Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special Lesions (NCT01532570) | Clinical Trial Compass
CompletedPhase 3
Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special Lesions
Japan18 participantsStarted 2012-01
Plain-language summary
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.
Who can participate
Age range16 Years – 75 Years
SexALL
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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.
What they're measuring
1
Percentage of Participants With Complete Response at Week 30