UMIN-CTR Clinical Trial

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
Email	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
Email	nobuhiko.kajio@keio.jp

Sponsor
Institute	Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047524