UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055650 |
|---|---|
| Receipt number | R000063553 |
| Scientific Title | Safety and efficacy of subcutaneous methotrexate therapy in methotrexate-subcutaneous-naive patients with rheumatoid arthritis (MESSAGE study) |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2024/11/29 09:37:45 |
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Basic information
Public title
Safety and efficacy of subcutaneous methotrexate therapy in methotrexate-subcutaneous-naive patients with rheumatoid arthritis (MESSAGE study)
Acronym
Safety and efficacy of subcutaneous MTX therapy in patients with rheumatoid arthritis
Scientific Title
Safety and efficacy of subcutaneous methotrexate therapy in methotrexate-subcutaneous-naive patients with rheumatoid arthritis (MESSAGE study)
Scientific Title:Acronym
Safety and efficacy of subcutaneous MTX therapy 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
This study is intended to evaluate the safety and efficacy of Metoject (investigational drug) in patients with rheumatoid arthritis (RA) under real-world conditions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Incidence of adverse events during investigational drug administration
2) Change from baseline to Week52 in SDAI
Key secondary outcomes
1) Incidence of gastrointestinal symptoms as adverse events
2) Disappearance rate of gastrointestinal symptoms observed at baseline
3) Measured values at each assessment timepoint and change from baseline to each assessment timepoint in F-scale and MCV
4) Measured values at each assessment timepoint and change from baseline to each assessment timepoint in SDAI, CDAI, DAS28-CRP
5) Measured values at each assessment timepoint and change from baseline to each assessment timepoint in tender joint count, swollen joint count, VAS (physician and patient), mHAQ, CRP, MMP-3, RF, and measured values of ACPA
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who were previously untreated with the investigational drug and are planning to start administration with it
2) Patients aged >=18 years at the time of informed consent
3) Patients who meet 2010 EULAR/ACR criteria
4) Female of child-bearing potential who can use appropriate contraceptive during the study and for at least 1 menstrual cycle after completion of administration, female in whom time from menopause to informed consent is >=1 year, or female of no child-bearing potential through sterilization
5) Virile male who can use appropriate contraceptive during the study and for at least 3 months after completion of administration
6) Patients who can adequately understand this study procedures, and voluntarily consent in writing to take part in this study
Key exclusion criteria
1) Pregnant women or women who may be pregnant
2) Patients with a history of hypersensitivity to any ingredient of the investigational drug
3) Patients with bone marrow suppression
4) Patients with chronic liver disease
5) Patients with renal impairment
6) Patients who have pleural effusion or ascites
7) Patients who have active tuberculosis
8) Patients otherwise whom principal investigator/sub- investigator considered medically ineligible to participate in the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tsukasa |
| Middle name | |
| Last name | Matsubara |
Organization
Matsubara Mayflower Hospital
Division name
Rheumatology / Orthopedics
Zip code
673-1462
Address
944-25 Fujita, Kato-shi, Hyogo, Japan
TEL
0795-42-8851
tiken@mayflower-hp.jp
Public contact
Name of contact person
| 1st name | Taketo |
| Middle name | |
| Last name | Kimura |
Organization
Mebix, Inc.
Division name
Clinical Operations
Zip code
107-0052
Address
Akasaka Intercity 1-11-44 Akasaka, Minato-ku, Tokyo, Japan
TEL
03-4362-4500
Homepage URL
Message-study_CRA@mebix.co.jp
Sponsor or person
Institute
Matsubara Mayflower Hospital
Institute
Department
Personal name
Funding Source
Organization
Eisai Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Eisai Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Matsubara Mayflower Hospital Ethics Committee
Address
944-25 Fujita, Kato-shi, Hyogo, 673-1462, Japan
Tel
0795-42-8851
tiken@mayflower-hp.jp
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
| 2024 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter observational study.
In this study, subjects scheduled to administrate the study drug will be enrolled and observed for 52 weeks from the start of administration of the study drug (week 0) after baseline assessment.
The enrollment period for this study is planned from October 2024 to March 2026.
Management information
Registered date
| 2024 | Year | 09 | Month | 27 | Day |
Last modified on
| 2024 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063553
