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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038817
Receipt No. 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 2020/02/19

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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
Email 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
Email takei.masami@nihon-u.ac.jp

Sponsor
Institute Nihon University School of Medicine
Institute
Department

Funding Source
Organization ConvergenceCT Japan KK
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
Email 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)

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 Open public recruiting
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
2020 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
2020 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044159

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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