Phase 3
N=18
Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special Lesions
Behcet's Disease · Behcet Syndrome · Neuro-Behcet's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01532570 ↗Enrolled (actual)
18
Serious AEs
11.1%
Results posted
Dec 2016
Primary outcome: Primary: Percentage of Participants With Complete Response at Week 30 — 54.5; 0; 100; 100 percentage of Complete Responders
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- TA-650 (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Tanabe Pharma Corporation
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Response at Week 30 |
54.5; 0; 100; 100 | — |
| SECONDARY Percentage of Participants With Complete Response at Week 14 and 54 |
54.5; 0; 100; 100; 60; 0 | — |
| SECONDARY Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD |
55.5; 41.3; 40.5; 42.7; 33.0; 11.8 | — |
| SECONDARY Imaging Findings:Endoscopic Examination for Intestinal BD |
9; 0; 0; 2; 9; 0 | — |
| SECONDARY Imaging Findings: Brain Magnetic Resonance Imaging (MRI) for Acute Neuro-BD |
2; 1; 1 | — |
| SECONDARY Imaging Findings: Brainstem MRI for Chronic Neuro-BD |
1; 1; 1 | — |
| SECONDARY Imaging Findings: CT, PET/CT for Vascular-BD |
3; 1; 0; 3; 1; 0 | — |
| SECONDARY Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD |
0.20; 0.00; 0.10; 0.10; 0.15; 0.10 | — |
| SECONDARY Concentration of Inflammatory Biomarker (CRP) of Vascular BD |
0.90; 0.25; 0.20; 0.10; 0.15; 0.15 | — |
| SECONDARY Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD |
31.0; 11.0; 8.0; 7.0; 8.5; 6.5 | — |
| SECONDARY Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD |
37; 3; 4; 2; 1; NA | — |
| SECONDARY Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD |
145; 2.5; 64.5; 2.2; 23; 35.1 | — |
| SECONDARY The Number of Improved Intestinal BD Patients From Baseline |
7; 9; 9; 8; 11; 10 | — |
| SECONDARY Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients |
1; 2; 1; 0; 1; 2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01532570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.