A Study of Adalimumab in Acute Vogt-Koyanagi-Harada Disease

NCT05590416 | Recruiting

• 1 other identifier: 2022KY-16
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This project is designed to test the hypothesis that adalimumab is clinically useful for patients with acuta Vogt-Koyanagi-Harada disease

Conditions

Vogt-Koyanagi-Harada Disease; Adalimumab

Outcome Measures

Primary Outcomes (2)

• Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit.

  The participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.

  24 weeks

• Recurrence rate

  The recurrence rates in adalimumab treatment group and control group

  24 weeks

Secondary Outcomes (2)

• Change in Anterior Chamber (AC) Cell Grade From Baseline to Each Visit

  24 weeks

• Prednisone exposure

  12 months

Study Arms (2)

adalimumab group

The initial dose of glucocorticoid is 1 mg/kg/day, and gradually stops within 90-180 days. Adalimumab is administered subcutaneously at an initial loading dose of 80 mg, followed by a 40 mg dose every other week (q2w) starting from the second week. Therapy will be continued 6 months after the disappearance of active ocular inflammation. Then, injection will extend for 3 days until withdrawal after 40 days apart.

Drug: Adalimumab

traditional therapy group

Acute VKH patients treatment with only glucocorticosteroid or glucocorticosteroid combined with immunosuppressive agents.

Interventions

Adalimumab DRUG

Adalimumab is administered subcutaneously at an initial loading dose of 80 mg, followed by a 40 mg dose every other week (q2w) starting from the second week. Therapy will be continued 6 months after the disappearance of active ocular inflammation. Then, injection will extend for 3 days until withdrawal after 40 days apart.

adalimumab group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

VKH patients were recruited from the uveitis centre of Tianjin Medical University Eye Hospital

You may qualify if:

• Subject is 18 to 70 years of age.
• Subjects who do not have previous, active or latent tuberculosis (TB).
• Subject must have Vogt-Koyanagi-Harada disease less than one month.
• Subject who were previously treated with systemic glucocorticoid less than one week.
• Subject meets at least 1 of the following criteria:
• )patients who reject using systemic glucocorticoid because of the long-term side effects. 2)patients with other high-risk or systemic disease were limited by the use of glucocorticoid. 3)patients with a little reparation of retinal detachments after a week treatment with powerful systemic glucocorticoid(≥1mg/kg/day).

You may not qualify if:

• Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes simplex virus (HSV).
• Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.
• Subject has previous exposure to anti-tumor necrosis factor (TNF) therapy or any biologic therapy with a potential therapeutic impact on non-infectious uveitis.
• Subject has received Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline visit.
• Subject has received intravitreal anti-VEGF therapy within 45 days of the Baseline visit for Lucentis® (ranibizumab) or Avastin® (bevacizumab) or within 60 days of the Baseline visit for anti-VEGF Trap (aflibercept).
• Subject has received intravitreal methotrexate within 90 days prior to the Baseline visit.

Sponsors & Collaborators

• Tianjin Medical University: lead

Study Sites (1)

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Uveomeningoencephalitic Syndrome

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Autoimmune Diseases of the Nervous System; Nervous System Diseases; Uveitis; Uveal Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

xiaomin zhang, M.D

CONTACT

+86-13920023990; xiaomzh@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 21, 2022
• Study Start: June 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 30, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

CN (1)