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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01671059
Other study ID # ML28314
Secondary ID
Status Completed
Phase N/A
First received August 20, 2012
Last updated August 1, 2016
Start date July 2012
Est. completion date September 2015

Study information

Verified date August 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Serbia: Agency for medicines and medical devices
Study type Observational

Clinical Trial Summary

This non-interventional study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the approved label will be followed for 6 months.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria

- Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment (in accordance with the local label); this can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit

Exclusion Criteria:

- Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit

- Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use

- Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra

- History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

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

Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients on RoActemra/Actemra at 6 months after treatment initiation 2 years No
Secondary Rates of dose modifications/interruptions 2 years No
Secondary Clinical/demographic patient characteristics at initiation of treatment 2 years No
Secondary Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR 2 years No
Secondary Efficacy: Monotherapy versus combination therapy 2 years No
Secondary Use of disease-modifying anti-rheumatic drugs (DMARDs) 2 years No
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