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

Sponsor
Jie Shen (Other)
Overall Status
Unknown status
CT.gov ID
NCT03107078
Collaborator
The Fifth Affiliated Hospital of Southern Medical University (Other), Huadu District People's Hospital of Guangzhou (Other), Zhujiang Hospital (Other)
200
1
4
60
3.3

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 1, 2016
Anticipated Primary Completion Date :
Oct 1, 2019
Anticipated Study Completion Date :
Oct 1, 2021

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Methylprednisolone
  • Outcome Measures

    Primary Outcome Measures

    1. Number of patients defined as Response for the Glucocorticoids Treatment based on the 7 parameters of eye assessment [2years]

      "Response" was defined as at least three of the following outcome measures: reduction in lid width by at least 3 mm; reduction in any of the class 2 NOSPECS signs by at least two grades; reduction in proptosis by at least 2 mm; reduction in intraocular pressure by at least 2 mm Hg; improvement in CAS by at least two points; improvement in diplopia (disappearance or degrade in degree); 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 [2years]

      "Deterioration" of each parameter was defined as follows: increase in lid width by at least 3 mm; increase in any of the class 2 NOSPECS signs by at least two grades; increase in proptosis by at least 2 mm; increase in intraocular pressure by at least 2 mm Hg; increase in CAS by at least two points; increase in diplopia (new onset or upgrade in degree); 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 [2years]

      "Unchanged" was defined as no change or changes smaller than previously defined in any of the mentioned parameters.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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. CASā‰„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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 the Third Affiliated Hospital of Southern Medical University Guangzhou Guangdong China 510515

    Sponsors and Collaborators

    • Jie Shen
    • The Fifth Affiliated Hospital of Southern Medical University
    • Huadu District People's Hospital of Guangzhou
    • Zhujiang Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jie Shen, Vice President;Doctoral Supervisor, The Third Affiliated Hospital of Southern Medical University
    ClinicalTrials.gov Identifier:
    NCT03107078
    Other Study ID Numbers:
    • ThirdAffiliatedHospitalOfSMU
    First Posted:
    Apr 11, 2017
    Last Update Posted:
    Apr 18, 2017
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:

    Study Results

    No Results Posted as of Apr 18, 2017