Behcet's disease
Conditions
Interventions
Participants will receive continuous administration of Etanercept BS.
Sponsors
Matsumoto Yoshinori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants who meet all of the following criteria are eligible for this study: 1. Provided informed consent after understanding the study purpose 2. Aged 18 years or older at the time of consent 3. Diagnosed with Behcet's disease that meets the International Study Group (ISG) International Criteria for Behcet's disease (1990) 4. At least three episodes of oral ulcers within the 12 months prior to registration 5. History of prior treatment with one or more non-bioloic drugs for Behcet's disease 6. Clinical indications for systemic therapy for oral ulcers 7. Two or more oral ulcers at any point during the screening period
Exclusion criteria
Exclusion criteria: Participants who fall under any of the following categories shall not be included in this study: 1. Participants who are unable to give free and voluntary consent 2. Patients who have received the study drug in another clinical trial within 4 weeks prior to enrollment 3. Patients who do not consent to contraception, are pregnant or lactating 4. Demyelinating disease 5. Deep-seated fungal infection 6. Recurrent bacterial infections 7. Suspected active infection with any type of acid-fast bacillus within 3 years prior to enrollment in the study 8. Uncontrolled malignancy or a history of malignancy 9. Hepatitis B surface antigen (HBs antigen) positive or HBV-DNA PCR positive at screening 10. Hepatitis C virus antibody positive at screening 11. Clinically significant abnormalities on chest X-ray at screening 12. Clinically significant abnormalities on 12-lead electrocardiogram at screening 13. Patients who have active major organ involvements related to Behcet's disease (eye: uveitis, central nervous system: meningoencephalitis, lung: pulmonary aneurysm, blood vessel: thrombophlebitis, gastrointestinal: ulcerative lesions). However, those who have developed major organ lesions more than one year prior to registration and are currently inactive, and those with mild inflammatory eye diseases that do not require systemic immunosuppressive therapy, are eligible for registration. 14. Patients who are considered inappropriate as research participants by the principal investigator or clinical investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the time curve (AUC12) from treatment initiation to week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Adverse events unrelated to study drug up to 12 weeks of treatment (Grade 3 or higher) 2 Adverse events unrelated to study drug up to 12 weeks of treatment 3 Efficacy at 6 and 12 weeks of treatment Percentage of patients achieving complete remission Change from baseline Change from baseline severity measured by Visual Assessment Scale (VAS) Percentage of patients who were able to continue study medication 4 Percentage of patients in complete remission at Week 6 and maintained remission through 12 weeks of treatment | — |
Contacts
Public ContactYoshinori Matsumoto
Okayama University Hospital
Outcome results
None listed