Randomized Trial of IVIg With or Without Cyclophosphamide in Pemphigus

• Status: Terminated
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare two standard treatments for pemphigus to determine which more effectively improves the clinical manifestations of the disease and decreases serum level of the autoantibodies which cause the disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Treatments: Antibodies; Cyclophosphamide; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

Criteria

Inclusion Criteria:

• Lesions consistent with pemphigus foliaceus or vulgaris

• Diagnosis confirmed by histology and IIF ≥ 40 within past month

• On ≥20mg/day of prednisone per day for two weeks or ≥ 80mg/day for one week

• Women of childbearing potential negative HCG obtained two weeks prior to first IVIg

• Agrees to two acceptable forms of contraception* if randomized to cyclophosphamide group:

• IUD (except progesterone T), Combination oral contraceptives, transdermal patch, vaginal ring, hormonal injectables or implantables, male latex condom, diaphragm, cervical cap, or vaginal sponge (contains spermicide)

• Normal organ function confirmed by CBC, UA, LFTs and Ig levels within defined inclusion criteria

• Responds yes to at least one of the criteria below:

• Persistence of clinical manifestations of disease despite steroid treatment

• Flare in disease activity after an attempt at steroid tapering

• Failure of established lesions to heal

• Rapidly progressive disease.

• Conventional therapy is relatively contraindicated i.e. side effects, co-morbid conditions

• systemic infections, peptic ulcers, osteoporosis, hypertension, cataracts or others

Exclusion Criteria:

• Use of IVIg within past 3 weeks or the use of a cytotoxic drug within the past 2 weeks

• Participating in another clinical trial at the time of screening and enrollment

• Medical condition that precludes use of IVIg or cyclophosphamide (i.e. pregnancy breastfeeding, underlying chronic infection, concurrent opportunistic infection, sepsis or volume depletion

• Renal insufficiency ( GFR <90, proteinuria (>1+, x 2), creatinine >1.8 or increased WBC or RBCs which cannot be explained by cystitis.)

• Known hypersensitivity to study drugs, IVIg or cyclophosphamide