UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022036 |
|---|---|
| Receipt number | R000025184 |
| Scientific Title | Comparison of the effects of single predonine and predonine-iguratimod therapy on the old elderly onset arthritis.randomized controlled trial. |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2020/10/26 09:49:56 |
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Basic information
Public title
Comparison of the effects of single predonine and predonine-iguratimod therapy on the old elderly onset arthritis.randomized controlled trial.
Acronym
The effects of iguratimod therapy on the elderly onset arthritis.
Scientific Title
Comparison of the effects of single predonine and predonine-iguratimod therapy on the old elderly onset arthritis.randomized controlled trial.
Scientific Title:Acronym
The effects of iguratimod therapy on the elderly onset arthritis.
Region
| Japan |
Condition
Condition
elderly onset arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects and the safety of single predonine and predonine-iguratimod therapy on the elderly onset arthritis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Revival rate (during two years from start of therapy)
Key secondary outcomes
dose of steroid(mg/day)
(after 6.12.18.24 month from start of therapy)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Predonine single group
Predonine treatment protocol starting with 15 mg/day for 4weeks and,12.5 mg/day a for 4 weeks,10 mg/day for 4-6 weeks, and tapering for 1mg/4-8 weeks until completion of treatment.
The intervention period are about two years.
Interventions/Control_2
Predonine-iguratimode group Predonine treatment protocol starting with 15mg/day for 4weeks and,12.5 mg/day a for 4weeks,10mg/day for 4-6 weeks,and tapering for 1mg/4-8 weeks until completion of treatment.
Iguratimod treatment protocol starting with 25mg/day for 4weeks.and increase to 50mg/day (When there is not tolerability,even 25mg/day is possible)
The intervention period are about two years.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Arthritis patient diagnosis to after 50 years old.
Patient not have a poor-prognosis gene (rheumatoid factor,antiCCP antibody, Sore bone in X-rays,high disease activity).
Key exclusion criteria
Predonine-iguratimode intolerable patients.
Patients not treated with predonine-iguratimode and such as an immunosuppressive drug or the biologicals within one month.
Pregnant or possibly pregnant patients.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Funauchi |
Organization
Kinki University Facalty of Medicine
Division name
Division of Hematology and Rheumatology
Zip code
589-0014
Address
377-2 Ohnohigashi, Osakasayama, Osaka Japan
TEL
0723660221
mn-funa@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Shinkai |
| Middle name | |
| Last name | Ri |
Organization
Kinki University Facalty of Medicine
Division name
Division of Hematology and Rheumatology
Zip code
589-0014
Address
377-2 Ohnohigashi, Osakasayama, Osaka Japan
TEL
0723660221
Homepage URL
http://www.med.kindai.ac.jp/rinri/index.html
jinhai@med.kindai.ac.jp
Sponsor or person
Institute
Kinki University Faculty of Medicine, Division of Hematology and Rheumatology
Institute
Department
Personal name
Funding Source
Organization
Kinki University Faculty of Medicine, Division of Hematology and Rheumatology
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
Kinki 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
近畿大学医学部附属病院 (大阪府) Kinki University Faculty of Medicine（Osaka）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 24 | Day |
Last modified on
| 2020 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025184
