UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational study For Investigating the ability of Recuperation of work/ house work State with Tocilizumab (Actemra) SubCutaneous treatment in biologics-naive RA patients
Title of the study (Brief title)	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 &#8805; 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	Yoshiya Tanaka
Organization	University of Occupational and Environmental Health, Japan
Division name	The First Department of Internal Medicine, School of Medicine
Address	1-1, Iseigaoka, Yahatanishi, Kitakyushu, 807-8555 Japan
TEL	093-603-1611
Email	tanaka@med.uoeh-u.ac.jp

Public contact
Name of contact person	Hideki Furuya
Organization	EPS Corporation
Division name	Clinical Coodinating Center Clinical Coodinating Department
Address	6-29 Shinogawamachi, Shinjuku-ku Tokyo, 162-0814, Japan
TEL	03-5684-7487
Homepage URL
Email	prj-first_act-scdc@eps.co.jp

Sponsor
Institute	EPS Corporation
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 09 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	https://doi.org/10.1186/s13075-018-1647-3
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014393