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

Summary

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

Conditions

• Chronic Hepatitis B
• Rheumatoid Arthritis
• Ankylosing Spondylitis
• Psoriatic Arthritis
• Juvenile Idiopathic Arthritis

Interventions

DRUG

Entecavir

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.

DRUG

Placebo

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.

Sponsors & Collaborators

• Konkuk University Medical Center

  collaborator OTHER

• Kyungpook National University Hospital

  collaborator OTHER

• Kyunghee University Medical Center

  collaborator OTHER

• Kyung Hee University Hospital at Gangdong

  collaborator OTHER

• Gachon University Gil Medical Center

  collaborator OTHER

• Daegu Catholic University Medical Center

  collaborator OTHER

• Eulji University Hospital

  collaborator OTHER

• SMG-SNU Boramae Medical Center

  collaborator OTHER

• The Catholic University of Korea

  collaborator OTHER

• Severance Hospital

  collaborator OTHER

• Ajou University School of Medicine

  collaborator OTHER

• Ewha Womans University Mokdong Hospital

  collaborator OTHER

• Inha University Hospital

  collaborator OTHER

• Chonnam National University Hospital

  collaborator OTHER

• Chonbuk National University Hospital

  collaborator OTHER

• Chungnam National University Hospital

  collaborator OTHER

• Hallym University Medical Center

  collaborator OTHER

• Hanyang University

  collaborator OTHER

• Dong-A University

  collaborator OTHER

• Korea University Guro Hospital

  collaborator OTHER

• Seoul National University Hospital

  lead OTHER

Principal Investigators

• Yeong wook Song, MD, PhD · Division of Rheumatology, Seoul National University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-09-01

Primary Completion

2015-08-31

Completion

2015-12-31

Countries

• South Korea

Study Locations