Clinical trial NCT00626678: Azathioprine Versus Placebo in 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pemphigus Vulgaris
Keywords: Pemphigus Vulgaris
Azathioprine
Prednisone
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-02-29
Enrollment: 48
Sex: ALL
Minimum age (years): 10
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: • Disease activity index
timeFrame: Throughout study; first two weeks every day, then weekly for two weeks, then monthly for eleven months
Secondary outcomes:
measure: Total dose of corticosteroid
timeFrame: At the end of study
measure: Occurence of any adverse event
timeFrame: Throughout study
measure: Occurence of Grade 3 or higher treatment-related adverse event
timeFrame: Throughout study
measure: Adverse events resulting in discontinuation and assessed by the investigators as at least possibly related to treatment
timeFrame: Throughout study
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Department of Dermatology, Tehran University of Medical Sciences
Study officials:
affiliation: Tehran University of Medical Sciences
name: Cheyda Chams-Davatchi, MD
role: STUDY_CHAIR
References: