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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00664599
First Posted: April 23, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hoffmann-La Roche
Information provided by:
Tehran University of Medical Sciences
April 20, 2008
April 23, 2008
October 12, 2017
April 2006
January 2008   (Final data collection date for primary outcome measure)
Visual acuity [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT00664599 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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)
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Behcet's Syndrome
  • 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).
    Other Names:
    • Mabthera
    • Rituxan
  • 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.
    Other Name: Cytoxan
  • Experimental: 1
    Rituximab
    Intervention: Drug: Rituximab
  • Active Comparator: 2
    Cytotoxics combination
    Intervention: Drug: Cytotoxic Combination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
January 2008
January 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
 
NCT00664599
132/12487
Yes
Not Provided
Not Provided
Fereydoun Davatchi, Head Rheumatology Research Center, Rheumatology Research Center, Tehran University for Medical Sciences
Tehran University of Medical Sciences
Hoffmann-La Roche
Study Chair: Fereydoun Davatchi, MD Rheumatology Research Center, Tehran University for Medical Sciences
Principal Investigator: Hormoz Shams, MD Rheumatology Research Center, Tehran University for Medical Sciences
Principal Investigator: Mozhgan Rezaipoor, MD Rheumatology Research Center, Tehran University for Medical Sciences
Principal Investigator: Farhad Shahram, MD Rheumatology Research Center, Tehran University for Medical Sciences
Principal Investigator: Cheyda Chams-Davatchi, MD Rheumatology Research Center, Tehran University for Medical Sciences
Principal Investigator: Bahar Sadeghi, MD Rheumatology Research Center, Tehran University for Medical Sciences
Tehran University of Medical Sciences
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP