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

NCT00664599 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2008-04-30

No results posted yet for this study

Summary

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

Conditions

  • Behcet's Syndrome

Interventions

DRUG

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).

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.

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Tehran University of Medical Sciences

    lead OTHER

Principal Investigators

  • Fereydoun Davatchi, MD · Rheumatology Research Center, Tehran University for Medical Sciences

  • Hormoz Shams, MD · Rheumatology Research Center, Tehran University for Medical Sciences

  • Mozhgan Rezaipoor, MD · Rheumatology Research Center, Tehran University for Medical Sciences

  • Farhad Shahram, MD · Rheumatology Research Center, Tehran University for Medical Sciences

  • Cheyda Chams-Davatchi, MD · Rheumatology Research Center, Tehran University for Medical Sciences

  • Bahar Sadeghi, MD · Rheumatology Research Center, Tehran University for Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • Iran

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00664599 on ClinicalTrials.gov