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

MedImmune LLC1 site in 1 country51 target enrollmentApril 2008

ConditionsDERMATOMYOSITIS OR POLYMYOSITIS

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: DERMATOMYOSITIS OR POLYMYOSITIS
Sponsor: MedImmune LLC
Enrollment: 51
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

April 2008

End Date

October 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

MedImmune LLC

Responsible Party

Sponsor

Eligibility Criteria

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;

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;

Outcomes

Primary Outcomes

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

Secondary Outcomes

The secondary endpoints of the study are the PK and IM of multiple IV doses of MEDI-545.(12 months)
The third endpoint of the study are the evaluations of disease activities.(12 months)