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 range
16 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this Phase 3 trial of TA-650 for Behcet's Disease has already completed, has the data been published, and what did it show about how many patients achieved a complete response by week 30?
2This trial specifically included patients with 'special lesions' like neuro-Behcet's disease — does my particular type or severity of Behcet's match the kinds of patients who were enrolled in this study?
3TA-650 appears to be an infliximab-type biologic treatment — given that this trial is now complete, is this therapy actually approved or available for Behcet's patients like me, or would I need to access it through another pathway?
4Since the trial measured complete response at 30 weeks, what happens after that point — is there evidence about whether the benefits last longer term, and what would my treatment plan look like beyond 30 weeks?
5Are there currently available standard treatments for Behcet's disease with special lesions that my care team would recommend trying first, before considering a biologic like the one studied in this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With Complete Response at Week 30