Clinical trial NCT05683626: Safety and Efficacy of Adalimumab Therapy for Treatment of Behcet's Disease-related Uveitis in Sohag University Hospital
Official title: Safety and Efficacy of Adalimumab Therapy for Treatment of Behcet's Disease-related Uveitis in Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uveitis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: BCVA
timeFrame: 1 year
Secondary outcomes:
measure: AC cells
timeFrame: 1 year
measure: vitreous haze
timeFrame: 1 year
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university
Study officials:
References: