Corticosteroid Combining Noncorticosteroid Systemic Immunomodulatory Therapy in VKH

Sponsor

Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05120687

Collaborator

(none)

200

Enrollment

Location

47.7

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the efficacy and safety of corticosteroidcombining noncorticosteroid systemic immunomodulatory therapy (NCSIT) for the treatment of Vogt Koyanagi Harada disease (VKH).

Condition or Disease	Intervention/Treatment	Phase
Vogt Koyanagi Harada Disease (VKH)	Drug: noncorticosteroid systemic immunomodulatory therapy (NCSIT)

Detailed Description

Vogt Koyanagi Harada disease (VKH) is a sort of autoimmune disease directed against uveal melanocytes, which is a common vision-threatening noninfectious uveitis in colored people. VKH patients given prednisone monotherapy are prone to relapse.

Noncorticosteroid systemic immunomodulatory therapy (NCSIT) demonstrated inflammation control and steroid-sparing effect in autoimmune diseases. Methotrexate as an antifolate metabolite has been widely used for its anti-inflammatory and immunomodulating properties. Adalimumab, humanized monoclonal anti-TNF-α antibody, have demonstrated the efficacy of noninfectious uveitis. Several randomized controlled trials have proved the efficacy and safety of NCSIT such as antimetabolite and biologics in non-infectious uveitis, while the optimal dose and treatment course remain unknown.

The investigators propose to explore the effect, safety and optimal dose of prednisone combining NCSIT in the treatment of VKH.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Efficacy and Safety of Corticosteroid Combining Noncorticosteroid Systemic Immunomodulatory Therapy in VKH

Actual Study Start Date :

Oct 15, 2021

Anticipated Primary Completion Date :

Oct 6, 2024

Anticipated Study Completion Date :

Oct 6, 2025

Arms and Interventions

Arm	Intervention/Treatment
Corticosteroid group Patients in corticosteroid group will receive systemic corticosteroid. In case of severe, the patients may receive methylprednisolone (no more than 1 gram/day) followed by gradual taper of oral prednisone.
Corticosteroid + NCSIT group Patients in corticosteroid + NCSIT group will receive systemic corticosteroids combined with Methotrexate or Adalimumab or other noncorticosteroid systemic immunomodulatory such as cyclophosphamide.	Drug: noncorticosteroid systemic immunomodulatory therapy (NCSIT) Patients in corticosteroid + NCSIT group will receive systemic corticosteroids combined with Methotrexate 15mg/week or Adalimumab 40mg /2weeks or Mycophenolate Mofetil 1g/day or Cyclosporin 50mg-100mg/day or cyclophosphamide 10mg/kg on two consecutive days every 2 weeks. Other Names: Methotrexate Adalimumab cyclophosphamide Cyclosporin Mycophenolate Mofetil

Arm

Intervention/Treatment

Corticosteroid group

Patients in corticosteroid group will receive systemic corticosteroid. In case of severe, the patients may receive methylprednisolone (no more than 1 gram/day) followed by gradual taper of oral prednisone.

Corticosteroid + NCSIT group

Patients in corticosteroid + NCSIT group will receive systemic corticosteroids combined with Methotrexate or Adalimumab or other noncorticosteroid systemic immunomodulatory such as cyclophosphamide.

Drug: noncorticosteroid systemic immunomodulatory therapy (NCSIT)

Patients in corticosteroid + NCSIT group will receive systemic corticosteroids combined with Methotrexate 15mg/week or Adalimumab 40mg /2weeks or Mycophenolate Mofetil 1g/day or Cyclosporin 50mg-100mg/day or cyclophosphamide 10mg/kg on two consecutive days every 2 weeks.

Other Names:

Methotrexate

Adalimumab

cyclophosphamide

Cyclosporin

Mycophenolate Mofetil

Outcome Measures

Primary Outcome Measures

Number of participants achieving corticosteroid-sparing effect [6 months]
Corticosteroid-sparing effect is defined by the following: (1) less than or equal to 0.5+ anterior chamber cells, less than or equal to 0.5+ vitreous haze and no active retinal or choroidal lesions; (2) no more than 10 mg of oral prednisone per day; (3) all the above-mentioned description should be maintained over 1 month

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Diagnosis is based on Revised International Diagnostic Criteria (Read et al. 2001b).
Age from 12 to 70 years old.
Patients have no contraindication of prednisone and immunosuppressive therapy, as determined by the investigator based on the results of laboratory and physical examinations.
Written informed consent is provided.

Exclusion Criteria:

Patients with other ocular diseases or fundus diseases: diabetic retinopathy, neovascular/wet age-related macular degeneration
History of renal or hepatic insufficiency, heart failure, systemic inflammatory disease or any other condition that, in the opinion of the investigator, would put the patients at risk by participating in the protocol.
History of infectious disease like chronic or active hepatitis B infection, HIV infection, immunodeficiency syndrome, chronic recurring infections, or active tuberculosis.
Female patients who were pregnant or considering becoming pregnant during the study.