UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052344 |
|---|---|
| Receipt number | R000059750 |
| Scientific Title | Efficacy in Methotrexate related intolerant subjective symptoms on switching from oral to subcutaneous injection of Methotrexate in Japanese patients with Rheumatoid Arthritis; Metojective study |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2025/04/19 22:16:37 |
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Basic information
Public title
Efficacy in Methotrexate related intolerant subjective symptoms on switching from oral to subcutaneous injection of Methotrexate in Japanese patients with Rheumatoid Arthritis; Metojective study
Acronym
Efficacy in Methotrexate related intolerant subjective symptoms on switching from oral to subcutaneous injection of Methotrexate in Japanese patients with Rheumatoid Arthritis; Metojective study
Scientific Title
Efficacy in Methotrexate related intolerant subjective symptoms on switching from oral to subcutaneous injection of Methotrexate in Japanese patients with Rheumatoid Arthritis; Metojective study
Scientific Title:Acronym
Efficacy in Methotrexate related intolerant subjective symptoms on switching from oral to subcutaneous injection of Methotrexate in Japanese patients with Rheumatoid Arthritis; Metojective study
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety of the subcutaneous methotrexate and oral methotrexate.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in nausea VAS from 0 to 13 weeks
Key secondary outcomes
Comparison of change in fatigue VAS from 0 to 13 weeks of treatment.
Change in RA disease activity (DAS28, DAS28ESR, SDAI, CDAI) from Week 0 to Week 13 of treatment
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) RA patients 18 years of age or older
2) Patients who have been taking MTX for at least 12 weeks (the same dose for at least 2 weeks at the time of enrollment)
3) Patients who have gastrointestinal symptoms such as nausea, vomiting, anorexia, or fatigue even after receiving 10 mg or 15 mg/week of foliac acid or 1 mg daily, and who have difficulty continuing MTX or require a dose reduction.
(4) Patients who have been fully informed of the study and who have given written consent of their own free will after sufficient understanding of the study
Key exclusion criteria
1) Patients under 18 years of age
2) Patients with drug allergy to MTX
3) Patients with serious liver disease (Grade 3 or higher in CTCAE Ver5.0)
4) Patients with serious renal disease (eGFR <30)
5) Patients with severe interstitial pneumonia
6) Patients with hematologic malignancies
7) Patients with pleural effusion or ascites
8) Patients with active tuberculosis or other infectious diseases
9) Women who are pregnant or may become pregnant
10) Women who are breast-feeding
11) Patients with cognitive impairment and inability to maintain adherence
12) Other patients who are deemed inappropriate as research subjects by the principal investigator or research coordinator.
12) Other patients deemed inappropriate as research subjects by the principal investigator or principal investigator's assistant.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shin-ichiro |
| Middle name | |
| Last name | Ohmura |
Organization
Seirei Hamamatsu General Hospital
Division name
Department of the Rheumatology
Zip code
430-8558
Address
2-12-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka
TEL
053-474-2222
s-omura0018@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | Shin-ichiro |
| Middle name | |
| Last name | Ohmura |
Organization
Seirei Hamamatsu General Hospital
Division name
Department of the Rheumatology
Zip code
430-8558
Address
2-12-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka
TEL
053-474-2222
Homepage URL
s-omura0018@sis.seirei.or.jp
Sponsor or person
Institute
Seirei Hamamatsu General Hospital
Institute
Department
Personal name
Funding Source
Organization
Seirei Hamamatsu general hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seirei Hamamatsu General Hospital
Address
2-12-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka
Tel
0534742222
s-omura0018@sis.seirei.or.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
| 2023 | 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
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2023 | Year | 09 | Month | 28 | Day |
Last modified on
| 2025 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059750
