Thyroid Eye DiseasePhase 2NCT02845336
Celecoxib for Thyroid Eye Disease
A Phase 2 study testing Celecoxib and artificial tears in people with Thyroid Eye Disease, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Eye Disease
- What is being tested?
- Celecoxib and artificial tears
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2017to 30 Jun 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wilmer Eye Institute, Johns Hopkins University
Baltimore, Maryland, 21287
About this study
Official title: An Open Label Trial of Celecoxib in the Treatment of Mild Thyroid Eye Disease
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.
Read the 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.
- Conditions
- Thyroid Eye Disease
- Being tested
- Celecoxib, artificial tears
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called Celebrex
celecoxib 100mg PO twice per day for 3 months
artificial tearsDrug
Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Drug: artificial tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline, 1, 3 and 6 months
Secondary outcomes (9)
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.
Measured: At baseline, 1, 3 and 6 months
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.
Measured: At baseline, 1, 3 and 6 months
Number of Participants With Ocular Misalignment
Presence or absence of ocular misalignment measured in prism diopters.
Measured: At baseline
Number of Participants With Ocular Misalignment
Presence or absence of ocular misalignment measured in prism diopters.
Measured: At 1 month
Number of Participants With Ocular Misalignment
Presence or absence of ocular misalignment measured in prism diopters.
Measured: At 3 months
Number of Participants With Ocular Misalignment
Presence or absence of ocular misalignment measured in prism diopters.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study start5 Mar 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Thyroid Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy J McCulley, MD, Principal investigator, Wilmer Eye Institute, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845336
- Sponsor's protocol ID
- IRB00094787
- Status last verified
- Jul 2020
- First submitted
- 20 Jul 2016
- Last updated
- 31 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Trial of Celecoxib in the Treatment of Mild Thyroid Eye Disease
- ClinicalTrials.gov ID
- NCT02845336
- Acronym / sponsor ID
- IRB00094787
- Conditions
- Thyroid Eye Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 5 Mar 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Posted 31 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celecoxib | Experimental | Drug: Celecoxib, Drug: artificial tearsPatients 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 | Drug: artificial tearsPatients who are randomized to standard treatment (requiring no prescription medication, but standard recommendations such as artificial tears, avoiding cigarette smoke) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- Pregnancy
- Previous treatment with corticosteroid for TED for >2wks
- Previous treatment with orbital radiation for TED
- Impaired renal function
- Impaired hepatic function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CelecoxibAlso: Celebrexcelecoxib 100mg PO twice per day for 3 months | Drug | Celecoxib |
| artificial tearsStandard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke. | Drug | Celecoxib, Control |
Primary outcome
Thyroid Eye Disease Clinical Activity Score
Time frame: 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
9 secondary outcomes
Proptosis as Measured in Millimeters With an Exophthalmometer (Right Eye)
Time frame: At baseline, 1, 3 and 6 months
Proptosis as Measured in Millimeters With an Exophthalmometer (Left Eye)
Time frame: At baseline, 1, 3 and 6 months
Number of Participants With Ocular Misalignment
Time frame: At baseline
Number of Participants With Ocular Misalignment
Time frame: At 1 month
Number of Participants With Ocular Misalignment
Time frame: At 3 months
Number of Participants With Ocular Misalignment
Time frame: At 6 months
Eyelid Retraction as Measured in Millimeters (Right Eye)
Time frame: At baseline, 1, 3 and 6 months
Eyelid Retraction as Measured in Millimeters (Left Eye)
Time frame: At baseline, 1, 3 and 6 months
Quality of Life as Assessed by a Thyroid Eye Disease Specific Survey of Quality of Life
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Thyroid Eye Disease
RecruitingObservational study
Early Risk Stratification of Thyroid Eye Disease in Newly Diagnosed Graves' Disease
Graves' Orbitopathy, Thyroid Eye Disease, TED
RecruitingPhase 3
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.
Graves Disease
RecruitingPhase 1
Evaluation of ETHY-001 for Safety, Tolerability, and Clinical Activity in Thyroid Eye Disease
Thyroid Eye Disease (TED), Graves' Disease
Active, not recruitingPhase 2
Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease
Graves Disease, Graves' Disease
RecruitingPhase 2
A Study to Learn About The Effects of Felzartamab on Thyroid Function and Its Safety in Adults With Graves' Disease Ages 18 to 75 Years Old
Graves' Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy J McCulley, MD principal investigator
Wilmer Eye Institute, Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celecoxib and artificial tears in people with Thyroid Eye Disease, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyroid Eye Disease Clinical Activity Score (time frame: At baseline, 1, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.