UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022296 |
|---|---|
| Receipt number | R000025603 |
| Scientific Title | Evaluation of regulatory T cell and disease activity after transdermal administration of Dovonex(r) ointment 50ug/g in patients with rheumatoid arthritis |
| Date of disclosure of the study information | 2016/05/15 |
| Last modified on | 2016/09/01 09:28:32 |
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Basic information
Public title
Evaluation of regulatory T cell and disease activity after transdermal administration of Dovonex(r) ointment 50ug/g in patients with rheumatoid arthritis
Acronym
Evaluation of regulatory T cell and disease activity after transdermal administration of Dovonex(r) ointment 50ug/g in patients with rheumatoid arthritis
Scientific Title
Evaluation of regulatory T cell and disease activity after transdermal administration of Dovonex(r) ointment 50ug/g in patients with rheumatoid arthritis
Scientific Title:Acronym
Evaluation of regulatory T cell and disease activity after transdermal administration of Dovonex(r) ointment 50ug/g in patients with rheumatoid arthritis
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate effect on Treg and change in disease activity after transdermal administration of Dovonex(r) ointment 50ug/g in patients with rheumatoid arthritis
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of Treg are evaluated before and 8 days after transermal administration of Dovonex(r) ointment 50ug/g.
Key secondary outcomes
Evaluate change in disease activity using RA activity indexes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Transdermal administration of 5g of Dovonex(r) ointment 50ug/g twice daily for 7 days. 7 days administration and following 7 days wash-out period are repeated twice.
Interventions/Control_2
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
1, Patients with rheumatoid arthritis diagnosed based on either ACR 1987 revised criteria or 2010 ACR/EULAR Classification
Criteria for Rheumatoid Arthritis.
2, Patients currently treated with antirheumatic drug (except for Cyclosporine and Tacrolimus)
3, 20 years of age or older at the time of consent.
4, Patients who are not during pregnancy or lactation.
5, Patients who consented in writing prior to the commencement of the study procedure.
Key exclusion criteria
1, Patients with other systemic autoimmune disease (e.g. systemic erythematosus).
2, Patients with history of hypersensitivity to Calcipotriol.
3, Patients with or with the risk of hypercalcemia, or whose serum calcium level exceed normal range.
4, Patients currently treated with Calcineurin antagonist (Cyclosporine or Tacrolimus).
5, Patients currently treated with anti-osteoporosis drugs (Vitamin D3, PTH).
6, Patients whose eGFR is 60 or lower.
7, Patients treated for bacterial infection within 30 days prior to the first administration of the study drug.
8, Uncooperative patients who might not comply with the protocol procedure.
9, Patients with malignant tumor requiring treatment within past 5 years.
10, Patients judged inappropriate for this study by principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TOMOMI TSURU |
Organization
Medical CO.LTA PS Clinic
Division name
Director
Zip code
Address
6-18, TENYAMACHI, HAKATA-KU, FUKUOKA, FUKUOKA
TEL
0922837777
tomomi-tsuru@lta-med.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | MIDORI SUZAKI |
Organization
Medical Co.LTA PS Clinic
Division name
Nurse
Zip code
Address
6-18, TENYAMACHI, HAKATA-KU, FUKUOKA, FUKUOKA
TEL
0922837777
Homepage URL
midori-suzaki@lta-med.com
Sponsor or person
Institute
Medical Co.LTA PS Clinic
Institute
Department
Personal name
Funding Source
Organization
Qmune
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Co.LTA PS Clinic
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
医療法人相生会ピーエスクリニック（福岡県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 15 | 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 | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 12 | Day |
Last modified on
| 2016 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025603
