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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041767
Receipt No. R000047673
Scientific Title Clinical course of patients with rheumatoid arthritis undergoing iguratimod with/without methotrexate.
Date of disclosure of the study information 2020/09/11
Last modified on 2020/09/11

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Basic information
Public title Retention rate of iguratimod with and without methotrexate in patients with rheumatoid arthritis.
Acronym Retention rate of iguratimod with and without methotrexate in patients with rheumatoid arthritis.
Scientific Title Clinical course of patients with rheumatoid arthritis undergoing iguratimod with/without methotrexate.
Scientific Title:Acronym Clinical course of patients with rheumatoid arthritis undergoing iguratimod with/without methotrexate; retrospectively observed trial.
Region
Japan

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

Objectives
Narrative objectives1 RA undergoing IGU was retrospectively observed. RA patients were divided into those treated with MTX+IGU and those treated with IGU. The clinical response, retention rate, and safety were evaluated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Iguratimod retention rate with and without methotrexate in patients with rheumatoid arthritis at 24 weeks.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 106 patients diagnosed with rheumatoid arthritis who were treated with Iguratimod during the period from 2014 to 2017.
Key exclusion criteria Patients were excluded if they had been treated with biological DMARDs (bDMARDs).
Patients with a connective tissue disease other than rheumatoid arthritis and patients previously treated with iguratimod were also excluded from the study.

Target sample size 106

Research contact person
Name of lead principal investigator
1st name Masanori
Middle name
Last name Funauchi
Organization Kindai University School of Medicine
Division name Department of Hematology and Rheumatology
Zip code 589-8511
Address 377-2 Ohnohigashi, Osakasayama, Osaka Japan
TEL 0723660221
Email mn-funa@med.kindai.ac.jp

Public contact
Name of contact person
1st name Asuka
Middle name Inoue
Last name Inoue
Organization Kindai University Nara Hospital
Division name Department of Hematology and Rheumatology
Zip code 630-0293
Address 377-2 Ohnohigashi, Osakasayama, Osaka Japan
TEL 0743770880
Homepage URL
Email asuka@med.kindai.ac.jp

Sponsor
Institute Department of Hematology and Rheumatology, Kindai University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kindai University medical department ethic screening committee
Address 377-2 Ohnohigashi, Osakasayama, Osaka Japan
Tel 0723660221
Email gakumu@med.kindai.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 11 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 106
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 Completed
Date of protocol fixation
2014 Year 01 Month 01 Day
Date of IRB
2018 Year 05 Month 22 Day
Anticipated trial start date
2014 Year 01 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is a retrospective study, and only examines medical records in the following items. The study schedule will be based on the start of IGU administration, and the following items will be evaluated at 24 and 54 weeks.

Retention rate of iguratimod (IGU) with and without MTX in rheumatoid arthritis (RA) after 24 weeks

Disease activity of RA with and without MTX (DAS28-CRP)
Side effects (infectious diseases, organ damage, etc.) that occurred during the oral administration period

Management information
Registered date
2020 Year 09 Month 11 Day
Last modified on
2020 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047673

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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