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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018017
Receipt No. R000020653
Scientific Title 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
Date of disclosure of the study information 2015/06/22
Last modified on 2017/12/23

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Basic information
Public title 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
Acronym Analysis for the reactivation of hepatitis B virus in patients treated with anti-tumor necrosis factor-alpha therapy
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Norihiro Furusyo
Organization Kyushu University Hospital
Division name Department of general internal medicine
Zip code
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
1st name
Middle name
Last name Masayuki Murata
Organization Kyushu University Hospital
Division name Department of general internal medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 04 Month 23 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000020653

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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