Clinical trial NCT02101307: Multicenter, Post-marketing, Non-interventional, Observational Study in RA Patients Treated With RoActemra/Actemra (Tocilizumab)
Official title: A Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-04-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with rheumatoid arthritis starting RoActemra/Actemra treatment

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients on RoActemra/Actemra treatment 6 months after treatment initiation
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of patients with systemic manifestation of RA
timeFrame: At Baseline
measure: Record of RA treatment history
timeFrame: 6 months
measure: Treatment patterns during observation period, assessed by alteration in dosing regimen
timeFrame: 6 months
measure: Efficacy as assessed by total joint count evaluation
timeFrame: 6 months
measure: Incidence of adverse events
timeFrame: 6 months
measure: Health-related quality of life as assessed by questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Beijing Union Hospital
city: Changsha
country: China
facility: Xiangya Hospital of Centre-South University
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Chongqing
country: China
facility: Southwest Hospital , Third Military Medical University
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
city: Guangzhou
country: China
facility: TCM-Integrated Hospital of Southern Medical University
city: Hangzhou
country: China
facility: Zhejiang People's Hospital
city: Hohhot
country: China
facility: Affiliated Hospital of Inner Mongolia Medical College
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan UN of Science and Technology
city: Nanchong
country: China
facility: Affiliated Hospital of North Sichuan Medical College
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
city: Shenzhen
country: China
facility: Futian District people's Hospital of Shenzhen City
city: Wuhan
country: China
facility: Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
city: Wuxi
country: China
facility: Wuxi People's Hospital
city: Xi'an
country: China
facility: The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
city: Yantai
country: China
facility: YanTaishan Hospital of Yantai City
city: Zhuzhou
country: China
facility: Zhuzhou Central Hospital
city: Ürümqi
country: China
facility: Xinjiang Uygur Autonomous Region People Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: