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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01683604
First received: September 5, 2012
Last updated: June 30, 2014
Last verified: June 2014

September 5, 2012
June 30, 2014
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
Not Provided
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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 c linical practice, efficacy and safety of RoActemra/Actemra (tocilizumab) in pati ents with rheumatoid arthritis who have had an inadequate response (or were into lerant to) treatment with non-biological DMARDs or with one biological agent. Da ta will be collected from each eligible patient initiated on RoActemra/Actemra t reatment by their treating physician according to approved label for 6 months fr om start of treatment.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Rheumatoid arthritis patients treated with tocilizumab

Rheumatoid Arthritis
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
37
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01683604
ML28144
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
June 2014

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