UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038817 |
|---|---|
| Receipt number | R000044159 |
| Scientific Title | Predictive factors for the safe reduction of Methotrexate in the patients of rheumatoid arthritis under the golimumab treatment |
| Date of disclosure of the study information | 2019/12/10 |
| Last modified on | 2023/06/08 10:01:43 |
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Basic information
Public title
Predictive factors for the safe reduction of Methotrexate in the patients of rheumatoid arthritis under the golimumab treatment
Acronym
Predictive factors for the safe reduction of Methotrexate in the patients of rheumatoid arthritis under the golimumab treatment
Scientific Title
Predictive factors for the safe reduction of Methotrexate in the patients of rheumatoid arthritis under the golimumab treatment
Scientific Title:Acronym
Predictive factors for the safe reduction of Methotrexate in the patients of rheumatoid arthritis under the golimumab treatment
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we retrospectively analyze the patient's demographics by using the electronic medical records from multiple hospitals to investigate the characteristics of the RA patients who maintained the remission or low disease activity with reduced MTX dose under the golimumab (GLM) treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The predictors for the safe reduction of Methotrexate in the patients of rheumatoid arthritis under the golimumab treatment. (Following factors from patient's demographics would be investigated: sex, age, weight, duration of illness, the information of pretreatment drugs (NSAIDs, steroids, DMARDs, bDMARDs etc.) administration periods of the pretreatment drugs, DAS28, CRP, ESR, anti-CCP antibodies, RF, SDAI, CDAI, HAQ-DI) dose of MTX, complications. etc.)
Key secondary outcomes
The characteristics of the patients who decreased MTX under the GLM treatment.
Evaluation of the disease activities of MTX-reduction group and MTX-non-reduction group. (DAS28CRP comparison data of 3M, 6M, 12M)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who is 20 years of age or more when obtaining consent.
Patients who were diagnosed as RA.
Patients who had over 6 months of the treatment history of 50 mg GLM + MTX and have collectable medical record.
(The patients who were prescribed GLM and MTX more than one month, even reducing MTX to 0 mg after the period.)
Key exclusion criteria
The patients who had treated with 100mg GLM.
The patients who have washout periods of GLM over twelve weeks. (To exclude the patients who have the possibility of treatment of other bDMARDs during washout periods)
The patients who reduced the MTX dose but increased up to previous dose due to managing conditions.
The patients who do not have the information about the disease activity (DAS28CRP) at baseline.
The patients who refuted to join the study.
The patients whom the researchers considered should not be included to the study.
Target sample size
458
Research contact person
Name of lead principal investigator
| 1st name | Masami |
| Middle name | |
| Last name | Takei |
Organization
Nihon University School of Medicine
Division name
Division of Hematology and Rheumatology
Zip code
173-8610
Address
30-1 Oyaguchikamicho,Itabashi-ku,Tokyo
TEL
03-3972-8111
takei.masami@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Masami |
| Middle name | |
| Last name | Takei |
Organization
Nihon University School of Medicine
Division name
Division of Hematology and Rheumatology
Zip code
173-8610
Address
30-1 Oyaguchikamicho,Itabashi-ku,Tokyo
TEL
03-3972-8111
Homepage URL
takei.masami@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
4DIN Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Janssen Pharmaceutical K.K.
Mitsubishi Tanabe Pharma Corporation
IRB Contact (For public release)
Organization
Nihon University School of Medicine
Address
30-1 Oyaguchikamicho,Itabashi-ku,Tokyo
Tel
03-3972-8111
takei.masami@nihon-u.ac.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
日本大学医学部附属板橋病院（東京都）、順天堂大学医学部附属順天堂医院（東京都）、聖路加国際病院（東京都）、東京都立大塚病院（東京都）、北海道内科リウマチ科病院（北海道）、横浜市立大学附属市民総合医療センター（神奈川県）、市立札幌病院（北海道）、埼玉医科大学総合医療センター（埼玉県）、藤田医科大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 10 | 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
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we retrospectively analyze the patient's demographics by using the electronic medical records from multiple hospitals to investigate the characteristics of the RA patients who maintained the remission or low disease activity with reduced MTX dose under the golimumab (GLM) treatment.
Management information
Registered date
| 2019 | Year | 12 | Month | 06 | Day |
Last modified on
| 2023 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044159
