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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044255
Receipt No. R000050544
Scientific Title Study of the effect of addition of IGU on clinical remission rate after bDMARDs discontinuation in patients with RA.
Date of disclosure of the study information 2021/05/19
Last modified on 2021/05/19

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Basic information
Public title Study of the effect of addition of iguratimod (IGU) on clinical remission rate after biologic disease modified anti-rheumatic drugs (bDMARDs) discontinuation in patients with rheumatoid arthritis(RA) .
Acronym Study of the effect of addition of IGU on clinical remission rate after bDMARDs discontinuation in patients with RA.
Scientific Title Study of the effect of addition of IGU on clinical remission rate after bDMARDs discontinuation in patients with RA.
Scientific Title:Acronym Study of the effect of addition of IGU on clinical remission rate after bDMARDs discontinuation in patients with RA.
Region
Japan

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

Objectives
Narrative objectives1 We prospectively evaluate whether the addition of iguratimod (IGU) could sustain clinical remission after biologic disease modified anti-rheumatic drugs(bDMARDs) discontinuation in patients with rheumatoid arthritis(RA).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoints of this study are DAS28-ESR, CDAI, and US-GLOESS score at 48 weeks.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 RA patients are divided into two groups by patient's decision.:bDMARDs discontinuation group(IGU- group) and IGU addition/bDMARDs discontinuation group(IGU+ group).
The RA patients in the IGU addition group are treated with 25 mg/day of IGU for the first 4 weeks, and subsequently treated with 25 mg/day or 50 mg/day at the discretion of each attending physician.
Interventions/Control_2 RA patients are divided into two groups by patient's decision.:bDMARDs discontinuation group(IGU- group) and IGU addition/bDMARDs discontinuation group(IGU+ group).
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 RA patients who fulfilled the following criteria are included:(i)> 1-year of bDMARDs;(ii)> 6-months disease activity score (DAS) 28-erythrocyte sedimentation rate (ESR) 2.6 or clinical disease activity index (CDAI) score <2.8.
Key exclusion criteria Patients with IGU contraindications, such as during warfarin potassium.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Tohru
Middle name
Last name Takeuchi
Organization Osaka Medical and Pharmaceutical University
Division name Department of Internal Medicine (IV)
Zip code 569-8686
Address 2-7 Daigakumachi, Takatsuki city, Osaka
TEL 072-683-1221
Email tooru.takeuchi@ompu.ac.jp

Public contact
Name of contact person
1st name Ayaka
Middle name
Last name Yoshikawa
Organization Osaka Medical and Pharmaceutical University
Division name Department of Internal Medicine (IV)
Zip code 569-8686
Address 2-7 Daigakumachi, Takatsuki city, Osaka
TEL 072-683-1221
Homepage URL
Email in1362@osaka-med.ac.jp

Sponsor
Institute Osaka Medical and Pharmaceutical University
Department of Internal Medicine (IV)
Institute
Department

Funding Source
Organization Osaka Medical and Pharmaceutical University
Department of Internal Medicine (IV)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka Medical and Pharmaceutical University
Address 2-7 Daigakumachi, Takatsuki city, Osaka
Tel 072-683-1221
Email rinri@ompu.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
2021 Year 05 Month 19 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 Preinitiation
Date of protocol fixation
2021 Year 04 Month 14 Day
Date of IRB
Anticipated trial start date
2021 Year 07 Month 01 Day
Last follow-up date
2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 05 Month 19 Day
Last modified on
2021 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050544

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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