UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037798 |
|---|---|
| Receipt number | R000043103 |
| Scientific Title | Effect of etanercept BS1 on physical function of elderly patients with rheumatoid arthritis in daily clinical practice(STEP1) |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2019/11/17 17:05:51 |
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Basic information
Public title
Effect of etanercept BS1 on physical function of elderly patients with rheumatoid arthritis in daily clinical practice(STEP1)
Acronym
Happiness
Scientific Title
Effect of etanercept BS1 on physical function of elderly patients with rheumatoid arthritis in daily clinical practice(STEP1)
Scientific Title:Acronym
Happiness
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology | Geriatrics | Orthopedics |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of etanercept BS1 on the physical function of elderly patients with rheumatoid arthritis who are scheduled to receive biologics.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in Locomo 25 and EQ5D-5L after 26 and 52 weeks from the start of treatment.
Key secondary outcomes
Onset of adversed events
Disease activety score based 28 joints
Simplified disease activity index
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients over 65 years old diagnosed with rheumatoid arthritis
Patients starting etanercept BS1 treatment
Key exclusion criteria
Patients who received biological or JAK inhibitors before study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Nobumasa |
| Middle name | |
| Last name | Miyake |
Organization
Miyake orthopedics clinic
Division name
Director
Zip code
420-0937
Address
2-24, Karase, Aoi-ku, Shizuoka city, Shizuoka
TEL
054-245-5544
orthomik@poplar.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Funahashi |
Organization
research Institute of Joint Desease
Division name
Vice president
Zip code
651-0085
Address
IN Toyo Building 9F, 3-2-5, Hatimandori, Chuo-ku, Kobe, Hyogo
TEL
078-230-1233
Homepage URL
kansetsusaisei123@cup.ocn.ne.jp
Sponsor or person
Institute
Happiness study Group
Institute
Department
Personal name
Funding Source
Organization
AYUMI pharmaceutical Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Katayama Orthopedic Rheumatology Clinic
Komagamine Orthopedic and Rheumatology Clinic
Mitsuka Rheumatology Clinic
Maki Tanaka Orthopedic Clinic
Miyake Orthopedic Clinic
Matsubara Mayflower Hospital
Matsubara Clinic
Sakaisakihana Hospital
Hara Hospital
Yoshii Hospital
Kondo Clinic for Rheumatology and Orthopaedics
Center for Arthritis and Clinical Rheumatology, Matsubara Clinic
Department of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Matsubara Mayflower Hosital
Address
944-25, Fujita, Kato, Hyogo
Tel
0795-42-8851
tiken@mayflower-hp.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
| 2019 | Year | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 05 | Month | 31 | Day |
Other
Other related information
To investigate how the elderly patients with rheumatoid arthritis keep their physical function with etanercept bio-similar
Also to investigate whether biological DMARDs is better treatment or not for the patients with elderly rheumatoid arthritis
Management information
Registered date
| 2019 | Year | 08 | Month | 26 | Day |
Last modified on
| 2019 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043103
| Research Plan | |
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| Registered date | File name |
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