UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022942 |
|---|---|
| Receipt number | R000026441 |
| Scientific Title | Observational study for lymphoproliferative disorders in patients with rheumatoid arthritis |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2020/07/02 10:07:10 |
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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
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
sakai.ryoko@twmu.ac.jp
Sponsor or person
Institute
Japan College of Rheumatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026441
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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