An Observational Study on RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis (TRUST)

Rheumatoid Arthritis Clinical Trial

Official title:

RheumaToid arthRitis Patients Treated With tocilizUmab in Real Clinical Practice: effectiveneSs and safeTy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394276
• Other study ID #: ML25728
• Status: Completed
• Phase: N/A
• First received: July 13, 2011
• Last updated: November 2, 2015
• Start date: April 2011
• Est. completion date: April 2013

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

This observational study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis. Data will be collected from patients for the 12 months following the first infusion of RoActemra/Actemra.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria

• Initiated on RoActemra/Actemra treatment according to the Summary of Product Characteristics not more than 6 months before opening of study center

Exclusion Criteria:

• Current serious infection

• Hypersensitivity to the active component or any of the excipients

• Pregnant women

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

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients achieving disease activity score DAS28 </= 3.2 after 6 months of treatment		approximately 2 years	No
Primary	Percentage of patients achieving remission (DAS28 < 2.6) after 6 months of treatment		approximately 2 years	No
Secondary	Disease activity score (DAS28) in patients on monotherapy with RoActemra/Actemra		approximately 2 years	No
Secondary	Comparison of disease activity score (DAS28) in patients with inadequate response to DMARDs and anti-TNF drugs		approximately 2 years	No
Secondary	Effect on fatigue: visual analogue scale VAS Fatigue		approximately 2 years	No
Secondary	Concomitant medications use (particularly corticosteroids)		approximately 2 years	No
Secondary	Percentage of patients discontinuing treatment with RoActemra/Actemra		approximately 2 years	No
Secondary	Safety: Incidence of adverse events		approximately 2 years	No
Secondary	Percentage of patients still on RoActemra/Actemra treatment 12 months after the 1st infusion		approximately 2 years	No
Secondary	Effect on synovitis: ultrasonography of hand		approximately 2 years	No