drugset / Trial / NCT00483119
Randomized Trial of IVIg With or Without Cyclophosphamide in Pemphigus
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-04
- Primary completion
- 2010-02
- Completion
- 2011-02
Publications
- Background Green MG, Bystryn JC. Effect of intravenous immunoglobulin therapy on serum levels of IgG1 and IgG4 antidesmoglein 1 and antidesmoglein 3 antibodies in pemphigus vulgaris. Arch Dermatol. 2008 Dec;144(12):1621-4. doi: 10.1001/archdermatol.2008.503.
- Background Czernik A, Bystryn JC. Kinetics of response to conventional treatment in patients with pemphigus vulgaris. Arch Dermatol. 2008 May;144(5):682-3. doi: 10.1001/archderm.144.5.682. No abstract available.
- Background Czernik A, Beutner EH, Bystryn JC. Intravenous immunoglobulin selectively decreases circulating autoantibodies in pemphigus. J Am Acad Dermatol. 2008 May;58(5):796-801. doi: 10.1016/j.jaad.2008.01.007.
- Background Czernik A, Bystryn JC. Improvement of intravenous immunoglobulin therapy for bullous pemphigoid by adding immunosuppressive agents: marked improvement in depletion of circulating autoantibodies. Arch Dermatol. 2008 May;144(5):658-61. doi: 10.1001/archderm.144.5.658.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 2 mg/kg | Oral |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 500 mg/kg | Intravenous |