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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01194401
Other study ID # ML22928
Secondary ID
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
Est. completion date
Est. primary completion date
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


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
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