Tocilizumab in the Treatment of Refractory Polymyositis and Dermatomyositis

Part of paid clinical trials in Los Angeles, California.

Sponsor
Chester Oddis
Study ID
NCT02043548
Phase
PHASE2
Status
Completed

Conditions

  • Dermatomyositis
  • Polymyositis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • tocilizumab — DRUG
    given at a dose of 8mg/kg by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6).
  • placebo — DRUG
    given by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6).

Study Details

The purpose of this multi-center pilot study is to determine if the drug tocilizumab (Actemra) is effective in the treatment of patients with refractory adult polymyositis (PM) and dermatomyositis (DM).

Key Dates

Start date
Oct 1, 2014
Status verified
Oct 2020
Primary completion
Jul 30, 2019
Completion
Jul 31, 2019

Study Design

Enrollment
36 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group A: Tocilizumab
    Tocilizumab will be given at a dose of 8mg/kg by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6).
  • Placebo Comparator: Group B: Placebo
    Placebo arm - no active drug

Primary Outcome Measure

Compare the Average Total Improvement Scores at Visits 2 Through 7 During the 6-month Treatment Period Between the Treatment and Placebo Arms [ Time Frame: Week 4, 8, 12, 16, 20, and 24 ]

Locations (7)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
University of Kansas Medical CenterKansas CityKansas66160-
Mayo ClinicRochesterMinnesota55905-
North Shore Long Island Jewish CenterGreat NeckNew York11021-
University of PittsburghPittsburghPennsylvania15261-
Vanderbilt UniversityNashvilleTennessee37235-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Los Angeles, CA

By research site
Cedars Sinai Medical Center· Los Angeles, CAUniversity of Kansas Medical Center· Kansas City, KSMayo Clinic· Rochester, MNNorth Shore Long Island Jewish Center· Great Neck, NYUniversity of Pittsburgh· Pittsburgh, PAVanderbilt University· Nashville, TN

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