UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033354
Receipt number R000038021
Scientific Title 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 2019/12/27 10:02:43

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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 or person

Institute

AbbVie GK

Institute

Department

Personal name



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

Value
https://center6.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