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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
History of Changes
  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:

MedlinePlus related topics: Myositis
U.S. FDA Resources

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
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 May 23, 2013