Rituximab for the Treatment of Severe Ocular Manifestations of Behcet's Disease - Full Text View

Sponsors and Collaborators:	Tehran University of Medical Sciences Hoffmann-La Roche
Information provided by:	Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00664599

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Rituximab in the Treatment of Resistant Ocular Inflammatory Lesions of Behcet's Disease (Pilot Study)

Resource links provided by NLM:

MedlinePlus related topics: Behcet's Syndrome Vasculitis

Drug Information available for: Rituximab

U.S. FDA Resources

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
1: Experimental 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).
2: Active Comparator 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.

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

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

Keywords provided by Tehran University of Medical Sciences:

Ocular lesions, Visual Acuity, Retinal Vasculitis

Study placed in the following topic categories:

Mouth Diseases
Uveitis, Anterior
Panuveitis
Uveal Diseases
Vasculitis
Immunologic Factors
Skin Diseases
Methylprednisolone
Rituximab
Eye Diseases
Vascular Diseases
Methylprednisolone acetate

Prednisolone acetate
Retinal Vasculitis
Cyclophosphamide
Behcet Syndrome
Azathioprine
Uveitis
Prednisolone
Methotrexate
Stomatognathic Diseases
Antirheumatic Agents
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Mouth Diseases
Uveitis, Anterior
Panuveitis
Uveal Diseases
Skin Diseases, Vascular
Disease
Vasculitis
Immunologic Factors
Skin Diseases
Antineoplastic Agents
Rituximab
Eye Diseases

Physiological Effects of Drugs
Vascular Diseases
Pharmacologic Actions
Behcet Syndrome
Pathologic Processes
Uveitis
Therapeutic Uses
Syndrome
Cardiovascular Diseases
Stomatognathic Diseases
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 11, 2009