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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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
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.

China1 site

  • Zhongshan Ophthalmic Center

    Guangzhou, Guangdong

Other trials in China

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.

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.

Study groups in NCT06087731
Study groupRoleWhat they receive
tocilizumabExperimentaladministrated 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  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)

  1. 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

  2. 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

  3. 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.

  1. First posted18 Oct 2023
  2. Study start23 Sep 2023
  3. Primary completion23 Sep 2023
  4. Study completion23 Sep 2023

Why it stopped: For some personal reasons.

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT06087731.

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.

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