UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012306 |
|---|---|
| Receipt number | R000014393 |
| Scientific Title | Observational study For Investigating the ability of Recuperation of work/ house work State with Tocilizumab (Actemra) SubCutaneous treatment in biologics-naive RA patients |
| Date of disclosure of the study information | 2013/12/11 |
| Last modified on | 2018/08/30 16:13:39 |
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Basic information
Public title
Observational study For Investigating the ability of Recuperation of work/ house work State with Tocilizumab (Actemra) SubCutaneous treatment in biologics-naive RA patients
Acronym
FIRST ACT-SC study
Scientific Title
Observational study For Investigating the ability of Recuperation of work/ house work State with Tocilizumab (Actemra) SubCutaneous treatment in biologics-naive RA patients
Scientific Title:Acronym
FIRST ACT-SC 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 compare the efficacy and safety, including improvement in paid work and housework, of treatment with tocilizumab subcutaneous injection (TCZ-SC) vs. Disease-modifying antirheumatic drugs (DMARDs) in patients with rheumatoid arthritis in the real clinical practice.
Basic objectives2
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 week 52) in paid workers, by the Work Productivity and Activity Impairment Questionnaire (WPAI)
Key secondary outcomes
Change in the percentage of presenteeism, absenteeism, and activity impairment of daily work by WPAI
Change in employment rate by WPAI
Changes in WFun
Changes in Frenchay Activities Index (FAI) among house workers
Changes in EuroQol 5 Dimension (EQ5D)
Changes in Health Assessment Questionnaire Disability Index (some questions are replaced to accommodate Japanese lifestyle differences and have been validated/confirmed)
Changes in disease activity by DAS28-ESR, Clinical disease activity index (CDAI), Simplified disease activity index (SDAI)
Conductes to assess the relationship between characteristics and each assessment outcome
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Age => 20 years at registration
(2) Diagnosis of rheumatoid arthritis according to the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria
(3) Currently being treated with one or more conventional DMARDs
(4) Patients engaged in work (either salaried or self-employed) or the patients primarily responsible for the housework in a family
(5) Disease activity as evidenced by DAS28-ESR ≥ 3.2
(6) Patients who did not receive biological DMARDs treatment previously.
(7) Attending physician has determined that the patient is eligible for treatment with a biological agent, in accordance with the guidelines on the use of biological agents in rheumatoid arthritis of the Japan College of Rheumatology
(8) Patients who want to be treated with TCZ-SC or who want to switch to, add, or increase the dose of a DMARD other than a biological agent
(9) Consent to study participation has been obtained in writing from the patient personally
Key exclusion criteria
(1) Patients who cannot use the drug in this study by contraindication.
(2) The principal investigator or co-investigator has determined that the participation of the patient in the study would not be appropriate
(3) Patients who have been registered and examined in this study
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiya Tanaka |
Organization
University of Occupational and Environmental Health, Japan
Division name
The First Department of Internal Medicine, School of Medicine
Zip code
Address
1-1, Iseigaoka, Yahatanishi, Kitakyushu, 807-8555 Japan
TEL
093-603-1611
tanaka@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Furuya |
Organization
EPS Corporation
Division name
Clinical Coodinating Center Clinical Coodinating Department
Zip code
Address
6-29 Shinogawamachi, Shinjuku-ku Tokyo, 162-0814, Japan
TEL
03-5684-7487
Homepage URL
prj-first_act-scdc@eps.co.jp
Sponsor or person
Institute
EPS Corporation
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
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
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
北海道大学病院/Hokkaido University
佐川昭リウマチクリニック /Sagawa Akira Rheumatology Clinic
札幌医科大学附属病院/Sapporo Medical University
吉田整形外科・リウマチ科クリニック/Yoshida Orthopaedic Clinic
光ヶ丘スペルマン病院/Hikarigaoka Spellman Hospital
大崎市民病院/Osaki Citizen Hospital
東北大学病院/Tohoku University
福島赤十字病院/Japanese Red Cross Fukushima Hospital
筑波大学附属病院/University of Tsukuba
井上病院 /Inoue Hospital
伊勢崎福島病院/Isesaki Fukushima Hospital
JCHO 埼玉メディカルセンター/Japan Community Healthcare Organization Saitama Medical Center
埼玉医科大学総合医療センター/Saitama Medical Unversity
千葉県済生会習志野病院/Chibaken Saiseikai Narashino Hospital
国立国際医療研究センター国府台病院/Kohnodai Hospital, National Center for Global Health and Medicine
東京大学医学部附属病院/The University of Tokyo
板橋中央総合病院/Itabashi Chuo Medical Center
順天堂大学医学部附属順天堂医院/Juntedo University
慶應義塾大学病院/Keio University
杏林大学医学部附属病院/Kyorin University
帝京大学医学部附属病院/Teikyo University
世田谷リウマチ膠原病クリニック/Setagaya Rheumatic Clinic
昭和大学病院/Showa University
聖路加国際病院/St. Luke's International Hospiral
東邦大学医療センター 大橋病院/Toho University
東京医科歯科大学医学部附属病院/Tokyo Medical and Dental University
東京医科大学病院/Tokyo Medical University
東京女子医科大学附属膠原病リウマチ痛風センター /Tokyo Women’s Medical University
独立行政法人国立病院機構 相模原病院/National Hospital Organization Sagamihara National Hospital
独立行政法人国立病院機構 横浜医療センター/National Hospital Organization Yokohama Medical Center
横浜市立大学附属市民総合医療センター/Yokohama City University
横浜南共済病院/Yokohama Minami Kyousai Hospital
新潟県立リウマチセンター/Niigata Rheumatic Center
新潟大学医歯学総合病院/Niigata University
富山県立中央病院/Toyama Prefectural Central Hospital
富山大学附属病院/University of Toyama
金沢医科大学病院/Kanazawa Medical University
独立行政法人国立病院機構 敦賀医療センター/National Hospital Organization Tsuruga Medical Center
丸の内病院/Marunouchi Hospital
静岡厚生病院/Shizuoka Welfare Hospital
名古屋市立大学病院/Nagoya City University
独立行政法人国立病院機構 名古屋医療センター/National Hospital Organization Nagoya Medical Center
伊勢リウマチハンドクリニック /Mamoru Hand Clinic
由良クリニック/Yura Clinic
京都大学医学部附属病院/Kyoto University
京都第一赤十字病院/Japanese Red Cross Kyoto Daiichi Hospital
独立行政法人国立病院機構 宇多野病院/National Hospital Organization Utano Hospital
大阪大学医学部附属病院/Osaka University
大阪赤十字病院/Japanese Red Cross Osaka Hospital
関西医科大学附属病院/Kansai Medical University
独立行政法人国立病院機構 大阪南医療センター/National Hospital Organization Osaka Minami Medical Center
大阪市立大学医学部附属病院/Osaka City University
大阪医科大学附属病院/Osaka Medical College
天理よろづ相談所病院/Tenri Hospital
尼崎医療生協病院/Amagasaki Co-op Hospital
兵庫医科大学病院/Hyogo College of Medicine
いわた整形リウマチクリニック/Iwata Rheumatic Clinic
甲南加古川病院/Kohnan Kakogawa Hospital
白浜はまゆう病院/Shirahama Hamayu Hospital
鳥取大学医学部附属病院/Tottori University
岡山済生会総合病院/Okayama Saiseikai General Hospital
岡山大学病院/Okayama University
徳島大学病院/Tokushima University
香川大学医学部附属病院/Kagawa University
宇多津病院/Utazu Hospital
道後温泉病院/Dohgo Spa Hospital
松山赤十字病院/Japanese Red Cross Matsuyama Hospital
海里マリン病院/Bay Side Misato Medical Center
高知大学医学部附属病院/Kochi University
九州大学病院/Kyushu University
産業医科大学病院/University of Occupational and Environmental Health, Japan
佐世保中央病院/Sasebo Chuo Hospital
熊本赤十字病院/Japanese Red Cross Kumamoto Hospital
くまもと森都総合病院/Kumamoto Shinto General Hospital
大分大学医学部附属病院/Oita University
市民の森病院/Shiminnomori Hospital
鹿児島赤十字病院/Japanese Red Cross Kagoshima Hospital
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.1186/s13075-018-1647-3
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
Main results already published
Date of protocol fixation
| 2013 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 02 | Month | 19 | Day |
Date analysis concluded
Other
Other related information
In addition to the primary endpoints, "Change in percent overall work impairment (at the last observation, up to week 52) in paid workers, by the Work Productivity and Activity Impairment Questionnaire (WPAI)", the following secondary endpoints will be assessed in the study.
(1) Change in the percent overall work impairment, percent of presenteeism, percent of absenteeism, and percent activity impairment, using the WPAI
(2) Change in the employment rate, using the WPAI
(3) Change in the Presenteeism Questionnaire score
(4) Change in Frenchay Activities Index (FAI) total score
(5) Change in EuroQol 5 Dimensions (EQ5D)
(6) Change in K6 improvement score
(7) Change in Japanese Health Assessment Questionnaire (J-HAQ) score
(8) Change in the disease activity score 28 (DAS28-ESR), clinical disease activity index (CDAI), Simplified disease activity index (SDAI) and remission rate of Boolean.
(9) Study of relationships between patient characteristics and each endpoint
(10) Study of relationships between improvement rate and each endpoint
Management information
Registered date
| 2013 | Year | 11 | Month | 15 | Day |
Last modified on
| 2018 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014393
