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An Observational Study on Long-Term Effectiveness and Safety of RoActemra/Actemra (Tocilizumab) in Daily Practice in Patients With Rheumatoid Arthritis (ICHIBAN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01194401
First received: September 1, 2010
Last updated: November 1, 2016
Last verified: November 2016

September 1, 2010
November 1, 2016
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Proportion of patients with clinical remission defined as disease activity score DAS28 < 2.6 [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01194401 on ClinicalTrials.gov Archive Site
  • Time to DAS28 remission [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Proportion of patients with good or moderate response according to EULAR criteria [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Time to good or moderate response according to EULAR criteria [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Factors related to response (C-reactive protein, rheumatoid factor, inadequate response to DMARDs or anti-TNF, duration of illness) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Dose-modifications and discontinuations of RoActemra/Actemra [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Efficacy of other possible RA therapies in case of inadequate response to RoActemra/Actemra (DAS28, EULAR criteria) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Safety of other possible RA therapies in case of inadequate response to RoActemra/Actemra (adverse events) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
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An Observational Study on Long-Term Effectiveness and Safety of RoActemra/Actemra (Tocilizumab) in Daily Practice in Patients With Rheumatoid Arthritis (ICHIBAN)
A Prospective, Non-interventional Multi-center Observational Study to Evaluate the Long-term Effectiveness and Safety of Tocilizumab in Patients With Active Rheumatoid Arthritis in Daily Practice
This prospective, multi-center observational study will assess the long-term efficacy and safety of RoActemra/Actemra in daily practice in patients with active moderate to severe rheumatoid arthritis who have an inadequate response or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. Data will be collected from patients initiated on RoActemra/Actemra treatment according to label by decision of the treating physician. Anticipated time for data collection from each patient will be 2 years.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Patients with inadequate response or intolerant to DMARDs and anti-TNF
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.
 
Active, not recruiting
3404
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Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Active moderate to severe rheumatoid arthritis
  • Inadequate response or intolerant to previous therapy with one or more disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists
  • Prescription of RoActemra/Actemra according to label

Exclusion Criteria:

Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01194401
ML22928
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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