A Prospective Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Prospective Observational Study to Assess Impact on Fatigue of RA Patients Treated With Roactemra in the Real Life Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01462162
• Other study ID #: ML27833
• Status: Completed
• Phase: N/A
• First received: October 27, 2011
• Last updated: October 1, 2015
• Start date: September 2011
• Est. completion date: November 2013

Study information

• Verified date: October 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Espanola de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial Summary

This prospective observational study will investigate the effect of RoActemra/Actemra (tocilizumab) on fatigue in patients with moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs or anti-TNF drugs. Data will be collected from patients for 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult Patients, >/=18 years of age

• Patients wih Rheumatoid Arthritis (RA)

Exclusion Criteria:

• Patients previously or currently treated with RoActemra/Actemra in clinical trials

• Absolute neutrophile count </=2x10 9/l

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

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fatigue outcome assessed by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) from baseline to month 6		6 months	No
Secondary	Change in fatigue score as assessed by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)		24 weeks	No
Secondary	Change in hemoglobin value		24 weeks	No
Secondary	Change in Disease Activity Score (DAS28)		6 months	No
Secondary	Safety (incidence of adverse events)		6 months	No
Secondary	Change in European League Against Rheumatism Score (EULAR)		6 months	No
Secondary	Change in swollen joint count (SJC28)		6 months	No