UMIN-CTR Clinical Trial

Basic information
Public title	Observational study for lymphoproliferative disorders in patients with rheumatoid arthritis
Acronym	Observational study for lymphoproliferative disorders in patients with rheumatoid arthritis (RA-LPD study)
Scientific Title	Observational study for lymphoproliferative disorders in patients with rheumatoid arthritis
Scientific Title:Acronym	Observational study for lymphoproliferative disorders in patients with rheumatoid arthritis (RA-LPD study)
Region	Japan

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

Objectives
Narrative objectives1	To investigate incidence rate of lymphoproliferative diseases (LPD), clinical characteristics, treatments for LPD, and prognosis in patients with rheumatoid arthritis retrospectively over three years.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence rate of lymphoproliferative disorders over three years in patients with rheumatoid arthritis
Key secondary outcomes	Prognosis of the registered patients with rheumatoid arthritis over three years, and clinical characteristics and treatments for LPD

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. From 2011.4.1 to 2011.7.31, Japanese rheumatoid arthritis (RA) patients who were 20 years old or older, and visited at least once the RA educational institutions that were authorized by Japan College of Rheumatology, and agreed to participate in this study 2. RA patients who were fulfilled the 1987 American College of Rheumatology classification criteria for RA or American College of Rheumatology/European League Against Rheumatism classification criteria for RA
Key exclusion criteria	1. Patients who were definitely diagnosed with lymphoma based on pathological data before the start of observation 2. Patients or their deputies who did not agree to participate in this study 3. Patients who were deemed to be unqualified due to medical or social reasons by attending physicians
Target sample size	57500

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masayoshi Harigai
Organization	Tokyo Women's Medical University Institute of Rheumatology
Division name	Department of Epidemiology and Pharmacoepidemiology of Rheumatic Diseases
Zip code
Address	10-22 Kawada-cho, Shinjuku-ku, Tokyo, 162-0054, Japan
TEL	03-5269-1725
Email	harigai.masayoshi@twmu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Ryoko Sakai
Organization	Tokyo Women's Medical University Institute of Rheumatology
Division name	Department of Epidemiology and Pharmacoepidemiology of Rheumatic Diseases
Zip code
Address	10-22 Kawada-cho, Shinjuku-ku, Tokyo, 162-0054, Japan
TEL	03-5269-1725
Homepage URL
Email	sakai.ryoko@twmu.ac.jp

Sponsor
Institute	Japan College of Rheumatology
Institute
Department

Funding Source
Organization	Japan College of Rheumatology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Osaka University Hospital
Name of secondary funder(s)	none

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	個々の施設名については本研究問い合わせ窓口にお問い合わせ下さい。

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 01 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	No longer recruiting
Date of protocol fixation	2016 Year 06 Month 27 Day
Date of IRB	2016 Year 03 Month 28 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date	2019 Year 07 Month 31 Day
Date of closure to data entry	2019 Year 12 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other

Other related information

Study design: retrospective observational study Patients: patients with rheumatoid arthritis (RA) who were 20 years old or older, and visited the institution at least once from 2011.4.1 to 2011.7.31 (if less than 300, all eligible RA patients will be registered at each institution, if more than 300, the first 300 patients will be registered) Collecting data: demographic data, clinical data and treatments for RA, RA disease activity, prognosis, development of lymphoproliferative disorders (LPD), and clinical data and treatments for LPD in patients with LPD

Management information
Registered date	2016 Year 06 Month 29 Day
Last modified on	2020 Year 07 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026441