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NYU: Is IVIg Effectiveness Improved by the Concurrent Administration of Cyclophosphamide

The purpose of the trial is to determine whether the effectiveness of IVIg is improved by the concurrent administration of cyclophosphamide. There is evidence that it can, but a formal randomized trial is required to be sure.


Background

The trial is important, not only to improve the treatment of pemphigus but also to improve the effectiveness and reduce the need for this very expensive treatment.


Enrollment Criteria

The entry requirments for the trial are:

  1. Age 18 or greater
  2. On at least 20 mg/day prednisone 
  3. Pemphigus antibodies in a titer of 40 or more 
  4. One or more of the following:
    • Persistent disease activity while on steroids or
    • flare in disease acivity while on tapering doses of steroids, or
    • failure of established lesions to heal, or
    • contraindications or complications to conventional therapy

Patients with renal insufficiency, chronic/opportunistic infections, or IgA deficiency are excluded.


Trial Details

All patients entered into the trial will be treated with a standard regimen of IVIg (4 cycles , 2 weeks apart). Additionally, half of the patients will be randomized to receive a standard dose of cyclophosphamide.

Contact Information

If you are interested in participating in this trial or referring a patient, please contact:

Dr. Jean-Claude Bystryn
Professor, Department of Dermatology
NYU School of Medicine
(212) 263-7333
[email protected]

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The P/P Registry has been approved by the Western Institutional Review Board (WIRB) and is actively enrolling participants.

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