UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of factors affecting patients' preference of biologics treatment modes with rheumatoid arthritis
Acronym	Investigation of factors affecting patients' preference of biologics treatment modes with rheumatoid arthritis
Scientific Title	Investigation of factors affecting patients' preference of biologics treatment modes with rheumatoid arthritis
Scientific Title:Acronym	Investigation of factors affecting patients' preference of biologics treatment modes with rheumatoid arthritis
Region	Japan

Condition
Condition	rheumatoid arthritis
Classification by specialty	Clinical immunology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We conduct a web-based questionnaire survey on rheumatoid arthritis (RA) patients to clarify the background factors affecting the patients' preference of biologics treatment modes (intravenous/subcutaneous (in- hospital)/subcutaneous (self)). It will contribute to the improvement of patients' satisfaction of RA treatment over the long term.
Basic objectives2	Others
Basic objectives -Others	Factors affecting the preference of treatment modes of rheumatoid arthritis patients using biologic disease-modifying antirheumatic drugs.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Factors affecting the preference of treatment modes of rheumatoid arthritis patients using biologic disease-modifying antirheumatic drugs.
Key secondary outcomes	*Presence or absence of a gap from the current treatment modes. *Factors which desire to change the treatment modes in the future.

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	99 years-old >=
Gender	Male and Female
Key inclusion criteria	*Patients with rheumatoid arthritis aged over 20 years. *Patients who regularly visit the hospital for the treatment of rheumatoid arthritis (At least once in 3 months). *Patients who consented via the web to participate in the present research.
Key exclusion criteria	No specific criteria
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Yamairi Middle name Last name Fumiko
Organization	Mitsubishi Tanabe Pharma Corporation
Division name	Medical Intelligence Department
Zip code	103-8405
Address	17-10, Ninonbashi-Koamicho, Chuo-ku, Tokyo
TEL	03-6748-7738
Email	rpp_mtpc@cc.mt-pharma.co.jp

Public contact
Name of contact person	1st name Kitahara Middle name Last name Yuriko
Organization	QLife Co., Ltd.
Division name	Medical Solution
Zip code	105-0001
Address	10th Floor, Toranomon33 Mori Bldg., 3-8-21 Toranomon, Minato-ku, Tokyo
TEL	03-6860-5020
Homepage URL
Email	y-kitahara@qlife.co.jp

Sponsor
Institute	Mitsubishi Tanabe Pharma Corporation
Institute
Department

Funding Source
Organization	Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)	Janssen Pharmaceutical K.K.

IRB Contact (For public release)
Organization	Medical corporation Takahashi clinic clinical trial examination committee
Address	5-1-31 Iwayakitamachi Nada-ku, Kobe-city, Hyogo
Tel	03-43662-4504
Email	no-mori@mebix.co.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	2020 Year 10 Month 22 Day

Related information
URL releasing protocol	https://link.springer.com/article/10.1007/s40744-021-00325-9
Publication of results	Published

Result
URL related to results and publications	https://link.springer.com/article/10.1007/s40744-021-00325-9
Number of participants that the trial has enrolled	400
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 06 Month 05 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 10 Month 13 Day
Date of IRB	2020 Year 10 Month 20 Day
Anticipated trial start date	2020 Year 10 Month 23 Day
Last follow-up date	2020 Year 11 Month 02 Day
Date of closure to data entry	2020 Year 11 Month 02 Day
Date trial data considered complete	2020 Year 11 Month 24 Day
Date analysis concluded	2020 Year 12 Month 18 Day

Other
Other related information	We conduct a web-based questionnaire survey from October 23, 2020 to November 2, 2020 for patients with rheumatoid arthritis registered in Rakuten Insight.

Management information
Registered date	2020 Year 10 Month 22 Day
Last modified on	2021 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048089