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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 currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01194401
First received: September 1, 2010
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Tocilizumab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Proportion of patients with clinical remission defined as disease activity score DAS28 < 2.6 [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 4000
Study Start Date: February 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194401

Contacts
Contact: Please reference Study ID Number: ML22928 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
Germany
Recruiting
Osnabrück, Germany, 49074
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01194401     History of Changes
Other Study ID Numbers: ML22928
Study First Received: September 1, 2010
Last Updated: May 7, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013