Back to results

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

Primary Purpose

Behcet's Syndrome

Status

Completed

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Rituximab

Cytotoxic Combination

About this trial

This is an interventional treatment trial for Behcet's Syndrome focused on measuring Ocular lesions, Visual Acuity, Retinal Vasculitis

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rheumatology Research Center, Shariati Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Rituximab

Cytotoxics combination

Outcomes

Primary Outcome Measures

Visual acuity

Secondary Outcome Measures

Inflammatory index for posterior uveitis

Inflammatory index for retinal vasculitis, especially for edema

Total Adjusted Disease Activity Index (TADAI)

Full Information

NCT ID

NCT00664599

First Posted

April 20, 2008

Last Updated

April 27, 2008

Sponsor

Tehran University of Medical Sciences

Collaborators

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00664599

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

April 2006 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Tehran University of Medical Sciences

Collaborators

Hoffmann-La Roche

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Behcet's Syndrome

Keywords

Ocular lesions, Visual Acuity, Retinal Vasculitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Rituximab

Arm Title

Arm Type

Active Comparator

Arm Description

Cytotoxics combination

Intervention Type

Drug

Intervention Name(s)

Rituximab

Other Intervention Name(s)

Mabthera, Rituxan

Intervention Description

Infusion of Rituximab, 1500 mg, two times with 15 days interval. Patients receive also Methotrexate (15 mg weekly) and Prednisolone (0.5 mg/daily).

Intervention Type

Drug

Intervention Name(s)

Cytotoxic Combination

Other Intervention Name(s)

Cytoxan

Intervention Description

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

Primary Outcome Measure Information:

Title

Visual acuity

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Inflammatory index for posterior uveitis

Time Frame

6 months

Title

Inflammatory index for retinal vasculitis, especially for edema

Time Frame

6 months

Title

Total Adjusted Disease Activity Index (TADAI)

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fereydoun Davatchi, MD

Organizational Affiliation