Unique ID issued by UMIN | UMIN000033354 |
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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 |
Cross-sectional Study Evaluating patieNt satisfaction,adherence featureS, and thEir association with sociodemographic and clinical characteristics of DMARDinadequate responder rheumatoid arthritis patients
SENSE
Cross-sectional Study Evaluating patieNt satisfaction,adherence featureS, and thEir association with sociodemographic and clinical characteristics of DMARDinadequate responder rheumatoid arthritis patients
SENSE
Japan | Asia(except Japan) | South America |
Europe | Africa |
Rheumatoid Arthritis
Clinical immunology | Orthopedics |
Others
NO
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.
Safety,Efficacy
To assess treatment satisfaction of patients with sub optimally controlled RA treated with conventional/targeted synthetic or biological DMARDs.
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.
Observational
18 | years-old | <= |
Not applicable |
Male and Female
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.
-
2000
1st name | Susumu |
Middle name | |
Last name | Adachi |
AbbVie GK
Medical
108-6302
3-5-27, Minato-ku, Tokyo
03-4577-1234
susumu.adachi@abbvie.com
1st name | Tsuyoshi |
Middle name | |
Last name | Harada |
AbbVie GK
Medical
108-6302
3-5-27, Minato-ku, Tokyo
03-4577-1234
tsuyoshi.harada@Abbvie.com
AbbVie GK
AbbVie GK
Profit organization
-
4-26-11-3F Sendagaya, Shibuya-ku, Tokyo
03-6804-2227
cns_jimu@triad-j.co.jp
NO
2018 | Year | 07 | Month | 10 | Day |
Unpublished
118
Completed
2018 | Year | 01 | Month | 30 | Day |
2018 | Year | 09 | Month | 11 | Day |
2018 | Year | 10 | Month | 01 | Day |
2019 | Year | 04 | Month | 02 | Day |
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.
2018 | Year | 07 | Month | 10 | Day |
2019 | Year | 12 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038021
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