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

NCT ID: NCT05683626

Last Updated: 2023-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2023-12-30

Brief Summary

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.

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.

Conditions

Uveitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Humira

subcutaneous injection

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Mervat Zidan Mahmoud

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag university

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Magdy M Amin, professor

Role: primary

portal@med.sohag.evu.eg

0934602963

Other Identifiers

MZMahmoud

Identifier Type: -

Identifier Source: org_study_id