UMIN-CTR Clinical Trial

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