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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01185522
First received: August 18, 2010
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PEPS: Pharmaco-Epidemiological Study of imPact of Tocilizumab Treatment in Real Life on RA patientS Fatigue

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Effect on fatigue intensity and predictive factors of fatigue improvement; assessments by visual analogue scale (VAS) and Facit questionnaire [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • correlation of fatigue outcome on VAS and Facit questionnaire [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Time to onset of RoActemra/Actemra effect on fatigue [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • PASS of the scales Facit fatigue, VAS fatigue, SF-36 vitality [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Correlation of fatigue evolution with evolution of components of other scales (pain, SF-36 vitality, depression, sleep quality, function) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Safety: Adverse events [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 719
Study Start Date: November 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with inadequate response to DMARDs or anti-TNF receiving RoActemra/Actemra according to standard of care

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01185522

Locations
France
Neuilly-sur-seine, France, 92521
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01185522     History of Changes
Other Study ID Numbers: ML22457
Study First Received: August 18, 2010
Last Updated: April 1, 2014
Health Authority: France: Commission Nationale de l'Informatique et des Libertés (CNIL)

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 23, 2014