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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01194401
• Other study ID #: ML22928
• Status: Active, not recruiting
• Phase: N/A
• First received: September 1, 2010
• Last updated: November 1, 2016

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3404
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with clinical remission defined as disease activity score DAS28 < 2.6		5 years	No
Secondary	Time to DAS28 remission		5 years	No
Secondary	Proportion of patients with good or moderate response according to EULAR criteria		5 years	No
Secondary	Time to good or moderate response according to EULAR criteria		5 years	No
Secondary	Factors related to response (C-reactive protein, rheumatoid factor, inadequate response to DMARDs or anti-TNF, duration of illness)		5 years	No
Secondary	Dose-modifications and discontinuations of RoActemra/Actemra		5 years	No
Secondary	Safety: Incidence of adverse events		5 years	No
Secondary	Efficacy of other possible RA therapies in case of inadequate response to RoActemra/Actemra (DAS28, EULAR criteria)		5 years	No
Secondary	Safety of other possible RA therapies in case of inadequate response to RoActemra/Actemra (adverse events)		5 years	No