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

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00664599
First received: April 20, 2008
Last updated: April 27, 2008
Last verified: April 2008
  Purpose

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


Condition Intervention Phase
Behcet's Syndrome
Drug: Rituximab
Drug: Cytotoxic Combination
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Rituximab in the Treatment of Resistant Ocular Inflammatory Lesions of Behcet's Disease (Pilot Study)

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory index for posterior uveitis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Inflammatory index for retinal vasculitis, especially for edema [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Total Adjusted Disease Activity Index (TADAI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Rituximab
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
Active Comparator: 2
Cytotoxics combination
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

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664599

Locations
Iran, Islamic Republic of
Rheumatology Research Center, Shariati Hospital
Tehran, Iran, Islamic Republic of, 14114
Sponsors and Collaborators
Tehran University of Medical Sciences
Hoffmann-La Roche
Investigators
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
  More Information

No publications provided

Responsible Party: Fereydoun Davatchi, Head Rheumatology Research Center, Rheumatology Research Center, Tehran University for Medical Sciences
ClinicalTrials.gov Identifier: NCT00664599     History of Changes
Other Study ID Numbers: 132/12487
Study First Received: April 20, 2008
Last Updated: April 27, 2008
Health Authority: Iran: Ethics Committee

Keywords provided by Tehran University of Medical Sciences:
Ocular lesions, Visual Acuity, Retinal Vasculitis

Additional relevant MeSH terms:
Behcet Syndrome
Mouth Diseases
Stomatognathic Diseases
Uveal Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Skin Diseases, Vascular
Skin Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Vasculitis
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 18, 2014