UMIN-CTR Clinical Trial

Basic information
Public title	Inhibitory effects on bone marrow edema and rapid radiographic progression by short term uage of biologics with early rheumatoid arthritis patients inadequate response to non biological disease modifying antirheumatic drugs with extensive bone marrow edema in hand magnetc resonance imaging
Acronym	Inhibitory effects on hand MRI bone marrow edema and rapid radiographiic progrssion by short term usage of biologics in early RA patients
Scientific Title	Inhibitory effects on bone marrow edema and rapid radiographic progression by short term uage of biologics with early rheumatoid arthritis patients inadequate response to non biological disease modifying antirheumatic drugs with extensive bone marrow edema in hand magnetc resonance imaging
Scientific Title:Acronym	Inhibitory effects on hand MRI bone marrow edema and rapid radiographiic progrssion by short term usage of biologics in early RA patients
Region	Japan

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

Objectives
Narrative objectives1	1) To investigate that good improvent of extensive bome marrow edema by therapies lead to the inhibition of radiographic joint damage, especially rapid radiographic progression (RRP). 2) To investigate thatcontinuation of good improvent of extensive bome marrow edema, the inhibition of radiographic joint damageand and RRP are possible in patients with RA with stopping or redusing BIO.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) At24 weeks, all of patients treated with BIO+DMARDs or DMARD enhancement(dose up,combination) are investigated for relationship beteen MRI BE and the inhibition of radiographic joint damageand and RRP. 2)Next 24,52 weeks, all of patients satisfing good improvent of extensive BE are investigated for the inhibition of MRI BE,radiographic joint damage and RRP between BIO free or reduction(+DMARDs)group and BIO+DMARDs continuation group,DMARDs enhancement continuation group. 3)Continuation rate of BIO free or reduction(+DMARDs)group in next24,52 weeks.
Key secondary outcomes	1)At 24 weeks after treatment, all of patients treated with BIO+DMARDs or DMARD enhancement(dose up,combination) are investigated for a) Percentage of DAS28 LDA,remission achievment b)Percentage of functional remission (HAQ-DI) c) Ultra sound PD, GS score in hand d)Changes of serum factors(cytokines etc) 2))Next 24,52 weeks, all of patients satisfing good improvent of extensive BE are investigated for above a)b)c)d)items.

Base
Study type	Interventional

Study design
Basic design	expanded access
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	In patients whose bone marrow edema score of hand MRI 24 weeks after biologic therapy improve >70 % compared with baseline bone marrow edema score, biologics are step down and step out over the 52 weeks. (Arm A)
Interventions/Control_2	In patients whose bone marrow edema score of hand MRI 24 weeks after biologic therapy improve >70 % compared with baseline bone marrow edema score, biologics are continued over the 52 weeks. (Arm B)
Interventions/Control_3	In patients whose bone marrow edema score of hand MRI 24 weeks after DMARDs dose up or combination therapy improve >70% compared with baseline bone marrow edema score, the DMARDs enhancement therapies are contined over the 52 weeks. (Arm C)
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Satisfied 2010ACR/EULAR criteria 2) Disease duration &#8804; 3 years. 3) No use of biologics 4) Use DMARDs including methotrexate. 5) DAS28-ESR &#8805; 3.2 6)Predonin dose &#8804;7.5mg/day 7) Extensive bone marrow edema in hand MRI (RAMRIS bone marrow score &#8805;15)
Key exclusion criteria	1) Severe infections. 2) Desire pregnancy or during pregnancy. 3) Inadequate to enter this trial.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kou Katayama
Organization	Katayama Orthopedic Rheumatology Clinic
Division name	Rheumatology
Zip code
Address	13-4-5-17,Toyooka,Asahikawa,Japan
TEL	0166-39-1155
Email	kou@kata-rheum.or.jp

Public contact
Name of contact person	1st name Middle name Last name Kou Katayama
Organization	Katayama Orthopedic Rheumatology Clinic
Division name	Rheumatology
Zip code
Address	13-4-5-17,Toyooka,Asahikawa,Japan
TEL	0166-39-1155
Homepage URL
Email	kou@kata-rheum.or.jp

Sponsor
Institute	Katayama Orthopedic Rheumatology Clinic
Institute
Department

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

Other related organizations
Co-sponsor	1)Departmentof Orthopedic Surgery, Asahikawa Medical University 2)Chondrex Inc 3)Asama Chemicals Co. Ltd
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	片山整形外科リウマチ科クリニック/Katayama Orthopedic Rheumatology Clinic 旭川医科大学病院/Asahikawa Medical University Hospital

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 13 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	Completed
Date of protocol fixation	2014 Year 04 Month 15 Day
Date of IRB	2014 Year 05 Month 20 Day
Anticipated trial start date	2014 Year 06 Month 13 Day
Last follow-up date	2019 Year 02 Month 12 Day
Date of closure to data entry	2020 Year 04 Month 06 Day
Date trial data considered complete	2020 Year 04 Month 06 Day
Date analysis concluded	2020 Year 06 Month 06 Day

Other
Other related information

Management information
Registered date	2014 Year 04 Month 02 Day
Last modified on	2020 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015873