Study of Anti-Viral Prophylaxis for HBsAg(+) or HBcAb(+)/HBsAb(-) Patients Starting Anti-TNFα

• Status: Terminated
• Trial end date: 2015-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Analysis of effect of anti-TNFα treatment on HBV reactivation among patients with systemic rheumatic disease, especially rheumatoid arthritis

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborators: Ajou University School of Medicine; Chonbuk National University Hospital; Chonnam National University Hospital; Chungnam National University Hospital; Daegu Catholic University Medical Center; Dong-A University; Eulji University Hospital; Ewha Womans University; Ewha Womans University Mokdong Hospital; Gachon University Gil Medical Center; Hallym University Medical Center; Hanyang University; Inha University Hospital; Konkuk University Medical Center; Korea University Guro Hospital; Kyung Hee University Hospital at Gangdong; Kyunghee University Medical Center; Kyungpook National University; Kyungpook National University Hospital; Severance Hospital; SMG-SNU Boramae Medical Center; The Catholic University of Korea
• Treatments: Entecavir

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