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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040712
Receipt No. R000046477
Scientific Title Effect of methotrexate on the development of lymphoma in rheumatoid arthritis patients
Date of disclosure of the study information 2020/06/11
Last modified on 2020/06/10

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Basic information
Public title Effect of methotrexate on the development of lymphoma in rheumatoid arthritis patients
Acronym Effect of methotrexate on the development of lymphoma in rheumatoid arthritis patients
Scientific Title Effect of methotrexate on the development of lymphoma in rheumatoid arthritis patients
Scientific Title:Acronym Effect of methotrexate on the development of lymphoma in rheumatoid arthritis patients
Region
Japan

Condition
Condition Rheumatoid arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study aimed to compare the number of rheumatoid arthritis patients who developed lymphoma between those treated by methotrexate treatment and by non-MTX treatment.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Analysis of rheumatoid arthritis (RA) patients who developed lymphoma between those treated by methotrexate (MTX) treatment and by non-MTX treatment.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Diagnosis of RA on our database.
Key exclusion criteria Not diagnosis of RA on our database.
Target sample size 20000

Research contact person
Name of lead principal investigator
1st name Npboru
Middle name
Last name Kitamura
Organization Nihon University School of Medicine
Division name Division of Hematology and Rheumatology, Department of Medicine
Zip code 173-8610
Address 30-1 Oyaguchi Kamichi Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Email kitamura.noboru@nihon-u.ac.jp

Public contact
Name of contact person
1st name Noboru
Middle name
Last name Kitamura
Organization Nihon University School of Medicine
Division name Division of Hematology and Rheumatology, Department of Medicine
Zip code 173-8610
Address 30-1 Oyaguchi Kamichi Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Homepage URL
Email kitamura.noboru@nihon-u.ac.jp

Sponsor
Institute Nihon University School of Medicine
Institute
Department

Funding Source
Organization Self Funding
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 Research Administration Division
Address 30-1 Oyaguchi Kamichi Itabashi-ku, Tokyo, Japan
Tel 03-3972-8111
Email med.kenjim@nihon-u.ac.jp

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

Other administrative information
Date of disclosure of the study information
2020 Year 06 Month 11 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 20000
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
2019 Year 10 Month 01 Day
Date of IRB
2019 Year 10 Month 18 Day
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study was a retrospective single-cohort study using "the Nihon University Clinical Data Management System".

Management information
Registered date
2020 Year 06 Month 10 Day
Last modified on
2020 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046477

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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