UMIN-CTR Clinical Trial

Basic information
Public title	Cross-sectional Study Evaluating patieNt satisfaction,adherence featureS, and thEir association with sociodemographic and clinical characteristics of DMARDinadequate responder rheumatoid arthritis patients
Acronym	SENSE
Scientific Title	Cross-sectional Study Evaluating patieNt satisfaction,adherence featureS, and thEir association with sociodemographic and clinical characteristics of DMARDinadequate responder rheumatoid arthritis patients
Scientific Title:Acronym	SENSE
Region	Japan Asia(except Japan) South America Europe Africa

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

Objectives
Narrative objectives1	What are the clinical, sociodemographic, workability, healthcare resource utilization characteristics, treatment satisfaction,preferences and residual unmet needs of patients with inadequate response to their current RA treatment with conventional/targeted synthetic or biological DMARDs.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To assess treatment satisfaction of patients with sub optimally controlled RA treated with conventional/targeted synthetic or biological DMARDs.
Key secondary outcomes	1.To assess the sociodemographic, clinical, functional, adherence and quality of life characteristics of sub optimally controlled RA patients treated with conventional/targeted synthetic or biological DMARDs. 2.To assess healthcare resource utilization (HRU) during 12 months prior to enrollment to the study in sub optimally controlled RA patients treated with conventional/targeted synthetic or biological DMARDs. 3.To assess electronic health literacy of sub optimally controlled RA patients treated with conventional/targeted synthetic or biological DMARDs. 4.To assess expectations towards RA therapy, medication preferences and needs for patient support of sub optimally controlled RA patients treated with conventional/targeted synthetic or biological DMARDs 5.To determine relationship between treatment satisfaction, its subdomains and patient characteristics. 6.To determine relationship between adherence and patient characteristics. 7.To determine relationship between medication preferences and patient characteristics. 8.To determine relationship between treatment expectations and patient characteristics. 9.To determine relationship between specific PSP-related needs and patient characteristics.

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.Male or female. Adult (18 years old or older). 2.Has rheumatoid arthritis, diagnosed either by the 1987revised ACR classification criteria or by the 2010 ACR,EULAR classification criteria for RA. 3.Currently treated with any kind of approved csDMARDs, tsDMARDs or bDMARDs. 4.Has been exposed to no more than 2 bDMARDs at the time of the enrollment. 5.His,her RA is sub optimally controlled, despite full tolerable dose of current DMARD therapy administered for more than 3months Definition of suboptimal disease control,having high or moderate disease activity for at least 1 month but not more than for 4months prior to the enrollment. 6.Understands the language and willing,able to complete the patient reported outcome questionnaires. 7.Does not participate in any kind of clinical study for RA. 8.Has provided written authorization to the investigator to use and,or disclose personal and,or health data, or informed consent if requested by the local regulations.
Key exclusion criteria	-
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Susumu Middle name Last name Adachi
Organization	AbbVie GK
Division name	Medical
Zip code	108-6302
Address	3-5-27, Minato-ku, Tokyo
TEL	03-4577-1234
Email	susumu.adachi@abbvie.com

Public contact
Name of contact person	1st name Tsuyoshi Middle name Last name Harada
Organization	AbbVie GK
Division name	Medical
Zip code	108-6302
Address	3-5-27, Minato-ku, Tokyo
TEL	03-4577-1234
Homepage URL
Email	tsuyoshi.harada@Abbvie.com

Sponsor
Institute	AbbVie GK
Institute
Department

Funding Source
Organization	AbbVie GK
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	-
Address	4-26-11-3F Sendagaya, Shibuya-ku, Tokyo
Tel	03-6804-2227
Email	cns_jimu@triad-j.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	2018 Year 07 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	118
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	2018 Year 01 Month 30 Day
Date of IRB	2018 Year 09 Month 11 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date	2019 Year 04 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

There is a need for better and in-depth understanding the clinical, socio-demographic, healtheconomic,adherence and PRO characteristics of RA patients with inadequate response to currently available DMARDs. Moreover, in the same sub-optimally controlled RA population, additional data are necessary about their treatment satisfaction, expectations and treatment preferences for RA. Evaluating differences in the above listed areas across subgroups of patients treated with different treatment modalities and regimes, route of RA treatment administration, clinical, demographic and PRO characteristics can guide personalized treatment, support shared treatment decision making and help achieve better disease outcomes in RA. Data collected in the study can also support the development of effective tools for improving adherence and may inform the optimal design of future patient support programs. Results will also inform about the current treatment strategies used in the management of the sub optimally controlled RA population.

Management information
Registered date	2018 Year 07 Month 10 Day
Last modified on	2019 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038021