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Belimumab in Remission of VASculitis
Belimumab in Remission of VASculitis

NCT01663623

CompletedPhase 3

Sponsor: Human Genome Sciences Inc., a GSK Company

Conditions: Vasculitis

Interventions: Placebo, Belimumab 10 mg/kg, Azathioprine

Countries: United States, Australia, Belgium, Canada, Czechia, France, Germany, Hungary

The purpose of this study is to evaluate the efficacy and safety of belimumab, in combination with azathioprine, for the maintenance of remission following a standard induction regimen in patients with Wegener's granulomatosis or microscopic polyangiitis. The random assignment in this study is "1 to 1" which means that participants have an equal chance of receiving belimumab or placebo.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

* Clinical diagnosis Wegener's granulomatosis or microscopic polyangiitis by Chapel Hill criteria.
* Disease flare in the past 26 weeks requiring treatment with high dose corticosteroids and 1 of the following medications: rituximab, oral cyclophosphamide OR IV cyclophosphamide.
* Tested positive for anti-proteinase 3 (anti-PR3) or anti-myeloperoxidase (anti-MPO) antibodies at any time prior to enrollment.
* Achieve remission no more than 26 weeks after first dose of induction treatment. Remission is defined as a Birmingham Vasculitis Activity (BVAS) score of 0 and receiving less than 10 mg/day of oral prednisone (or equivalent) on 2 consecutive visits 21 to 35 days apart.
* Maintenance therapy on this study must start no more than 2 weeks after confirmation of remission.

Key Exclusion Criteria:

* Pregnant or nursing.
* Receipt of a B cell targeted therapy (other than rituximab) at anytime
* Receipt of an investigational biological agent within the past 60 days.
* Required management of acute or chronic infections within the past 60 days.
* Current drug or alcohol abuse or dependence.
* Current or past positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
* History of severe allergic reaction to contrast agents or biological medicines.
Locations (89)
  • Birmingham, Alabama, United States
  • Mobile, Alabama, United States
  • Tucson, Arizona, United States
  • Covina, California, United States
  • Palo Alto, California, United States
  • San Leandro, California, United States
  • Chicago, Illinois, United States
  • Kansas City, Kansas, United States
  • Boston, Massachusetts, United States
  • West Springfield, Massachusetts, United States
  • Detroit, Michigan, United States
  • Rochester, Minnesota, United States
  • Camden, New Jersey, United States
  • Great Neck, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Columbus, Ohio, United States
  • Portland, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Wyomissing, Pennsylvania, United States
  • Milwaukee, Wisconsin, United States
  • Garran, Australian Capital Territory, Australia
  • New Lambton, New South Wales, Australia
  • Malvern, Victoria, Australia
  • Liverpool, Australia
  • Brussels, Belgium
  • Brussels, Belgium
  • Leuven, Belgium
  • Hamilton, Ontario, Canada
  • + 59 more on CT.gov