UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021157 |
|---|---|
| Receipt number | R000024008 |
| Scientific Title | Clinical trial for efficacy and safety related to weekly dosage regimens of methotrexate |
| Date of disclosure of the study information | 2016/02/29 |
| Last modified on | 2018/08/02 17:21:37 |
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Basic information
Public title
Clinical trial for efficacy and safety related to weekly dosage regimens of methotrexate
Acronym
Clinical trial for Adverse event related to Weekly dosage regimens of Methotrexate
(ADDMe trial)
Scientific Title
Clinical trial for efficacy and safety related to weekly dosage regimens of methotrexate
Scientific Title:Acronym
Clinical trial for Adverse event related to Weekly dosage regimens of Methotrexate
(ADDMe trial)
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 (at a dose of over 8mg/week to 16mg/week) for RA patient who had not achieved remission despite 8mg/week or less dose of MTX for at least 4 weeks. As reference data, to compare MTX-PGs concentration in red blood cells of patients in both groups.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of liver disfunction at Week 20.
Key secondary outcomes
The incidence of adverse events.
The change in DAS28 at Week 20 from Week 0.
The change in SDAI at Week 20 from Week 0.
Concentrations of MTX polyglutamates in red blood cells at Week 0 and Week 20.
Laboratery datas during obsevational term.
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 considered as a block.
Blocking
YES
Concealment
Central registration
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)RA patient who had not achieved remission despite 8mg/week or less dose of MTX for at least 4 weeks.
3)Patient who is within 14 days before change of MTX dose.
4)Patient who elapsed at least 8 weeks after if using biologics, JAK inhibitors or immunosuppressants (leflunomide, tacrolimus or mizolibine).
5) Outpatients (there are no schedules of hospitalization during a clinical trial period).
6) 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 at any dose within 4weeks prior to study entry or first end point
6)Pateint whose body weight is less than or equal to 40kg
7)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 first end point
8)Patient who received NSAIDs with an overdosage within 4 weeks prior to the study entry or during the study.
9) Patient who is currently under treatment or treatmented with biologics, JAK inhibitor or immunosappressants within 8 weeks prior to the study entry.
(Surgery)
10)Patient who had surgery judged to have an influence on this study by doctor
11)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)
12)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
13)Patient who can not go to a hospital for check-up on an appointed day
14)When principal investigator or sub investigators of this study judge the patients disqualified as a subject of this study
Target sample size
120
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
nagaokacrt@msn.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Okamoto |
Organization
AYUMI Pharmaceutical Corporation
Division name
Department of Medical Affers, Division of Research and Development
Zip code
Address
105 Jibu-cho, Fushimi-ku, Kyoto City, Kyoto
TEL
075-632-9700
Homepage URL
masahiro.okamoto@ayumi-pharma.com
Sponsor or person
Institute
Yokohama Minami Kyousai Hospital
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
AYUMI Pharmaceutical corporation
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）Yokohama Minami Kyousai Hospital（Kanagawa)
佐川昭リウマチクリニック（北海道）Sagawa Akira Rheumatology Clinic（Hokkaido)
片山整形外科リウマチ科クリニック（北海道）Katayama Orthopedic Rheumatology Clinic（Hokkaido）
横浜市立大学附属 市民総合医療センター（神奈川）Yokohama City University Medical Center（Kanagawa)
松波総合病院 リウマチセンター（岐阜）Matsunami General Hospital Rheumatology Center
（Gifu)
昭和大学江東豊洲病院（東京）Showa University Koto Toyosu Hospital（Tokyo)
KKR札幌医療センター斗南病院（北海道）KKR Sapporo Medical Center Tonan Hospital（Hokkaido)
市立札幌病院（北海道）Sapporo City General Hospital（Hokkaido)
国立病院機構北海道医療センター（北海道）Hokkaido Medical Center（Hokkaido)
手稲渓仁会病院（北海道）Teine Keijinkai Hospital（Hokkaido）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://ard.bmj.com/content/77/Suppl_2/992.1
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
| 2016 | Year | 01 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 01 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 23 | Day |
Last modified on
| 2018 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024008
