Study of Anti-Viral Prophylaxis for HBsAg(+) or HBcAb(+)/HBsAb(-) Patients Starting Anti-TNFα
Chronic Hepatitis B, Rheumatoid Arthritis, Ankylosing Spondylitis
About this trial
This is an interventional prevention trial for Chronic Hepatitis B focused on measuring HBV surface antigen, Anti-HBc positive, Anti-TNFα Treatment, Reactivation
Eligibility Criteria
Inclusion Criteria:
- 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-TNFα 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-TNFα 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-TNFα 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:
- 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)
- Patient who is pregnant or breastfeeding or willing to be pregnant
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
- 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
Sites / Locations
- Hallym University Sacred Heart Hospital
- Dong-A University, College of Medicine
- Daegu Catholic Medical Center
- Kyungpook National University Hospital
- Chungnam National University Hospital
- Daejun Eulji University Hospital
- Chonnam National University Hospital
- Gachon University Gil Medical Center
- Inha University Hospital
- Chonbuk National University Hospital
- Seoul National University Hospital
- Ewha Womans University Mokdong Hospital
- Hanyang University Hospital
- Konkuk University Hospital
- Korea University Guro Hospital
- Kyung Hee University Gangdong Hospital
- Kyunghee University Medical Center
- Severance Hospital
- SMG-SNU Boramae Medical Center
- The Catholic University of Korea, Seoul St. Mary's
- The Catholic University of Korea, Yeouido St. Mary's Hospital
- Ajou University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Experimental Group
Control Group
Entecavir (Baraclude (Bristol-Myers Squibb) 0.5mg.) will be taken orally on an empty stomach (2 hours after a meal or at least 2 hours before the next meal), once daily from 1 week before starting anti-TNFα and continue 72 weeks after anti-TNFα is administered.
Placebo of Entecavir (prepared by Bristol-Myers Squibb) will be taken orally on an empty stomach (2 hours after a meal or at least 2 hours before the next meal), once daily from 1 week before starting anti-TNFα and continue 72 weeks after anti-TNFα is administered.