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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00898989
Other study ID # 2009-a00055-52
Secondary ID
Status Completed
Phase N/A
First received May 11, 2009
Last updated December 18, 2010
Start date April 2009
Est. completion date April 2010

Study information

Verified date December 2010
Source Institut de Myologie, France
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age > 18 years old

- Written consent

Exclusion Criteria:

- Current infection

- Cancer within 1 year

- Immune deficiency

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
France Hopital Pitié-Salpêtrière Paris

Sponsors (2)

Lead Sponsor Collaborator
Institut de Myologie, France Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary muscle strength 2 evaluations at an interval of 9 months No
Secondary immune response 1 measure at inclusion No
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