Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special Lesions

Tanabe Pharma Corporation

Status and phase

Completed

Phase 3

Conditions

Behcet Syndrome

Neuro-Behcet's Disease

Behcet's Disease

Treatments

Drug: TA-650

Study type

Interventional

Funder types

Industry

Identifiers

NCT01532570

TA-650-23

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of TA-650 in patients with Behcet's disease ( BD ) with special lesions after the administration of TA-650 at a dosage of 5 mg/kg in weeks 0, 2, and 6, then every 8 weeks after week 14 up to week 46.

Enrollment

18 patients

Sex

All

Ages

16 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who were diagnosed with the complete or incomplete type of Behcet's disease according to "The criteria for a diagnosis of Behcet's disease, Ministry of Health, Labour and Welfare in Japan (partially revised in 2010)"
Patients who have special lesions despite having received conventional treatments for special lesions, or patients who cannot receive conventional treatments due to intolerability.
Patients who have clinical symptoms associated with each special lesions.

Exclusion criteria

Patients with intestinal, neuro-, vascular Behcet's disease in whom a differential diagnosis of each Behcet's disease from other conditions．
Patients who have received treatment with infliximab within 1 year before enrollment for another purpose than treating special lesions; or patients whose previous treatment with infliximab was discontinued due to adverse events.
Patients who had participated in another clinical study and had received a study drug within 12 weeks before giving acquirement.