UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013614 |
|---|---|
| Receipt number | R000015873 |
| 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 |
| Date of disclosure of the study information | 2014/06/13 |
| Last modified on | 2020/04/06 12:17:35 |
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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 ≤ 3 years.
3) No use of biologics
4) Use DMARDs including methotrexate.
5) DAS28-ESR ≥ 3.2
6)Predonin dose
≤7.5mg/day 7) Extensive bone marrow edema in hand
MRI (RAMRIS bone marrow score ≥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
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
kou@kata-rheum.or.jp
Sponsor or person
Institute
Katayama Orthopedic Rheumatology Clinic
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015873
