Analysis for the reactivation of hepatitis B virus (HBV) in rheumatoid arthritis or psoriasis patients with past HBV infection treated with anti-tumor necrosis factor-alpha therapy

Analysis for the reactivation of hepatitis B virus (HBV) in rheumatoid arthritis or psoriasis patients with past HBV infection treated with anti-tumor necrosis factor-alpha therapy - Analysis for the reactivation of hepatitis B virus in patients treated with anti-tumor necrosis factor-alpha therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018017

Enrollment

Registered

2015-06-22

Start date

2012-04-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rheumatoid arthritis or psoriasis patients with past hepatitis B virus infection

Interventions

The effect of preventive lamivudine, adefovir or entecavir on de novo HBV hepatitis.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with the following category (A) or (B): (A) Rheumatoid arthritis patients who receive anti-TNF-alpha therapy because they experienced inadequate responses to non-steroidal anti-inflammatory drugs (NSAIDs) or disease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate. (B) Patients who fall any under any of the following: 1. Psoriasis vulgaris or psoriatic arthritis patients who are inadequate responses to conventional systemic treatments including ultraviolet treatment and have rash areas over 10% of body surface area, or have severe rash or arthrosis refractory to conventional treatments. 2. Generalized pustular psoriasis 3. Psoriatic erythroderma (2) Hepatitis B surface (HBs) antigen negative and anti-hepatitis B core (HBc) positive. (3) Serum HBV DNA measured by a real-time PCR is undetectable at the time of entry. (4) Patients aged 20 years old or over 20 years old (5) Patients with sign informed consent form

Exclusion criteria

Exclusion criteria: (1) Patients with severe infection such as sepsis. (2) Patients with active tuberculosis (3) Patients with history of demyelinating diseases such as multiple sclerosis (4) Patients with congestive heart failure (5) Patients who are pregnant or lactating women, and are women of childbearing potential (6) Patients with history of hypersensitivity to anti-tumor necrosis factor-alpha agents or nucleoside analogues (7) Patients with hepatitis C virus infection or human immunodeficiency virus-1 infection

Design outcomes

Primary

Measure	Time frame
1. The incidence of HBV reactivation in rheumatoid arthritis patients with past HBV infection treated with anti-tumor necrosis factor-alpha therapy. 2. The incidence of HBV reactivation in psoriasis arthritis patients with past HBV infection treated with anti-tumor necrosis factor-alpha therapy.	—

Countries

Japan

Contacts

Public ContactMasayuki Murata

Kyushu University Hospital Department of general internal medicine

mmurata@gim.med.kyushu-u.ac.jp092-642-5909

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026