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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100730
    • Beijing Union Hospital
  • Beijing, China, 100083
    • Peking University Third Hospital
  • Beijing, China, 100034
    • Peking University First Hospital
  • Changsha, China, 410008
    • Xiangya Hospital of Centre-South University
  • Chengdu, China, 610041
    • West China Hospital, Sichuan University
  • Chengdu, China, 610072
    • Sichuan Provincial People's Hospital
  • Chongqing, China, 400038
    • Southwest Hospital , Third Military Medical University
  • Guangzhou, China, 510000
    • Sun Yat-sen Memorial Hospital
  • Guangzhou, China, 510515
    • Nanfang Hospital, Southern Medical University
  • Guangzhou, China, 510630
    • The First Affiliated Hospital of Jinan University
  • Guangzhou, China
    • TCM-Integrated Hospital of Southern Medical University
  • Hangzhou, China
    • Zhejiang People's Hospital
  • Hohhot, China
    • Affiliated Hospital of Inner Mongolia Medical College
  • Kunming, China, 650032
    • The First People's Hospital of Yunnan Province
  • Luoyang, China, 471003
    • The First Affiliated Hospital of Henan UN of Science and Technology
  • Nanchong, China
    • Affiliated Hospital of North Sichuan Medical College
  • Nanjing, China, 210029
    • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
  • Shenzhen, China
    • Futian District people's Hospital of Shenzhen City
  • Wuhan, China, 430030
    • Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
  • Wuxi, China, 214023
    • Wuxi People's Hospital
  • Xi'an, China, 710038
    • The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
  • Xiamen, China, 361003
    • The First Affiliated hospital of Xiamen University
  • Yantai, China
    • YanTaishan Hospital of Yantai City
  • Zhuzhou, China
    • ZhuZhou Central Hospital
  • Ürümqi, China, 830001
    • Xinjiang Uygur Autonomous Region People Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with rheumatoid arthritis starting RoActemra/Actemra treatment

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
RA Patients on RoActemra/Actemra treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients on RoActemra/Actemra treatment 6 months after treatment initiation	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events	6 months
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
Health-related quality of life as assessed by questionnaire	6 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2014
• Primary Completion (Actual): May 22, 2017
• Study Completion (Actual): May 22, 2017

Study Registration Dates

• First Submitted: March 28, 2014
• First Submitted That Met QC Criteria: March 28, 2014
• First Posted (Estimate): April 2, 2014

Study Record Updates

• Last Update Posted (Actual): December 29, 2017
• Last Update Submitted That Met QC Criteria: December 28, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: ML28429