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

Behcet's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01532570
• Other study ID #: TA-650-23
• Status: Completed
• Phase: Phase 3
• First received: February 6, 2012
• Last updated: September 2, 2014
• Start date: January 2012
• Est. completion date: May 2014

Study information

• Verified date: September 2014
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Behcet Syndrome
• Behcet's Disease
• Neuro-Behcet's Disease

Intervention

Drug:
• TA-650
TA-650 will be intravenously infused at a dosage of 5 mg/kg slowly over a period of more than 2 hours at the first administration (weeks 0), 2, and 6, and then every 8 weeks up to week 46. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.

Locations

Country	Name	City	State
Japan	Investigational site	Chubu
Japan	Investigational site	Hokkaido
Japan	Investigational site	Kanto
Japan	Investigational site	Kinki
Japan	Investigational site	Kyusyu
Japan	Investigational site	Tohoku

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Assessment of improvement using for Specific Clinical Symptom and Imaging Findings and Biomarkers		Week 30	No
Secondary	Global Assessment of improvement using for Specific Clinical Symptom and Imaging Findings and Biomarkers		Week 14, Week 54	No
Secondary	Patient General Visual Analogue Scale		Week 0, 2, 6, then every 4 weeks after Week 14 up to Week 46	No
Secondary	Imaging Findings: Endoscopic examination for Intestinal BD, MRI for Neuro-BD, CT etc for Vascular BD		Week 14, Week 30, Week 54	No
Secondary	Inflammatory Biomarker ( CRP etc)		Week 0, 2, 6, then every 4 weeks after Week 14 up to Week 46	No
Secondary	Cell Counts and IL-6 concentration in CSF for Neuro-BD		Week 14, Week 30, Week 54	No
Secondary	Change from Baseline in Specific Clinical Symptom for each type BD		Week 0, 2, 6, then every 4 weeks after Week 14 up to Week 46	No