UMIN-CTR Clinical Trial

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

rheumatoid arthritis

Classification by specialty

Medicine in general

Clinical immunology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

tanaka@med.uoeh-u.ac.jp

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

Email

prj-first_act-scdc@eps.co.jp

Institute

EPS Corporation

Institute

Department

Personal name

Organization

Chugai Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2013

Year

12

Month

11

Day

URL releasing protocol

Publication of results

Partially published

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

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 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

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