Multicenter, Post-marketing, Non-interventional, Observational Study in RA Patients Treated With RoActemra/Actemra (Tocilizumab)
A Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab
1 other identifier
observational
400
1 country
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2014
Typical duration for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2014
CompletedFirst Posted
Study publicly available on registry
April 2, 2014
CompletedStudy Start
First participant enrolled
July 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2017
CompletedDecember 29, 2017
December 1, 2017
2.9 years
March 28, 2014
December 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients on RoActemra/Actemra treatment 6 months after treatment initiation
6 months
Secondary Outcomes (6)
Proportion of patients with systemic manifestation of RA
At Baseline
Record of RA treatment history
6 months
Treatment patterns during observation period, assessed by alteration in dosing regimen
6 months
Efficacy as assessed by total joint count evaluation
6 months
Incidence of adverse events
6 months
- +1 more secondary outcomes
Study Arms (1)
RA Patients on RoActemra/Actemra treatment
Eligibility Criteria
Adult patients with rheumatoid arthritis starting RoActemra/Actemra treatment
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Peking University First Hospital
Beijing, 100034, China
Peking University Third Hospital
Beijing, 100083, China
Beijing Union Hospital
Beijing, 100730, China
Xiangya Hospital of Centre-South University
Changsha, 410008, China
West China Hospital, Sichuan University
Chengdu, 610041, China
Sichuan Provincial People's Hospital
Chengdu, 610072, China
Southwest Hospital , Third Military Medical University
Chongqing, 400038, China
Sun Yat-sen Memorial Hospital
Guangzhou, 510000, China
Nanfang Hospital, Southern Medical University
Guangzhou, 510515, China
The First Affiliated Hospital of Jinan University
Guangzhou, 510630, China
TCM-Integrated Hospital of Southern Medical University
Guangzhou, China
Zhejiang People's Hospital
Hangzhou, China
Affiliated Hospital of Inner Mongolia Medical College
Hohhot, China
The First People's Hospital of Yunnan Province
Kunming, 650032, China
The First Affiliated Hospital of Henan UN of Science and Technology
Luoyang, 471003, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, 210029, China
Futian District people's Hospital of Shenzhen City
Shenzhen, China
Xinjiang Uygur Autonomous Region People Hospital
Ürümqi, 830001, China
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
Wuhan, 430030, China
Wuxi People's Hospital
Wuxi, 214023, China
The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
Xi'an, 710038, China
The First Affiliated Hospital of Xiamen University
Xiamen, 361003, China
YanTaishan Hospital of Yantai City
Yantai, China
Zhuzhou Central Hospital
Zhuzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2014
First Posted
April 2, 2014
Study Start
July 9, 2014
Primary Completion
May 22, 2017
Study Completion
May 22, 2017
Last Updated
December 29, 2017
Record last verified: 2017-12