UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012473 |
|---|---|
| Receipt number | R000014532 |
| Scientific Title | Study for variations of safety and efficacy profile caused by division of weekly dose of methotrexate (preliminary study) |
| Date of disclosure of the study information | 2013/12/04 |
| Last modified on | 2015/07/06 09:57:18 |
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Basic information
Public title
Study for variations of safety and efficacy profile caused by division of weekly dose of methotrexate
(preliminary study)
Acronym
SAME study
Scientific Title
Study for variations of safety and efficacy profile caused by division of weekly dose of methotrexate
(preliminary study)
Scientific Title:Acronym
SAME study
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety when administered by dividing into 3 times and when administered at once doses per week of MTX for rheumatoid arthritis patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Adverse event rates by questionnaire in observation period
Key secondary outcomes
SDAI of 12 weeks and 19 weeks from the start of observation period
DAS28 of 12 weeks and 19weeks from the start of observation period
Concentration of MTX polyglutamates in red blood cells
Laboratory test values in observation period
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
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of weekly MTX dose at once
Interventions/Control_2
administration by dividing three times of weekly MTX dose
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients, fulfilled the ACR 1987 reviced criteria for the classification of rheumatoid arthritis and patients, fulfilled the ACR/EULAR 2010 criteria for the classification of rheumatoid arthritis.
2) Patients that are determined to need additional doses above 8mg / week despite of treatment with methotrexate
3) Outpatients (there are no schedules of hospitalization during a clinical trial period).
4) Patients who can provide written informed concent by themselves.
Key exclusion criteria
(Complication)
Patients who had any of the following diagnoses or medical history
1)Autoimmune disease, except for RA and Sjogren's syndrome, and malignancy.
2)Drug allergy
3)Severe heart, lung, liver, kidney and heamatological disorders
(Treatment)
4)Patient who recived intramuscular, intoravenous or epidural injection of corticosteroids within 4 weeks prior to the entry or during study
5)Patient who recived intraarticular corticosteroid at dose of over 20mg/month of prednisolone, and patients who recieved intraarticular corticosteroid at any dose within 4weeks prior to study entry or the day for observation of first end point
6)Patient who recived systemic corticosteroid with a dose of>10mg of predonisolone within 4 weeks prior to the study or during the study and Patients whose corticosteroid dose were changed within 4 weeks prior to the day for observation of first end point
7)Patient who received NSAIDs with an overdosage within 4 weeks prior to the study entry or during the study
(Surgery)
8)Patient who had surgery judged to have an influence on this study by doctor
9)Patient who had the following treatment or procedure:plasma exchange, leukocyte depleted therapy or arthrocentesis against affected joint. except for the arthrocenesis following intraarticular injection of corticosteroid, within 4 weeks prior to the study entry or during the study
(Others)
10)Patient who is in pregnancy, lactating, or with a possibility of the pregnancy and woman who hopes for pregnancy during study or within 1 month after the end of this study, and man who wishes his partner be pregnant during the study or within 3 months after the end of this study
11)Patient who can not go to a hospital for check-up on an appointed day
12)When principal investigator or sub investigators of this study judge the patients disqualified as a subject of this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shohei Nagaoka |
Organization
Yokohama Minami Kyousai Hospital
Division name
Deputy director
Zip code
Address
1-21-1, Rikuurahigashi, Kanazawa-ku, Yokohama City, Kanagawa
TEL
045-782-2101
nagaokascrt@msn.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Okamoto |
Organization
Santen Pharmaceutical CO.,Ltd.
Division name
Rheumatology Research & Development Center
Zip code
Address
8916-16, Takayama-cho, Ikoma City, Nara
TEL
0743-79-4736
Homepage URL
masahiro.okamoto@santen.co.jp
Sponsor or person
Institute
Yokohama Minami Kyousai Hospital
Santen Pharmaceutical CO.,Ltd.
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
Santen Pharmaceutical 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
横浜南共済病院（神奈川県） Yokohama Minami Kyousai Hospital（Kanagawa）
参天製薬株式会社 奈良開発研究センター（奈良県）Santen Pharmaceutical CO.,Ltd. Nara R&D center (Nara)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://ard.bmj.com/content/74/Suppl_2/260.2.abstract?sid=36807678-3c45-42f7-8619-1b9a5d92f398
Number of participants that the trial has enrolled
Results
There were no significant differences in the average of age , disease duration (5.8yr), and baseline DAS28(CPR)(2.84) between two groups. There were also no differences in the improvement of DAS28(CPR)(-0.95 vs -0.75) between two groups and weekly MTX dose(11.5mg vs 11.4mg) . Three adverse events were observed only in 3-dose regimen group . The remarkable difference was observed in MTX-PGs(18.8%), 3-dose regimen group showed significantly higher concentration of MTX-PG1+2 than single-dose group. On the other hand, 3-doses regimen group showed slight lower MTX-PG4+5 than single-dose regimen group, and there was no difference in MTX-PG3. The efficacy did not show significant difference between two groups. Liver function may be affected by concentration of MTX-PG1+2, which elevated in divided dosage regimen group. Further investigation is required in a larger population.
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
| 2013 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 11 | Day |
Date of closure to data entry
| 2015 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2015 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Poster presentation in EULAR2015
Management information
Registered date
| 2013 | Year | 12 | Month | 03 | Day |
Last modified on
| 2015 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014532
