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A Study to Evaluate Safety of Multi-Dose MEDI-545 in Adult Patients With Dermatomyositis or Polymyositis | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study to Evaluate Safety of Multi-Dose MEDI-545 in Adult Patients With Dermatomyositis or Polymyositis

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

NCT00533091•MedImmune LLC

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female adults at least 18 years of age at the time of randomization;
•Written informed consent obtained from the patient or the patient's legal representative prior to receipt of any study medication or beginning study procedures;
•Probable or definite PM or DM according to the Bohan and Peter criteria (Bohan, 1975);
•For patients with PM, documentation of a muscle biopsy result that is consistent with the diagnosis of PM;
•All patients including those with DM must meet at least two of the following criteria:
•Strength in MMT greater ≥ 80/150 but ≤ 125/150 using the MMT-8 muscle group testing;
•Patient Global Activity Assessment by visual analog scale (VAS)≥ 2.0 cm on a 10 cm scale, which is included as part of CLINHAQ;
•Physician Global Activity Assessment by VAS ≥ 2.0 cm on a 10 cm scale, which is included as part of MDAAT;
•CLINHAQ disability index ≥ 0.25;
•Global extramuscular activity assessment ≥ 1.0 cm on a 10-cm VAS scale (this measure is the physician's composite evaluation and is based on assessments of activity scores on the constitutional, cutaneous, skeletal, gastrointestinal, pulmonary and cardiovascular scales of the MDAAT;
+6 more criteria

Exclusion Criteria

•Receipt of MEDI-545 in any previous clinical study or prior randomization into the trial;
•History of allergy or reaction to any component of the study drug formulation;
•Inclusion body myositis, cancer-associated myositis, myositis associated with another connective tissue disease, environmentally-associated myositis, or drug-related myopathy;
•A history of or a family history of noninflammatory myopathy, scapular winging, atrophy, or hypertrophy of the calf muscles;
•Receiving prednisone \> 35 mg/day (or an equivalent dose of another corticosteroid) within 14 days before Study Day 0;
•Receiving the following dosages of medications within 28 days before Study Day 0: hydroxychloroquine \> 600 mg/day, mycophenolate mofetil \> 3 g/day, methotrexate \> 25 mg/week, azathioprine \> 3 mg/kg/day, or any dose of cyclophosphamide, cyclosporine, or thalidomide;
•Have received fluctuating doses of antimalarials, mycophenolate mofetil, methotrexate, leflunomide, or azathioprine within 28 days before Study Day 0 or fluctuating doses of corticosteroids within 14 days before Study Day 0;
•Have received leflunomide \> 20 mg/day in the 6 months prior to Study Day 0;
•Treatment with any investigational drug therapy within 28 days before Study Day 0 or biologic therapies (eg, rituximab) within 30 days or 5 half-lives of the biologic agent, whichever is longer, before Study Day 0;
•In the investigator's opinion, evidence of clinically significant active infection, including ongoing, chronic infection, within 28 days before Study Day 0;
+18 more criteria

Locations (14)

Research Site

Scottsdale, Arizona, United States

Research Site

Stanford, California, United States

Research Site

Whittier, California, United States

Research Site

Fort Lauderdale, Florida, United States

Research Site

Miami, Florida, United States

Research Site

Evansville, Indiana, United States

Research Site

Kansas City, Kansas, United States

Research Site

Baltimore, Maryland, United States

Research Site

Cumberland, Maryland, United States

Research Site

Boston, Massachusetts, United States

Key Dates

Start Date

April 1, 2008

Primary Completion Date

August 1, 2010

Completion Date

October 1, 2010

Last Updated

May 28, 2012

Enrollment

ACTUAL participants

Conditions

DERMATOMYOSITIS OR POLYMYOSITIS

Interventions

MEDI-545

BIOLOGICAL

Placebo

OTHER

Safety and Efficacy of ULSC on Disease Severity and Steroid Tapering in Participants With Dermatomyositis/ Polymyositis (DM/PM), Also Known as Idiopathic Inflammatory Myopathy (IIM)

NCT07160205

Idiopathic Inflammatory Myositis (IIM)DERMATOMYOSITIS OR POLYMYOSITIS

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 28, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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