an Exophthalmometer (Left Eye) 1 month	21.5 millimeters	—
Proptosis as Measured in Millimeters With an Exophthalmometer (Left Eye) 3 months	21.5 millimeters	—
Proptosis as Measured in Millimeters With an Exophthalmometer (Left Eye) 6 months	21.5 millimeters	—

SECONDARY outcome

Timeframe: At baseline

Population: No participant in control arm was assessed for this outcome measure.

Presence or absence of ocular misalignment measured in prism diopters.

Outcome measures

Measure	Celecoxib n=1 Participants 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.	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.
Number of Participants With Ocular Misalignment Present	0 Participants	—
Number of Participants With Ocular Misalignment Absent	1 Participants	—

SECONDARY outcome

Timeframe: At 1 month

Population: No participant in control arm was assessed for this outcome measure.

Presence or absence of ocular misalignment measured in prism diopters.

Outcome measures

Measure	Celecoxib n=1 Participants 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.	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.
Number of Participants With Ocular Misalignment Present	0 Participants	—
Number of Participants With Ocular Misalignment Absent	1 Participants	—

SECONDARY outcome

Timeframe: At 3 months

Population: No participant in control arm was assessed for this outcome measure.

Presence or absence of ocular misalignment measured in prism diopters.

Outcome measures

Measure	Celecoxib n=1 Participants 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.	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.
Number of Participants With Ocular Misalignment Present	0 Participants	—
Number of Participants With Ocular Misalignment Absent	1 Participants	—

SECONDARY outcome

Timeframe: At 6 months

Population: No participant in control arm was assessed for this outcome measure.

Presence or absence of ocular misalignment measured in prism diopters.

Outcome measures

Measure	Celecoxib n=1 Participants 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.	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.
Number of Participants With Ocular Misalignment Absent	1 Participants	—
Number of Participants With Ocular Misalignment Present	0 Participants	—

SECONDARY outcome

Timeframe: At baseline, 1, 3 and 6 months

Population: No participant in control arm was assessed for this outcome measure.

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.

Outcome measures

Measure	Celecoxib n=1 Participants 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.	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.
Eyelid Retraction as Measured in Millimeters (Right Eye) Baseline	0.5 millimeters	—
Eyelid Retraction as Measured in Millimeters (Right Eye) 1 month	0.5 millimeters	—
Eyelid Retraction as Measured in Millimeters (Right Eye) 3 months	0.5 millimeters	—
Eyelid Retraction as Measured in Millimeters (Right Eye) 6 months	0.5 millimeters	—

SECONDARY outcome

Timeframe: At baseline, 1, 3 and 6 months

Population: No participant in control arm was assessed for this outcome measure.

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.

Outcome measures

Measure	Celecoxib n=1 Participants 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.	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.
Eyelid Retraction as Measured in Millimeters (Left Eye) Baseline	2 millimeters	—
Eyelid Retraction as Measured in Millimeters (Left Eye) 1 month	2 millimeters	—
Eyelid Retraction as Measured in Millimeters (Left Eye) 3 months	2 millimeters	—
Eyelid Retraction as Measured in Millimeters (Left Eye) 6 months	2 millimeters	—

SECONDARY outcome

Timeframe: 6 months

Population: This measure was not assessed. No data was collected.

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.

Outcome measures

Outcome data not reported

Adverse Events

Celecoxib

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Timothy J McCulley, MD

Johns Hopkins University

Phone: 4105503000

Email: tmccull5@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place