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Your Environment. Your Health.

Validation of IMACS and PRINTO Definitions of Improvement

Principal Investigator:

Lisa Rider, NIEHS, NIH

Study Design:

Natural history study

Types & Number of IIM Studied:

Adult and Juvenile Dermatomyositis, Polymyositis, Overlap Myositis, Inclusion Body Myositis (> 100 patients)

Entry Criteria:

Probable or definite Bohan and Peter criteria; Griggs et al. 1995 Annals of Neurology Inclusion Body Myositis criteria

IMACS Core Set Measures Included:

All: Physician and Patient Global Activity and Damage Assessments, Manual Muscle Testing, Childhood Myositis Assessment Scale, [Childhood] Health Assessment Questionnaire, muscle enzymes, Myositis Disease Activity Assessment Tool, Myositis Damage Index; Health Related Quality of Life by SF-36 and Child Health Questionnaire

Other Measures Included:

Disease Activity Score, demographic and treatment data, extended measures

Primary Outcome:

IMACS and PRINTO Definitions of Improvement

Study Duration:

Baseline and 6 - 9 month evaluation. Open

Funding:

NIEHS, NIH

Comments:

Ongoing. Extramural centers may apply for enrollment into IMACS registry by obtaining local IRB approval of this protocol.

Contact:

Lisa Rider, M.D.
Deputy Chief and Staff Clinician, Environmental Autoimmunity Group
riderl@mail.nih.gov
Frederick W. Miller, M.D., Ph.D.
Deputy Chief, Clinical Research Branch and Principal Investigator
millerf@mail.nih.gov

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