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PEPS: Pharmaco-Epidemiological Study of imPact of Tocilizumab Treatment in Real Life on RA patientS Fatigue


N/A
18 Years
N/A
Not Enrolling
Both
Rheumatoid Arthritis

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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 Libert├ęs (CNIL)

Study ID:

ML22457

NCT ID:

NCT01185522

Start Date:

January 2010

Completion Date:

September 2011

Related Keywords:

  • Rheumatoid Arthritis
  • Arthritis
  • Arthritis, Rheumatoid

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