Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone

Condition(s) targeted: Pemphigus Vulgaris

Intervention: Azathioprine (Drug); Prednisone (Drug); Placebo (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Tehran University of Medical Sciences

Official(s) and/or principal investigator(s):
Cheyda Chams-Davatchi, MD, Study Chair, Affiliation: Tehran University of Medical Sciences

Overall contact:
Cheyda Chams-Davatchi, M.D., Phone: 00989121301062, Email: cheyda@davatchi.net

Description: Pemphigus vulgaris is an autoimmune, chronic and recurrent blistering disease with unknown etiology that affects mucosa and skin of patients with significant morbidity and mortality.

The treatment back-bone is based on prednisolone administration. There are controversies on the opportunity of adding immunosuppressive drugs. For some, they are just corticosteroid sparing drugs. For others, they are disease modifying drugs.

The purpose of this trial is to compare efficacy and safety of azathioprine vs. placebo in new cases of pemphigus vulgaris treated with prednisolone.

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Adjuvant Azathioprine Therapy in New Cases of Pemphigus Vulgaris Receiving Prednisone

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: • Disease activity index

Secondary outcome:

Total dose of corticosteroid

Occurence of any adverse event

Occurence of Grade 3 or higher treatment-related adverse event

Adverse events resulting in discontinuation and assessed by the investigators as at least possibly related to treatment

Detailed description: The purpose of this trial is to compare efficacy and safety of azathioprine vs. placebo in new cases of pemphigus vulgaris treated with prednisolone.

Official Title: Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Azathioprine in New Cases of Pemphigus Vulgaris Receiving Prednisolone

Randomized Double Blind Controlled Trial of Azathioprine versus Placebo in new cases of Pemphigus Vulgaris treated with Prednisolone

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Controlled, Parallel Assignment, Safety/Efficacy Study

Condition Intervention Phase Pemphigus Vulgaris Drug: Azathioprine Drug: Prednisolone Other: Placebo Phase II

Minimum age: 10 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Lesions clinically consistent with pemphigus vulgaris

- Diagnosis confirmed by histology in terms of acantholysis within past month

- Positive DIF

Exclusion Criteria:

- Any nursing or pregnant woman

- Any history of chronic diseases including liver disease, Chronic Renal Failure,

Chronic Heart Failure or Ischemic Heart Disease

- Present diagnosis of hepatitis confirmed by serology or elevated hepatic enzymes;

- Clinically significant concurrent medical disease or laboratory abnormalities

evidenced by one or more of the following:

- Hepatobiliary AST or ALT ≥ 1. 5 × upper limit of normal (ULN);alkaline phosphatase ≥

1. 5 × ULN; or, total bilirubin > 90% of the ULN;

- Renal serum creatinine > 1. 5 mg/dL; or, significant proteinuria > 2+ on urinary dip

test;

- Hematologic hemoglobin < 11 mg/dL; leukocytes < 3. 5 × 109/L; neutrophils < 1. 5 ×

109/L; or, platelets < 100 × 109/L; Presence of anemia, leukopenia or thrombocytopenia

- Any sign of patient's non-compliance

- Known hypersensitivity to study drugs, prednisone or azathioprine

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

Cheyda Chams-Davatchi, M.D., Phone: 00989121301062, Email: cheyda@davatchi.net

Department of Dermatology, Tehran University of Medical Sciences, Tehran, Iran, Islamic Republic of

Starting date: December 2008
Ending date: May 2010
Last updated: December 13, 2008