Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05683626 |
| Other study ID # |
MZMahmoud |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 15, 2022 |
| Est. completion date |
December 30, 2023 |
Study information
| Verified date |
January 2023 |
| Source |
Sohag University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
