Safety and Efficacy of Adalimumab Therapy for Treatment of Behcet's Disease-related Uveitis in Sohag University Hospital

the goal of this prospective cohort study is to asses the Safety and efficacy of Adalimumab therapy for treatment of Behcet's disease-related uveitis in adult patients at sohag university hospital.

Patients will receive adalimumab (40 IU), subcutaneous injection every two weeks for 6 months either as a primary treatment or if refractory to corticosteroids and at least one conventional synthetic immunosuppressive drug.

Study Overview

• Status: Recruiting
• Conditions: Uveitis
• Intervention / Treatment: Drug: Humira

Detailed Description

Study design: Prospective cohort study. Sample size: 40 eyes of adult patients with complete Behçet's disease associated uveitis either male or female will be included in the study.

1. Inclusion Criteria:

   Adult patients with complete Behçet's disease associated uveitis . BD was diagnosed according to the classification criteria for BD proposed by the International Study Group for Behçet Disease .

2. Exclusion Criteria:

   Any patient with HIV, HBV, HCV, syphilis, toxoplasma, tuberculosis or other infections; liver, renal, cardiac or demyelinating diseases as well as substance abuse and malignancies will be excluded from the study

3. Treatment plan:

Patients will receive adalimumab (40 IU), subcutaneous injection every two weeks for 6 months either as a primary treatment or if refractory to corticosteroids and at least one conventional synthetic immunosuppressive drug.

Patients will start adose of systemic corticosteroids (methylprednisolone 1mg/kg/day) ,it will be tapered based on clinical improvement of uveitis and systemic symptoms of behcet disease.

Also In case of anterior uveitis, topical prednisolone acetate 1% every hour and topical cyclopentolate hydrochloride 1% two or five times per day were prescribed. If it was necessary, pulse corticosteroid therapy was used (1 g/day, for 3-5 days) for severe uveitic attacks.

Evaluation:

All patients will be evaluated by a safety monitoring board including both ophthalmologist and a rheumatolgist who will be acknowledge in the acknowledgment section later on.

Follow up schedule ; 1st month, 3rd month and 6th month or in case of necessity (relapse or safety concerns).

Full ophthalmological examination will be done for all patients include;

1. slit lamp biomicroscopy.
2. VA testing (uncorrected and best corrected visual acuity)
3. intraocular pressure measurement.
4. fundus examination..
5. ocular coherence tomography.
6. flourescene angiography. Clinical data regarding BCVA, anterior chamber cells and vitreous cells will be collected at baseline ,3 month and at the end of follow-up; OCT will be performed at the start of therapy, at 3- and 6-month follow-up visit and whenever an ocular flare will be suspected.

FA will be performed at the start of therapy and at the end of follow up period.

The diagnosis of macular edema and vasculitis will be based on clinical, OCT, and angiographic findings.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 82511
    • Recruiting
    • Sohag University
    • Contact: Magdy M Amin, professor; Phone Number: 0934602963; Email: portal@med.sohag.evu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

40 eyes of adult patients with complete Behçet's disease associated uveitis either male or female will be included in the study.

Patients will receive adalimumab (40 IU), subcutaneous injection every two weeks for 6 months either as a primary treatment or if refractory to corticosteroids and at least one conventional synthetic immunosuppressive drug.

Patients will start adose of systemic corticosteroids (methylprednisolone 1mg/kg/day) ,it will be tapered based on clinical improvement of uveitis and systemic symptoms of behcet disease.

Also In case of anterior uveitis, topical prednisolone acetate 1% every hour and topical cyclopentolate hydrochloride 1% two or five times per day were prescribed. If it was necessary, pulse corticosteroid therapy was used (1 g/day, for 3-5 days) for severe uveitic attacks.

Description

Inclusion Criteria:

• Adult patients with complete Behçet's disease associated uveitis .

Exclusion Criteria:

• Any patient with HIV, HBV, HCV, syphilis, toxoplasma, tuberculosis or other infections; liver, renal, cardiac or demyelinating diseases as well as substance abuse and malignancies will be excluded from the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BCVA	best corrected visual acuity	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AC cells	anterior chamber cells	1 year
vitreous haze	vitreous haze	1 year

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: January 4, 2023
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Estimate): January 13, 2023

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Eye Diseases; Genetic Diseases, Inborn; Stomatognathic Diseases; Mouth Diseases; Uveitis, Anterior; Panuveitis; Uveal Diseases; Vasculitis; Hereditary Autoinflammatory Diseases; Skin Diseases, Genetic; Skin Diseases, Vascular; Behcet Syndrome; Uveitis; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: MZMahmoud

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes