A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670045
• Other study ID #: ML28216
• Status: Completed
• Phase: N/A
• First received: August 17, 2012
• Last updated: February 1, 2016
• Start date: March 2012
• Est. completion date: June 2014

Study information

• Verified date: February 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: National Agency for Drug and Food Control (NA-DFC)
• Study type: Observational

Clinical Trial Summary

This multi-center observational 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 licensed label will be followed for 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• 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

• Patient in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in accordance with the local label (DMARD-IR, TNF-IR or need of RoActemra/Actemra monotherapy); 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

• Patients who have received treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra

• Patients with a 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

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients on RoActemra/Actemra at 6 months		approximately 2 years	No
Secondary	Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment		approximately 2 years	No
Secondary	Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR		approximately 2 years	No
Secondary	Time to reduction/withdrawal of DMARDs and/or corticosteroids		approximately 2 years	No
Secondary	Physician Global Assessment of disease activity		approximately 2 years	No
Secondary	Safety: Incidence of adverse events		approximately 2 years	No
Secondary	Rates of dose modifications/interruptions		approximately 2 years	No