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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Behcet's Syndrome

Keywords

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Ocular lesions, Visual Acuity, Retinal Vasculitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Rituximab

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

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

2

Cytotoxics combination

Group Type ACTIVE_COMPARATOR

Cytotoxic Combination

Intervention Type DRUG

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

Interventions

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Rituximab

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

Intervention Type DRUG

Cytotoxic Combination

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

Intervention Type DRUG

Other Intervention Names

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Mabthera Rituxan Cytoxan

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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