Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone

Tehran University of Medical Sciences

Status and phase

Completed

Phase 2

Conditions

Pemphigus Vulgaris

Treatments

Drug: Azathioprine

Drug: Placebo

Drug: Prednisone

Study type

Interventional

Funder types

Other

Identifiers

NCT00626678

87- 01-30 - 6907

Details and patient eligibility

About

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.

Full 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

Enrollment

48 estimated patients

Sex

All

Ages

10 to 75 years old

Volunteers

No Healthy Volunteers

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