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Rituximab in Dermatomyositis

Study Title:

An open label trial to evaluate the safety and efficacy of rituximab in the treatment of patients with dermatomyositis

Principal Investigator:

David Fiorentino, M.D., Ph.D.

Study Hypothesis:

B cell depletion with Rituximab will be safe and effective therapy for skin and muscle inflammation in patients with dermatomyositis

Study Design:

Open label, single center, pilot study

Types & Number of IIM Studied:

8 adult dermatomyositis patients

Entry Criteria:

  • Diagnosis of probable or definite dermatomyositis by Bohan/Peter criteria (Bohan and Peter 1975), including classic dermatologic features defined by Sontheimer's criteria
  • Active muscle disease with either elevated laboratory markers of muscle breakdown (ie. CPK >400 U/L or aldolase >8 U/L) OR a MMT modified MRC score of <85
  • Active skin disease with s DSSI>2

IMACS Core Set Measures Included:

Physician Global Activity-VAS, Patient Global Activity-VAS, Muscle Strength Testing-MMT, Functional Assessment Tools-HAQ, Laboratory-Muscle Enzymes, Extramuscular Assessment-Myositis Disease Activity Assessment Tool (MDAAT)

Other Measures Included:

Patient Pruritus Assessment, Dermatomyositis Skin Severity Index (DSSI), Skin photographs, CD19 B cell level, Safety laboratory measures (CBC, CMP, Urinalysis)

Primary Outcome:

  • Safety Endpoints
    • Incidence of treatment emergent adverse events (AE's) including infections, infusion reactions and disease progression.
    • Safety assessment will include physical examination with vital signs, routine blood work (hematology and chemistry) and immunological testing.
  • Primary Efficacy Endpoint: Partial remission (PR) at 24 weeks, defined as:
    • At least a 50% reduction in creatine phosphokinase (CPK) if baseline values are >2x upper limits of normal OR
    • o 50% improvement of manual muscle strength test (MMT) using the modified Medical Research Council (MRC) scale (Daniels and Worthingham 1972), defined as a 50% reduction in the difference between maximum strength (score of 90) and the patient's baseline score (if baseline score is <85) OR
    • 75% reduction in cutaneous lesions using the Dermatomyositis Skin Severity Index (DSSI) if baseline score is > 2

Key Trial Dates:

Start of Enrollment - 12/17/2004
Study Completion - 8/28/2007

Funding Sources:

Genentech, Inc.

Publications:

Chung L, Genovese MC, Fiorentino DF. A pilot trial of rituximab in the treatment of patients with dermatomyositis., Arch Dermatol, 2007 Jun;143(6):763-7.[Abstract ]

Contact:

David Fiorentino, M.D., Ph.D.
Assistant Professor of Dermatology
Stanford University School of Medicine
North Campus Outpatient Center
450 Broadway, C-234
Redwood City, CA 94063
Tel (650) 721-7160
fiorentino@stanford.edu


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