Clinical Trials Directory

Trials / Completed

CompletedNCT00664599

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

Effect of Rituximab in the Treatment of Resistant Ocular Inflammatory Lesions of Behcet's Disease (Pilot Study)

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Tehran University of Medical Sciences · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

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

Interventions

TypeNameDescription
DRUGRituximabInfusion of Rituximab, 1500 mg, two times with 15 days interval. Patients receive also Methotrexate (15 mg weekly) and Prednisolone (0.5 mg/daily).
DRUGCytotoxic CombinationPulse cyclophosphamide 1000 mg in perfusion, once monthly monthly. Azathioprine 3 mg/kg/body weight daily + prednisolone 0.5 mg/kg/daily.

Timeline

Start date
2006-04-01
Primary completion
2008-01-01
Completion
2008-01-01
First posted
2008-04-23
Last updated
2008-04-30

Locations

1 site across 1 country: Iran

Source: ClinicalTrials.gov record NCT00664599. Inclusion in this directory is not an endorsement.