A Non-Interventional Study Evaluating Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab)

Rheumatoid Arthritis Clinical Trial

Official title:

A Multi-Center, Non-inteRventional Study in rheumatOid Arthritis patientS Treated With Tocilizumab in Serbia- ACROSS; (Part of Global Umbrella Project)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01671059
• Other study ID #: ML28314
• 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

• 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

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