UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017429 |
|---|---|
| Receipt number | R000020111 |
| Scientific Title | Observational study For Investigating the ability of Recuperation of work/ house work State with adalimumab treatment in RA patients in tohoku |
| Date of disclosure of the study information | 2015/05/07 |
| Last modified on | 2015/05/06 12:22:55 |
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Basic information
Public title
Observational study For Investigating the ability of Recuperation of work/ house work State with adalimumab treatment in RA patients in tohoku
Acronym
AT HOME study
Scientific Title
Observational study For Investigating the ability of Recuperation of work/ house work State with adalimumab treatment in RA patients in tohoku
Scientific Title:Acronym
AT HOME study
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Medicine in general | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety, including improvement in paid work and housework, of treatment with adalimumab in patients with rheumatoid arthritis in tohoku area
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Change in percent overall work impairment (at the last observation, up to week72) in paid workers, by the Work Productivity and Activity Impairment Questionnaire (WPAI)
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Age => 20 years and 75<years at registration
(2)Diagnosis of rheumatoid arthritis according to the American College of Rheumatology ACR criteria
(3) Patients who want to be treated with adalimumab and MTX
(4)Consent to study participation has been obtained in writing from the patient personally
Key exclusion criteria
(1)Patients who pregnant
(2)Patients who cannot use the drug in this study by contraindication.
(3)The principal investigator or co-investigator has determined that the participation of the patient in the study would not be appropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomonori ISHII |
Organization
Tohoku university hospital
Division name
Crieto
Zip code
Address
1-1, seiryocho, aobaku, senndai
TEL
022-717-7165
tishii@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomonori ISHII |
Organization
Tohoku university hospital
Division name
Crieto
Zip code
Address
1-1, seiryocho, aobaku, senndai
TEL
022-717-7165
Homepage URL
tishii@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku uviversity hospital
Institute
Department
Personal name
Funding Source
Organization
ichinohazama academy
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 05 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
pre obxervation period
Management information
Registered date
| 2015 | Year | 05 | Month | 06 | Day |
Last modified on
| 2015 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020111
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
