Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone

Pemphigus Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626678
• Other study ID #: 87- 01-30 - 6907
• Status: Completed
• Phase: Phase 2
• First received: February 21, 2008
• Last updated: November 26, 2010
• Start date: January 2008
• Est. completion date: September 2010

Study information

• Verified date: November 2010
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2010
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pemphigus
• Pemphigus Vulgaris

Intervention

Drug:
• Azathioprine
It is given in a consistent dosage of 2.5 mg/kg/day throughout the study
• Prednisone
Oral corticosteroid initiated at 2 mg/kg/day dosage. Dosage may be tapered primarily by 1/3 total dosage if no new blister, then 5 mg every three days to reach the daily dosage of 30 mg then tapered by 1.25 mg every week to reach daily dosage of 20 mg/day, then tapered by 1.25 mg every two weeks to reach daily dosage of 10 mg, then tapered by 1.25 mg monthly to reach daily dosage of 7.5 mg and continue this dosage for six months then tapered to 5 mg/day if no new lesions are observed as determined by clinical assessment of the investigator.
• Placebo
Placebo given in place of Azathioprine 2.5 mg/kg/day throughout the study

Locations

Country	Name	City	State
Iran, Islamic Republic of	Department of Dermatology, Tehran University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Disease activity index		Throughout study; first two weeks every day, then weekly for two weeks, then monthly for eleven months
Secondary	Total dose of corticosteroid		At the end of study
Secondary	Occurence of any adverse event		Throughout study
Secondary	Occurence of Grade 3 or higher treatment-related adverse event		Throughout study
Secondary	Adverse events resulting in discontinuation and assessed by the investigators as at least possibly related to treatment		Throughout study