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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 17, 2014
Last verified: November 2014
  Purpose

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.


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:


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 ]

Enrollment: 3400
Study Start Date: February 2010
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
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: November 17, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

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

ClinicalTrials.gov processed this record on November 20, 2014