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Completed

NCT Number: NCT00664599

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

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

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Key information

Conditions

Behcet's Syndrome Behcet Syndrome Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Genetic Diseases, Inborn Hereditary Autoinflammatory Diseases Mouth Diseases Panuveitis Retinal Diseases Retinal Vasculitis Skin Diseases Skin Diseases, Genetic Skin Diseases, Vascular Skin and Connective Tissue Diseases Stomatognathic Diseases Uveal Diseases Uveitis Uveitis, Anterior Vascular Diseases Vasculitis

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rheumatology Research Center, Shariati Hospital

Tehran, Tehran Province, 14114, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

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).

Other names: Mabthera, Rituxan

Cytotoxic Combination

Drug

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

Other names: Cytoxan

Primary outcomes

  1. Visual acuity

    Time frame: 6 months

Secondary outcomes

  1. Inflammatory index for posterior uveitis

    Time frame: 6 months

  2. Inflammatory index for retinal vasculitis, especially for edema

    Time frame: 6 months

  3. Total Adjusted Disease Activity Index (TADAI)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 23, 2008
Registry last updated
Apr 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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