UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016606 |
|---|---|
| Receipt number | R000019271 |
| Scientific Title | Efficacy and safety of electroporation and MTX combination therapy for the patients with RA |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2019/02/19 08:32:00 |
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Basic information
Public title
Efficacy and safety of electroporation and MTX combination therapy for the patients with RA
Acronym
Combination therapy of electroporation and MTX for the patients with RA
Scientific Title
Efficacy and safety of electroporation and MTX combination therapy for the patients with RA
Scientific Title:Acronym
Combination therapy of electroporation and MTX for the patients with RA
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of electroporation using for drug delivery system for patients with rheumatoid arthritis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Disease activity of local inflammation by Visual Analogue Scale (VAS)
Key secondary outcomes
1. Ultrasound assessment: Gray and power dopplar scale of local site.
2. Disease activity assessment: Mean value of DAS28, Mean change from baseline of DAS28.
3. Joint destruction: Change of modified Total Sharp Score (mTSS) from baseline.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
* Evaluate the articular synovitis by gray and power dopplar scale using ultrasound (US).
* Injection MTX (5mg/ml, 1ml) into MP or PIP joint using guide of US. After three minutes, perform electroporation for four angles with US gel.
* Condition of electroporation is 50V/cm 250ms 4puluse.
* Single intervention of injection MTX or combination of MTX and electroporation. Evaluation is performed at 2, 4, 12, and 26 weeks after baseline.
Interventions/Control_2
* Evaluate the articular synovitis by gray and power dopplar scale using ultrasound (US).
* Injection MTX (5mg/ml, 1ml) into MP or PIP joint using guide of US.
* Single intervention of injection MTX or combination of MTX and electroporation. Evaluation is performed at 2, 4, 12, and 26 weeks after baseline.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
* Rheumatoid arthritis (RA)
* No limitation of duration of RA
* Patient who are recieving standard RA treatment
* Patient who are stable disease activity during three months by Methotrexate
* Patient who have swelling and tenderness at PIP or MP joint by positive power dopplar of ultrasound
* Patient who are stable disease activity during three months by Steroid or biologic agent
Key exclusion criteria
* Patient who had a history of hypersensitivity for Methotrexate
* Patient who have history of implantation and metallic material
* Patient who had a significant unstable RA disease status
* Patients who have infection disease
* Patient who was pregnant, planning on becoming pregnant or breast feeding Patient who had a history of seizures
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Inui |
Organization
Osaka City University Medical School
Division name
Department of Orthopedic Surgery
Zip code
Address
Osaka
TEL
06-6645-3852
inuken@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Inui |
Organization
Osaka City University Medical School
Division name
Department of Orthopedic Surgery
Zip code
Address
Osaka
TEL
06-6645-3852
Homepage URL
inuken@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Medical School, Department of Orthopedic Surgery
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (C)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | 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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 23 | Day |
Last modified on
| 2019 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019271
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