UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018017 |
|---|---|
| Receipt number | 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 09:37:26 |
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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
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
mmurata@gim.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of general internal medicine, Kyushu-University hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020653
