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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033354
Receipt No. R000038021
Official scientific title of the study Cross-sectional Study Evaluating patieNt satisfaction,adherence featureS, and thEir association with sociodemographic and clinical characteristics of DMARDinadequate responder rheumatoid arthritis patients
Date of disclosure of the study information 2018/07/10
Last modified on 2018/07/10

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Basic information
Official scientific title of the study Cross-sectional Study Evaluating patieNt satisfaction,adherence featureS, and thEir association with sociodemographic and clinical characteristics of DMARDinadequate responder rheumatoid arthritis patients
Title of the study (Brief title) 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 Susumu Adachi
Organization AbbVie GK
Division name Medical
Address 3-5-27, Minato-ku, Tokyo
TEL 03-4577-1234
Email susumu.adachi@abbvie.com

Public contact
Name of contact person Tsuyoshi Harada
Organization AbbVie GK
Division name Medical
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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 01 Month 30 Day
Anticipated trial start date
2018 Year 08 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
2018 Year 07 Month 10 Day


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

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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