A Non-interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01562327
First received: March 21, 2012
Last updated: October 6, 2014
Last verified: October 2014

March 21, 2012
October 6, 2014
March 2012
March 2014   (final data collection date for primary outcome measure)
  • Proportion of patients on RoActemra/Actemra treatment 6 months after initiation of treatment [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Rates of dose modifications/interruptions [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Efficacy: Monotherapy versus combination therapy [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Laboratory parameters prior to and during infective adverse events and serious adverse events [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Quality of life: HAQ-DI/VAS-Fatigue/FACIT-Fatigue/Patient Global Assessment of disease activity [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01562327 on ClinicalTrials.gov Archive Site
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A Non-interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis
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This multi-center, observational study will evaluate the clinical practice patte rns, efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with mod erate to severe rheumatoid arthritis. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician acc ording to local label for 6 months from start of treatment.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Rheumatoid arthritis patients treated with tocilizumab

Rheumatoid Arthritis
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Cohort
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Moderate to severe rheumatoid arthritis
  • 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
  • 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
Argentina
 
NCT01562327
ML28142
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

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