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Using A Novel Classification System in Intravenous GCs Therapy of TAO: A Multi-central, Randomized, Open, Superior Trial

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ClinicalTrials.gov Identifier: NCT03107078
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : April 18, 2017
Sponsor:
Collaborators:
The Fifth Affiliated Hospital of Southern Medical University
Huadu District People's Hospital of Guangzhou
Zhujiang Hospital
Information provided by (Responsible Party):
Jie Shen, The Third Affiliated Hospital of Southern Medical University

Brief Summary:
For patients with active moderate-to-severe thyroid associated ophthalmopathy (TAO), the Intravenous Glucocorticoids (GCs) is the recommended therapy. However, the efficacy of GCs is not satisfied. Investigators established a novel classification of TAO for the first time to assess more precisely for better personal treatment.

Condition or disease Intervention/treatment Phase
Thyroid Associated Ophthalmopathy Drug: Glucocorticoids Phase 4

Detailed Description:
TAO is one of most common extra thyroid manifestation of dysfunctional thyroid disease. Since the morbidity of TAO has been increasing rapidly, Investigators' team is intended to verify the feasibility of the new type of classification system established by the related parameters of orbital MRI scan. Based on classification, investigators compare the efficacy of two GCs therapy. According to MRI,investigators measure the optimal T2 signal intensity ratio (SIR) for the treatment of TAO, which may help to find a better treatment time for therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Using A Novel Classification System in Intravenous Glucocorticoids Therapy of TAO: A Multi-central, Randomized, Open, Superior Trial
Actual Study Start Date : October 1, 2016
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Experimental: Group Ia

I:The increase of fat volume dominates .

a:The weekly protocol was as follows: 0.5 g glucocorticoids weekly for 6 weeks, followed by 0.25 g weekly for 6 weeks.

Drug: Glucocorticoids
Intravenous Glucocorticoids (GCs)
Other Name: Methylprednisolone

Experimental: Group Ib
I:The increase of fat volume dominates. b:The "qod" protocol was as follows: 0.5 g glucocorticoids qod. for 3 interval days per month for 3 months.
Drug: Glucocorticoids
Intravenous Glucocorticoids (GCs)
Other Name: Methylprednisolone

Experimental: Group IIa

II:The increase of extraocular muscles volume dominates .

a:The weekly protocol was as follows: 0.5 g glucocorticoids weekly for 6 weeks, followed by 0.25 g weekly for 6 weeks.

Drug: Glucocorticoids
Intravenous Glucocorticoids (GCs)
Other Name: Methylprednisolone

Experimental: Group IIb
II:The increase of extraocular muscles volume dominates . b:The "qod" protocol was as follows: 0.5 g glucocorticoids qod. for 3 interval days per month for 3 months.
Drug: Glucocorticoids
Intravenous Glucocorticoids (GCs)
Other Name: Methylprednisolone




Primary Outcome Measures :
  1. Number of patients defined as Response for the Glucocorticoids Treatment based on the 7 parameters of eye assessment [ Time Frame: 2years ]

    "Response" was defined as at least three of the following outcome measures:

    1. reduction in lid width by at least 3 mm;
    2. reduction in any of the class 2 NOSPECS signs by at least two grades;
    3. reduction in proptosis by at least 2 mm;
    4. reduction in intraocular pressure by at least 2 mm Hg;
    5. improvement in CAS by at least two points;
    6. improvement in diplopia (disappearance or degrade in degree);
    7. improvement in visual acuity by 1 Snellen line.

  2. Number of patients defined as Deterioration for the Glucocorticoids Treatment based on the 7 parameters of eye assessment [ Time Frame: 2years ]

    "Deterioration" of each parameter was defined as follows:

    1. increase in lid width by at least 3 mm;
    2. increase in any of the class 2 NOSPECS signs by at least two grades;
    3. increase in proptosis by at least 2 mm;
    4. increase in intraocular pressure by at least 2 mm Hg;
    5. increase in CAS by at least two points;
    6. increase in diplopia (new onset or upgrade in degree);
    7. decrease in visual acuity by 1 Snellen line.

  3. Number of patients defined as Unchange for the Glucocorticoids Treatment based on the 7 parameters of eye assessment [ Time Frame: 2years ]
    "Unchanged" was defined as no change or changes smaller than previously defined in any of the mentioned parameters.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The diagnostic standard of TAO is according to Bartley's criteria.
  2. Patients with active moderate-to-severe TAO based on 2016 EUGOGO guidelines.
  3. CAS≥3/7.
  4. None of the patients received any glucocorticoids therapy or orbital radiotherapy in the previous 3 months.

Exclusion Criteria:

  1. NOSPECS is 0 or 1.Only signs,no symptoms.Signs include:reduced blink(Stellwag symptoms),two reduced cohesion(Mobius levy),moving slowly on the eyelids(Von Graefe sign),to the point of view,the forehead wrinkled skin should not(Joffroyv levy).
  2. Suffering from other eye diseases or wearing contact lenses.
  3. Suffering from other autoimmune diseases.
  4. Acute and chronic infectious diseases.
  5. Diabetic retinopathy or hypertensive fundus lesions.
  6. Patients received orbital decompression or other orbital surgery.
  7. Suffering from eye trauma or ocular surface disease.
  8. Special occupants, and the working environment has obvious air pollution etc.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107078


Contacts
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Contact: Jie Shen, Doctor 13808893818 shenjiedr@163.com
Contact: Zhangfang Li, Master 13427525514 leecandy520@163.com

Locations
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China, Guangdong
the Third Affiliated Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: zhang qun    020-62784060    Zq1979@smu.edu.cn   
Sub-Investigator: Shen Jie         
Sponsors and Collaborators
Jie Shen
The Fifth Affiliated Hospital of Southern Medical University
Huadu District People's Hospital of Guangzhou
Zhujiang Hospital

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Responsible Party: Jie Shen, Vice President;Doctoral Supervisor, The Third Affiliated Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03107078     History of Changes
Other Study ID Numbers: ThirdAffiliatedHospitalOfSMU
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Graves Ophthalmopathy
Eye Diseases
Eye Diseases, Hereditary
Graves Disease
Exophthalmos
Orbital Diseases
Genetic Diseases, Inborn
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Methylprednisolone
Glucocorticoids
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents