Rituximab for the Treatment of Severe Ocular Manifestations of Behcet's Disease

Tehran University of Medical Sciences20 enrolled

Overview

The purpose of this study is to find if Rituximab can improve severe ocular lesions of Behcet's Disease.

To test in a single blind randomized control study the efficacy of Rituximab versus combination of pulse cyclophosphamide and azathioprine. Both group receiving 0.5 mg/kg/daily prednisolone.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Behcet's Syndrome

Interventions

RituximabDRUG

Infusion of Rituximab, 1500 mg, two times with 15 days interval. Patients receive also Methotrexate (15 mg weekly) and Prednisolone (0.5 mg/daily).

Cytotoxic CombinationDRUG

Pulse cyclophosphamide 1000 mg in perfusion, once monthly monthly. Azathioprine 3 mg/kg/body weight daily + prednisolone 0.5 mg/kg/daily.

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Behcet's Disease fulfilling the new International Criteria for Behcet's Disease * Having active ocular lesions (posterior and/or retinal vasculitis) * Resistant to cytotoxic drugs + prednisolone 0.5 mg/kg Exclusion Criteria: * Visual acuity less than 1/10 on Snellen chart * Antecedent of allergic reaction to any component of the therapeutic regimen

Locations (1)

Rheumatology Research Center, Shariati Hospital

Tehran, Tehran Province, Iran

Outcomes

Primary Outcomes

Visual acuity

Time frame: 6 months

Secondary Outcomes

Inflammatory index for posterior uveitis

Time frame: 6 months

Inflammatory index for retinal vasculitis, especially for edema

Time frame: 6 months

Total Adjusted Disease Activity Index (TADAI)

Time frame: 6 months

Data from ClinicalTrials.gov

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