UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041767 |
|---|---|
| Receipt number | 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 21:51:34 |
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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
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
asuka@med.kindai.ac.jp
Sponsor or person
Institute
Department of Hematology and Rheumatology, Kindai University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047673
