UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041633 |
|---|---|
| Receipt number | R000047524 |
| Scientific Title | Predictions for relapse of rheumatoid arthritis after discontinuation of biologics |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2022/09/04 15:36:53 |
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Basic information
Public title
Predictions for relapse of rheumatoid arthritis after discontinuation of biologics
Acronym
Predictions for relapse of rheumatoid arthritis after discontinuation of biologics
Scientific Title
Predictions for relapse of rheumatoid arthritis after discontinuation of biologics
Scientific Title:Acronym
Predictions for relapse of rheumatoid arthritis after discontinuation of biologics
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We hypothesized that the molecular status of rheumatoid arthritis patients who are clinically in remission varies from person to person, and that prognosis depends on whether or not they have achieved molecular remission. The aim of this study is to investigate the clinical significance of achieving molecular remission in rheumatoid arthritis patients based on multi-omics analysis that may be a predictor of future relapse.
Basic objectives2
Others
Basic objectives -Others
We aim to investigate molecular markers that predict relapse after discontinuation of biologic agents.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between molecular remission status before tocilizumab discontinuation and relapse after discontinuation.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The following individuals who had blood samples stored in the laboratory of Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine with written informed consent: (1) healthy individuals, (2) patients with active rheumatoid arthritis who were untreated at the time of sample collection, (3) patients with rheumatoid arthritis who had achieved clinical remission under tocilizumab at the time of sample collection, and (4) patients with rheumatoid arthritis who had achieved clinical remission under tocilizumab at the time of sample collection and who had discontinued tocilizumab treatment within 12 months of sample collection.
Key exclusion criteria
Patients considered unsuitable on medical grounds by study sponsors.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Suzuki |
Organization
Keio University School of Medicine
Division name
Division of Rheumatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3786
katsuyas@z5.keio.jp
Public contact
Name of contact person
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Kajio |
Organization
Keio University School of Medicine
Division name
Division of Rheumatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3786
Homepage URL
nobuhiko.kajio@keio.jp
Sponsor or person
Institute
Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine.
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review Board of Keio
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3503
med-nintei-jimu@adst.keio.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 | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
96
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
| 2020 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We conduct comprehensive genetic and proteomic analysis of blood samples from healthy individuals and rheumatoid arthritis patients. and mathematical models will be developed to define molecular remission based on comprehensive molecular and clinical information from healthy individuals and untreated active rheumatoid arthritis patients, and the relationship between molecular remission and imaging and functional assessment in rheumatoid arthritis patients who are in clinical remission will be analyzed. In addition, we will search molecular markers that predict relapse after discontinuation of biologic agents.
Management information
Registered date
| 2020 | Year | 09 | Month | 01 | Day |
Last modified on
| 2022 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047524
