TocilizumabPhase 2NCT06087731
Efficacy and Safety of Tocilizumab for TAO
A Phase 2 study testing Tocilizumab in people with Tocilizumab and Thyroid Associated Ophthalmopathy, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of tocilizumab treating Thyroid Associated Ophthalmopathy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tocilizumab, Thyroid Associated Ophthalmopathy
- What is being tested?
- Tocilizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2023to 23 Sep 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years old
- Clinical diagnosis of Thyroid-associated ophthalmopathy
- Euthyroid status at least 1 months before baseline.
- No previous specific therapy for TAO, except for local measures
- Written informed consent is obtained
Who cannot join
- Uncontrolled diabetes or hypertension
- Renal or hepatic insufficiency.
- Infectious diseases (HIV, HBV,TB and so on)
- History of mental/psychiatric disorder
- Other ocular diseases or fundus diseases.
- Any previous systemic medications or surgery for the treatment of TAO
- Pregnant or lactating females.
- Intolerability of tocilizumab
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Tocilizumab for Patients With Thyroid-associated Ophthalmopathy
This study aims to evaluate the efficacy and safety of tocilizumab treating Thyroid Associated Ophthalmopathy.
Read the detailed description
Thyroid Associated Ophthalmopathy(TAO) is one of autoimmune orbital diseases characterized by enlargement of the extraocular muscles and increase in fatty or/and orbit connective tissue volume affecting the appearance and visual function of the eyes. In TAO pathogenesis, orbital fibroblasts are activated by autoantibodies against the thyrotropin receptor TSHR and the insulin-like growth factor-1 receptor. The fibroblasts then secrete interleukin-6 (IL-6), macrophage chemoattractant protein-1, and transforming growth factor-ß. In orbital preadipocyte fibroblasts, IL-6 increases expression of the thyrotropin receptor TSHR, and the orbital volume is relative to IL-6 mRNA expression. Thus, IL-6 may have several roles in the pathogenesis of TAO. Tocilizumab, a recombinant humanized IgG1 monoclonal antibody against IL-6 receptors, is FDA-approved for the treatment of rheumatoid arthritis, giant cell arteritis and juvenile idiopathic arthritis with a good toleration. The investigators carry this perspective cohort study to evaluate the efficacy of tocilizumab in TAO.
- Conditions
- Tocilizumab, Thyroid Associated Ophthalmopathy
- Being tested
- Tocilizumab
- Keywords
- Thyroid Associated Ophthalmopathy, tocilizumab
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Tocilizumab (8mg/kg) every 4 wekks
| Study group | Role | What they receive |
|---|---|---|
| tocilizumab | Experimental | administrated with tocilizumab (8mg/kg) every four weeks Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume and signal intensity of each extraocular muscles and soft tissue in MRI images
The volume and signal intensity of each extraocular muscles and soft tissue are analyzed in the MRI slides of each patients. each part of each extraocular muscles and soft tissue were measured three times and two trained performers will do this assignment respectively.
Measured: month 1，month 3，month 6
Clinical Activity Score
Spontaneous orbital pain. Gaze evoked orbital pain. Eyelid swelling that is considered to be due to active (inflammatory phase) GO. Eyelid erythema. Conjunctival redness that is considered to be due to active (inflammatory phase) GO (ignore "equivocal" redness).
Chemosis. Inflammation of caruncle or plica
Measured: month 1，month 3，month 6
eyelid aperture
For the assessment of eyelid aperture, the same millimeter ruler should be used by the same observer. When performed this assessment, participants should relax their eyes and keep looking ahead and the observers should keep the ruler perpendicular to their eyelid.
Measured: month 1，month 3，month 6
exophthalmos
For the assessment of exophthalmos, the same Hertel instrument and ideally the same observer should be used on each occasion. Additionally the same intercanthal distance (ICD) should be used on each occasion.
Measured: month 1，month 3，month 6
eyelid lag
For the assessment of eyelid aperture, the same millimeter ruler should be used by the same observer. Lid lag is defined that the lid margin distance in downgaze. The upper eyelid positions above (recorded '+') or below (recorded '-') the superior limbus will be measured in millimeters.
Measured: month 1，month 3，month 6
retraction of the upper and lower eyelids
For the assessment of eyelid aperture, the same millimeter ruler should be used by the same observer. The upper eyelid positions above (recorded '+') or below (recorded '-') the superior limbus and the lower eyelid positions above (recorded '+') or below (recorded '-') the posterior limbus will be measured in millimeters on the primary position with relaxed status.
Measured: month 1，month 3，month 6
Secondary outcomes (3)
ocular motility
The head of each participant is adjusted to fix on the modified perimeter and set the visual axis of the examined eye on the center of the optimal visual target in visual chart. The other eye should be covered. The participantshould move the examined eye to follow the movement of the visual target until he/she cannot identify the exact visual target in vertical and horizontall directions respectively. And the extreme scales of these four directions (upgaze, downgaze, abduction and adduction) for each eye are obtained.
Measured: month 1，month 3，month 6
Graves' Ophthalmopathy Quality of Life Scale
The Graves' Ophthalmopathy Quality of Life (GO-QOL) questionnaire [4]includes visual functioning and psychosocial functioning. A raw score of each part is calculated by adding each score of 8 question, namely 1, 2, or 3 for each question which means marked, mild, or absent limitation, the final score ranging from 0 (full limitation) to 100 (no limitation) is calculated as the following rule: (raw score - 8) ÷ 16 × 100]. GO-QOL will be completed at screening, week 0, week 4 and week 12. The data will also be recorded to assess activity of TAO and impact on quality of life respectively.
The GO-QOL is a 16-item self-administered questionnaire used to assess the perceived effects of TAO by the patients on their daily physical and psychosocial functioning.
Measured: month 1，month 3，month 6
inflammatory markers changes
Serum inflammatory markers （systemic）including neutrophil, lymphocyte, platelet, monocyte, WBC, NLR, PLR, MLR, SII,SIRI, PIV, WMR and others.
Measured: month 1，month 3，month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start23 Sep 2023
- Primary completion23 Sep 2023
- Study completion23 Sep 2023
Why it stopped: For some personal reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TocilizumabStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Liang, Sun Yat-sen University
- Investigators
- Dan Liang, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087731
- Sponsor's protocol ID
- 2023TAOIL-6
- Status last verified
- Apr 2023
- First submitted
- 22 Sep 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tocilizumab for Patients With Thyroid-associated Ophthalmopathy
- ClinicalTrials.gov ID
- NCT06087731
- Acronym / sponsor ID
- 2023TAOIL-6
- Conditions
- Tocilizumab, Thyroid Associated Ophthalmopathy
- Keywords
- Thyroid Associated Ophthalmopathy, tocilizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: For some personal reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 23 Sep 2023 (actual)
- Primary completion
- 23 Sep 2023 (actual)
- Study completion
- 23 Sep 2023 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy and safety of tocilizumab treating Thyroid Associated Ophthalmopathy.
Detailed description
Thyroid Associated Ophthalmopathy(TAO) is one of autoimmune orbital diseases characterized by enlargement of the extraocular muscles and increase in fatty or/and orbit connective tissue volume affecting the appearance and visual function of the eyes. In TAO pathogenesis, orbital fibroblasts are activated by autoantibodies against the thyrotropin receptor TSHR and the insulin-like growth factor-1 receptor. The fibroblasts then secrete interleukin-6 (IL-6), macrophage chemoattractant protein-1, and transforming growth factor-ß. In orbital preadipocyte fibroblasts, IL-6 increases expression of the thyrotropin receptor TSHR, and the orbital volume is relative to IL-6 mRNA expression. Thus, IL-6 may have several roles in the pathogenesis of TAO. Tocilizumab, a recombinant humanized IgG1 monoclonal antibody against IL-6 receptors, is FDA-approved for the treatment of rheumatoid arthritis, giant cell arteritis and juvenile idiopathic arthritis with a good toleration. The investigators carry this perspective cohort study to evaluate the efficacy of tocilizumab in TAO.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tocilizumab | Experimental | Drug: Tocilizumabadministrated with tocilizumab (8mg/kg) every four weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-70 years old
- Clinical diagnosis of Thyroid-associated ophthalmopathy
- Euthyroid status at least 1 months before baseline.
- No previous specific therapy for TAO, except for local measures
- Written informed consent is obtained
Key exclusion criteria (8 listed)
- Uncontrolled diabetes or hypertension
- Renal or hepatic insufficiency.
- Infectious diseases (HIV, HBV,TB and so on)
- History of mental/psychiatric disorder
- Other ocular diseases or fundus diseases.
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 |
|---|---|---|
| TocilizumabTocilizumab (8mg/kg) every 4 wekks | Drug | tocilizumab |
Primary outcome
volume and signal intensity of each extraocular muscles and soft tissue in MRI images
Time frame: month 1，month 3，month 6
The volume and signal intensity of each extraocular muscles and soft tissue are analyzed in the MRI slides of each patients. each part of each extraocular muscles and soft tissue were measured three times and two trained performers will do this assignment respectively.
Clinical Activity Score
Time frame: month 1，month 3，month 6
Spontaneous orbital pain. Gaze evoked orbital pain. Eyelid swelling that is considered to be due to active (inflammatory phase) GO. Eyelid erythema. Conjunctival redness that is considered to be due to active (inflammatory phase) GO (ignore "equivocal" redness). Chemosis. Inflammation of caruncle or plica
eyelid aperture
Time frame: month 1，month 3，month 6
For the assessment of eyelid aperture, the same millimeter ruler should be used by the same observer. When performed this assessment, participants should relax their eyes and keep looking ahead and the observers should keep the ruler perpendicular to their eyelid.
exophthalmos
Time frame: month 1，month 3，month 6
For the assessment of exophthalmos, the same Hertel instrument and ideally the same observer should be used on each occasion. Additionally the same intercanthal distance (ICD) should be used on each occasion.
eyelid lag
Time frame: month 1，month 3，month 6
For the assessment of eyelid aperture, the same millimeter ruler should be used by the same observer. Lid lag is defined that the lid margin distance in downgaze. The upper eyelid positions above (recorded '+') or below (recorded '-') the superior limbus will be measured in millimeters.
retraction of the upper and lower eyelids
Time frame: month 1，month 3，month 6
For the assessment of eyelid aperture, the same millimeter ruler should be used by the same observer. The upper eyelid positions above (recorded '+') or below (recorded '-') the superior limbus and the lower eyelid positions above (recorded '+') or below (recorded '-') the posterior limbus will be measured in millimeters on the primary position with relaxed status.
3 secondary outcomes
ocular motility
Time frame: month 1，month 3，month 6
Graves' Ophthalmopathy Quality of Life Scale
Time frame: month 1，month 3，month 6
inflammatory markers changes
Time frame: month 1，month 3，month 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Dan Liang principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
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 Tocilizumab in people with Tocilizumab and Thyroid Associated Ophthalmopathy, run by Sun Yat-sen University at 1 site in China.
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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 28 Nov 2023. 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 China. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
volume and signal intensity of each extraocular muscles and soft tissue in MRI images (time frame: month 1，month 3，month 6). The study lists 6 primary outcomes in all. 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 28 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.