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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012473
Receipt No. 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

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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
Email 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
Email masahiro.okamoto@santen.co.jp

Sponsor
Institute Yokohama Minami Kyousai Hospital
Santen Pharmaceutical CO.,Ltd.
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014532

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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