PEPS: Pharmaco-Epidemiological Study of imPact of Tocilizumab Treatment in Real Life on RA patientS Fatigue
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Rheumatoid Arthritis
Both
Rheumatoid Arthritis
Trial Information
PEPS: Pharmaco-Epidemiological Study of imPact of Tocilizumab Treatment in Real Life on RA patientS Fatigue
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Moderate to severe rheumatoid arthritis
- Inadequate response to disease-modifying antirheumatic drugs (DMARDS) or anti-TNF
(tumor necrosis factor) drugs
Exclusion Criteria:
- Hypersensitivity to RoActemra/Actemra or any component
- Active infection
- Participation in a clinical trial in rheumatoid arthritis
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Effect on fatigue intensity and predictive factors of fatigue improvement; assessments by visual analogue scale (VAS) and Facit questionnaire
Outcome Time Frame:
4 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
France: Commission Nationale de l'Informatique et des Libertés (CNIL)
Study ID:
ML22457
NCT ID:
NCT01185522
Start Date:
January 2010
Completion Date:
September 2011
Related Keywords:
- Rheumatoid Arthritis
- Arthritis
- Arthritis, Rheumatoid
Name | Location |
|---|
