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: October 6, 2014
Last verified: October 2014
  Purpose

This prospective, observational study will assess the effect of RoActemra/Actemr a (tocilizumab) on fatigue in patients with moderate to severe rheumatoid arthri tis who have an inadequate response to disease-modifying antirheumatic drugs (DM ARDS) or anti TNF (tumor necrosis factor) drugs. Eligible patients receiving RoA ctemra/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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 6, 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 October 19, 2014