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

Rheumatoid Arthritis Clinical Trial

Official title:

A Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101307
• Other study ID #: ML28429
• Status: Completed
• Phase: N/A
• First received: March 28, 2014
• Last updated: December 28, 2017
• Start date: July 9, 2014
• Est. completion date: May 22, 2017

Study information

• Verified date: December 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 22, 2017
• Est. primary completion date: May 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
China	Beijing Union Hospital	Beijing
China	Peking University First Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	Xiangya Hospital of Centre-South University	Changsha
China	Sichuan Provincial People's Hospital	Chengdu
China	West China Hospital, Sichuan University	Chengdu
China	Southwest Hospital , Third Military Medical University	Chongqing
China	Nanfang Hospital, Southern Medical University	Guangzhou
China	Sun Yat-sen Memorial Hospital	Guangzhou
China	TCM-Integrated Hospital of Southern Medical University	Guangzhou
China	The First Affiliated Hospital of Jinan 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
China	The First Affiliated Hospital of Henan UN of Science and Technology	Luoyang
China	Affiliated Hospital of North Sichuan Medical College	Nanchong
China	Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School	Nanjing
China	Futian District people's Hospital of Shenzhen City	Shenzhen
China	Xinjiang Uygur Autonomous Region People Hospital	Ürümqi
China	Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech	Wuhan
China	Wuxi People's Hospital	Wuxi
China	The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)	Xi'an
China	The First Affiliated Hospital of Xiamen University	Xiamen
China	YanTaishan Hospital of Yantai City	Yantai
China	Zhuzhou Central Hospital	Zhuzhou

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients on RoActemra/Actemra treatment 6 months after treatment initiation		6 months
Secondary	Proportion of patients with systemic manifestation of RA		At Baseline
Secondary	Record of RA treatment history		6 months
Secondary	Treatment patterns during observation period, assessed by alteration in dosing regimen		6 months
Secondary	Efficacy as assessed by total joint count evaluation		6 months
Secondary	Incidence of adverse events		6 months
Secondary	Health-related quality of life as assessed by questionnaire		6 months