- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00898989
Muscle Strength and Inflammatory Response in Patients With Inclusion Body Myositis (IBMan)
December 18, 2010 updated by: Institut de Myologie, France
Evaluation of Muscle Strength and Inflammatory Response in Patients With Inclusion Body Myositis
Comparison of a group of 20 IBM patients with 20 controls matched on age, gender and weight.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
42
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Paris, France, 75013
- Hôpital Pitié-Salpétrière
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Primary care clinic
Description
Inclusion Criteria:
- Age > 18 years old
- Written consent
Exclusion Criteria:
- Current infection
- Cancer within 1 year
- Immune deficiency
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Control
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Inclusion Body Myositis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
muscle strength
Time Frame: 2 evaluations at an interval of 9 months
|
2 evaluations at an interval of 9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
immune response
Time Frame: 1 measure at inclusion
|
1 measure at inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
May 11, 2009
First Submitted That Met QC Criteria
May 11, 2009
First Posted (Estimate)
May 12, 2009
Study Record Updates
Last Update Posted (Estimate)
December 21, 2010
Last Update Submitted That Met QC Criteria
December 18, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-a00055-52
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Novartis PharmaceuticalsCompletedSporadic Inclusion Body MyositisUnited States
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Institut National de la Santé Et de la Recherche...CompletedInclusion Body Myositis (IBM)France
-
La-ser Europe LimitedUnknownSporadic Inclusion Body Myositis
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Regeneron PharmaceuticalsWithdrawnSporadic Inclusion Body Myositis
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Phoenix Neurological Associates, LTDUnknown
-
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-
Novartis PharmaceuticalsCompletedSporadic Inclusion Body MyositisUnited States, Belgium, Italy, Australia, Netherlands, Switzerland, France, United Kingdom, Denmark, Japan