Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis in Australia

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: September 5, 2012
Last updated: August 17, 2015
Last verified: August 2015

September 5, 2012
August 17, 2015
July 2012
June 2014   (final data collection date for primary outcome measure)
Proportion of patients on RoActemra/Actemra treatment [ Time Frame: Approximately 2.5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01683604 on ClinicalTrials.gov Archive Site
  • Rates of dose modifications/interruptions [ Time Frame: Approximately 2.5 years ] [ Designated as safety issue: No ]
  • Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment [ Time Frame: Approximately 2.5 years ] [ Designated as safety issue: No ]
  • Efficacy: Response according to joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR [ Time Frame: Approximately 2.5 years ] [ Designated as safety issue: No ]
  • Efficacy: Proportion of patients on RoActemra/Actemra monotherapy [ Time Frame: Approximately 2.5 years ] [ Designated as safety issue: No ]
  • Laboratory parameters prior to and during infective adverse events and serious adverse events [ Time Frame: Approximately 2.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: Approximately 2.5 years ] [ Designated as safety issue: No ]
  • Quality of life: HAQ-DI/VAS-Fatigue/FACIT-Fatigue/Patient Global Assessment of disease activity [ Time Frame: Approximately 2.5 years ] [ Designated as safety issue: No ]
Same as current
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Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis in Australia
A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab
This multi-center, observational study will evaluate the treatment patterns in clinical practice, efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis who have had an inadequate response (or were intolerant to) treatment with non-biological DMARDs or with one biological agent. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for 6 months from start of treatment.
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Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Rheumatoid arthritis patients treated with tocilizumab
Rheumatoid Arthritis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Severe rheumatoid arthritis
  • Inadequate response (or intolerant) to non-biological DMARDs or one biologic agent
  • Patients initiating treatment with RoActemra/Actemra on their physician's decision (in accordance with the local label), including patients who started treatment with RoActemra/Actemra in the 8 weeks prior to the enrolment visit

Exclusion Criteria:

  • RoActemra/Actemra treatment more than 8 weeks prior to the enrolment visit
  • Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
  • Enrolled in an ongoing clinical trial and/or treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
  • History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
18 Years and older
Contact information is only displayed when the study is recruiting subjects
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP