UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044255 |
|---|---|
| Receipt number | 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 12:02:16 |
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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
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
in1362@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Department of Internal Medicine (IV)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050544
