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

Last updated: March 2, 2017
Sponsor: Seoul National University Hospital
Overall Status: Terminated

Phase

3

Condition

Psoriatic Arthritis

Ankylosing Spondylitis

Hepatitis B

Treatment

N/A

Clinical Study ID

NCT01694264
H-1112-073-390
  • Ages 16-85
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Chronic hepatitis B, inactive HBsAg carriers or anti-HBc antibody positive patientswith AST, ALT level equal or lower than 2x ULN

  • Patient who has systemic rheumatic disease for which anti-TNFα treatment indicationhas 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 otherDMARDs against underlying RA, AS, PsA, or JRA. Patient who also fully understands thatanti-TNFα agent expenses are not covered in this study.

  • Patient who is willing and able to comply with the study drug regimen and all otherstudy requirements

  • Patient who is willing and able to provide a written informed consent to participatein the study

Exclusion

Exclusion Criteria:

  • Patient who has liver cirrhosis or a history of hepatocellular carcinoma (HCC) orfindings suggestive of HCC, such as suspicious foci or elevated serum alphafetoprotein (AFP)

  • Patient who received interferon or other immunomodulatory treatment for HBV infectionin 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 wasappropriate in duration according to the Korea Food and Drug Administration (KFDA) guidelines for management of latent TB in patients being treated withbiologic agents

  • Patient with a history of herpes zoster within 2 months before screening for thisstudy

  • Active malignancy or a history of treated malignancy less than 5 years prior toscreening

  • 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 thepatient unsuitable for inclusion in the study such as alcohol and drug abuse

Study Design

Total Participants: 43
Study Start date:
September 01, 2012
Estimated Completion Date:
December 31, 2015

Study Description

Biologic agents, especially anti-TNFα treatments are widely used in inflammatory arthritis such as rheumatoid arthritis (RA) and ankylosing spondylitis (AS). More than 60% of RA or AS patients achieve good clinical response to anti-TNFα treatment. However, TNFα is also an important mediator participating in the normal immune response to infectious agents, in particular intracellular microorganisms in the human body. Therefore, opportunistic infections such as tuberculosis, viral and fungal infections have been of concern when using anti-TNFα agents. With accumulating experience, the treatment guideline for anti-TNFα therapy in latent tuberculosis is now well established. It is noteworthy that there are a number of case reports describing hepatitis B virus (HBV) reactivation in otherwise asymptomatic carriers who received anti-TNFα treatment. Anti-TNFα agents are now utilized as a promising treatment regimen for RA and AS treatment for even HBsAg carriers, yet there are still concerns of the risk of anti-TNFα therapy contributing to HBV reactivation. In our previous studies, we found that anti-viral therapy before starting anti-TNFα treatment may reduce the incidence of HBV reactivation, and that entecavir is likely more suitable in long-term prophylaxis for HBsAg carriers under anti-TNFα treatment. This justifies the need of a prospective trial that could demonstrate the long-term effects of prophylaxis in using anti-TNFα therapy in this subgroup of patients. It would help clinicians understand 1) whether anti-viral therapy is necessary in inactive HBsAg carriers initiating anti-TNFα treatment, and 2) at what time point would we most likely witness HBV reactivation after starting anti-TNFα therapy without anti-viral therapy coverage. In addition to established nationwide network of Rheumatologists working in major academic institutes in Korea, our division in Seoul National University Hospital has led many multi-center trials throughout the past years. In summary, the question of whether to combine anti-viral prophylaxis in HBsAg carriers starting anti-TNFα therapy is an important issue to Rheumatologists. There is no guideline for managing this subset of patients, and clinicians normally begin anti-viral therapy after the patient's liver function worsens. Therefore, our nationwide network of specialists proposes to launch a prospective study to investigate the benefit of anti-viral prophylaxis with entecavir in HBsAg carriers starting anti-TNFα treatment.

Connect with a study center

  • Hallym University Sacred Heart Hospital

    Anyang,
    Korea, Republic of

    Site Not Available

  • Dong-A University, College of Medicine

    Busan,
    Korea, Republic of

    Site Not Available

  • Daegu Catholic Medical Center

    Daegu,
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Hospital

    Daegu,
    Korea, Republic of

    Site Not Available

  • Chungnam National University Hospital

    Daejun,
    Korea, Republic of

    Site Not Available

  • Daejun Eulji University Hospital

    Daejun,
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hospital

    Gwangju,
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Medical Center

    Incheon,
    Korea, Republic of

    Site Not Available

  • Inha University Hospital

    Incheon,
    Korea, Republic of

    Site Not Available

  • Chonbuk National University Hospital

    Jeonju,
    Korea, Republic of

    Site Not Available

  • Ewha Womans University Mokdong Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Hanyang University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Konkuk University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Korea University Guro Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Kyung Hee University Gangdong Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Kyunghee University Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • SMG-SNU Boramae Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 110-744
    Korea, Republic of

    Site Not Available

  • Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Seoul St. Mary's

    Seoul,
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Yeouido St. Mary's Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon,
    Korea, Republic of

    Site Not Available

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