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

NCT05683626 | Unknown DMC FDA Drug

• 1 other identifier: MZMahmoud
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Uveitis

Outcome Measures

Primary Outcomes (1)

• BCVA

  best corrected visual acuity

  1 year

Secondary Outcomes (2)

• AC cells

  1 year

• vitreous haze

  1 year

Interventions

Humira DRUG

subcutaneous injection

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university

Sohag, 82511, Egypt

RECRUITING

MeSH Terms

Conditions

Uveitis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 13, 2023
• Study Start: December 15, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 30, 2023
• Last Updated: January 13, 2023

Record last verified: 2023-01

Locations

EG (1)