Clinical Trial: Pharmacoepidemiologic General Research Extension: PGRx-sIBM Study

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Pharmacoepidemiologic General Research Extension: PGRx-sIBM Study

Brief Summary:

Sporadic inclusion body myositis (sIBM) is a rare idiopathic inflammatory myopathy characterized by chronic proximal leg and distal arm asymmetric muscle weakness. Its prevalence is estimated between 10 and 100 cases per million, over the age of 50. Little is known about the natural course of the disease, the delay between onset and diagnosis, the patterns of disease management and treatment in routine practice, as well as the burden for patients.

The objectives of the PGRx-sIBM study will be to describe:

  • The epidemiology of the disease (estimation of the prevalence, age at onset, delay between onset and diagnosis, diagnosis process, etc.)
  • The patterns of disease management and treatment in routine practice
  • The burden of the disease for patients and their informal caregiver, as well as the quality of life of patients
  • The burden of the disease for informal caregivers

This will be an observational (non-interventional), cross-sectional (transversal) study.

Study setting The PGRx-sIBM will take place in France, Italy, Switzerland and Spain. Recruitment centers will be public and private practices and hospitals from urban or rural areas. In each recruitment center, at least one physician will act as a study investigator, in charge of identifying and recruiting patients.

Inclusion of patients

Patients will be included by their specialized physician (neurologist, Internal Medicine) during a regular outpatient visit, provided that they meet the following inclusion criteria:

  • Disability [ Time Frame: Within the last 12 months ]
    Measured by the Clinical Global Impression scale and the use of assisitive devices
  • Quality of Life [ Time Frame: Within the last 7 days ]
    EQ-D5


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: La-ser Europe Limited

Dates:
Date Received: April 6, 2016
Date Started: May 2016
Date Completion: February 2017
Last Updated: April 14, 2016
Last Verified: April 2016