Multicenter, Post-marketing, Non-interventional, Observational Study in RA Patients Treated With RoActemra/Actemra (Tocilizumab)

NCT ID: NCT02101307

Last Updated: 2017-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-09

Study Completion Date

2017-05-22

Brief Summary

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This non-interventional study will observe the usage and efficacy of RoActemra/Actemra in patients with rheumatoid arthritis (RA) who have recently begun treatment. The treatment regimen will be directed by the treating physician according to clinical practice. Patients are expected to be observed for approximately 6 months after beginning treatment.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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RA Patients on RoActemra/Actemra treatment

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients at least 18 years of age
* Patients with a diagnosis of moderate to severe RA according to the revised (1987) ACR criteria
* Patient in whom the treating physician has made the decision to commence RoActemra/Actemra treatment (in accordance with the local label). This can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
* Patient has given informed consent

Exclusion Criteria

* Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
* Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
* Patients who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
* Patients with a history of autoimmune disease or of any joint inflammatory disease other than RA
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Peking University First Hospital

Beijing, , China

Site Status

Peking University Third Hospital

Beijing, , China

Site Status

Beijing Union Hospital

Beijing, , China

Site Status

Xiangya Hospital of Centre-South University

Changsha, , China

Site Status

West China Hospital, Sichuan University

Chengdu, , China

Site Status

Sichuan Provincial People's Hospital

Chengdu, , China

Site Status

Southwest Hospital , Third Military Medical University

Chongqing, , China

Site Status

Sun Yat-sen Memorial Hospital

Guangzhou, , China

Site Status

Nanfang Hospital, Southern Medical University

Guangzhou, , China

Site Status

The First Affiliated Hospital of Jinan University

Guangzhou, , China

Site Status

TCM-Integrated Hospital of Southern Medical University

Guangzhou, , China

Site Status

Zhejiang People's Hospital

Hangzhou, , China

Site Status

Affiliated Hospital of Inner Mongolia Medical College

Hohhot, , China

Site Status

The First People's Hospital of Yunnan Province

Kunming, , China

Site Status

The First Affiliated Hospital of Henan UN of Science and Technology

Luoyang, , China

Site Status

Affiliated Hospital of North Sichuan Medical College

Nanchong, , China

Site Status

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

Nanjing, , China

Site Status

Futian District people's Hospital of Shenzhen City

Shenzhen, , China

Site Status

Xinjiang Uygur Autonomous Region People Hospital

Ürümqi, , China

Site Status

Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

Wuhan, , China

Site Status

Wuxi People's Hospital

Wuxi, , China

Site Status

The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)

Xi'an, , China

Site Status

The First Affiliated Hospital of Xiamen University

Xiamen, , China

Site Status

YanTaishan Hospital of Yantai City

Yantai, , China

Site Status

Zhuzhou Central Hospital

Zhuzhou, , China

Site Status

Countries

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China

Other Identifiers

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ML28429

Identifier Type: -

Identifier Source: org_study_id