Muscle Strength and Inflammatory Response in Patients With Inclusion Body Myositis (IBMan)

This study has been completed.
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by:
Institut de Myologie, France
ClinicalTrials.gov Identifier:
NCT00898989
First received: May 11, 2009
Last updated: December 18, 2010
Last verified: December 2010
  Purpose

Comparison of a group of 20 IBM patients with 20 controls matched on age, gender and weight.


Condition
Inclusion Body Myositis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of Muscle Strength and Inflammatory Response in Patients With Inclusion Body Myositis

Resource links provided by NLM:


Further study details as provided by Institut de Myologie, France:

Primary Outcome Measures:
  • muscle strength [ Time Frame: 2 evaluations at an interval of 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • immune response [ Time Frame: 1 measure at inclusion ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: April 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Inclusion Body Myositis
Control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

  • Age > 18 years old
  • Written consent

Exclusion Criteria:

  • Current infection
  • Cancer within 1 year
  • Immune deficiency
  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: NCT00898989

Locations
France
Hopital Pitié-Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Institut de Myologie, France
Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Olivier BENVENISTE MD PHD, Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00898989     History of Changes
Other Study ID Numbers: 2009-a00055-52
Study First Received: May 11, 2009
Last Updated: December 18, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Myositis
Myositis, Inclusion Body
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 21, 2014