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

April 27, 2008 updated by: Tehran University of Medical Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Rituxan
  • Mabthera
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 Names:
  • Cytoxan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual acuity
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Inflammatory index for posterior uveitis
Time Frame: 6 months
6 months
Inflammatory index for retinal vasculitis, especially for edema
Time Frame: 6 months
6 months
Total Adjusted Disease Activity Index (TADAI)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Collaborators

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: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

April 20, 2008

First Submitted That Met QC Criteria

April 22, 2008

First Posted (Estimate)

April 23, 2008

Study Record Updates

Last Update Posted (Estimate)

April 30, 2008

Last Update Submitted That Met QC Criteria

April 27, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 132/12487

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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