NCT00664599

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2008

Completed
Last Updated

April 30, 2008

Status Verified

April 1, 2008

Enrollment Period

1.8 years

First QC Date

April 20, 2008

Last Update Submit

April 27, 2008

Conditions

Behcet's Syndrome

Keywords

Ocular lesions, Visual Acuity, Retinal Vasculitis

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    6 months

Secondary Outcomes (3)

  • Inflammatory index for posterior uveitis

    6 months

  • Inflammatory index for retinal vasculitis, especially for edema

    6 months

  • Total Adjusted Disease Activity Index (TADAI)

    6 months

Study Arms (2)

1

EXPERIMENTAL

Rituximab

Drug: Rituximab

2

ACTIVE COMPARATOR

Cytotoxics combination

Drug: Cytotoxic Combination

Interventions

RituximabDRUG

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

Also known as: Mabthera, Rituxan
1
Cytotoxic CombinationDRUG

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

Also known as: Cytoxan
2

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Visual acuity less than 1/10 on Snellen chart
  • Antecedent of allergic reaction to any component of the therapeutic regimen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology Research Center, Shariati Hospital

Tehran, Tehran Province, 14114, Iran

Location

MeSH Terms

Conditions

Behcet SyndromeRetinal Vasculitis

Interventions

RituximabCyclophosphamide

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesUveitis, AnteriorPanuveitisUveitisUveal DiseasesEye DiseasesVasculitisVascular DiseasesCardiovascular DiseasesHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, VascularRetinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Fereydoun Davatchi, MD

    Rheumatology Research Center, Tehran University for Medical Sciences

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 20, 2008

First Posted

April 23, 2008

Study Start

April 1, 2006

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

April 30, 2008

Record last verified: 2008-04

Locations

IR(1)