An Observational Study of RoActemra/Actemra in Patients With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Multicenter REtrospective Study to Evaluate coMpliance to Therapy and Drug survIval of Tocilizumab (TCZ) in patientS With Moderate to Severe actIve rheumatOid Arthritis in routiNe Daily Clinical Practice (REMISSION Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01375478
• Other study ID #: ML25580
• Status: Completed
• Phase: N/A
• First received: June 16, 2011
• Last updated: November 1, 2016
• Start date: April 2011
• Est. completion date: April 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial Summary

This open-label, retrospective, observational study will evaluate the compliance to RoActemra/Actemra (tocilizumab) therapy in patients with moderate to severe rheumatoid arthritis. Six months data will be collected from patients records.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, over 18 years of age

• Moderate to severe rheumatoid arthritis

• RoActemra/Actemra treatment must have been initiated 6 months prior to signing the informed consent form

Exclusion Criteria:

• Patients with rheumatic autoimmune disease other than rheumatoid arthritis

• Patients who are not willing to sign the informed consent form

• Patients who participate in interventional trials during the period of this observational study

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

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

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who remained under continued RoActemra/Actemra treatment		6 months	No
Secondary	Reasons for withdrawal		6 months	No
Secondary	Frequency of withdrawal		6 months	No
Secondary	Frequency of dose modification		6 months	No
Secondary	Reasons for dose modification		6 months	No
Secondary	Safety: Incidence of adverse events		6 months	No