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Open Label Extension Study of Brentuximab Vedotin in Early dcSSc
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Summary
The purpose of this study is to assess safety and efficacy of Brentuximab vedotin, a CD30-directed antibody-drug conjugate, in patients with active diffuse cutaneous systemic sclerosis (dcSSc) who relapsed after discontinuation of Brentuximab vedotin.
Official title: An Open Label Extension Study of Brentuximab Vedotin Treatment in Active Diffuse Cutaneous Systemic Sclerosis (Diffuse Scleroderma)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
11
Start Date
2024-02-14
Completion Date
2026-07-01
Last Updated
2024-11-18
Healthy Volunteers
No
Conditions
Interventions
Brentuximab vedotin
Dose 0.6mg/kg will be given every 3 weeks for 16 cycles (48 weeks), in addition to standard of care medications for SSc that may include cyclophosphamide, methotrexate, azathioprine, mycophenolate mofetil (MMF, cellcept) and mycophenolic acid (myfortic)
Locations (1)
Rheumatology Clinic, St. Joseph's Health Care
London, Ontario, Canada