An Observational Study of the Impact of RoActemra/Actemra on Fatigue in Patients With Rheumatoid Arthritis (PEPS)

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185522
• Other study ID #: ML22457
• Status: Completed
• Phase: N/A
• First received: August 18, 2010
• Last updated: November 2, 2015
• Start date: November 2010
• Est. completion date: May 2011

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission Nationale de l'Informatique et des Libertés (CNIL)
• Study type: Observational

Clinical Trial Summary

This prospective, observational study will assess 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 (DMARDS) or anti TNF (tumor necrosis factor) drugs. Eligible patients receiving RoActemra/Actemra according to the standard of care will be followed for 4 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 719
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on fatigue intensity and predictive factors of fatigue improvement; assessments by visual analogue scale (VAS) and Facit questionnaire		4 months	No
Secondary	correlation of fatigue outcome on VAS and Facit questionnaire		4 months	No
Secondary	Time to onset of RoActemra/Actemra effect on fatigue		4 months	No
Secondary	Correlation of effect on fatigue with clinical status and disease activity; swollen joint count (SJC28), tender joint count (TJC28), VAS patient's global activity/pain		4 months	No
Secondary	PASS of the scales Facit fatigue, VAS fatigue, SF-36 vitality		4 months	No
Secondary	Correlation of fatigue evolution with evolution of components of other scales (pain, SF-36 vitality, depression, sleep quality, function)		4 months	No
Secondary	Safety: Adverse events		4 months	No