UMIN-CTR Clinical Trial

Basic information
Public title	A survey of treatment goals and mutual understanding between patients and physicians in terms of the treatment of rheumatoid arthritis
Acronym	A survey of treatment goals and mutual understanding between patients and physicians in terms of the treatment of rheumatoid arthritis
Scientific Title	A survey of treatment goals and mutual understanding between patients and physicians in terms of the treatment of rheumatoid arthritis
Scientific Title:Acronym	A survey of treatment goals and mutual understanding between patients and physicians in terms of the treatment of rheumatoid arthritis
Region	Japan

Condition
Condition	Rheumatoid Arthritis
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In the treatment of rheumatoid arthritis (RA), one of the important factor for improving satisfaction in patients is considered as closing gaps between patients with RA and physicians about treatment goals. The aim of this survey is to understand currently existing gaps.
Basic objectives2	Others
Basic objectives -Others	Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The differences between the importance of treatment goals in patients, that in physicians, and that in patients understood by physicians.
Key secondary outcomes	- The difference between the importance of treatment goals in patients and the importance of inhibition of joint destruction for achieving goals, - The difference between the importance of treatment goals in patients and goals presented by physicians, - The difference between information that patients want to express to physicians, that patients expressed to physicians, and that were presented by physicians, - The difference between information that patients expressed to physicians and that physicians asked to patients, - The difference between consent of patients and and consent of patients that physicians understand to goals presented by physicians, - The difference between satisfaction of patients to goals presented by physicians and consent of patients that physicians understand, - The factors associating with satisfaction and consent of patients, - The difference between the importance of long-term and short-term treatment goals in patients, - The difference between the importance of long-term and short-term treatment goals in physicians.

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	A) Patients survey Include patients eligible for the all following criteria from patients registered in MHP: (i) Patients with history of diagnosis with RA; (ii) Patients currently prescribed with medications for RA. B) Physicians survey Include physicians eligible for the all following criteria: (i) Physicians who work in any following department: rheumatology, general internal medicine, orthopedics; (ii) Physicians who have more than 4 patients with RA at the date of the survey.
Key exclusion criteria	A) Patients survey Exclude patients with any one following criteria: (i) Patients who work for any of the following organizations - market research companies - media companies - advertising companies - hospitals or clinics - pharmaceutical companies - pharmaceutical wholesalers (ii) Patients with any one following criteria - without history of medical treatment for RA - with history of medical treatment for RA which is withdrawn - with history of medical treatment for RA which is determined B) Physicians survey Exclude physicians without any one inclusion criteria.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name Takehana
Organization	Medilead Inc.
Division name	Marketing Intelligence Dept.
Zip code	163-1424
Address	Tokyo Opera City Tower, 3-20-2 Nishishinjuku, Shinjuku-ku, Tokyo 163-1424 JAPAN
TEL	03-6859-2295
Email	j_takehana@medi-l.com

Public contact
Name of contact person	1st name Eriko Middle name Last name Wakita
Organization	Medilead Inc.
Division name	Marketing Intelligence Dept.
Zip code	163-1424
Address	Tokyo Opera City Tower, 3-20-2 Nishishinjuku, Shinjuku-ku, Tokyo 163-1424 JAPAN
TEL	03-6859-2295
Homepage URL
Email	e_wakita@medi-l.com

Sponsor
Institute	Others Eisai Co., Ltd.
Institute
Department

Funding Source
Organization	Others Eisai Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Japanese Association for the Promotion of State-of-the-Art in Medicine
Address	2-24-2, Chikusa, Chikusa, Nagoya, Aichi, Japan
Tel	052-745-6881
Email	info-irb@japsam.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	2021 Year 06 Month 11 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	2021 Year 06 Month 01 Day
Date of IRB	2021 Year 06 Month 16 Day
Anticipated trial start date	2021 Year 06 Month 16 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry	2021 Year 06 Month 30 Day
Date trial data considered complete	2021 Year 07 Month 14 Day
Date analysis concluded

Other
Other related information	This is a cross-sectional study using a web-based questionnaire survey. All responses will be anonymized directly after responders complete their answers.

Management information
Registered date	2021 Year 06 Month 07 Day
Last modified on	2022 Year 12 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050772