UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	Analysis for the reactivation of hepatitis B virus in patients treated with anti-tumor necrosis factor-alpha therapy
Region	Japan

Condition
Condition	rheumatoid arthritis or psoriasis patients with past hepatitis B virus infection
Classification by specialty	Hepato-biliary-pancreatic medicine Clinical immunology Infectious disease Dermatology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the incidence of hepatitis B virus (HBV) reactivation and the changes in HBV serum markers before HBV reactivation in rheumatoid arthritis or psoriasis patients with past HBV infection treated with anti-tumor necrosis factor-alpha therapy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The effect of preventive lamivudine, adefovir or entecavir on de novo HBV hepatitis.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	70

Research contact person
Name of lead principal investigator	Norihiro Furusyo
Organization	Kyushu University Hospital
Division name	Department of general internal medicine
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5909
Email	furusyo@gim.med.kyushu-u.ac.jp

Public contact
Name of contact person	Masayuki Murata
Organization	Kyushu University Hospital
Division name	Department of general internal medicine
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5909
Homepage URL
Email	mmurata@gim.med.kyushu-u.ac.jp

Sponsor
Institute	Department of general internal medicine, Kyushu-University hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	九州大学病院

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 23 Day
Anticipated trial start date	2012 Year 04 Month 23 Day
Last follow-up date	2016 Year 03 Month 09 Day
Date of closure to data entry	2016 Year 03 Month 09 Day
Date trial data considered complete	2016 Year 03 Month 09 Day
Date analysis concluded	2016 Year 03 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 22 Day
Last modified on	2017 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020653