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 currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01194401
First received: September 1, 2010
Last updated: July 14, 2014
Last verified: July 2014

September 1, 2010
July 14, 2014
February 2010
August 2016   (final data collection date for primary outcome measure)
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
Not Provided
Not Provided
 
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 eff icacy and safety of RoActemra/Actemra in daily practice in patients with active moderate to severe rheumatoid arthritis who have an inadequate response or are i ntolerant to one or more disease-modifying antirheumatic drugs (DMARDs) or tumou r necrosis factor (TNF) antagonists. Data will be collected from patients initia ted on RoActemra/Actemra treatment according to label by decision of the treatin g physician. Anticipated time for data collection from each patient will be 2 ye ars.

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

Patients with inadequate response or intolerant to DMARDs and anti-TNF

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.
 
Recruiting
3400
August 2016
August 2016   (final data collection date for primary outcome measure)

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:

N/A

Both
18 Years and older
No
Contact: Reference Study ID Number: ML22928 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
Germany
 
NCT01194401
ML22928
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

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