A Study to Evaluate Safety of Multi-Dose MEDI-545 in Adult Patients With Dermatomyositis or Polymyositis
The primary objective of the study is to evaluate the safety and tolerability of multiple IV doses of MEDI-545 in adult patients with myositis.
DERMATOMYOSITIS OR POLYMYOSITIS
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase 1B, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Safety of Multiple-Dose, Intravenously Administered MEDI-545, A Fully Human Anti Interferon-Alpha Monoclonal Antibody, In Adult Patients With Dermatomyositis or Polymyositis|
- The primary endpoints of the study are safety and tolerability of multiple intravenous (IV) doses of MEDI-545 in adult patients with Dermatomyositis or Polymyositis, assessed primarily by summarizing AEs assessing changes in viral cultures and titers. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- The secondary endpoints of the study are the PK and IM of multiple IV doses of MEDI-545. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- The third endpoint of the study are the evaluations of disease activities. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Study Completion Date:||October 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 1
MEDI-545 is supplied as a sterile liquid containing 0.75 mL of MEDI-545 solution at a concentration of 100 mg/mL in a 3 mL single-use glass vial.
Dosage, frequency and duration: MEDI-545 (0.3, 1.0, 3.0, or 10.0 mg/kg) will be administered via infusion over at least 60 minutes every 2 weeks for 26 weeks.
Dosage form: Placebo is supplied as a sterile liquid containing a 0.75 mL solution in a 3 mL single-use vial.
Dosage, frequency and duration: Placebo (0.3, 1.0, 3.0, or 10.0 mg/kg) will be administered via infusion over at least 60 minutes every 2 weeks for 12 weeks.
Thereafter, subjects will receive MEDI-545, at the dose specified in the dose cohort they are assigned, every 2 weeks for an additional 12 weeks.
The primary objective of the study is to evaluate the safety and tolerability of multiple intravenous (IV) doses of MEDI-545 in adult patients with dermatomyositis (DM) or polymyositis (PM).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00533091
|United States, Arizona|
|Scottsdale, Arizona, United States, 85258|
|United States, California|
|Stanford, California, United States, 94305|
|Whittier, California, United States, 90606|
|United States, Florida|
|Fort Lauderdale, Florida, United States, 33334|
|Miami, Florida, United States, 33136|
|United States, Indiana|
|Evansville, Indiana, United States, 47714|
|United States, Kansas|
|Kansas City, Kansas, United States, 66160|
|United States, Maryland|
|Baltimore, Maryland, United States, 21224|
|Cumberland, Maryland, United States, 21502|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02115|
|United States, New Hampshire|
|Lebanon, New Hampshire, United States, 03756|
|United States, New York|
|Lake Success, New York, United States, 11042|
|United States, Oregon|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|Duncansville, Pennsylvania, United States, 16635|
|Study Director:||Dominique Ethgen, M.D.||MedImmune LLC|