Clinical trial NCT01532570: Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special Lesions
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Behcet's Disease
Behcet Syndrome
Neuro-Behcet's Disease
Keywords: Behcet's disease
intestinal Behcet's disease
neuro-Behcet's disease
vascular Behcet's disease
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2012-02-14
Enrollment: 18
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Complete Response at Week 30
timeFrame: Week 30
Secondary outcomes:
measure: Percentage of Participants With Complete Response at Week 14 and 54
timeFrame: Week 14, Week 54
measure: Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD
timeFrame: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54
measure: Imaging Findings:Endoscopic Examination for Intestinal BD
timeFrame: Week 14, Week 30, Week 54
measure: Imaging Findings: Brain Magnetic Resonance Imaging (MRI) for Acute Neuro-BD
timeFrame: Week 14, Week 30, Week 54
measure: Imaging Findings: Brainstem MRI for Chronic Neuro-BD
timeFrame: Week 14, Week 30, Week 54
measure: Imaging Findings: CT, PET/CT for Vascular-BD
timeFrame: Week 14, Week 30, Week 54
measure: Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD
timeFrame: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54
measure: Concentration of Inflammatory Biomarker (CRP) of Vascular BD
timeFrame: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54
measure: Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD
timeFrame: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54
measure: Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD
timeFrame: Week 0, Week 14, Week 30, Week 54
measure: Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD
timeFrame: Week 0, Week 14, Week 30, Week 54
measure: The Number of Improved Intestinal BD Patients From Baseline
timeFrame: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54
measure: Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
timeFrame: Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54
measure: Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
timeFrame: Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54
Other outcomes:
Locations:
city: Chubu
country: Japan
facility: Investigational site
city: Hokkaido
country: Japan
facility: Investigational site
city: Kanto
country: Japan
facility: Investigational site
city: Kinki
country: Japan
facility: Investigational site
city: Kyusyu
country: Japan
facility: Investigational site
city: Tohoku
country: Japan
facility: Investigational site
Study officials:
affiliation: Yokohama City University Graduate School of Medicine
name: Yoshiaki Ishigatsubo, MD, Ph.D
role: STUDY_DIRECTOR
affiliation: Kitasato University Kitasato Institute Hospital
name: Toshifumi Hibi, MD
role: STUDY_DIRECTOR
affiliation: Kitasato University School of Medicine
name: Shunsei Hirohata, MD
role: STUDY_DIRECTOR
affiliation: Mitsubihsi Tanabe Pharma Corporation
name: Kazuoki Kondo, MD
role: STUDY_DIRECTOR
References:
citation: Hibi T, Hirohata S, Kikuchi H, Tateishi U, Sato N, Ozaki K, Kondo K, Ishigatsubo Y. Infliximab therapy for intestinal, neurological, and vascular involvement in Behcet disease: Efficacy, safety, and pharmacokinetics in a multicenter, prospective, open-label, single-arm phase 3 study. Medicine (Baltimore). 2016 Jun;95(24):e3863. doi: 10.1097/MD.0000000000003863.