None listed
Conditions
Interventions
Drug : Entecavir (Baraclude (Bristol-Myers Squibb) 0.5mg.) or corresponding placebo will be taken orally on an empty stomach (2 hours after a meal or at least 2 hours before the next meal), once daily
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Male or female 16 to 85 years of age * Chronic hepatitis B, inactive HBsAg carriers or anti-HBc antibody positive patients with AST, ALT level equal or lower than 2x ULN Patient who has systemic rheumatic disease for which anti-TNFa treatment indication has been approved by the KFDA; rheumatoid arthritis (RA, 1987 ACR criteria), ankylosing spondylitis (AS, modified New York criteria), psoriatic arthritis (PsA, modified ESSG criteria), and juvenile rheumatoid arthritis (JRA, 1977 ACR criteria). * Patient who is eligible to start anti-TNFa treatment (etanercept, infliximab, adalimumab, golimumab, and certolizumab pegol) due to treatment failure of other DMARDs against underlying RA, AS, PsA, or JRA. Patient who also fully understands that anti-TNFa agent expenses are not covered in this study. * Patient who is willing and able to comply with the study drug regimen and all other study requirements. * Patient who is willing and able to provide a written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: * Patient who has liver cirrhosis or a history of hepatocellular carcinoma (HCC) or findings suggestive of HCC, such as suspicious foci or elevated serum alpha fetoprotein (AFP) * Patient who received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study Patient who has concomitant other chronic viral infection (HCV or HIV) * A history of chronic infection, recent serious or life-threatening infection. Especially: - Patient with current clinical or laboratory evidence of active tuberculosis (TB) or latent TB unless there is documentation of prior anti-TB treatment was appropriate in duration according to the Korea Food and Drug Administration (KFDA) guidelines for management of latent TB in patients being treated with biologic agents - Patient with a history of herpes zoster within 2 months before screening for this study * Active malignancy or a history of treated malignancy less than 5 years prior to screening * Patient who is pregnant or breastfeeding or willing to be pregnant * Patients who are not cooperative or unable to comply with the study procedures * Patients with any other condition which the investigator’s judgment would make the patient unsuitable for inclusion in the study such as alcohol and drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV reactivation rate | — |
Secondary
| Measure | Time frame |
|---|---|
| HBV reactivation rate ;(If reactivated) time to reactivation (week);(if not reactivated) Change in DNA titer | — |
Countries
Korea, Republic of
Contacts
Public ContactKichul Shin
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Outcome results
None listed