Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone
- Conditions
- Pemphigus Vulgaris
- Interventions
- Registration Number
- NCT00626678
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- Lesions clinically consistent with pemphigus vulgaris
- Diagnosis confirmed by histology in terms of acantholysis within past month
- Positive DIF
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Azathioprine Oral administration of prednisone and azathioprine throughout study 1 Prednisone Oral administration of prednisone and azathioprine throughout study 2 Prednisone Oral administration of prednisone and placebo throughout study 2 Placebo Oral administration of prednisone and placebo throughout study
- Primary Outcome Measures
Name Time Method • Disease activity index Throughout study; first two weeks every day, then weekly for two weeks, then monthly for eleven months
- Secondary Outcome Measures
Name Time Method Total dose of corticosteroid At the end of study Occurence of any adverse event Throughout study Occurence of Grade 3 or higher treatment-related adverse event Throughout study Adverse events resulting in discontinuation and assessed by the investigators as at least possibly related to treatment Throughout study
Trial Locations
- Locations (1)
Department of Dermatology, Tehran University of Medical Sciences
🇮🇷Tehran, Iran, Islamic Republic of