UMIN-CTR Clinical Trial

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
Email	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
Email	jinhai@med.kindai.ac.jp

Sponsor
Institute	Kinki University Faculty of Medicine, Division of Hematology and Rheumatology
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025184