A Retrospective, Observational Study of RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Retrospective, Multi-center, Observational Study of Daily Practice Patterns and Outcomes of the Management of Rheumatoid Arthritis Patients Without Documented Erosions Treated With RoACTEMRA in Belgium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01921478
• Other study ID #: ML25271
• Status: Completed
• Phase: N/A
• First received: August 9, 2013
• Last updated: August 9, 2013
• Start date: August 2010
• Est. completion date: November 2010

Study information

• Verified date: August 2013
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Observational

Clinical Trial Summary

This retrospective, multi-centre, observational study will assess the daily practice patterns and outcomes of the management of rheumatoid arthritis in patients treated with RoActemra/Actemra (tocilizumab). No actual patient will be enrolled in this study; data will be collected from medical records.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >=18 years of age

• Diagnosed with rheumatoid arthritis and moderate to severe disease activity defined as a DAS28 >=5.1

• Inadequate responder to at least 2 non-biological DMARDs

• Absence of documented erosions at start of RoActemra/Actemra treatment

• Received RoActemra/Actemra treatment for at least 6 months

• Availability of data from at least the RoActemra/Actemra treatment initiation visit and the 6 months visit

Exclusion Criteria:

• Contraindications for treatment with RoActemra/Actemra

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

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Joint erosion assessment in clinical practice		6 months	No
Secondary	Disease Activity Score 28		6 months	No
Secondary	C-reactive protein assessment		6 months	No
Secondary	Swollen joint counts		6 months	No
Secondary	Tender joint counts		6 months	No
Secondary	Erythrocyte Sedimentation Rate		6 months	No
Secondary	Evolution of the pattern of joint erosion		6 months	No
Secondary	Patient's global assessment of disease activity (Visual Analogue Scale)		6 months	No